Publications by authors named "Shiro Tanaka"

260 Publications

Exposures associated with the onset of Kawasaki disease in infancy from the Japan Environment and Children's Study.

Sci Rep 2021 Jun 25;11(1):13309. Epub 2021 Jun 25.

Department of Pediatrics, Graduate School of Medicine, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.

Kawasaki disease (KD) is an acute systemic vasculitis that mainly affects infants and young children. The etiology of KD has been discussed for several decades; however, no reproducible risk factors have yet been proven. We used the Japan Environment and Children's Study data to explore the association between the causal effects of exposure during the fetal and neonatal periods and KD onset. The Japan Environment and Children's Study, a nationwide birth cohort study, has followed approximately 100,000 children since 2011. We obtained data on exposures and outcomes from the first trimester to 12 months after birth. Finally, we included 90,486 children who were followed for 12 months. Among them, 343 children developed KD. Multivariate logistic regression revealed that insufficient intake of folic acid during pregnancy (odds ratio [OR], 1.37; 95% CI 1.08-1.74), maternal thyroid disease during pregnancy (OR, 2.03; 95% CI 1.04-3.94), and presence of siblings (OR, 1.33; 95% CI 1.06-1.67) were associated with KD onset in infancy. In this study, we identified three exposures as risk factors for KD. Further well-designed studies are needed to confirm a causal relationship between these exposures and KD onset.
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http://dx.doi.org/10.1038/s41598-021-92669-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8233341PMC
June 2021

Association of advanced glycation end-products levels with vascular events in postmenopausal women.

Geriatr Gerontol Int 2021 Jun 20. Epub 2021 Jun 20.

Department of Orthopedic Surgery, Jikei University School of Medicine, Tokyo, Japan.

Aim: Advanced glycation end-products (AGEs) are a known factor that accelerates vascular complications. AGEs (e.g. pentosidine or N-ε-carboxy-methyl-lysine [CML]) have been particularly investigated in patients with diabetes or chronic kidney disease and have been associated not only with arteriosclerosis, but also with novel vascular events. On the contrary, the correlation of vascular events with AGEs has not been sufficiently investigated in groups excluding those with diabetes or chronic kidney disease. The present study aimed to evaluate the impact of AGEs on the history of vascular events in postmenopausal women excluding those with diabetes or renal insufficiency.

Methods: Japanese postmenopausal women were registered to the study after obtaining informed consent. Patients with critical illness, including diabetes mellitus and renal insufficiency, were excluded from the study. Participants were asked about their medical histories during the registration for the Nagano Cohort Study. Non-fasting serum and urine samples were collected to measure biochemical markers, including urinary pentosidine and serum CML levels.

Results: Among 357 postmenopausal women, 32 had a history of vascular events. After adjusting age and other variables known to be associated with the presence of vascular event history, positive correlations between AGEs and vascular event history were observed (standardized odds ratio of log[pentosidine] 1.38, 95% CI 0.96-2.00, P = 0.086; standardized odds ratio of log[CML] 1.73, 95% CI 1.10-2.74, P = 0.019).

Discussion: The present results showed a significant association between serum CML and the presence of vascular event history, suggesting that serum CML might play a role in vascular events. Geriatr Gerontol Int ••; ••: ••-•• Geriatr Gerontol Int 2021; ••: ••-••.
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http://dx.doi.org/10.1111/ggi.14218DOI Listing
June 2021

Machine-learning model derived gene signature predictive of paclitaxel survival benefit in gastric cancer: results from the randomised phase III SAMIT trial.

Gut 2021 May 12. Epub 2021 May 12.

Program in Cancer and Stem Cell Biology, Duke-NUS Medical School, Singapore

Objective: To date, there are no predictive biomarkers to guide selection of patients with gastric cancer (GC) who benefit from paclitaxel. Stomach cancer Adjuvant Multi-Institutional group Trial (SAMIT) was a 2×2 factorial randomised phase III study in which patients with GC were randomised to Pac-S-1 (paclitaxel +S-1), Pac-UFT (paclitaxel +UFT), S-1 alone or UFT alone after curative surgery.

Design: The primary objective of this study was to identify a gene signature that predicts survival benefit from paclitaxel chemotherapy in GC patients. SAMIT GC samples were profiled using a customised 476 gene NanoString panel. A random forest machine-learning model was applied on the NanoString profiles to develop a gene signature. An independent cohort of metastatic patients with GC treated with paclitaxel and ramucirumab (Pac-Ram) served as an external validation cohort.

Results: From the SAMIT trial 499 samples were analysed in this study. From the Pac-S-1 training cohort, the random forest model generated a 19-gene signature assigning patients to two groups: Pac-Sensitive and Pac-Resistant. In the Pac-UFT validation cohort, Pac-Sensitive patients exhibited a significant improvement in disease free survival (DFS): 3-year DFS 66% vs 40% (HR 0.44, p=0.0029). There was no survival difference between Pac-Sensitive and Pac-Resistant in the UFT or S-1 alone arms, test of interaction p<0.001. In the external Pac-Ram validation cohort, the signature predicted benefit for Pac-Sensitive (median PFS 147 days vs 112 days, HR 0.48, p=0.022).

Conclusion: Using machine-learning techniques on one of the largest GC trials (SAMIT), we identify a gene signature representing the first predictive biomarker for paclitaxel benefit.

Trial Registration Number: UMIN Clinical Trials Registry: C000000082 (SAMIT); ClinicalTrials.gov identifier, 02628951 (South Korean trial).
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http://dx.doi.org/10.1136/gutjnl-2021-324060DOI Listing
May 2021

Retrolaminar Block Versus Paravertebral Block for Pain Relief After Less-Invasive Lung Surgery: A Randomized, Non-Inferiority Controlled Trial.

Cureus 2021 Feb 27;13(2):e13597. Epub 2021 Feb 27.

Department of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Kyoto, JPN.

Introduction A retrolaminar block (RLB) is a modified paravertebral technique with a local anesthetic injected at the retrolaminar site. The aim of this non-inferiority, parallel-group, prospective, and randomized study was to compare the analgesic efficacy of the paravertebral block (PVB) and RLB after lung surgery. Methods Eligible subjects were patients aged more than 20 years, with American Society of Anesthesiologists physical status Ⅰ or II, who were scheduled to undergo video-assisted thoracoscopic surgery (VATS) or limited thoracotomy because of lung disease. Patients were randomly allocated to receive either a PVB or RLB using a computer-generated sequence and sealed opaque envelopes. The PVB and RLB were induced by injecting 20 mL of 0.50% ropivacaine and 40 mL 0.25% ropivacaine, respectively. As the primary outcome variable, we considered the area under the curve (AUC) of the postoperative pain intensity using the trapezoidal method. Pain intensity was assessed using an 11-point numerical rating scale (NRS). We converted the NRS (0-10) into the visual analog scale (VAS) (0-100 mm) proportionally. We compared the AUC of the converted NRS (AUC-cNRS) on coughing between one and two hours after the operation. The non-inferiority margin was set at 25 mm × h in the AUC-cNRS. Patients and nurses were blinded to group assignments. Secondary outcomes included time to perform the block, NRS for pain intensity at rest and on coughing at one, two, four, 24, and 48 hours after the operation, the incidence of postoperative nausea and vomiting, time to first morphine use after the operation, and cumulative morphine consumption at 24 and 48 hours after the operation. Results In each group, 25 patients were randomized and analyzed. No significant difference in the AUC-cNRS was noted between the groups (P = 0.117). The mean difference in the AUC-cNRS (group RLB minus group PVB) was 13.42 mm × h, 95% confidence interval, -3.48 to 30.32 mm × h. However, when patients with unexpectedly extended skin incision were excluded from the analysis, the AUC-cNRS of group RLB was significantly higher as compared to group PVB (P = 0.0388). The time to perform the block was longer in PVB as compared to the RLB group (P < 0.0001). No significant differences were noted in the remaining secondary outcomes. Conclusion The non-inferiority of RLB as compared to PVB was not confirmed. Though RLB has the advantage of a shorter time to perform, RLB is not recommended for patients undergoing VATS or limited thoracotomy because of lack of efficacy as compared to PVB.
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http://dx.doi.org/10.7759/cureus.13597DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8007332PMC
February 2021

Association of estimated plasma volume and weight loss after long-term administration and subsequent discontinuation of the sodium-glucose cotransporter-2 inhibitor tofogliflozin.

Diabetes Obes Metab 2021 07 4;23(7):1660-1665. Epub 2021 May 4.

Department of Haematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.

Sodium-glucose cotransporter-2 inhibitors (SGLT2) are drugs that have been reported to have several effects through the regulation of plasma volume, for example, antihypertensive effects. This study aimed to clarify the impact of long-term administration and subsequent discontinuation of the SGLT2 inhibitor tofogliflozin on estimated plasma volume (ePV), brain natriuretic peptide (BNP) and the relationship between changes in ePV, BNP and body weight (BW). Data from 157 participants with type 2 diabetes receiving tofogliflozin monotherapy in a phase 3 study were analysed. Changes in variables or correlations among them during a 52-week administration and a 2-week post-treatment period were investigated. Percent change in ePV was calculated using the Strauss formula. Significant decreases in BW, ePV and ln-transformed BNP (ln-BNP) were noted by week 52. %ΔBW was not significantly correlated with %ΔePV and Δln-BNP, while %ΔePV was significantly correlated with Δln-BNP. Two weeks after discontinuation of tofogliflozin, BW, ePV and ln-BNP were significantly increased. %ΔBW was significantly correlated with %ΔePV and Δln-BNP. Furthermore, ePV and BNP were significantly higher than baseline levels.
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http://dx.doi.org/10.1111/dom.14387DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8252731PMC
July 2021

Dipeptidyl peptidase-4 inhibitor, anagliptin, alters hepatic insulin clearance in relation to the glycemic status in Japanese individuals with type 2 diabetes.

J Diabetes Investig 2021 Mar 9. Epub 2021 Mar 9.

Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.

Aims/introduction: This study investigated the impact of the dipeptidyl peptidase-4 inhibitor, anagliptin, on hepatic insulin clearance (HIC) in Japanese type 2 diabetes patients and explored its relationship to glycemic status.

Materials And Methods: Data on 765 participants in anagliptin phase 2 and 3 studies were analyzed. Adjusted changes in variables during 12 weeks of anagliptin therapy were compared with a placebo. HIC was calculated as the ratio, C-peptide area under the curve 0-120 min to insulin area under the curve 0-120 min, after a meal tolerance test. To explore the effects of baseline HIC levels on variables, participants receiving anagliptin were divided according to quartiles of baseline HIC. Furthermore, multivariate analysis investigated the association between baseline HIC levels and glycemic status.

Results: Anagliptin significantly reduced glycosylated hemoglobin levels (P < 0.001 vs placebo) and HIC levels (P < 0.01). Longer duration of diabetes, lower body mass index, higher glycosylated hemoglobin and lower insulin secretion capacity were observed with increases in baseline HIC levels. Improvements in glycosylated hemoglobin, glycoalbumin and 1,5-anhydroglucitol levels were greater in the relatively higher HIC group (baseline HIC levels ≥median) than in the lower HIC group (
Conclusions: Anagliptin affected HIC levels according to HIC baseline levels. Higher baseline HIC values might result in improved hyperglycemia through reduced HIC.
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http://dx.doi.org/10.1111/jdi.13543DOI Listing
March 2021

Sodium Intake and Incidence of Diabetes Complications in Elderly Patients with Type 2 Diabetes-Analysis of Data from the Japanese Elderly Diabetes Intervention Study (J-EDIT).

Nutrients 2021 Feb 21;13(2). Epub 2021 Feb 21.

Department of Endocrinology and Metabolism, Tokyo Metropolitan Geriatric Hospital, 35-2 Sakaecho, Itabashi-ku, Tokyo 173-0015, Japan.

This study investigates the associations between sodium intake and diabetes complications in a nationwide cohort of elderly Japanese patients with type 2 diabetes aged 65-85. Data from 912 individuals regarding their dietary intake at baseline is analyzed and assessed by the Food Frequency Questionnaire based on food groups. Primary outcomes are times to diabetic retinopathy, overt nephropathy, cardiovascular disease (CVD), and all-cause mortality during six years. We find that mean sodium intake in quartiles ranges from 2.5 g to 5.9 g/day. After adjustment for confounders, no significant associations are observed between sodium intake quartiles and incidence of diabetes complications and mortality, except for a significant trend for an increased risk of diabetic retinopathy ( = 0.039). Among patients whose vegetable intake was less than the average of 268.7 g, hazard ratios (HRs) for diabetic retinopathy in patients in the second, third, and fourth quartiles of sodium intake compared with the first quartile were 0.87 (95% CI, 0.31-2.41), 2.61 (1.00-6.83), and 3.70 (1.37-10.02), respectively. Findings indicate that high sodium intake under conditions of low vegetable intake is associated with an elevated incidence of diabetic retinopathy in elderly patients with type 2 diabetes.
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http://dx.doi.org/10.3390/nu13020689DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7926689PMC
February 2021

Post-induction MRD by FCM and GATA1-PCR are significant prognostic factors for myeloid leukemia of Down syndrome.

Leukemia 2021 Feb 15. Epub 2021 Feb 15.

Division of Leukemia and Lymphoma, Children's Cancer Center, National Center for Child Health and Development, Tokyo, Japan.

Myeloid leukemia of Down syndrome (ML-DS) is associated with good response to chemotherapy, resulting in favorable outcomes. However, no universal prognostic factors have been identified to date. To clarify a subgroup with high risk of relapse, the role of minimal residual disease (MRD) was explored in the AML-D11 trial by the Japanese Pediatric Leukemia/Lymphoma Study Group. MRD was prospectively evaluated at after induction therapy and at the end of all chemotherapy, using flow cytometry (FCM-MRD) and GATA1-targeted deep sequencing (GATA1-MRD). A total of 78 patients were eligible and 76 patients were stratified to the standard risk (SR) group by morphology. In SR patients, FCM-MRD and GATA1-MRD after induction were positive in 5/65 and 7/59 patients, respectively. Three-year event-free survival (EFS) and overall survival (OS) rates were 93.3% and 95.0% in the FCM-MRD-negative population, and 60.0% and 80.0% in the positive population. Three-year EFS and OS rates were both 96.2% in the GATA1-MRD-negative population, and 57.1% and 71.4% in the positive population. Adjusted hazard ratios for associations of FCM-MRD or GATA1-MRD with EFS were 10.98 (p = 0.01) and 27.68 (p < 0.01), respectively. Detection of MRD by either FCM or GATA1 after initial induction therapy represents a significant prognostic factor for predicting ML-DS relapse.
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http://dx.doi.org/10.1038/s41375-021-01157-wDOI Listing
February 2021

Efficacy and safety of 0.01% atropine for prevention of childhood myopia in a 2-year randomized placebo-controlled study.

Jpn J Ophthalmol 2021 May 14;65(3):315-325. Epub 2021 Feb 14.

Department of Frontier Medical Science and Technology for Ophthalmology, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kamigyo-ku, Kyoto, Kyoto, 602-0841, Japan.

Purpose: Atropine eye drops prevent the progression of myopia, but their use has not been tested in the Japanese schoolchildren population. Here, we evaluate the efficacy and safety of 0.01% atropine eye drops for myopia control in Japanese children.

Study Design: Multicenter (7 university hospitals), randomized, double-masked, placebo-controlled trial.

Methods: Participants were 171 Japanese schoolchildren aged 6 to 12 years, with progressive myopia, spherical equivalence (SE) of -1.00 to -6.00 diopters (D), and astigmatism of ≤1.5 D. They were randomized to receive either 0.01% atropine (n=85) or placebo (n=86) eye drops once nightly OU for 24 months. Primary and secondary efficacy endpoints were changes in SE and axial length (AL), respectively, from baseline to month 24.

Results: Data from 168 subjects were analyzed. At month 24, compliance was similar in both groups (atropine: 83.3%; placebo: 85.7%). The least squares mean change in SE and AL from baseline were, respectively, -1.26 D (95% confidence interval [CI]: -1.35, -1.17) and 0.63 mm (0.59, 0.67) for atropine and -1.48 D (- 1.57, -1.39) and 0.77 mm (0.73, 0.81) for placebo. Inter-group differences were 0.22 D (95% CI: 0.09, 0.35; P < 0.001) for SE and - 0.14 mm (-0.20, -0.08; P < 0.001) for AL. Three patients experienced mild allergic conjunctivitis side effects, with no inter-group difference in incidence (atropine: 2.4%; 2/84 patients; placebo: 1.4%; 1/84 patients).

Conclusion: With good compliance, 0.01% atropine is effective and safe for preventing the progression of childhood myopia.
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http://dx.doi.org/10.1007/s10384-021-00822-yDOI Listing
May 2021

Salvage Therapy After Regorafenib or Trifluridine/Tipiracil Treatment of Metastatic Colorectal Cancer: A Conditional Landmark Analysis.

Anticancer Res 2021 Feb;41(2):1055-1062

Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan;

Background/aim: This study aimed to describe the chemotherapy effects after trifluridine/tipiracil (TFTD) and/or regorafenib treatment in colorectal cancer (CRC) patients.

Patients And Methods: Patients receiving regorafenib or TFTD for metastatic CRC during 2013-2018 were selected and divided into two groups: one with additional chemotherapy after regorafenib or TFTD (CTX group) and one without additional chemotherapy (Non-CTX group). Patients were followed up from a landmark point (90 days from the last day of administration of regorafenib or TFTD). We compared overall survival (OS) between the groups.

Results: The median OS was 7.7 months in the CTX group and 4.1 months in the non-CTX groups. Several sensitivity analyses did not negate the survival advantage detected in the CTX group.

Conclusion: The chemotherapy after regorafenib or TFTD was associated with prolonged OS in advanced CRC patients. Further study is required to determine appropriate treatment choice.
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http://dx.doi.org/10.21873/anticanres.14862DOI Listing
February 2021

A 52-week randomized controlled trial of ipragliflozin or sitagliptin in type 2 diabetes combined with metformin: The N-ISM study.

Diabetes Obes Metab 2021 03 8;23(3):811-821. Epub 2021 Jan 8.

Department of Internal Medicine, Niigata University Faculty of Medicine, Niigata, Japan.

Aim: To compare the long-term efficacy of sodium-glucose co-transporter-2 inhibitors and dipeptidyl peptidase-4 inhibitors as second-line drugs after metformin for patients not at high risk of atherosclerotic cardiovascular disease (ASCVD).

Materials And Methods: In a 52-week randomized open-label trial, we compared ipragliflozin and sitagliptin in Japanese patients diagnosed with type 2 diabetes, without prior ASCVD and treated with metformin. The primary endpoint was a glycated haemoglobin (HbA1c) reduction of ≥0.5% (5.5 mmol/mol) without weight gain at 52 weeks.

Results: Of a total of 111 patients (mean age 59.2 years, mean body mass index [BMI] 26.6 kg/m , 61.3% men), 54 patients received ipragliflozin and 57 received sitagliptin. After 52 weeks, achievement of the primary endpoint was not significantly different (37.0% and 40.3%; P = 0.72). HbA1c reduction rate at 24 weeks was greater for sitagliptin (56.1%) than for ipragliflozin (31.5%; P = 0.01). From 24 to 52 weeks, the HbA1c reduction with sitagliptin was attenuated, with no significant difference in HbA1c reduction after 52 weeks between sitagliptin (54.4%) and ipragliflozin (38.9%; P = 0.10). Improvements in BMI, C-peptide and high-density lipoprotein cholesterol were greater with ipragliflozin than with sitagliptin. Adverse events occurred in 17 patients with ipragliflozin and in 10 patients with sitagliptin (P = 0.11).

Conclusion: The HbA1c-lowering effect at 24 weeks was greater with sitagliptin than with ipragliflozin, but with no difference in efficacy related to HbA1c and body weight at 52 weeks. However, some ASCVD risk factors improved with ipragliflozin.
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http://dx.doi.org/10.1111/dom.14288DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7898334PMC
March 2021

Exploratory assessment of treatment-dependent random-effects distribution using gradient functions.

Stat Med 2021 01 30;40(2):226-239. Epub 2020 Oct 30.

Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan.

In analyzing repeated measurements from randomized controlled trials with mixed-effects models, it is important to carefully examine the conventional normality assumption regarding the random-effects distribution and its dependence on treatment allocation in order to avoid biased estimation and correctly interpret the estimated random-effects distribution. In this article, we propose the use of a gradient function method in modeling with the different random-effects distributions depending on the treatment allocation. This method can be effective for considering in advance whether a proper fit requires a model that allows dependence of the random-effects distribution on covariates, or for finding the subpopulations in the random effects.
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http://dx.doi.org/10.1002/sim.8770DOI Listing
January 2021

The outcomes of relapsed acute myeloid leukemia in children: Results from the Japanese Pediatric Leukemia/Lymphoma Study Group AML-05R study.

Pediatr Blood Cancer 2021 01 29;68(1):e28736. Epub 2020 Sep 29.

Division of Leukemia and Lymphoma, Children's Cancer Center, National Center for Child Health and Development, Tokyo, Japan.

Background: The prognosis of children with acute myeloid leukemia (AML) has improved with the efficacy of hematopoietic cell transplantation (HCT) as a second-line therapy and improvements in supportive care following anthracycline- and cytarabine-based chemotherapy; however, the outcomes of children with relapsed AML still remain unsatisfactory.

Procedure: In order to identify prognostic factors and improve their prognosis, we analyzed 111 patients who relapsed after treatment with the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-05 protocol and who were registered in the retrospective JPLSG AML-05R study.

Results: The 5-year overall survival rate was 36.1%. The major determinant of survival was duration from the diagnosis to relapse. The mean duration in the nonsurviving group (10.1 ± 4.1 months) was shorter than that in the surviving group (16.3 ± 8.3 months) (P < .01). Moreover, achieving a second complete remission (CR2) prior to HCT was associated with a good prognosis (P < .01). Etoposide, cytarabine, and mitoxantrone (ECM)- or fludarabine, cytarabine, and granulocyte colony-stimulating factor (FLAG)-based regimens were therefore recommended for reinduction therapy (P < .01). A genetic analysis also revealed the prognostic significance of FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication as a poor prognostic marker (P = .04) and core binding factor-AML, t(8;21), and inv(16) as good prognostic markers (P < .01).

Conclusions: Achieving a CR2 prior to HCT is important in order to improve the prognosis of relapsed pediatric AML. Recent molecular targeted therapies, such as FLT3 inhibitors, may contribute to overcome their prognoses. Larger prospective investigations are necessary to establish individualized treatment strategies for patients with relapsed childhood AML.
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http://dx.doi.org/10.1002/pbc.28736DOI Listing
January 2021

Microbial community composition in iron deposits and manganese crusts formed in riverine environments around the Aso area in Japan.

Res Microbiol 2020 Oct - Nov;171(7):271-280. Epub 2020 Sep 24.

Civil Engineering Research Laboratory, Central Research Institute of Electric Power Industry, Abiko, Chiba, 270-1194, Japan. Electronic address:

The Kurokawa river flowing through the Aso Caldera in Southwest Japan is influenced by groundwater containing high concentration of dissolved metals (Fe and Mn) and is associated with orange deposits in the upstream and thick black crusts on the wall of artificial waterway tunnel with several km lengths in the midstream regions. X-ray fluorescence analysis revealed that the orange deposits contained up to 34.4% Fe and black crusts comprised up to 25.4% and 10.6% Mn and Fe, respectively. Although naturally occurring Mn-oxides and crusts are considered biogenic in pH-neutral freshwater environments, the whole microbial community in Mn crust and their contribution to Mn crust formation in these environments remain unclear. High-throughput molecular sequencing for bacteria and eukaryotes including fungi revealed black Mn crusts had a high abundance of Sphingomonas, Hyphomicrobium, Bacillus, Pseudomonas, and Mortierella, previously reported genera including several species with Mn-oxidizing activity in Mn crusts or nodules of other marine and freshwater environments. In addition, one bacterial isolate and one fungal isolate with Mn-oxidizing activity were obtained from black Mn crust. These results suggest that multiple Mn-oxidizing bacteria including Pseudomonas and fungi are involved in Mn crust formation on the wall of dark waterway tunnel in the oligotrophic environment of the Kurokawa river.
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http://dx.doi.org/10.1016/j.resmic.2020.09.003DOI Listing
June 2021

Assessment of asthma severity according to treatment steps in Japanese pediatric patients: a descriptive cross-sectional study using an administrative claims database.

J Asthma 2020 Sep 22:1-7. Epub 2020 Sep 22.

Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan.

Objectives: Japan has one of the highest asthma prevalence rates in Asia; however, there is a lack of epidemiological studies on asthma among children in Japan. This study aimed to describe the severity of asthma and the prescription patterns for its treatment among pediatric patients, by using a large-scale claims database.

Methods: The analysis datasets were extracted from the JMDC database for the period of April 1, 2009 to March 30, 2015; included records were restricted to patients between 2 and 15 years of age. The Japanese Pediatric Guidelines for the treatment and management of asthma (JPGL) steps were used as a proxy for asthma treatment and severity. We also described the characteristics of asthma in children by stratifying the prevalence and incidence cohorts by index years.

Results: In the prevalence cohort (56% male), from 2010 to 2014, approximately 80-90% of the children received step 1 or 2 treatment, with the remainder receiving step 3 or 4 treatment, as defined by the JPGL. The majority (approximately 90%) of patients visited clinics for asthma treatment, while a minority visited hospitals.

Conclusions: Our study showed the severity of asthma among Japanese pediatric patients, as well as their demographic characteristics, using a large-scale claims database. The majority of pediatric asthma patients received treatment for mild-to-moderate asthma, while less than 10% received treatment for severe asthma.
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http://dx.doi.org/10.1080/02770903.2020.1821057DOI Listing
September 2020

Family Support for Medical Nutritional Therapy and Dietary Intake among Japanese with Type 2 Diabetes (JDDM 56).

Nutrients 2020 Aug 31;12(9). Epub 2020 Aug 31.

Department of Hematology, Endocrinology, and Metabolism, Niigata University Faculty of Medicine, 1-757 Asahimachi-dori, Chuoh-ku, Niigata 951-8510, Japan.

The aim of this study was to investigate the association between habitual dietary intake for patients with diabetes and the content of family support for medical nutritional therapy (MNT). Analyzed were 289 Japanese with type 2 diabetes (men, 58.5%; mean age, 62.0 years; mean HbA1c, 53.4 mmol/mol) who completed the Food Frequency Questionnaire and Diabetes Family Behavior Checklist (DFBC). Relationships of mean values for food group intake to DFBC responses regarding MNT were examined using multivariate analysis of covariance. Positive response to "Praise for following diet" was associated with lower sweets intake (none: 60.1 g/day; ≥once monthly: 50.9 g/day, = 0.038) and higher seasoning intake (none: 21.6 g/day, ≥once monthly: 24.1 g/day, = 0.046). Energy intake was higher with positive responses to "Eat at the same time that you do" (none: 1636 kcal/day, ≥once monthly: 1818 kcal/day, = 0.038). "Nags about not following diet" was associated with higher fish (none: 68.7 g/day, ≥once monthly: 78.7 g/day, = 0.042) and salt intake (none: 8.3 g/day, ≥once monthly: 9.0 g/day, = 0.014). Eating foods not part of the diabetic diet (none: 218.4 g/day, ≥once monthly: 246.9 g/day, = 0.014) resulted in a higher vegetable intake. In females, significant differences in relationships in the overall analysis were reversed. Our results clarified relationships between types of family support of patients with type 2 diabetes and their dietary intake and the importance of sex differences for more effective MNT.
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http://dx.doi.org/10.3390/nu12092649DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7551803PMC
August 2020

Randomized head-to-head comparison of minodronic acid and raloxifene for fracture incidence in postmenopausal Japanese women: the Japanese Osteoporosis Intervention Trial (JOINT)-04.

Curr Med Res Opin 2020 11 14;36(11):1847-1859. Epub 2020 Sep 14.

Department of Internal Medicine, Research Institute and Practice for Involutional Diseases, Nagano, Japan.

Aims: We conducted a head-to-head randomized trial of minodronate, a bisphosphonate, and raloxifene, a selective estrogen receptor modulator, to obtain clinical evidence and information about their efficacy and safety.

Methods: The Japanese Osteoporosis Intervention Trial protocol number 4 (JOINT-04) trial is a multi-center, open-labeled, blinded endpoints, head-to-head randomized trial of minodronate and raloxifene. Ambulatory elderly women with osteoporosis (age, >60 years) were randomly allocated to the raloxifene or minodronate group by central registration. The co-primary endpoints included any one of osteoporotic fractures (vertebral, humeral, femoral, and radial fractures), vertebral fractures, and major osteoporotic fractures (clinical vertebral, humeral, femoral, and radial fractures). The biological effects of each drug, patients' quality of life, and drug safety were assessed based on the secondary outcomes. This study was registered at the University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) under trial identification number UMIN000005433.

Results: A total of 3896 patients were randomized to the minodronate and raloxifene groups, and drug efficacy assessments were performed for 3247 patients (1623 and 1624 patients, respectively). Among these patients, 1176 and 1187 patients received allocated treatment for 2 years. The incidence rate ratios for osteoporotic, vertebral, and major osteoporotic fractures in the minodronate group were 0.94 (95% CI: 0.78-1.13,  = .494), 0.86 (95% CI: 0.70-1.05,  = .147), and 1.22 (95% CI: 0.86-1.74,  = .274), respectively. Compared to the raloxifene group, the minodronate group showed significantly increased bone mineral density of the lumbar spine for each visit (6 months:  = .007, 12 months:  = .0003, 24 months: <.0001). Also, serious adverse reactions were observed for four and six patients in the minodronate and raloxifene groups, respectively.

Conclusions: Overall, there were no statistical differences in the incidence rates of osteoporotic, vertebral, or major osteoporotic fractures between the two groups. Serious adverse reactions were rare in both groups.
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http://dx.doi.org/10.1080/03007995.2020.1816537DOI Listing
November 2020

Association between Low Protein Intake and Mortality in Patients with Type 2 Diabetes.

Nutrients 2020 Jun 1;12(6). Epub 2020 Jun 1.

Department of Hematology, Endocrinology, and Metabolism, Niigata University Faculty of Medicine, 1-757 Asahimachi-dori, Chuoh-ku, Niigata 951-8510, Japan.

The aim of this study was to investigate the association between protein intake and mortality risk in patients with type 2 diabetes. We analyzed a pooled data of 2494 diabetic patients from two prospective longitudinal studies. Nutritional intake was assessed using a Food Frequency Questionnaire at baseline. Protein intake per body weight (kg) per day was categorized into quartile groups. Adjusted hazard ratios (HRs) and 95% confidence interval (CI) were calculated using Cox regression analysis. During the six-year follow-up, there were 152 incidents of all-cause mortality. The HR for mortality in the lowest quartile of protein intake per body weight compared with the highest quartile was 2.26 (95% CI: 1.34-3.82, = 0.002) after adjustment for covariates. Subgroup analyses revealed significant associations between low protein intake and mortality in patients aged over 75 years or under 65 years. After further adjustment of the total energy intake, a significant association between protein intake and mortality remained in patients aged ≥ 75 years, whereas the association was attenuated in those aged < 65 years. Our results suggest that adequate protein intake is necessary in older diabetic patients over 75 years, whereas with diabetes, whereas whole optimal total energy intake is required in younger patients with type 2 diabetes.
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http://dx.doi.org/10.3390/nu12061629DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7352318PMC
June 2020

Intravenous itraconazole compared with liposomal amphotericin B as empirical antifungal therapy in patients with neutropaenia and persistent fever.

Mycoses 2020 Aug 28;63(8):794-801. Epub 2020 May 28.

Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.

Background: Fungal infections are a major complication of neutropaenia following chemotherapy. Their early diagnosis is difficult, and empirical antifungal treatment is widely used, and uses of less toxic drugs that reduce breakthrough infection are required.

Objective: We conducted a multicentre, open-label, randomised, non-inferiority trial to compare the safety and efficacy of intravenous itraconazole (ivITCZ) and liposomal amphotericin B (LAmB) as empirical antifungal therapy in patients with haematological malignancies with neutropaenia and persistent fever.

Methods: Patients with haematological malignancies who developed fever refractory to broad-spectrum antibacterial agents under neutropaenia conditions were enrolled. Patients were randomised for treatment with LAmB (3.0 mg/kg/d) or ivITCZ (induction: 400 mg/d, maintenance: 200 mg/d).

Results: Observed overall favourable response rates of 17/52 (32.7%) and 18/50 (36.0%) in the LAmB and ivITCZ groups, with a model-based estimate of a 4% difference (90% CI, -12% to 20%), did not fulfil the statistical non-inferiority criterion. In the LAmB group, there were two cases of breakthrough infection and five cases of probable invasive fungal disease, whereas in the itraconazole group, neither breakthrough infection nor probable invasive fungal disease occurred. Patients in the ivITCZ group had significantly fewer grade 3-4 hypokalaemia-related events than LAmB group patients (P < .01). The overall incidence of adverse events tended to be lower in the ivITCZ group (P = .07).

Conclusion: ivITCZ showed similar efficacy and safety as LAmB as empirical antifungal therapy in haematological malignancy patients with febrile neutropaenia, although the small sample size and various limitations prevented demonstration of its non-inferiority.
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http://dx.doi.org/10.1111/myc.13100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7497187PMC
August 2020

Predisposition to prolonged neutropenia after chemotherapy for paediatric acute myeloid leukaemia is associated with better prognosis in the Japanese Paediatric Leukaemia/Lymphoma Study Group AML-05 study.

Br J Haematol 2021 04 26;193(1):176-180. Epub 2020 Apr 26.

Division of Leukemia and Lymphoma, Children's Cancer Center, National Center for Child Health and Development, Tokyo, Japan.

The variability in myelosuppression after chemotherapy for acute myeloid leukaemia (AML) can affect its prognosis; however, the underlying mechanism remains controversial. In the Japanese Paediatric Leukaemia/Lymphoma Study Group AML-05 study, we showed that prolonged neutropenia was associated with high overall survival (P = 0·011) and low frequency of relapse (P = 0·042) in patients without granulocyte-colony stimulating factor (G-CSF) who completed the indicated treatment protocol. Our data indicate that predisposition to prolonged neutropenia after chemotherapy is correlated with a better outcome of AML treatment. Our results promote the usage of individualised drug dosing strategies to improve the therapeutic outcome in AML patients.
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http://dx.doi.org/10.1111/bjh.16656DOI Listing
April 2021

Microcystic, Elongated and Fragmented Pattern Invasion Can Adversely Influence Preoperative Staging for Low-grade Endometrial Carcinoma.

Magn Reson Med Sci 2021 Mar 19;20(1):20-27. Epub 2020 Feb 19.

Department of Diagnostic Imaging and Nuclear Medicine, Kyoto University Graduate School of Medicine.

Purpose: To investigate the influence of microcystic, elongated and fragmented (MELF) pattern invasion on preoperative evaluation of lymph node (LN) metastasis and myometrial invasion in patients with low-grade endometrial carcinoma.

Methods: The study included 192 consecutive patients with low-grade endometrial carcinoma who underwent preoperative computed tomography (CT) and magnetic resonance imaging (MRI), followed by surgery. One hundred sixty one of 192 patients underwent LN dissection and were analyzed for LN metastasis. All patients were analyzed for myometrial invasion. Presence of enlarged LN was evaluated by using size criteria on CT. Depth of myometrial invasion was evaluated on MRI using T-weighted imaging, diffusion-weighted imaging and contrast-enhanced T-weighted imaging comprehensively. Sensitivity and specificity for LN metastasis and deep myometrial invasion were evaluated for MELF group and non-MELF group. The difference of sensitivity between two groups was compared using Chi-square and Fisher's exact test.

Results: MELF pattern invasion was identified in 43/192 patients (22%). LN metastases were observed in 18/39 patients in MELF group and 6/122 patients in non-MELF group for pelvic LN and 11/29 patients in MELF group and 4/57 patients in non-MELF group for para-aortic LN. Sensitivity for the detection of pelvic LN metastasis in MELF group was significantly lower than in non-MELF group (16.7% vs 66.7%). As for the assessment of the deep myometiral invasion, pathological deep myometrial invasion were found in 31/43 patients in MELF group and 32/149 patients in non-MELF group. Sensitivity in MELF group showed lower values than in non-MELF group (54.8% vs 78.1% for reader 1, 54.8% vs 62.5% for reader 2), although there was no statistically significant difference (P = 0.09 for reader 1 and P = 0.72 for reader 2).

Conclusion: In case of low-grade endometrial carcinoma with MELF pattern invasion, preoperative staging by CT and MRI have a risk for underestimation.
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http://dx.doi.org/10.2463/mrms.mp.2019-0153DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7952211PMC
March 2021

Prognostic index consisting of early post-transplant variables <2 weeks in adult living-donor liver transplantation.

Hepatol Res 2020 Jun 18;50(6):741-753. Epub 2020 Feb 18.

Department of Surgery, Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Kyoto University Graduate School of Medicine, Kyoto, Japan.

Aim: Six-month recipient mortality after adult-to-adult living-donor liver transplantation (LDLT) remains high. Early and accurate prediction of recipient outcome and continuous monitoring of recipient severity after surgery are both essential for guiding appropriate care. This study was designed to identify early post-transplant parameters associated with 6-month mortality, and thereby to construct a discriminatory prognostic index (PI).

Methods: We retrospectively analyzed 400 consecutive primary adult-to-adult LDLTs in our center (2006-2017). Perioperative variables were comprehensively analyzed for their accuracy in predicting recipient mortality by comparing the area under the receiver operating characteristic (AUROC) of each factor.

Results: The AUROCs of preoperative predictive factors, for example, Model for End-stage Liver Disease (MELD) score and donor age, were 0.56 and 0.64, respectively, whereas those of post-transplant platelet count (PLT), total bilirubin (T-BIL), and prothrombin time - international normalized ratio (INR) on postoperative day (POD)-7-14 were 0.71/0.84, 0.68/0.82, and 0.71/0.78, respectively. Logistic regression analysis provided a formula: PI  = 3.39 + 0.12 × PLT  - 0.09 × T-BIL  - 1.23 × INR , indicating a high AUROC of 0.87. Recipient 6-month survival with PI  < 2.38 (n = 173) was 71.7%, whereas that with PI  ≥ 2.38 (n = 222) was 97.7% (P < 0.001). The AUROCs of PI were as high as 0.8 in the subgroups with younger donors (<50 years of age), right lobe grafts, ABO-identical/compatible combinations, or low MELD score (<20), indicating usefulness of PI to identify unexpectedly complicated cases within the first week.

Conclusions: A novel, post-transplant survival estimator, PI, accurately predicts recipient 6-month mortality within 1-2 weeks after adult LDLT. Daily monitoring of PI could facilitate early interventions including retransplantation in critically ill patients.
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http://dx.doi.org/10.1111/hepr.13489DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7317571PMC
June 2020

Association of increased hepatic insulin clearance and change in serum triglycerides or β-hydroxybutyrate concentration via the sodium/glucose-cotransporter 2 inhibitor tofogliflozin.

Diabetes Obes Metab 2020 06 14;22(6):947-956. Epub 2020 Feb 14.

Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.

Aims: Obesity and hepatic fat accumulation diminish hepatic insulin clearance, which can cause hyperinsulinaemia. Sodium/glucose-cotransporter 2 inhibitors (SGLT2-is) improve insulin resistance and hyperinsulinaemia by weight loss via increased urinary glucose excretion in type 2 diabetes. However, there are few reports of the influence of SGLT2-is on hepatic insulin clearance. We examined the impact of an SGLT2-i on hepatic insulin clearance and explored the clinical influence associated with changes in hepatic insulin clearance via an SGLT2-i and the mechanism of the effects of SGLT2-i.

Materials And Methods: Data were analysed from 419 patients with type 2 diabetes controlled by diet and exercise. Patients received a placebo or the SGLT2-i tofogliflozin (TOFO) (placebo: n = 56; TOFO: n = 363) orally once daily for ≥24 weeks. Hepatic insulin clearance was calculated from the ratio of areas under the curve (AUC) of C-peptide and insulin levels derived from oral meal tolerance test data (C-peptide AUC /insulin AUC : HIC ). The correlation of HIC via the SGLT2-i with other clinical variables was analysed using multivariate analysis.

Results: HIC was significantly increased via TOFO at week 24. Furthermore, with TOFO insulin and triglyceride (TG) levels were significantly reduced (P < 0.001) and β-hydroxybutyrate (BHB) was significantly elevated (P < 0.001). Changes in HIC were significantly correlated with changes in TG and BHB via TOFO.

Conclusions: Increased HIC was significantly associated with reduced TG via TOFO and contributed to the greater increase in BHB compared with placebo in addition to the correction of hyperinsulinaemia.
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http://dx.doi.org/10.1111/dom.13980DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7318197PMC
June 2020

Correction to: Prophylactic sivelestat for esophagectomy and in-hospital mortality: a propensity score-matched analysis of claims database.

J Anesth 2020 Feb;34(1):161-162

Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan.

In the original version of the article, the Tables 2 and 3 was published incorrectly. The correct version of Tables 2 and 3 are given below.
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http://dx.doi.org/10.1007/s00540-019-02726-1DOI Listing
February 2020

Design of a randomized trial of teriparatide followed by alendronate: Japanese Osteoporosis Intervention Trial-05 (JOINT-05).

J Bone Miner Metab 2020 May 1;38(3):412-417. Epub 2020 Jan 1.

Eikokai Ono Hospital, 973 Tenjin-cho, Ono, Hyogo, 675-1316, Japan.

Introduction: Despite advances in drug treatment, the optimal treatment strategy for severe osteoporosis remains uncertain.

Materials And Methods: This article reports the design and rationale for the Japanese Osteoporosis Intervention Trial-05 (JOINT-05), a randomized, controlled trial that compares the efficacy and safety of teriparatide followed by alendronate with alendronate monotherapy for severe osteoporosis.

Results: Postmenopausal women aged at least 75 years were eligible for the study if they were at high risk of fracture. Patients were recruited from 113 institutions in Japan between October 2014 and December 2017. They were randomly assigned in a 1:1 ratio to the sequential therapy arm (once-weekly subcutaneous injections of teriparatide 56.5 μg for 72 weeks followed by alendronate for 48 weeks) or monotherapy arm (alendronate for 120 weeks). The regimens for alendronate are 5 mg (orally administered once daily), 35 mg (orally administered once weekly), or 900 μg (intravenously administered once every 4 weeks). The primary endpoint is the incidence of morphometric vertebral fracture at 72 weeks. The secondary endpoints include the incidence of morphometric vertebral fracture at 120 weeks; incidence of morphometric vertebral or non-vertebral fractures at 72 and 120 weeks; incidence of clinical vertebral fracture at 72 and 120 weeks; changes in bone mineral density, quality of life scores (EuroQol 5 Dimensions and the Japanese Osteoporosis Quality of Life Questionnaire short form), and a visual analog scale for back pain; and adverse events.

Conclusion: We reported the design and rationale for the JOINT-05. The trial is registered with the Japan Registry of Clinical Trials (jRCTs031180235) and the University Hospital Medical Information Network-Clinical Trials Registry (UMIN000015573).
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http://dx.doi.org/10.1007/s00774-019-01074-0DOI Listing
May 2020

Electronic health record nested pragmatic randomized controlled trial of a reminder system for serum lithium level monitoring in patients with mood disorder: KONOTORI study protocol.

Trials 2019 Dec 11;20(1):706. Epub 2019 Dec 11.

Department of Health Promotion and Human Behavior, Graduate School of Medicine/School of Public Health, Kyoto University, Kyoto, Japan.

Background: The weaknesses of classical explanatory randomized controlled trials (RCTs) include limited generalizability, high cost, and time burden. Pragmatic RCTs nested within electronic health records (EHRs) can be useful to overcome such limitations. Serum lithium monitoring has often been underutilized in real-world practice in Japan. This trial aims to evaluate the effectiveness of the EHR-nested reminder system for serum lithium level monitoring in the maintenance of therapeutic lithium concentration and in the improvement of the quality of care for patients on lithium maintenance therapy.

Methods: The Kyoto Toyooka nested controlled trial of reminders (KONOTORI trial) is an EHR-nested, parallel-group, superiority, stratified, permuted block-randomized controlled trial. Screening, random allocation, reminder output, and outcome collection will be conducted automatically by the EHR-nested trial program. Patients with a mood disorder taking lithium carbonate for maintenance therapy will be randomly allocated to the two-step reminder system for serum lithium monitoring or to usual care. The primary outcome is the achievement of therapeutic serum lithium concentration between 0.4 and 1.0 mEq/L at 18 months after informed consent.

Discussion: The KONOTORI trial uses EHRs to enable the efficient conduct of a pragmatic trial of the reminder system for lithium monitoring. This may contribute to improved quality of care for patients on lithium maintenance therapy.

Trial Registration: University Hospital Medical Information Network (UMIN) Clinical Trials Registry, UMIN000033633. Registered on 3 July 2018.
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http://dx.doi.org/10.1186/s13063-019-3847-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6907204PMC
December 2019

Linear or circular stapler? A propensity score-matched, multicenter analysis of intracorporeal esophagojejunostomy following totally laparoscopic total gastrectomy.

Surg Endosc 2020 12 9;34(12):5265-5273. Epub 2019 Dec 9.

Department of Surgery, Graduate School of Medicine, Kyoto University, 54, Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.

Background: Presently, there is no consensus as to what procedure of intracorporeal esophagojejunostomy (EJS) in totally laparoscopic total gastrectomy (TLTG) is best to reduce postoperative complications. The aim of this study was to demonstrate the superiority of linear stapled reconstruction in terms of anastomotic-related complications for EJS in TLTG.

Methods: We collected data on 829 consecutive gastric cancer patients who underwent TLTG reconstructed by the Roux-en-Y method with radical lymphadenectomy between January 2010 and December 2016 in 13 hospitals. The patients were divided into two groups according to reconstruction method and matched by propensity score. Postoperative EJS-related complications were compared between the linear stapler (LS) and the circular stapler (CS) groups.

Results: After matching, data from 196 patients in each group were analyzed. The overall incidence of EJS-related complications was significantly lower in the LS group than in the CS group (4.1% vs. 11.7%, p = 0.008). The incidence of EJS anastomotic stenosis during the first year after surgery was significantly lower in the LS group than in the CS group (1.5% vs. 7.1%, p = 0.011). The incidence of EJS bleeding did not differ significantly between the groups, although no bleeding was observed in the LS group (0% vs. 2.0%, p = 0.123). The incidence of EJS leakage did not differ significantly between the groups (2.6% vs. 3.6%, p = 0.771).

Conclusion: The use of linear stapled reconstruction is safer than the use of circular stapled reconstruction for intracorporeal EJS in TLTG because of its lower risks of stenosis.
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http://dx.doi.org/10.1007/s00464-019-07313-9DOI Listing
December 2020

Correction to: The association of urinary pentosidine levels with the prevalence of osteoporotic fractures in postmenopausal women.

J Bone Miner Metab 2020 Mar;38(2):275

Department of Orthopedic Surger, Jikei University School of Medicine, Tokyo, Japan.

In the original publication of the article, the following sentence under the abstract section was published incorrectly as "A multivariable logistic regression analysis revealed that urinary pentosidine was significantly associated with the prevalence of fracture after adjustment for known risk factors for fracture (odds ratio 1.92, 95% CI 1.09-3.37, P = 0.023)."
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http://dx.doi.org/10.1007/s00774-019-01056-2DOI Listing
March 2020

Analysis of the association between paternity and reoperation for urethral obstruction in adult hypospadias patients who underwent two-stage repair in childhood.

BMC Urol 2019 Oct 4;19(1):88. Epub 2019 Oct 4.

Department of Urology, Hyogo College of Medicine, Mukogawacho 1-1, Nishinomiya, Hyogo, 663-8501, Japan.

Background: The association between surgical outcome of hypospadias repair and long-term male reproductive function has not been documented. The purpose of this study was to clarify association between paternity in adult hypospadias patients and reoperation for urethral obstruction after two-stage repair during childhood.

Methods: Ninety hypospadias patients who underwent the same kind of two-stage repair in our institute by a single surgeon, were initially treated at < 18 years old, and who were ≥ 18 years old during the survey were included in the study. Present physical, social, and life status were evaluated by a mailed self-entry questionnaire, and clinical background and surgical outcome data were evaluated by medical records. National survey data of the general population were used as external control. The paternity rate of the patient groups was evaluated by Kaplan-Meier curve analysis and log-rank tests.

Results: Twenty-six patients (28.9%) underwent 43 reoperations after completion of the initial repair. Twelve patients were reoperated for obstructive complication (Study group) and were compared with 14 patients who were reoperated only for non-obstructive causes and 64 patients who were not reoperated as Study control group (N = 78). The Study group patients showed sexual intercourse rate and marriage rate not statistically different in comparison with the Study control, although marriage rate at 32.5 years old were lower than the general population (p = 0.048, z-test). None of the Study group achieved paternity, which showed a significant difference to the Study control (p = 0.032, log-rank test). The difference was also statistically significant in the analysis among the 31 married patients (p = 0.012, log-rank test). Patients reoperated for obstructive complication documented worsened Quality of Life score in the International Prostate Symptom Score (2.3 ± 2.0 vs. 1.4 ± 1.2, p = 0.031, t-test) and ejaculation problems (66.7% vs. 17.4%, p = 0.003, chi-square test).

Conclusions: History of reoperation for obstructive complication was associated with lower paternity rate in patients with hypospadias, presumably for multifactorial causes associated with marriage age and ejaculation problems. The present results may implicate importance of uncomplicated urethroplasty during childhood for achieving paternity, although it should be further tested in the future for larger groups of hypospadias patients.
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http://dx.doi.org/10.1186/s12894-019-0512-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6778371PMC
October 2019
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