Publications by authors named "Yoichi M Ito"

153 Publications

The type rather than the daily dose or number of antipsychotics affects the incidence of hyperglycemic progression.

Prog Neuropsychopharmacol Biol Psychiatry 2021 Oct 9;113:110453. Epub 2021 Oct 9.

Department of Psychiatry, Hokkaido University Graduate School of Medicine, North 15, West 7, Sapporo 060-8638, Japan. Electronic address:

There have been concerns that antipsychotics increase the incidence of hyperglycemic progression. Many factors have been suggested to contribute to the risk of antipsychotic-induced hyperglycemic progression, including the type, daily dose, and number of antipsychotics; however, few studies have examined these relationships. This study aimed to examine the affect of antipsychotic treatment-associated factors on hyperglycemic progression, after adjustment for the affect of background factors suggested to be associated with hyperglycemic progression. This was a nationwide, multicenter, prospective cohort study examining the incidence of hyperglycemic progression during a 12 mo period following the initiation of newly prescribed antipsychotic medication. Demographic data, medication history, and blood test values were collected from 631 study participants with normal blood glucose levels at baseline for 12 mo. The primary endpoint (incidence of hyperglycemic progression) was defined as progression from normal to prediabetic or probable diabetic status, and was evaluated based on the Japanese monitoring guidance in patients with schizophrenia. To further examine the affect of antipsychotics on glucose metabolism over time, we examined changes in HbA1c levels 3, 6, and 12 mo after the initiation of treatment with each antipsychotic. We found that treatment with zotepine and clozapine was associated with a significantly high incidence of hyperglycemic progression. Furthermore, changes in HbA1c levels 6 mo after the initiation of zotepine treatment were significantly higher than those following blonanserin and haloperidol treatments. In contrast, there was no significant difference in the change in total cholesterol, triglycerides, HDL cholesterol, and BMI during the same period. Moreover, the "daily dose" and "number" of antipsychotics did not show an association with the incidence of hyperglycemic progression. However, in a post hoc analysis in which the antipsychotics were divided into two groups according to the strength of blockade of H, M, M, and 5-HT receptors, the incidence of hyperglycemic progression was higher in the medium- and high-daily dose groups than in the low-daily dose group in the antipsychotic group with strong blockade of these receptors. Our study indicated that the type of antipsychotic had a greater affect on the incidence of hyperglycemic progression than the daily dose of antipsychotics or their number. Among these, zotepine was most likely to increase the incidence of hyperglycemic progression, suggesting the need for caution when these antipsychotics are prescribed.
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http://dx.doi.org/10.1016/j.pnpbp.2021.110453DOI Listing
October 2021

Developing a questionnaire on the quality of working life for female medical and healthcare professionals.

Ind Health 2021 Sep 28. Epub 2021 Sep 28.

Department of Dental Health Center, Fukuoka Dental College, Japan.

This study aimed to develop a questionnaire on the quality of working life among female medical and healthcare professionals and examine its validity and reliability. The questionnaire was developed from an item pool drawing on the literature. The four trait scales included 40 items, covering female-specific stress in continuing a career, stress of lifestyle in maintaining personal values, job satisfaction and social support network. The questionnaire's validity and reliability were assessed using data from 1,784 female doctors, dentists, and nurses. Validity was examined using exploratory factor analysis on each trait for construct validity, and multitrait scaling analysis for convergent and discriminant validity. Reliability was tested using Cronbach's alpha for trait subscales and scales. Exploratory factor analysis on each trait was convergent. One trait derived three subscales, and another two. The remaining two traits were convergent for one factor. Multitrait scaling analysis showed that all scales and subscales were independent. The questionnaire was therefore internally consistent and had construct validity. Cronbach's alpha was 0.85 for the total and between 0.72 and 0.83 for the subscales. These results validate the four-trait combination questionnaire and suggest that it would be suitable for use in future research, perhaps in combination with other existing scales.
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http://dx.doi.org/10.2486/indhealth.2020-0257DOI Listing
September 2021

Elevated serum CYFRA 21-1 level as a diagnostic marker for thymic carcinoma.

Thorac Cancer 2021 Sep 27. Epub 2021 Sep 27.

Department of Surgical Pathology, Hokkaido University Hospital, Hokkaido University, Sapporo, Japan.

Background: No useful tumor markers have been identified for the diagnosis of thymic carcinomas. Serum cytokeratin 19 fragment, measured using the CYFRA 21-1 immunoassay, is used as a tumor marker for squamous cell carcinomas in various malignant tumors. Here, we evaluated the value of CYFRA 21-1 in diagnosing thymic carcinoma.

Methods: We retrospectively reviewed 94 patients with pathological diagnoses of thymic carcinoma or thymoma (32 and 62 patients, respectively) who were referred to our departments between January 2000 and March 2019. Primary outcomes included tumor marker levels and their diagnostic accuracy.

Results: Patients with thymic carcinoma were significantly more likely to be male (thymic carcinoma, 68.8%; thymoma, 40.3%; p = 0.02), have an advanced TNM stage (p < 0.01), and a significantly higher CYFRA 21-1 level than those with thymoma (thymic carcinoma: median = 4.2 ng/ml; interquartile range [IQR] = 2.1-6.1 ng/ml vs. thymoma: median = 1.2 ng/ml; IQR = 0.9-1.7 ng/ml; p < 0.01). Receiver operating characteristic curves demonstrated that the area under the curve for CYFRA 21-1 to distinguish thymic carcinoma from thymoma was 0.86 (95% confidence interval [CI]: 0.74-0.93; cutoff = 2.7 ng/ml; sensitivity = 68.8%; specificity = 95.2%). Multivariable analysis demonstrated that CYFRA 21-1 (odds ratio = 25.6; 95% CI: 4.6-141.6; p < 0.01) was an independent predictor for thymic carcinoma after adjusting for TNM stage.

Conclusions: Serum CYFRA 21-1 level may help in diagnosing thymic carcinoma.
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http://dx.doi.org/10.1111/1759-7714.14158DOI Listing
September 2021

Association of abdominal visceral adiposity with sputum IL-5 levels in asthma.

Allergol Int 2021 Sep 14. Epub 2021 Sep 14.

Department of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan. Electronic address:

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http://dx.doi.org/10.1016/j.alit.2021.08.003DOI Listing
September 2021

Thrombocytopenia Associated with Unrecognized Non-Alcoholic Fatty Liver Disease Is an Independent Predictor of Perioperative Significant Blood Loss in Cervical Laminoplasty.

World Neurosurg 2021 Sep 9. Epub 2021 Sep 9.

Department of Orthopedic Surgery, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan. Electronic address:

Objective: To identify risk factors for significant blood loss (SBL) in cervical laminoplasty, especially regarding thrombocytopenia and coagulopathy resulting from non-alcoholic fatty liver disease (NAFLD).

Methods: We retrospectively investigated differences in patient background data, laboratory data at the time of admission, and surgery-related data of 317 patients who underwent cervical laminoplasty and were divided into SBL (estimated blood loss [EBL] + drainage [D] ≥500 g) and non-SBL (EBL + D < 500 g) groups. To evaluate liver status, we used the fibrous 4 index and considered fibrous 4 index ≥1.85 as a representative phenotype for NAFLD with liver fibrosis. In addition, the risk factor for perioperative SBL was investigated using multiple logistic regression analysis, and the cutoff value was calculated.

Results: Incidence of perioperative SBL in cervical laminoplasty was 7.3% (23/317). Compared with the non-SBL group, the SBL group demonstrated significantly lower platelet count (PLT), lower aspartate aminotransferase, longer operation time, and greater number of opened laminae. According to multivariate analysis, lower PLT and a greater number of opened laminae were identified as significant risk factors for perioperative SBL. The cutoff value of PLT for predicting SBL was determined to be 16.7 × 10/μL using a receiver operating characteristic curve. The liver fibrosis group revealed significantly lower PLT and greater EBL + D than the non-liver fibrosis group.

Conclusions: Thrombocytopenia is an independent predictor of perioperative SBL in cervical laminoplasty. Thus, patients with mild thrombocytopenia that may be associated with NAFLD must be carefully monitored to avoid perioperative SBL.
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http://dx.doi.org/10.1016/j.wneu.2021.09.012DOI Listing
September 2021

Close association between non-alcoholic fatty liver disease and ossification of the posterior longitudinal ligament of the spine.

Sci Rep 2021 08 31;11(1):17412. Epub 2021 Aug 31.

Department of Orthopedic Surgery, Hokkaido University Graduate School of Medicine, Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.

Ossification of the posterior longitudinal ligament (OPLL) of the spine is a disease of unknown etiology occurring frequently in individuals with metabolic disturbances. Obesity has been suggested as a potential risk factor for the severity of OPLL. We aimed to investigate whether non-alcoholic fatty liver disease (NAFLD) is associated with OPLL severity. We assessed the severity of NAFLD by a liver-to-spleen (L/S) ratio on computed tomography (CT) scans of 85 symptomatic OPLL patients at a single institution in Japan. We also assessed the severity of OPLL by CT reconstruction sagittal and axial images. The prevalence of NAFLD in middle-aged patients (age < 70 years, n = 50) was 80.3%, which was 2.5-8 times higher than that in the general Japanese population (9-30%). The ossification index of the spinal ligaments increased in proportion to the severity of fatty liver. The L/S ratio was revealed as a significant risk factor associated with the total ossification index (standardized β: -0.40, 95% confidence interval - 54.34 to - 4.22). This study suggests the potential contribution of NAFLD to the progression of OPLL. The close association between NAFLD and OPLL demonstrated in this study warrants further study to elucidate the causal nature of this relationship.
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http://dx.doi.org/10.1038/s41598-021-96714-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8408257PMC
August 2021

Three-day regimen of oseltamivir for post-exposure prophylaxis of influenza in hospital wards: a study protocol for a prospective, multi-center, single-arm trial.

BMC Infect Dis 2021 Aug 30;21(1):887. Epub 2021 Aug 30.

Center for Regional Medicine, Gifu University School of Medicine, 1-1 Yanagido, Gifu, Gifu, 501-1194, Japan.

Background: In a previous retrospective observational study, a 3-day regimen of oseltamivir as post-exposure prophylaxis (PEP) for preventing transmission of influenza in wards was shown to be comparable to 7- to 10-day regimens provided index cases were immediately separated from close contacts. In order to confirm the efficacy of a 3-day regimen, we started to conduct a prospective, multi-center, single-arm trial.

Methods: This study is a prospective, multi-center, single-arm study designed by the Sectional Meeting of Clinical Study, Japan Infection Prevention and Control Conference for National and Public University Hospitals. Index patients with influenza are prescribed a neuraminidase inhibitor and are discharged immediately or transferred to isolation rooms. The close contacts are given oseltamivir as 75 mg capsules once daily for adults or 2 mg/kg (maximum of 75 mg) once daily for children for 3 days as PEP. All close contacts are monitored for development of influenza for 7 days after starting PEP.

Discussion: A 3-day regimen of oseltamivir as PEP has advantages over 7- to 10-day regimens in terms of costs, medication adherence and adverse effects. Trial registration The Institutional Review Board of Hokkaido University Hospital for Clinical Research, 015-0518, registered on November 11, 2016. UMIN Clinical Trials Registry, UMIN000024458, disclosed on October 31, 2016. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027881 . Japan Registry of Clinical Trials, jRCTs011180015, disclosed on March 14, 2019. https://jrct.niph.go.jp/latest-detail/jRCTs011180015.
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http://dx.doi.org/10.1186/s12879-021-06602-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8407088PMC
August 2021

Development and validation of a prediction model based on the organ-based metabolic tumor volume on FDG-PET in patients with differentiated thyroid carcinoma.

Ann Nucl Med 2021 Nov 11;35(11):1223-1231. Epub 2021 Aug 11.

Department of Diagnostic Imaging, Graduate School of Medicine, Hokkaido University, Kita 15, Nishi 7, Kita-Ku, Sapporo, Hokkaido, 060-8638, Japan.

Background: Although patients with differentiated thyroid cancer (DTC) generally have a good prognosis, patients with a large metabolic tumor volume (MTV) on FDG-PET may experience poor clinical courses. We measured organ-based MTVs and tested its prognostic performance in comparison to conventional MTV (cMTV).

Methods: We retrospectively analyzed the cases of 280 patients who received their first I-131 therapy in 2003-2014 at our hospital and showed an FDG-avid metastatic lesion. We randomly divided the patients into training (n = 190) and validation (n = 90) datasets. We classified the MTVs as MTV, MTV, MTV, MTV, and MTV and tested with/without dichotomization vis-à-vis overall survival (OS). Based on the estimated weighting coefficients of the organ-based MTVs, we propose a new index: the adjusted whole-body MTV (aMTV). Using the validation dataset, we compared the aMTV with cMTV for predicting OS.

Results: In a univariate analysis, MTV and MTV were more strongly correlated with the OS than the dichotomized forms, whereas the dichotomized forms of MTV, MTV, and MTV were more strongly correlated with OS than the continuous variables. The aMTV was thus expressed as 0.69 × dic(MTV) + 0.02 × MTV + 1.05 × dic(MTV) + 1.58 × dic(MTV) + 0.01 × MTV, where dic(x) represents 0 or 1 based on the optimized cut-off. In the model evaluation using the validation group, aMTV was a significant predictor of OS with a higher c-index (0.7676) than cMTV (0.7218).

Conclusion: In DTC patients with FDG-avid metastasis before I-131 therapy, all organ-based MTVs were significant predictors of prognosis. As the aMTV outperformed the cMTV for predicting prognoses, we recommend measuring the MTV on an organ basis.
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http://dx.doi.org/10.1007/s12149-021-01664-xDOI Listing
November 2021

Exploratory clinical trial on the safety and capability of dMD-001 in lumbar disc herniation: Study protocol for a first-in-human pilot study.

Contemp Clin Trials Commun 2021 Sep 29;23:100805. Epub 2021 Jun 29.

Department of Orthopaedic Surgery, Hokkaido University Hospital, N14W5, Sapporo, Japan.

Herniated nucleus pulposus (NP), one of the most common diseases of the spine, is surgically treated by removing the sequestered NP. However, intervertebral disc (IVD) defects may remain after discectomy, leading to inadequate tissue healing and predisposing patients to IVD degeneration. An acellular, bioresorbable, ultra-purified alginate (UPAL) gel (dMD-001) implantation system can be used to fill any IVD defects in order to prevent IVD degeneration after discectomy. This first-in-human pilot study aims to determine the feasibility, safety, and perceived patient response to a combined treatment involving discectomy and UPAL gel implantation for herniated NP. We designed a one-arm, double-centre, open-label, pilot trial. The study started in November 2018 and will run until a sample of 40 suitable participants is established. Patients aged 20-49 years, diagnosed with isolated lumbar IVD herniation and scheduled for discectomy represent suitable candidates. All eligible participants who provide informed consent undergo standard discectomy followed by UPAL gel implantation. The primary outcomes of the trial will be the feasibility and safety of the procedure. Secondary outcomes will include self-assessed clinical scores and magnetic resonance imaging-based measures of morphological and compositional quality of the IVD tissue. Initial outcomes will be published at 24 weeks. Analysis of feasibility and safety will be performed using descriptive statistics. Both intention-to-treat and per-protocol analyses of treatment trends of effectiveness will be conducted.
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http://dx.doi.org/10.1016/j.conctc.2021.100805DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8261539PMC
September 2021

Determination of brain tumor recurrence using C-methionine positron emission tomography after radiotherapy.

Cancer Sci 2021 Oct 13;112(10):4246-4256. Epub 2021 Aug 13.

Department of Nuclear Medicine, Hokkaido University Hospital, Sapporo, Japan.

We conducted a prospective multicenter trial to compare the usefulness of C-methionine (MET) and F-fluorodeoxyglucose (FDG) positron emission tomography (PET) for identifying tumor recurrence. Patients with clinically suspected tumor recurrence after radiotherapy underwent both C-MET and F-FDG PET. When a lesion showed a visually detected uptake of either tracer, it was surgically resected for histopathological analysis. Patients with a lesion negative to both tracers were revaluated by magnetic resonance imaging (MRI) at 3 months after the PET studies. The primary outcome measure was the sensitivity of each tracer in cases with histopathologically confirmed recurrence, as determined by the McNemar test. Sixty-one cases were enrolled, and 56 cases could be evaluated. The 38 cases where the lesions showed uptake of either C-MET or F-FDG underwent surgery; 32 of these cases were confirmed to be subject to recurrence. Eighteen cases where the lesions showed uptake of neither tracer received follow-up MRI; the lesion size increased in one of these cases. Among the cases with histologically confirmed recurrence, the sensitivities of C-MET PET and F-FDG PET were 0.97 (32/33, 95% confidence interval [CI]: 0.85-0.99) and 0.48 (16/33, 95% CI: 0.33-0.65), respectively, and the difference was statistically significant (P < .0001). The diagnostic accuracy of C-MET PET was significantly better than that of F-FDG PET (87.5% vs. 69.6%, P = .033). No examination-related adverse events were observed. The results of the study demonstrated that C-MET PET was superior to F-FDG PET for discriminating between tumor recurrence and radiation-induced necrosis.
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http://dx.doi.org/10.1111/cas.15001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8486205PMC
October 2021

Work environment for hospital nurses in Japan: The relationships between nurses' perceptions of their work environment and nursing outcomes.

Nurs Open 2021 09 1;8(5):2470-2487. Epub 2021 May 1.

Faculty of Health Science, Aino University, Osaka, Japan.

Aim: To investigate nurses' perceptions of their work environment and to investigate the relationships between variables measuring the work environment (WE) and nursing outcomes (NO ).

Design: A 2-year prospective longitudinal survey (2013-2015).

Method(s): Descriptive statistics of nurse demographics, organizational WE and NOs were calculated by position. The associations between Practice Environment Scale of the Nursing Work Index (PES-NWI) and NOs were examined for each unit.

Results: The participants were 2,992 staff nurses, 137 nurse managers (NMs), and 8 chief nursing officers in Phase 1 and 7,849, 371 and 23 in Phase 2, respectively. The higher the job position, the better the WE was rated. The higher the PES-NWI scores, the better the outcomes. Descriptive statistics about organizational WEs and NOs and the statistically significant associations between the two were identified.
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http://dx.doi.org/10.1002/nop2.762DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8363352PMC
September 2021

Log-linear relationship between endogenous insulin secretion and glycemic variability in patients with type 2 diabetes on continuous glucose monitoring.

Sci Rep 2021 04 27;11(1):9057. Epub 2021 Apr 27.

Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, N-15, W-7, Kita-ku, Sapporo, 060-8638, Japan.

The contribution of endogenous insulin secretion to glycemic variability (GV) may differ between patients with impaired insulin secretion and those with preserved secretion. Our objective was to determine the linearity of the relationship between fasting C-peptide (CPR) as a marker of endogenous insulin secretion and GV in type 2 diabetes (T2DM), regardless of the type of antidiabetic treatment. We conducted a prospective observational study using continuous glucose monitoring obtained from 284 Japanese outpatients with T2DM with various HbA1c values and antidiabetic treatment. We constructed a prediction curve of base-line CPR versus coefficient of variation (CV) and identified the clinical factors associated with CV using multiple regression analysis. Fasting CPR showed a significant negative log-linear relationship with CV (P < 0.0001), and the latter being strikingly high in the low-CPR group. The multiple regression analysis showed that low CPR was an independent predictor of high CV (P < 0.0001). The significant correlations were sustained in both patients with/without insulin treatment. The contribution of endogenous insulin secretion to GV depends on the extent of insulin secretion impairment. Fasting CPR may represent a useful indicator of GV instability in T2DM.
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http://dx.doi.org/10.1038/s41598-021-88749-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8079412PMC
April 2021

Assessment of the confidence interval in the multivariable normal tissue complication probability model for predicting radiation-induced liver disease in primary liver cancer.

J Radiat Res 2021 May;62(3):483-493

Department of Medical Physics, Hokkaido University Hospital, Sapporo, Japan.

We developed a confidence interval-(CI) assessing model in multivariable normal tissue complication probability (NTCP) modeling for predicting radiation-induced liver disease (RILD) in primary liver cancer patients using clinical and dosimetric data. Both the mean NTCP and difference in the mean NTCP (ΔNTCP) between two treatment plans of different radiotherapy modalities were further evaluated and their CIs were assessed. Clinical data were retrospectively reviewed in 322 patients with hepatocellular carcinoma (n = 215) and intrahepatic cholangiocarcinoma (n = 107) treated with photon therapy. Dose-volume histograms of normal liver were reduced to mean liver dose (MLD) based on the fraction size-adjusted equivalent uniform dose. The most predictive variables were used to build the model based on multivariable logistic regression analysis with bootstrapping. Internal validation was performed using the cross-validation leave-one-out method. Both the mean NTCP and the mean ΔNTCP with 95% CIs were calculated from computationally generated multivariate random sets of NTCP model parameters using variance-covariance matrix information. RILD occurred in 108/322 patients (33.5%). The NTCP model with three clinical and one dosimetric parameter (tumor type, Child-Pugh class, hepatitis infection status and MLD) was most predictive, with an area under the receiver operative characteristics curve (AUC) of 0.79 (95% CI 0.74-0.84). In eight clinical subgroups based on the three clinical parameters, both the mean NTCP and the mean ΔNTCP with 95% CIs were able to be estimated computationally. The multivariable NTCP model with the assessment of 95% CIs has potential to improve the reliability of the NTCP model-based approach to select the appropriate radiotherapy modality for each patient.
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http://dx.doi.org/10.1093/jrr/rrab011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8127660PMC
May 2021

Acute Oral Calcium Suppresses Food Intake Through Enhanced Peptide-YY Secretion Mediated by the Calcium-Sensing Receptor in Rats.

J Nutr 2021 05;151(5):1320-1328

School of Agriculture, Hokkaido University, Sapporo, Japan.

Background: Dietary calcium has been proposed to reduce appetite in human studies. Postprandial satiety is mainly controlled by gut hormones. However, the effect of calcium on appetite and the role of gut hormones remain unclear.

Objectives: We examined whether oral administration of calcium reduces food intake in rats and investigated the underlying mechanism.

Methods: Male Sprague Dawley rats (8-12 wk old) were used after an overnight fastifffng. In a series of 2 trials with 1-wk interval between challenges, food intake was measured 0.5-24 h after oral gavage of a vehicle (saline containing 1.5% carboxymethyl cellulose) as the control treatment, or the vehicle containing various calcium compounds [calcium chloride (CaCl2), calcium carbonate, calcium lactate, in a random order] at 150 mg calcium/kg dose. A conditional taste aversion test was conducted. In separate experiments, plasma calcium and gut hormone concentrations were measured 15 or 30 min after oral administration of the calcium compounds. In anesthetized rats, portal peptide-YY (PYY) concentrations were measured after intraluminal administration of a liquid meal with or without additional calcium.

Results: Oral CaCl2 reduced food intake acutely (30 min, ∼20%, P < 0.05) compared with control rats, without taste aversion. Plasma PYY concentration was higher (100%, P < 0.05) in CaCl2-preloaded rats than in control rats, 15 min after administration. In anesthetized rats, luminal meal + CaCl2 induced a 4-fold higher increase in plasma PYY than the control treatment did. Oral administration of a calcium-sensing receptor (CaSR) agonist suppressed food intake (∼30%, P < 0.05), but CaCl2 and CaSR agonist did not suppress food intake under treatment with a PYY receptor antagonist. Furthermore, the CaSR antagonist attenuated the effect of CaCl2 on food intake.

Conclusions: CaCl2 suppresses food intake partly by increasing CaSR-mediated PYY secretion in rats. Our findings could at least partially explain the satiating effect of calcium.
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http://dx.doi.org/10.1093/jn/nxab013DOI Listing
May 2021

Intravenous infusion of auto serum-expanded autologous mesenchymal stem cells in spinal cord injury patients: 13 case series.

Clin Neurol Neurosurg 2021 Apr 18;203:106565. Epub 2021 Feb 18.

Department of Neurology, Yale University School of Medicine, New Haven, CT, 06510, USA.

Background: Although spinal cord injury (SCI) is a major cause of disability, current therapeutic options remain limited. Recent progress in cellular therapy with mesenchymal stem cells (MSCs) has provided improved function in animal models of SCI. We investigated the safety and feasibility of intravenous infusion of MSCs for SCI patients and assessed functional status after MSC infusion.

Methods: In this phase 2 study of intravenous infusion of autologous MSCs cultured in auto-serum, a single infusion of MSCs under Good Manufacturing Practice (GMP) production was delivered in 13 SCI patients. In addition to assessing feasibility and safety, neurological function was assessed using the American Spinal Injury Association Impairment Scale (ASIA), International Standards for Neurological and Functional Classification of Spinal Cord (ISCSCI-92). Ability of daily living was assessed using Spinal Cord Independence Measure (SCIM-III). The study protocol was based on advice provided by the Pharmaceuticals and Medical Devices Agency in Japan. The trial was registered with the Japan Medical Association (JMA-IIA00154).

Results: No serious adverse events were associated with MSC injection. There was neurologic improvement based on ASIA grade in 12 of the 13 patients at six months post-MSC infusion. Five of six patients classified as ASIA A prior to MSC infusion improved to ASIA B (3/6) or ASIA C (2/6), two ASIA B patients improved to ASIA C (1/2) or ASIA D (1/2), five ASIA C patients improved and reached a functional status of ASIA D (5/5). Notably, improvement from ASIA C to ASIA D was observed one day following MSC infusion for all five patients. Assessment of both ISCSCI-92, SCIM-III also demonstrated functional improvements at six months after MSC infusion, compared to the scores prior to MSC infusion in all patients.

Conclusion: While we emphasize that this study was unblinded, and does not exclude placebo effects or a contribution of endogenous recovery or observer bias, our observations provide evidence supporting the feasibility, safety and functional improvements of infused MSCs into patients with SCI.
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http://dx.doi.org/10.1016/j.clineuro.2021.106565DOI Listing
April 2021

Resveratrol improves motor function in patients with muscular dystrophies: an open-label, single-arm, phase IIa study.

Sci Rep 2020 11 25;10(1):20585. Epub 2020 Nov 25.

Department of Pediatrics, Sapporo Medical University School of Medicine, Sapporo, 060-8543, Japan.

Muscular dystrophies (MDs) are inherited disorders characterized by progressive muscle weakness. Previously, we have shown that resveratrol (3,5,4'-trihydroxy-trans-stilbene), an antioxidant and an activator of the protein deacetylase SIRT1, decreases muscular and cardiac oxidative damage and improves pathophysiological conditions in animal MD models. To determine whether resveratrol provides therapeutic benefits to patients with MDs, an open-label, single-arm, phase IIa trial of resveratrol was conducted in 11 patients with Duchenne, Becker or Fukuyama MD. The daily dose of resveratrol was 500 mg/day, which was increased every 8 weeks to 1000 and then 1500 mg/day. Primary outcomes were motor function, evaluated by a motor function measure (MFM) scale, muscular strength, monitored with quantitative muscle testing (QMT), and serum creatine kinase (CK) levels. Adverse effects and tolerability were evaluated as secondary outcomes. Despite the advanced medical conditions of the patients, the mean MFM scores increased significantly from 34.6 to 38.4 after 24 weeks of medication. A twofold increase was found in the mean QMT scores of scapula elevation and shoulder abduction. Mean CK levels decreased considerably by 34%. Diarrhoea and abdominal pain was noted in six and three patients, respectively. Resveratrol may provide some benefit to MD patients.
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http://dx.doi.org/10.1038/s41598-020-77197-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7688653PMC
November 2020

Quantitative analysis of treatments using real-time image gated spot-scanning with synchrotron-based proton beam therapy system log data.

J Appl Clin Med Phys 2020 Dec 5;21(12):10-19. Epub 2020 Nov 5.

Global Station for Quantum Medical Science and Engineering, Global Institution for Collaborative Research and Education (GI-CoRE), Hokkaido University, Sapporo, Japan.

A synchrotron-based real-time image gated spot-scanning proton beam therapy (RGPT) system with inserted fiducial markers can irradiate a moving tumor with high accuracy. As gated treatments increase the beam delivery time, this study aimed to investigate the frequency of intra-field adjustments corresponding to the baseline shift or drift and the beam delivery efficiency of a synchrotron-based RGPT system. Data from 118 patients corresponding to 127 treatment plans and 2810 sessions between October 2016 and March 2019 were collected. We quantitatively analyzed the proton beam delivery time, the difference between the ideal beam delivery time based on a simulated synchrotron magnetic excitation pattern and the actual treatment beam delivery time, frequency corresponding to the baseline shift or drift, and the gating efficiency of the synchrotron-based RGPT system according to the proton beam delivery machine log data. The mean actual beam delivery time was 7.1 min, and the simulated beam delivery time in an ideal environment with the same treatment plan was 2.9 min. The average difference between the actual and simulated beam delivery time per session was 4.3 min. The average frequency of intra-field adjustments corresponding to baseline shift or drift and beam delivery efficiency were 21.7% and 61.8%, respectively. Based on our clinical experience with a synchrotron-based RGPT system, we determined the frequency corresponding to baseline shift or drift and the beam delivery efficiency using the beam delivery machine log data. To maintain treatment accuracy within ± 2.0 mm, intra-field adjustments corresponding to baseline shift or drift were required in approximately 20% of cases. Further improvements in beam delivery efficiency may be realized by shortening the beam delivery time.
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http://dx.doi.org/10.1002/acm2.13029DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7769392PMC
December 2020

Right ventriculo-pulmonary arterial uncoupling and poor outcomes in pulmonary arterial hypertension.

Pulm Circ 2020 Jul-Sep;10(3):2045894020957223. Epub 2020 Oct 5.

First Department of Medicine, Hokkaido University Hospital, Sapporo, Japan.

Right ventricular function critically affects the prognosis of patients with pulmonary arterial hypertension. We aimed to analyze the prognostic value of right ventricular indices calculated using magnetic resonance imaging and right heart catheterization metrics in pulmonary arterial hypertension. We retrospectively collected data from 57 Japanese patients with pulmonary arterial hypertension and 18 controls and calculated six indices of right ventricular function: two indices of contractility (end-systolic elastance calculated with right ventricular maximum pressure and with magnetic resonance imaging metrics); two indices of right ventricular-pulmonary arterial coupling (end-systolic elastance/arterial elastance calculated with the pressure method (end-systolic elastance/arterial elastance (P)) and with the volume method (end-systolic elastance/arterial elastance (V)); and two indices of right ventricular diastolic function (stiffness (β) and end-diastolic elastance). We compared the indices between controls and patients with pulmonary arterial hypertension and examined their prognostic role. In patients with pulmonary arterial hypertension, end-systolic elastance (right ventricular maximum pressure) was higher (pulmonary arterial hypertension 0.94 (median) vs control 0.42 (mmHg/mL),  < 0.001), end-systolic elastance/arterial elastance (V) was lower (pulmonary arterial hypertension 0.72 vs control 1.69,  < 0.001), and β and end-diastolic elastance were significantly higher than those in the controls. According to the log-rank test, end-systolic elastance/arterial elastance (P) and end-diastolic elastance were significantly associated with the composite event rate. According to the multivariate Cox regression analysis, decreased end-systolic elastance/arterial elastance (P) was associated with a higher composite event rate (hazard ratio 11.510, 95% confidence interval: 1.954-67.808). In conclusion, an increased right ventricular contractility, diastolic dysfunction, and a trend of impaired right ventricular-pulmonary arterial coupling were observed in our pulmonary arterial hypertension cohort. According to the multivariate outcome analysis, a decreased end-systolic elastance/arterial elastance (P), suggestive of impaired right ventricular-pulmonary arterial coupling, best predicted the pulmonary arterial hypertension-related event.
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http://dx.doi.org/10.1177/2045894020957223DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543138PMC
October 2020

Effects of Repeated I-Iodobenzylguanidine Radiotherapy on Tumor Size and Tumor Metabolic Activity in Patients with Metastatic Neuroendocrine Tumors.

J Nucl Med 2021 05 16;62(5):685-694. Epub 2020 Oct 16.

Department of Diagnostic Radiology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.

I-iodobenzylguanidine (I-MIBG) radiotherapy has shown some survival benefits in metastatic neuroendocrine tumors (NETs). European Association of Nuclear Medicine clinical guidelines for I-MIBG radiotherapy suggest a repeated treatment protocol, although none currently exists. The existing single-high-dose I-MIBG radiotherapy (444 MBq/kg) has been shown to have some benefits for patients with metastatic NETs. However, this protocol increases adverse effects and requires alternative therapeutic approaches. Therefore, the aim of this study was to evaluate the effects of repeated I-MIBG therapy on tumor size and tumor metabolic response in patients with metastatic NETs. Eleven patients with metastatic NETs (aged 49.2 ± 16.3 y) prospectively received repeated 5,550-MBq doses of I-MIBG therapy at 6-mo intervals. In total, 31 treatments were performed. The mean number of treatments was 2.8 ± 0.4, and the cumulative I-MIBG dose was 15,640.9 ± 2,245.1 MBq (286.01 MBq/kg). Tumor response was observed by CT and F-FDG PET or by F-FDG PET/CT before and 3-6 mo after the final I-MIBG treatment. On the basis of the CT findings with RECIST, 3 patients showed a partial response and 6 patients showed stable disease. The remaining 2 patients showed progressive disease. Although there were 2 progressive-disease patients, analysis of all patients showed no increase in summed length diameter (median, 228.7 mm [interquartile range (IQR), 37.0-336.0 mm] to 171.0 mm [IQR, 38.0-270.0 mm]; = 0.563). In tumor region-based analysis with partial-response and stable-disease patients ( 9), I-MIBG therapy significantly reduced tumor diameter (79 lesions; median, 16 mm [IQR, 12-22 mm] to 11 mm [IQR, 6-16 mm]; < 0.001). Among 5 patients with hypertension, there was a strong trend toward systolic blood pressure reduction ( 0.058), and diastolic blood pressure was significantly reduced ( 0.006). Eighty-two percent of metastatic NET patients effectively achieved inhibition of disease progression, with reduced tumor size and reduced metabolic activity, through repeated I-MIBG therapy. Therefore, this relatively short-term repeated I-MIBG treatment may have potential as one option in the therapeutic protocol for metastatic NETs. Larger prospective studies with control groups are warranted.
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http://dx.doi.org/10.2967/jnumed.120.250803DOI Listing
May 2021

Health-related quality of life in Japanese patients with bladder cancer measured by a newly developed Japanese version of the Bladder Cancer Index.

Int J Clin Oncol 2020 Dec 24;25(12):2090-2098. Epub 2020 Aug 24.

Department of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.

Introduction: We validated a Japanese version of the Bladder Cancer Index (BCI) as a tool for measuring health-related quality of life (HRQOL) in bladder cancer patients treated with various surgical procedures.

Methods: The reliability and validity of the Japanese BCI were examined in 397 Japanese patients with bladder cancer via cross-sectional analysis. The patients simultaneously completed the Short Form (SF)-12, EQ-5D, and the Functional Assessment of Cancer Therapy-General and Bladder (FACT-G and FACT-BL). The differences in BCI subscales among various treatment groups were analyzed.

Results: This study involved 397 patients (301 males and 96 females), with a mean age of 70 years and a median disease duration of 29 months (IQR: 12-66 months). Of these patients, 221 underwent transurethral resection of a bladder tumor, and 176 patients underwent radical cystectomy (ileal conduit: 101 patients, ileal neobladder: 49, and ureterostomy: 26). Cronbach's alpha coefficient was ≥ 0.78 for all subscales, except the bowel bother subscale. Despite moderate correlations being detected between the function and bother score in urinary and bowel domains, the sexual function score was inversely correlated with the sexual bother score (r = - 0.19). A missing value percentage of > 15% was associated with old age (p < 0.05). The mean domain scores differed significantly among distinct clinically relevant treatment groups.

Conclusions: Although revisions are needed to make it easier for elderly patients to comprehend, we confirmed the reliability and validity of the Japanese BCI. The Japanese BCI could be used for cross-cultural assessments of HRQOL in bladder cancer patients.
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http://dx.doi.org/10.1007/s10147-020-01770-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7677272PMC
December 2020

Social participation patterns and the incidence of functional disability: The Japan Gerontological Evaluation Study.

Geriatr Gerontol Int 2020 Aug 30;20(8):765-772. Epub 2020 Jun 30.

Department of Social Preventive Medical Sciences, Center for Preventive Medical Sciences, Chiba University, Chiba, Japan.

Aim: To examine whether patterns of social participation vary in their associations with functional disability.

Methods: Data from 44 978 participants (22 750 men and 22 228 women) who participated in the 2010 Japan Gerontological Evaluation Study were analyzed; a study of those aged ≥65 years from 23 municipalities in eight prefectures. Social participation information was obtained at baseline with an eight-item questionnaire. Incidence of functional disability from 2010 to 2013 was defined as a new certification of eligibility for municipal public long-term care insurance. Social participation patterns were analyzed using exploratory factor analysis and participants were classified into quartiles of factor scores of social participation patterns. A competing risk model was used to calculate the hazard ratios and 95% confidence intervals for the incidence of functional disability in 3 years of follow-up.

Results: Two social patterns were identified: sports groups/clubs and hobby groups, and political groups/organizations and industry/trade associations. For both patterns, compared with participants in the lowest quartile, participants in the highest quartile were more likely to be male, college educated, high-income and current drinkers. Both patterns were associated with reduced incidence of functional disability (adjusted hazard ratios for top quartile of sports and hobby pattern: 0.66, 95% confidence interval: 0.59, 0.74; for political and industry/trade pattern: 0.81, 95% confidence interval: 0.72, 0.90; P for trend <0.001 for both).

Conclusions: Those whose social participation patterns were characterized by frequent participation in sports groups/clubs and hobby groups or political groups/organizations and industry/trade associations were less likely to develop a functional disability. Geriatr Gerontol Int 2020; 20: 765-772.
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http://dx.doi.org/10.1111/ggi.13966DOI Listing
August 2020

Single-Center Noninferiority Randomized Trial on the Efficacy and Safety of Low- and High-Dose Rush Oral Milk Immunotherapy for Severe Milk Allergy.

Int Arch Allergy Immunol 2020 22;181(9):699-705. Epub 2020 Jun 22.

Department of Pediatrics, Osaka Habikino Medical Center, Habikino, Japan.

Introduction: Oral immunotherapy (OIT) has been reported to be effective but associated with a risk of severe symptoms. Thus, an OIT method with decreased risk is required.

Objectives: We aimed to evaluate the efficacy and safety of low- and high-dose OIT regimens in children with severe milk allergy.

Methods: Overall, 33 participants (median age, 9 years; median final dose of the milk oral food challenge [OFC], 2 mL) were included. The participants were randomly assigned to groups that received either a low (20 mL; n = 19) or high (100 mL; n = 14) maintenance target dose of OIT. The dose was gradually increased to the target dose in the rush escalation phase and was then maintained daily at home. The primary endpoint was the final OFC dose at 6 months of OIT. Adverse events during OIT were evaluated.

Results: The final OFC dose after OIT was significantly higher than that before OIT in both groups (low-dose, p = 0.000; high-dose, p = 0.006), but there was no significant difference in the final OFC dose between the 2 groups (p = 0.767). In the maintenance phase, the high-dose group had significantly more severe symptoms than did the low-dose group (0.5%, 11/2,355 total intake events vs. 0.1%, 4/3,230 total intake events; p = 0.018).

Conclusions: An equally increased dose effect was observed for maintenance OIT doses of 20 and 100 mL in children with severe milk allergy. The risk of severe symptoms in the maintenance phase was lower in the low-dose group. A low-dose OIT regimen is recommended for severe milk allergy.
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http://dx.doi.org/10.1159/000508627DOI Listing
February 2021

Oncological outcomes of a multicenter cohort treated with axitinib for metastatic renal cell carcinoma.

Cancer Sci 2020 Jul 12;111(7):2460-2471. Epub 2020 Jun 12.

Department of Urology, Ibaraki Prefectural Central Hospital, Ibaraki Cancer Center, Kasama, Japan.

The present study aimed to evaluate the efficacy of the real-world use of axitinib and to develop a prognostic model for stratifying patients who could derive long-term benefit from axitinib. This was a retrospective, descriptive study evaluating the efficacy of axitinib in patients with metastatic renal cell carcinoma that had been treated with 1 or 2 systemic antiangiogenic therapy regimens at 1 of 36 hospitals belonging to the Japan Urologic Oncology Group between January 2012 and February 2019. The primary outcome was overall survival (OS). Using a split-sample method, candidate variables that exhibited significant relationships with OS were chosen to create a model. The new model was validated using the rest of the cohort. In total, 485 patients were enrolled. The median OS was 34 months in the entire study population, whereas it was not reached, 27 months, and 14 months in the favorable, intermediate, and poor risk groups, respectively, according to the new risk classification model. The following 4 variables were included in the final risk model: the disease stage at diagnosis, number of metastatic sites at the start of axitinib therapy, serum albumin level, and neutrophil : lymphocyte ratio. The adjusted area under the curve values of the new model at 12, 36, and 60 months were 0.77, 0.82, and 0.82, respectively. The efficacy of axitinib in routine practice is comparable or even superior to that reported previously. The patients in the new model's favorable risk group might derive a long-term survival benefit from axitinib treatment.
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http://dx.doi.org/10.1111/cas.14449DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7385391PMC
July 2020

Combination of minimum wiping pressure and number of wipings that can remove pseudo-skin dirt: A digital image color analysis.

Skin Res Technol 2020 Sep 16;26(5):639-647. Epub 2020 Mar 16.

Faculty of Health Sciences, Hokkaido University, Hokkaido, Japan.

Background: Excessive wiping friction in skin care may lead to skin damage. Bed baths are required to remove skin dirt without affecting the skin barrier function; the wiping pressure and number of wipings that satisfy these two requirements have not been clarified. This study aimed to determine the minimum wiping pressure and number of wipings that can remove skin dirt.

Materials And Methods: In this quasi-experimental study, 50 healthy adults received an adhesion of pseudo-oily and aqueous dirt, randomly assigned to the left and right forearms. Each participant was wiped three times with wiping pressure classified into six randomly assigned categories. The dirt removal rate was calculated by color-analyzing images captured before and after each wiping, and its dependence on the combination of wiping pressure and number of wipings was assessed using a linear mixed model.

Results: The combinations achieving oily dirt removal rates of 80% or more were wiping once and pressure ≥50 mmHg, wiping twice and pressure ≥40 mmHg, and wiping thrice and pressure ≥10 mmHg. Aqueous dirt was removed almost completely by wiping once, even with pressure ≥5 mmHg.

Conclusion: Wiping with at least 10 mmHg or more three times can sufficiently remove both oily and aqueous dirt. Dirt removal rates with weak pressure can be made about as effective as those achieved with strong pressure by increasing the number of wipings. This result can be applied to daily nursing, home care, and long-term care health facilities.
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http://dx.doi.org/10.1111/srt.12844DOI Listing
September 2020

Reference values for the locomotive syndrome risk test quantifying mobility of 8681 adults aged 20-89 years: A cross-sectional nationwide study in Japan.

J Orthop Sci 2020 Nov 12;25(6):1084-1092. Epub 2020 Mar 12.

Kanai Hospital, Kyoto, Japan. Electronic address:

Background: The locomotive syndrome risk test was developed to quantify the decrease in mobility among adults, which could eventually lead to disability. The purpose of this study was to establish reference values for the locomotive syndrome risk test for adults and investigate the influence of age and sex.

Methods: We analyzed 8681 independent community dwellers (3607 men, 5074 women). Data pertaining to locomotive syndrome risk test (the two-step test, the stand-up test, and the 25-question geriatric locomotive function scale [GLFS-25]) scores were collected from seven administrative areas of Japan.

Results: The reference values of the three test scores were generated and all three test scores gradually decreased among young-to-middle-aged individuals and rapidly decreased in individuals aged over 60 years. The stand-up test score began decreasing significantly from the age of 30 years. The trajectories of decrease in the two-step test score with age was slightly different between men and women especially among the middle-aged individuals. The two physical test scores were more sensitive to aging than the self-reported test score.

Conclusion: The reference values generated in this study could be employed to determine whether an individual has mobility comparable to independent community dwellers of the same age and sex.
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http://dx.doi.org/10.1016/j.jos.2020.01.011DOI Listing
November 2020

Prenatal exposure to 11 perfluoroalkyl substances and fetal growth: A large-scale, prospective birth cohort study.

Environ Int 2020 03 4;136:105355. Epub 2020 Feb 4.

Center for Environmental and Health Sciences, Hokkaido University, Japan. Electronic address:

Background: Prenatal maternal exposure to perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) has been reportedly associated with decreased birth weight. Although a majority of epidemiological studies concerning perfluoroalkyl substances (PFAS) have focused on PFOS and PFOA, epidemiological studies of PFAS with longer carbon chains are scarce. In this study, we investigated whether prenatal maternal exposure to 11 PFAS, in particular those with longer carbon chains, is associated with fetal growth.

Methods: The study included 1985 mother-infant pairs (inclusive of preterm and post-term infants), who enrolled in a large-scale, prospective birth cohort study in any of the 37 hospitals in Hokkaido, Japan between 2003 and 2009. The concentration of 11 PFAS was measured in maternal plasma collected during the third trimester of pregnancy, using ultra-performance liquid chromatography in combination with triple quadrupole mass spectrometry. Associations between the measured PFAS values and weight, length, and head circumference of all newborns at birth were examined using multiple regression analyses with adjustment for potential confounders based on data collected from medical records, questionnaires, and those for maternal plasma samples.

Results: Of the 11 PFAS analyzed, prenatal perfluorononanoic acid (PFNA) [per log10-unit: regression coefficient (β) = -96.2 g, 95% confidence intervals (95% CI), -165.3 to -27.1] and perfluorodecanoic acid (PFDA) (β = -72.2 g, 95% CI, -138.1 to -6.3) concentrations were inversely associated with birth weight. Furthermore, PFNA concentrations were inversely associated with birth length (per Log unit: β = -0.48 cm, 95% CI; - 0.86 to -0.11). Maternal perfluorotridecanoic acid (PFTrDA) exposure showed a significant inverse association with birth weight only for female infants (per Log unit: β = -99.8 g, 95% CI, - 193.7 to -6.0) (P for interaction = 0.04).

Conclusions: Our findings suggest that prenatal, maternal exposure to PFAS with longer carbon chains tends to be inversely associated with birth size of newborn infants, which may indicate that these commercially used compounds have an adverse effect on fetal growth.
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http://dx.doi.org/10.1016/j.envint.2019.105355DOI Listing
March 2020

Analysis of treatment process time for real-time-image gated-spot-scanning proton-beam therapy (RGPT) system.

J Appl Clin Med Phys 2020 Feb 30;21(2):38-49. Epub 2019 Dec 30.

Global Station for Quantum Medical Science and Engineering, Global Institution for Collaborative Research and Education (GI-CoRE), Hokkaido University, Sapporo, Japan.

We developed a synchrotron-based real-time-image gated-spot-scanning proton-beam therapy (RGPT) system and utilized it to clinically operate on moving tumors in the liver, pancreas, lung, and prostate. When the spot-scanning technique is linked to gating, the beam delivery time with gating can increase, compared to that without gating. We aim to clarify whether the total treatment process can be performed within approximately 30 min (the general time per session in several proton therapy facilities), even for gated-spot-scanning proton-beam delivery with implanted fiducial markers. Data from 152 patients, corresponding to 201 treatment plans and 3577 sessions executed from October 2016 to June 2018, were included in this study. To estimate the treatment process time, we utilized data from proton beam delivery logs during the treatment for each patient. We retrieved data, such as the disease site, total target volume, field size at the isocenter, and the number of layers and spots for each field, from the treatment plans. We quantitatively analyzed the treatment process, which includes the patient load (or setup), bone matching, marker matching, beam delivery, patient unload, and equipment setup, using the data obtained from the log data. Among all the cases, 90 patients used the RGPT system (liver: n = 34; pancreas: n = 5; lung: n = 4; and prostate: n = 47). The mean and standard deviation (SD) of the total treatment process time for the RGPT system was 30.3 ± 7.4 min, while it was 25.9 ± 7.5 min for those without gating treatment, excluding craniospinal irradiation (CSI; head and neck: n = 16, pediatric: n = 31, others: n = 15); for CSI (n = 11) with two or three isocenters, the process time was 59.9 ± 13.9 min. Our results demonstrate that spot-scanning proton therapy with a gating function can be achieved in approximately 30-min time slots.
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http://dx.doi.org/10.1002/acm2.12804DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7020995PMC
February 2020

The urethral position may shift due to urethral catheter placement in the treatment planning for prostate radiation therapy.

Radiat Oncol 2019 Dec 12;14(1):226. Epub 2019 Dec 12.

Department of Radiation Medical Science and Engineering, Faculty of Medicine, Hokkaido University, North-15, West-7, Kita-Ku, Sapporo, Hokkaido, 060-8638, Japan.

Purpose: To determine the best method to contour the planning organ at risk volume (PRV) for the urethra, this study aimed to investigate the displacement of a Foley catheter in the urethra with a soft and thin guide-wire.

Methods: For each patient, the study used two sets of computed tomography (CT) images for radiation treatment planning (RT-CT): (1) set with a Foley urethral catheter (4.0 mm diameter) plus a guide-wire (0.46 mm diameter) in the first RT-CT and (2) set with a guide-wire alone in the second CT recorded 2 min after the first RT-CT. Using three fiducial markers in the prostate for image fusion, the displacement between the catheter and the guide-wire in the prostatic urethra was calculated. In 155 consecutive patients treated between 2011 and 2017, 5531 slices of RT-CT were evaluated.

Results: Assuming that ≥3.0 mm of difference between the catheter and the guide-wire position was a significant displacement, the urethra with the catheter was displaced significantly from the urethra with the guide-wire alone in > 20% of the RT-CT slices in 23.2% (36/155) of the patients. The number of patients who showed ≥3.0 mm anterior displacement with the catheter in ≥20% RT-CT slices was significantly larger at the superior segment (38/155) than at the middle (14/155) and inferior segments (18/155) of the prostatic urethra (p < 0.0167).

Conclusions: The urethral position with a Foley catheter is different from the urethral position with a thin and soft guide-wire in a significant proportion of the patients. This should be taken into account for the PRV of the urethra to ensure precise radiotherapy such as in urethra-sparing radiotherapy.
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http://dx.doi.org/10.1186/s13014-019-1424-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6909476PMC
December 2019

Effectiveness and Safety of Double-Blind, Placebo-Controlled, Low-Dose Oral Immunotherapy with Low Allergen Egg-Containing Cookies for Severe Hen's Egg Allergy: A Single-Center Analysis.

Int Arch Allergy Immunol 2019 2;180(4):244-249. Epub 2019 Oct 2.

Shitennoji University, Osaka, Japan.

Introduction: The usefulness of low-dose oral immunotherapy (OIT) for the treatment of egg allergy has been unclear.

Objective: To evaluate the efficacy and safety of OIT with low allergen cookies (LACs) containing a low dose of hen's egg.

Method: Thirty-three patients with severe hen's egg allergy were randomly administered either OIT with LACs (n = 21) or placebo (n = 12). Two patients in the LACs group withdrew before completing OIT. The primary endpoint was the number of good responders (G-R), patients with negative results in the oral food challenge (OFC) with a final dose of 2 g hard-boiled egg whites after 4 months of OIT, in each group. Total OFC Aichi score for anaphylaxis/cumulative protein dose (TS/Pro) as the marker of severity of food allergy was also compared. Adverse events during OIT were evaluated using patients' diaries.

Results: The proportion of G-R in the LACs group was higher than in the placebo group (7/19 [37%] vs. 1/12 [8%], χ2 test; p = 0.077). The TS/Pro after OIT in the LACs group was lower than in the placebo group (median score, 44.2 vs. 104.1, p = 0.059; Mann-Whitney U test). The threshold and TS/Pro before and after OIT significantly improved in the LACs group (p = 0.015, p = 0.027, respectively; Wilcoxon signed-rank test). There were 99 recorded incidences of symptoms of 1,938 intake events in the LACs group during OIT. Of these, 90 were mild; no severe symptoms occurred.

Conclusions: OIT with LACs potentially increases the OFC threshold and decreases allergy severity and is a relatively safe treatment modality.
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http://dx.doi.org/10.1159/000502956DOI Listing
December 2019
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