Publications by authors named "Xiao-Hui Guo"

89 Publications

[Application of umbrella design and basket design in evidence-based research for traditional Chinese medicine].

Zhongguo Zhong Yao Za Zhi 2021 Apr;46(8):2010-2015

Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine Guangzhou 510120, China Science and Innovation Center of Guangzhou University of Chinese Medicine Guangzhou 510405, China.

This paper introduced the basic definition, application scope, advantages and challenges of the master protocol, basket design, umbrella design and platform trial, and put forward the idea of using master protocol, basket design and umbrella design in Chinese medicine(CM) by considering the characteristics of CM and research experiences. The author pointed out that master protocol, basket design and umbrella design, as a high-efficiency research and design strategy, can be used in the clinical research on the treatment of the same disease with different therapies, the treatment of different diseases with the same therapy and the combination of diseases and CM syndromes. In particular, the exploration from the classification of CM syndromes can supplement the gaps in the cli-nical research on CM syndromes. In the application of such designs, it is also necessary to pay attention to their potential challenges and develop reasonable and feasible plans on research implementation, management and statistical analysis in advance to meet these challenges.
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http://dx.doi.org/10.19540/j.cnki.cjcmm.20210204.501DOI Listing
April 2021

Molecular Phylogeny and Taxonomy of the Genus Minidiscus (Bacillariophyceae), with Description of Mediolabrus gen. nov.

J Phycol 2020 12 20;56(6):1443-1456. Epub 2020 Jul 20.

Natural History Museum of Denmark, University of Copenhagen, Øster Farimagsgade 5, 1307, Copenhagen K, Denmark.

The genus Minidiscus comprises a group of ecologically-important and globally-distributed planktonic diatoms that are characterized by their small cell size, high mantle and processes more or less concentrated in the valve center. Monoclonal strains were established from collections along the Chinese coast. In the phylogenetic analyses inferred from a LSU and SSU dataset, six Minidiscus species clustered into two well-supported clades. The first clade was located within a larger clade formed mainly by Thalassiosira taxa, and the second clade appeared as sister to a clade comprising the genus Skeletonema. Hence, presently known Minidiscus do not form a monophyletic clade, but rather make up a phenotypic grouping. Based on the morphology of the type species, M. trioculatus, as well as morphological characters of all taxa in the clade with M. trioculatus, Minidiscus is characterized by having fultoportula(e) in the valve center or sub-centered close to a single rimoportula, and the cells are usually cylindrical. Mediolabrus gen. nov. is proposed to accommodate species in the second clade. The main difference between Minidiscus and Mediolabrus is the type of process found in the valve (sub-)center, with fultoportula(e) close to a rimoportula in the former, and only a single rimoportula in the latter. According to the above criteria, previously described Minidiscus taxa were re-examined, and either retained in Minidiscus or transferred to Mediolabrus.
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http://dx.doi.org/10.1111/jpy.13038DOI Listing
December 2020

Reversible renal infarctions associated with pheochromocytoma: a case report.

Chin Med J (Engl) 2020 06;133(12):1481-1482

Department of Endocrinology, Peking University First Hospital, Beijing 100034, China.

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http://dx.doi.org/10.1097/CM9.0000000000000759DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7339374PMC
June 2020

Toll-like receptor 4 gene polymorphisms rs4986790 and rs4986791 and age-related macular degeneration susceptibility: a meta-analysis.

Ophthalmic Genet 2020 02 27;41(1):31-35. Epub 2020 Feb 27.

Department of Ophthalmology, The 1st Medical Center of Chinese PLA General Hospital, Beijing, People's Republic of China.

: Several studies have investigated two single nucleotide polymorphisms (SNPs) (rs4986790 and rs4986791) of toll-like receptor 4 (TLR4) and age-related macular degeneration (AMD) susceptibility. However, their results varied. Here, we performed a systematic review and meta-analysis to investigate the association between these two SNPs and AMD susceptibility.: We searched the PubMed and Web of Science databases for articles indexed up to July 20, 2019. Studies investigating the association between TLR4 polymorphisms rs4986790 (Asp299Gly) and rs4986791 (Thr399Ile) and AMD susceptibility were included in this systematic review. The results of the included studies were pooled with allele contrast, recessive, dominant and overdominant models. The quality of the included studies was assessed using the Newcastle-Ottawa Scale. Egger's test was used to evaluate publication bias.: Six studies with 9 cohorts were included in this systematic review and meta-analysis. The recessive and overdominant models showed that rs4986790 was significantly associated with AMD susceptibility, with odds ratios (ORs) of 0.73 and 1.41, respectively. By contrast, rs4986791 was not associated with AMD susceptibility. No publication bias was observed for either rs4986791 or rs4986790.: The current evidence supports the hypothesis that rs4986790 but not rs4986791 is associated with AMD susceptibility.
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http://dx.doi.org/10.1080/13816810.2020.1723117DOI Listing
February 2020

Evaluation of the gestational diabetes mellitus diagnostic criteria recommended by the international association of diabetes and pregnancy study group for long-term maternal postpartum outcomes in mainland China.

Medicine (Baltimore) 2020 Feb;99(8):e19242

Department of Endocrinology.

The gestational diabetes mellitus (GDM) diagnostic criteria recommended by the International Association of Diabetes and Pregnancy Study Group (IADPSG) were established based on the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study and have been the most commonly used criteria for determining GDM worldwide. Although individuals from mainland China were not included in the HAPO study, the IADPSG criteria have been used in China since 2011. However, the appropriateness of the criteria for evaluating maternal postpartum outcomes in mainland China are unknown. We conducted this study to determine whether the IADPSG criteria are appropriate for Chinese patients for evaluating long-term maternal postpartum outcomes.Eighty-four patients who were diagnosed with hyperglycemia during pregnancy and had delivery in Peking University First Hospital from February 2007 to December 2009 were enrolled in the study. For patients in Group A, GDM was diagnosed using both the National Diabetes Data Group (NDDG) and the IADPSG criteria, while patients in Group B, gestational impaired glucose tolerance (GIGT) was diagnosed using the NDDG criteria while GDM was diagnosed based on the IADPSG criteria. Anthropometric data, glucose metabolism, lipid profiles, β cell function, and insulin resistance index were evaluated and compared to baseline after 5- to 6-year postpartum period.Patients in group A had significantly higher oral glucose tolerance test (OGTT) fasting, 2-hour and 3-hour plasma glucose levels compared to patients in group B at 24 to 28 weeks of gestation (P < .05). No significant differences were observed between the groups for anthropometric data, postpartum abnormal glucose metabolism (50.91% vs 44.83%, P = .596), type 2 diabetes mellitus (T2DM) (16.36% vs 3.45%, P = .167), lipid profiles, β cell function (homeostasis model assessment β-cell function index (HOMA-β) 1.04 vs 0.99, P = .935) and insulin resistance (homeostasis model assessment insulin resistance index (HOMA-IR) 2.01 vs 1.69, P = .583).Patients diagnosed with GDM using either the NDDG or IADPSG criteria had abnormal glucose levels and lipid metabolism after delivery. Patients with mild hyperglycemia had similar postpartum β-cell functional impairment and insulin resistance to those with moderate hyperglycemia during pregnancy. Hence, with respect to maternal long-term postpartum outcomes, the IADPSG diagnostic criteria for GDM could be appropriate for patients in mainland China.
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http://dx.doi.org/10.1097/MD.0000000000019242DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7034689PMC
February 2020

Search for clinical predictors of good glycemic control in patients starting or intensifying oral hypoglycemic pharmacological therapy: A multicenter prospective cohort study.

J Diabetes Complications 2020 02 20;34(2):107464. Epub 2019 Oct 20.

Department of Endocrinology, Guang An Men Hospital, China Academy of Chinese Medical Science, Beijing 102600, China.

Aims: Our aim was to search for clinical predictors of good glycemic control in patients starting or intensifying oral hypoglycemic pharmacological therapy.

Methods: A multicenter, prospective cohort of 499 diabetic subjects was enrolled in this study: patients with newly diagnosed diabetes (NDM group) or poor glycemic control with oral antidiabetic drugs (OADs) (PDM group). All subjects then started or intensified OADs therapy and followed up for 91 days. Glycemic control was determined according to HbA1c at day 91 with HbA1c <7% considered good.

Results: The proportions of patients with good glycemic control after follow up for 91 days were 66.9% and 34.8% in NDM group and PDM group respectively. Logistic regression analysis showed that the change in GA at 28 days was the only predictor of good glycemic control in NDM patients (OR = 1.630, 95% CI 1.300-2.044, P < 0.001). In PDM patients, changes in GA at 28 days, CPI, baseline HbA1c, diabetic duration, and BMI were all independent predictors of good glycemic control (All P < 0.05).

Conclusions: GA decline is a good predictor of future success in newly diagnosed patients. In patients intensifying therapy, beside GA decline, other individualized clinical characteristics should also be considered.
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http://dx.doi.org/10.1016/j.jdiacomp.2019.107464DOI Listing
February 2020

Delayed diagnosis of acromegaly in a patient with focal segmental Glomerulosclerosis: a rare case report and literature review.

BMC Nephrol 2019 11 27;20(1):435. Epub 2019 Nov 27.

Renal Division, Department of Medicine, Peking University First Hospital; Institute of Nephrology, Peking University; Key Laboratory of Renal Disease, Ministry of Health of China; Key Laboratory of CKD Prevention and Treatment, Ministry of Education of China, Beijing, 100034, China.

Background: Experimental studies have demonstrated that hypersecretion of growth hormone (GH) is associated with development of glomerular sclerosis. However, clinical case of such condition is very rare. Here we presented a case of focal segmental glomerulosclerosis (FSGS) associated with acromegaly.

Case Presentation: A 63-year-old man was diagnosed as nephrotic syndrome with minimal change disease for 2 years. Prednisone 1 mg/kg/day for 9 months led to no response. After admission, the second kidney biopsy indicated FSGS (NOS variant). On admission, his acromegalic features were noticed and he complained with a 20-year history of soft tissue swelling of hands and feet. Serum GH and insulin-like growth factor 1 (IGF-1) concentrations were both elevated significantly. An oral glucose tolerance test showed inadequate suppression of serum GH. The presence of a pituitary macroadenoma with a diameter of 1.4 cm by MRI confirmed the diagnosis of acromegaly. Then, the tumor was subtotally removed by trans-sphenoidal surgery. Partial remission of proteinuria was achieved 3 months after surgery and maintained during follow-up, with gradual reduce of corticosteroid.

Conclusions: This rare case suggested that the hypersecretion of GH may participate, at least in part, in FSGS development and progression. Early diagnosis and treatment of acromegaly is beneficial.
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http://dx.doi.org/10.1186/s12882-019-1626-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6880637PMC
November 2019

Thyroid function of twin-pregnant women in early pregnancy.

Chin Med J (Engl) 2019 Sep;132(17):2033-2038

Department of Endocrinology, Peking University First Hospital, Beijing 100034, China.

Background: Serum human chorionic gonadotrophin (hCG) is higher in twin than that in singleton pregnancies. As hCG stimulates the thyroid to produce more free thyroxine (FT4), which may lead to decreased thyroid-stimulating hormone (TSH) levels, the reference ranges of thyroid-related indicators may differ between singleton and twin pregnancies in the first trimester. This study aimed to establish reference ranges for thyroid-related indicators in early twin pregnancies and to compare them with singleton pregnancies.

Methods: Data of 820 twin-pregnant women were extracted from the established database of all pregnant women who delivered at Peking University First Hospital from October 2013 to May 2018; 160 who met National Academy of Clinical Biochemistry criteria were included to establish TSH and FT4 reference ranges. We screened 480 (3:1 paired) women with singleton pregnancies from the same database as controls. The Mann-Whitney test for TSH and FT4 levels was applied for comparisons between singleton and twin pregnancies.

Results: First-trimester reference ranges (4-12 gestational weeks) for twin pregnancies were: TSH 0.69 (0.01-3.35) mIU/L and FT4 16.38 (12.45-23.34) pmol/L. Median TSH was significantly lower at 7 to 12 gestational weeks than that at 4 to 6 gestational weeks (0.62 vs. 0.96 mIU/L, Z = -1.964, P = 0.049); FT4 was not significantly different between the two groups. Compared to singleton pregnancies, median TSH was significantly lower (0.69 vs. 1.27 mIU/L, Z = -6.538, P = 0.000), and FT4 was significantly higher (16.38 vs. 14.85 pmol/L, Z = -7.399, P = 0.000) in twin pregnancies in the first trimester.

Conclusions: Specific reference ranges for thyroid-related indicators for twin pregnancies are needed to avoid a misdiagnosis of thyroid dysfunction. Moreover, establishment of separate reference ranges for 4 to 6 and 7 to 12 gestational weeks in twin pregnancies may be considered.
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http://dx.doi.org/10.1097/CM9.0000000000000381DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6793799PMC
September 2019

Effects of Artesunate on the Expressions of Insulin-Like Growth Factor-1, Osteopontin and C-Telopeptides of Type II Collagen in a Rat Model of Osteoarthritis.

Pharmacology 2018 13;101(1-2):1-8. Epub 2017 Sep 13.

The Third Department of Orthopedics, The Fifth Hospital of Harbin, Harbin, PR China.

Objective: The study aims to explore the effects of artesunate on insulin-like growth factor-1 (IGF-1), Osteopontin (OPN), and C-telopeptides of type II collagen (CTX-II) in serum, synovial fluid (SF), and cartilage tissues of rats with osteoarthritis (OA).

Methods: OA models were established. Normal model, artesunate, and Viatril-S groups (20 rats respectively) were set. Enzyme-linked immunosorbent assay, IHC staining, and quantitative real-time polymerase chain reaction were conducted to calculate IGF-1, OPN, and CTX-II levels in serum, SF, and cartilage tissues of rats. The pathological changes in cartilage tissues were evaluated with Mankin score and Hematoxylin-Eosin staining.

Results: Compared with the normal group, the model group showed increased IGF-1 level; decreased OPN, CTX-II levels in the serum and SF; and contrary results were seen in the cartilage tissues. A gradual ascending IGF-1 level and descending OPN and CTX-II levels existed in the serum and SF in the artesunate and Viatril-S groups after 2 weeks. The model group showed the most obvious pathological changes and highest Mankin score compared with the other groups. Higher IGF-1 level and lower OPN, CTX-II levels were exhibited in the cartilage tissue in the artesunate and Viatril-S groups but not in the model group.

Conclusion: Artesunate and Viatril-S inhibit OA development by elevating IGF-1 level and reducing OPN and CTX-II levels.
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http://dx.doi.org/10.1159/000479160DOI Listing
August 2018

Processing of calamine with modern analytical techniques: Processed with Huanglian Decoction () and Sanhuang Decoction ().

Chin J Integr Med 2017 Nov 28;23(11):850-857. Epub 2017 Jul 28.

Institute of Pharmaceutical & Food Engineering, Shanxi University of Traditional Chinese Medicine, Jinzhong, Shanxi Province, 030619, China.

Objective: To determine the pyrolysis characteristics of calcined and processed calamine, qualitatively and quantitatively compare the contents of related elements, morphology and functional groups of the pyrolysis products dried at different heating temperatures and explore the critical temperature and the optimal drying temperature for the process of calamine with Huanglian Decoction (HLD, ) and San Huang Decoction (SHD, ).

Methods: Pyrolysis products were prepared by programmable and constantly heating the calcined and processed calamine to or at different heating temperatures. Thermogravimetry (TG) was used to test their pyrolysis characteristics. Fourier transform infrared spectroscopy and scanning electron microscopeenergy dispersive spectrometer were used to determine their morphology, functional groups and element contents. Page model was used to investigate the constant drying kinetics of processed calamine.

Results: The adding of HLD or SHD to calcined calamine (CC) can slow its weight loss in drying pyrolysis process. The temperature ranges where HLD and SHD can affect its weight loss were 65-150 °C and 74-180 °C, respectively. The drying temperature was optimized as 90 °C. The drying kinetic for the processed calamine fits Page model shows good linearity.

Conclusions: Conclusions: The critical temperature and the optimal drying temperature where HLD and SHD can affect the weight loss rate in the process of calamine were explored using the theories and methods of both biophysical chemistry and processing of Chinese materia medica. This work provides a good example for the study of the process of other Chinese medicines using modern analytical techniques.
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http://dx.doi.org/10.1007/s11655-017-2798-9DOI Listing
November 2017

Association between the 8-oxoguanine DNA glycosylase gene Ser326Cys polymorphism and age-related cataract: a systematic review and meta-analysis.

Int Ophthalmol 2018 Aug 19;38(4):1451-1457. Epub 2017 Jun 19.

Department of Laboratory Medicine, General Hospital of Ji'nan Military Region of PLA, Ji'nan, 250031, Shandong Province, People's Republic of China.

Purpose: To investigate the association between the 8-oxoguanine DNA glycosylase (OGG1) gene Ser326Cys (rs1052133) polymorphism and age-related cataract (ARC).

Methods: MEDLINE and EMBASE were searched to identify potential studies published before May 19, 2017, investigating the association between the OGG1 gene Ser326Cys polymorphism and ARC risk. The quality of eligible studies was assessed using the Newcastle-Ottawa Scale tool. The association between the OGG1 gene Ser326Cys polymorphism and ARC was analyzed using meta-analysis. Publication bias and sensitivity analyses were also performed.

Results: Six studies were included in this systematic review, and five of these studies with Hardy-Weinberg equilibrium were included in a meta-analysis. The sample size of the meta-analysis was 3716, including 1831 patients with cataract and 1885 controls. Odds ratios (ORs) were 0.67 (95% confidence interval (CI) 0.52-0.85), 0.90 (95% CI 0.54-1.51), 0.52 (95% CI 0.32-0.85) and 0.72 (95% CI 0.56-0.92) for recessive, dominant, additive and allele contrast models, respectively. Sensitivity analysis indicated that the results of the meta-analysis were robust. No publication bias was observed.

Conclusions: The OGG1 gene Ser326Cys polymorphism was associated with ARC risk.
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http://dx.doi.org/10.1007/s10792-017-0606-3DOI Listing
August 2018

[Value of nutritional risk screening in evaluating adverse clinical outcomes in children with severe pneumonia].

Zhongguo Dang Dai Er Ke Za Zhi 2017 Mar;19(3):322-326

Department of Pediatrics, The People's Hospital of Binzhou, Binzhou, Shandong 256610, China.

Objective: To investigate the nutritional risk in children with severe pneumonia using the Screening Tool for the Assessment of Malnutrition in Paediatrics (STAMP) and the association between nutritional risk and adverse clinical outcomes.

Methods: According to the STAMP score, 216 children with severe pneumonia were classified into high nutritional risk group (HR group; n=98), moderate nutritional risk group (MR group; n=65), and low nutritional risk group (LR group; n=53). Fasting blood samples were collected to measure the levels of insulin-like growth factor-1 (IGF-1), adiponectin, leptin, non-esterified fatty acid (NEFA), albumin, transferrin, prealbumin, and retinol binding protein (RBP). The adverse clinical outcomes were recorded.

Results: Compared with the MR and LR groups, the HR group had significantly lower serum levels of IGF-1, leptin, adiponectin, prealbumin, and RBP, as well as a significantly higher serum level of NEFA (P<0.05). Compared with the MR and LR groups, the HR group had a significantly higher proportion of children admitted to the intensive care unit and a significantly longer duration of mechanical ventilation (P<0.05). The HR group had a significantly longer mean hospital stay and a significantly higher incidence rate of complications compared with the LR and MR groups (P<0.05).

Conclusions: Nutritional risk screening has an important value in evaluating the clinical outcome of children with severe pneumonia, and children at a higher nutritional risk tend to have more adverse clinical outcomes.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7390143PMC
March 2017

Investigation into knowledge, attitude, and practice regarding medical nutrition therapy among patients with diabetes in China: Results from a national multicenter cross-sectional study.

J Diabetes 2017 Sep 5;9(9):865-873. Epub 2016 Dec 5.

Department of Clinical Nutrition, Peking University First Hospital, Beijing, China.

Background: The aim of the present study was to investigate knowledge, attitude, and practice (KAP) associated with medical nutrition therapy (MNT) among Chinese adult patients with diabetes and prediabetes.

Methods: From May to August 2014, a cross-sectional study was conducted in 40 hospitals across China. The KAP of respondents was investigated through a pretested structured questionnaire in face-to-face interviews. Anthropometric and biochemical data were collected, and KAP scores were recorded according to patient responses.

Results: In all, responses from 7017 of 7508 patients were analyzed. The mean (±SD) overall KAP score was 9.63 ± 3.46, with individual scores for the K, A, and P components being 2.69 ± 1.90, 1.77 ± 1.99, and 5.17 ± 1.99, respectively (out of possible total scores of 19, 6, 3, and 10, respectively). All scores were higher in respondents who received ≥15 min MNT education than in those with shorter sessions. Patients with higher KAP scores exhibited significantly better glycemic control, with a higher proportion achieving target HbA1c, fasting plasma glucose, and 2-h postprandial blood glucose levels (P < 0.05). "Health publicity in hospitals" and "expert outpatient services" were the most favorable means of acquiring MNT information. The two predominant concerns associated with MNT were "the feasibility" and "the authenticity and professionalism of the information".

Conclusions: Patients with diabetes and prediabetes achieved moderate scores for KAP towards MNT. Glycemic control was positively correlated with the KAP score. Thus, MNT education should be improved, with a particular focus on feasibility and authenticity and professionalism, in China.
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http://dx.doi.org/10.1111/1753-0407.12500DOI Listing
September 2017

Glycated albumin is superior to glycated hemoglobin for glycemic control assessment at an early stage of diabetes treatment: A multicenter, prospective study.

J Diabetes Complications 2016 Nov - Dec;30(8):1609-1613. Epub 2016 Jul 16.

Department of Endocrinology, Peking University First Hospital, Beijing, 100034, China.

Aims: This study was to determine whether serum glycated albumin (GA) was a better indicator of glycemic control than hemoglobin A1c (HbA1c) when starting a new treatment regimen for type 2 diabetes.

Methods: Newly diagnosed type 2 diabetes patients, or patients who had poor glycemic control with oral hypoglycemic agents, were enrolled at 10 hospitals in Beijing. Serum GA, HbA1c, fasting blood glucose (FBG), and C-peptide were assayed on Days 0, 14, 28, and 91 after treatment.

Results: Four hundred ninety-nine patients were enrolled. Mean FBG, GA and HbA1c decreased significantly in patients at Days 14, 28, and 91. In patients with improved glycemic control, the reduction of GA and HbA1c levels was 10.5±13.3% vs. 5.1±5.4% on Day 14, 16.0±13.4% vs. 9.0±7.0% on Day 28, and 18.0±16.7% vs. 18.3±9.4% on Day 91, respectively, compared with baseline values. Changes in GA on Day 14, 28 and 91 were all closely correlated with changes in HbA1c on Day 91. Change in GA on Day 14 was correlated with treatment effectiveness evaluated by HbA1c on Day 91.

Conclusions: GA may be a useful marker for assessing glycemic control at an early stage of new diabetes treatment and assist in guiding adjustments to treatment and therapy.
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http://dx.doi.org/10.1016/j.jdiacomp.2016.07.007DOI Listing
March 2018

Evaluation of Diagnostic Efficiency of Ultrasound Features on Malignant Thyroid Nodules in Chinese Patients.

Chin Med J (Engl) 2016 Aug;129(15):1784-8

Department of Endocrinology, Peking University First Hospital, Beijing 100034, China.

Background: The aim of this study was to evaluate the efficacy of ultrasonic features in predicting the malignancy of thyroid nodules in a group of Chinese patients.

Methods: In all, 762 patients with thyroid nodules (424 malignant and 338 benign) underwent ultrasound (US) check and surgery between March 2011 and July 2014 at Peking University First Hospital were identified. Univariate and receiver operating characteristic (ROC) analyses were performed to calculate the sensitivity, specificity, negative and positive predictive values of each US feature, and the accuracy of their combinations for prediction of malignancy.

Results: Patients with malignant nodules were younger and without obvious risk history than those in the benign group (P < 0.001, P = 0.93). No individual US sign was fully predictive of a malignant lesion. The Youden indexes of irregular margins and hypoechogenicity were the first and second highest in all US features, which were 51.9% and 45.2%, respectively. The sensitivity of solid components (89.7%) and hypoechogenicity (89.2%) and the specificity of taller-than-wide shape (98.5%) and microcalcifications (90.6%) were the first and second highest in all US features. Intranodular flow on a color Doppler examination was a weak predictor of malignancy. Under ROC analysis excepting intranodular flow, the 95% confidence interval (CI) of areas under the curves of hypoechogenicity and irregular margins with any one of the US features were overlapped that of five-feature combinations (95% CI: 0.850-0.901).

Conclusions: We should be alert with taller-than-wide shape and microcalcifications. Intranodular flow was a weak predictor of malignancy. According to Youden indexes and ROC analysis, irregular margins and hypoechogenicity combined with solid component or taller-than-wide shapes or microcalcifications have a high predicative value for malignant thyroid nodules in Chinese patients.
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http://dx.doi.org/10.4103/0366-6999.186643DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4976564PMC
August 2016

Management of hypertension and diabetes mellitus by cardiovascular and endocrine physicians: a China registry.

J Hypertens 2016 08;34(8):1648-53

aCentre for Epidemiological Studies and Clinical Trials, Shanghai Key Laboratory of Hypertension, The Shanghai Institute of Hypertension, Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai bDepartment of Cardiology, Beijing Anzhen Hospital, Capital Medical University cDepartment of Endocrinology, Peking University First Hospital dDepartment of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.

Objective: We investigated hypertension and diabetes mellitus in two management settings, namely cardiology and endocrinology, and their associations with albuminuria while accounting for the management of these two diseases.

Methods: Our multicentre registry included patients (≥20 years) seen for hypertension in cardiology or for diabetes mellitus in endocrinology. We administered a questionnaire and measured blood pressure, glycosylated haemoglobin A1c and albuminuria.

Results: Presence of both hypertension and diabetes was observed in 32.9% of hypertensive patients in cardiology (n = 1291) and 58.9% of diabetic patients in endocrinology (n = 1168). When both diseases were present, the use of combination antihypertensive therapy [odds ratio (OR) 0.31, P < 0.0001] and inhibitors of the renin-angiotensin system (OR 0.66, P = 0.0009) was less frequent in endocrinology than cardiology, and the use of combination antidiabetic therapy (OR 0.16, P < 0.0001) was less frequent in cardiology than endocrinology. The control of hypertension and diabetes, however, was not different between the two management settings (P ≥ 0.21), regardless of the therapeutic target (SBP/DBP < 140/90 or 130/80 mmHg and glycosylated haemoglobin A1c <7.0 or 6.5%). The prevalence of albuminuria was higher (P ≤ 0.02) in the presence of both diseases (23.3%) than those with either hypertension (12.6%) or diabetes alone (15.9%).

Conclusion: Hypertension and diabetes mellitus were often jointly present, especially in the setting of endocrinology. The management was insufficient on the use of combination antihypertensive therapy and inhibitors of the renin-angiotensin system in endocrinology and for combination antidiabetic therapy in cardiology, indicating a need for more intensive management and better control of both clinical conditions.
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http://dx.doi.org/10.1097/HJH.0000000000000994DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4933577PMC
August 2016

The value of short- and long-acting glucagon-like peptide-1 agonists in the management of type 2 diabetes mellitus: experience with exenatide.

Authors:
Xiao-Hui Guo

Curr Med Res Opin 2016 11;32(1):61-76. Epub 2015 Nov 11.

a Endocrinology Department , Peking University First Hospital , Beijing , China.

Background: Only about half of patients with type 2 diabetes treated with antihyperglycemic drugs achieve glycemic control (HbA1c <7%), most commonly due to poor treatment adherence. Glucagon-like peptide-1 (GLP-1) receptor agonists act on multiple targets involved in glucose homeostasis and have a low risk of causing hypoglycemia. While GLP-1 receptor (GLP-1R) agonists share the same mechanism of action, clinical profiles of individual agents differ, particularly between short- and long-acting agents. In this article, recent findings regarding the pharmacology of GLP-1 agonists are reviewed, and the clinical effects of short- versus long-acting agents are compared.

Data Sources: Relevant articles were identified through a search of PubMed using the keywords glucagon-like peptide-1, GLP-1, glucagon-like peptide-1 receptor agonist, GLP-1R agonist, and exenatide for publications up to 22 May 2015. Supporting data were obtained from additional searches for albiglutide, dulaglutide, liraglutide and lixisenatide as well as from the bibliographies of key articles.

Findings: Short-acting GLP-1R agonists produce greater reductions in postprandial glucose levels by slowing gastric emptying, whereas long-acting GLP-1R agonists produce greater reductions in fasting blood glucose by stimulating insulin secretion from the pancreas. These characteristics can be exploited to provide individualized treatment to patients. A large body of evidence supports the benefits of short- and long-acting exenatide as add-on therapy in patients with inadequate glycemic control despite maximum tolerated doses of metformin and/or sulfonylurea. Exenatide is generally well tolerated and no new safety concerns were identified during long-term follow-up of up to 5 years. A limitation of this review of short-and long-acting GLP-1 receptor agonists is that it focuses on exenatide rather than all the drugs in this class. However, the focus on a single molecule helps to avoid any confusion that may be introduced as a result of differences in molecular structure and size.

Conclusions: Short-acting GLP-1R agonists including exenatide are well suited to patients with type 2 diabetes with exaggerated postprandial glucose excursions and for co-administration with basal insulin therapy. Long-acting GLP-1R agonists including once weekly exenatide offer greater convenience and are well suited to patients who require specific control of fasting hyperglycemia.
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http://dx.doi.org/10.1185/03007995.2015.1103214DOI Listing
September 2016

Complete mitochondrial genome of a parthenogenetic subterranean termite, Reticulitermes aculabialis Tsai et Hwang (Isoptera: Rhinotermitidae).

Mitochondrial DNA A DNA Mapp Seq Anal 2016 09 23;27(5):3133-4. Epub 2015 Feb 23.

a College of Life Sciences, Northwest University , Xi'an , China.

The complete mitochondrial genome of a parthenogenetic termite Reticulitermes aculabialis was assembled and analyzed. The mitogenome is 16,475 bp long and contains the same gene repertoire and gene order as other Reticulitermes species (13 protein-coding genes, 22 tRNA genes, 2 rRNA genes and control region). Coding genes (PCGs, tRNAs and rRNAs) are 14,688 bp in length, occupying 89.15% of the total genomic size. The A + T content of the mitogenome is 65.78%.
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http://dx.doi.org/10.3109/19401736.2015.1007299DOI Listing
September 2016

Characterization and energy potential of food waste from catering service in Hangzhou, China.

Waste Manag Res 2014 Aug 30;32(8):791-5. Epub 2014 Jun 30.

College of Environmental and Resource Sciences, Zhejiang University, Hangzhou, China.

Safe disposal of food waste is becoming an impending issue in China with the rapid increase of its production and the promotion of environmental awareness. Food waste from catering services in Hangzhou, China, was surveyed and characterized in this study. A questionnaire survey involving 632 units across the urban districts showed that 83.5% of the food waste was not properly treated. Daily food waste production from catering units was estimated to be 1184.5 tonnes. The ratio of volatile solid to total solid, easily biodegradable matter (including crude fat, crude protein and total starch) content in total solid and the ratio of total organic carbon to nitrogen varied in ranges of 90.1%-93.9%, 60.9%-72.1%, and 11.9-19.9, respectively. Based on the methane yield of 350 mL g VS(-1) in anaerobic batch tests, annual biogas energy of 1.0 × 10(9) MJ was estimated to be recovered from the food waste. Food waste from catering services was suggested to be an attractive clean energy source by anaerobic digestion.
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http://dx.doi.org/10.1177/0734242X14537867DOI Listing
August 2014

Randomized, double blinded, placebo-controlled trial to evaluate the efficacy and safety of tolvaptan in Chinese patients with hyponatremia caused by SIADH.

J Clin Pharmacol 2014 Dec;54(12):1362-7

Department of Endocrinology, Key laboratory of endocrinology, Ministry of Health, Peking Union Medical College Hospital, Chinese Academe of Medical Sciences & Peking Union Medical College, Beijing 100730, China.

To study the effect of tolvaptan on non-acute, non-hypovolemic hyponatremia in inappropriate secretion of antidiuretic hormone (SIADH) syndrome in Chinese patients. Hyponatremic SIADH patients received placebo (N = 18) or tolvaptan (N = 19) at an initial dose of 15 mg/day with further titration to 30 mg/day and 60 mg/day based on serum sodium concentrations. Randomized, double-blind, placebo-controlled trial. Primary endpoint was the change of the serum sodium from baseline to days 4 and 7. Analysis of covariance (ANCOVA) was used for statistical analysis. At day 4, average daily changes in serum sodium levels from baseline was 1.9 ± 2.9 mmol/L (1.9 ± 2.9 mEq/L) in the placebo group and 8.1 ± 3.6 mmol/L (8.1 ± 3.6 mEq/L) in the tolvaptan group; at day 7, the values were 2.5 ± 3.9 mmol/L (2.5 ± 3.9 mEq/L) and 8.6 ± 3.9 mmol/L (8.6 ± 3.9 mmEq/L) for the placebo and tolvaptan groups (ANCOVA, P < 0.001). At days 4 and 7, daily urine output and proportions of patients with normalized serum sodium were significantly superior in the tolvaptan group. The most common adverse events occurring in the tolvaptan group were dry mouth and thirst. Tolvaptan demonstrated superiority to placebo in the treatment of Chinese SIADH patients with hyponatremia by elevating serum sodium concentration with acceptable safety profile.
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http://dx.doi.org/10.1002/jcph.342DOI Listing
December 2014

Effectiveness of different waist circumference cut-off values in predicting metabolic syndrome prevalence and risk factors in adults in China.

Biomed Environ Sci 2014 May;27(5):325-34

Department of Epidemiology and Statistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences, School of Basic Medicine, Peking Union Medical College, Beijing 100730, China.

Objective: To study the effectiveness of waist circumference cut-off values in predicting the prevalence of metabolic syndrome (MetS) and risk factors in adults in China.

Methods: A cross-sectional survey was condcuted in 14 provinces (autonomous region, municipality) in China. A total of 47,325 adults aged⋝20 years were selected by multistage stratified sampling, and questionnaire survey and physical and clinical examination were conducted among them. MetS was defined according to the International Diabetes Federation (IDF) criteria and modified IDF criteria.

Results: The age-standardized prevalence of MetS was 24.2% (22.1% in men and 25.8% in women) and 19.5% (22.1% in men and 18.0% in women) according to the IDF criteria and modified IDF criteria respectively. The age-standardized prevalence of pre-MetS was 8.1% (8.6% in men and 7.8% in women) according to the modified IDF criteria. The prevalence of MetS was higher in urban residents than rural residents and in northern China residents than in southern China residents. The prevalence of central obesity was about 30% in both men and women according to the ethnicity-specific cut-off values of waist circumference for central obesity (90 cm for men and 85 cm for women). Multivariate regression analysis revealed no significant difference in risk factors between the two MetS definitions.

Conclusion: Using both the modified IDF criteria and ethnicity-specific cut-off values of waist circumference can provide more useful information about the prevalence of MetS in China. Conclusion Using both the modified IDF criteria and ethnicity-specific cut-off values of waist circumference can provide more useful information about the prevalence of MetS in China.
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http://dx.doi.org/10.3967/bes2014.057DOI Listing
May 2014

Pyrolysis characteristics of radix rhizoma rhei, cortex moudan radicis, and radix sanguisorbae and correlations with the carbonizing process of Chinese herbs.

Chin J Nat Med 2014 Jan;12(1):55-64

Shanxi University of Traditional Chinese Medicine, Taiyuan 030024, China.

Aim: The aim of the work is to study the pyrolysis characteristics of radix rhizoma rhei, cortex moudan radicis, and radix sanguisorbae in an inert atmosphere of argon (Ar), and to investigate the mechanism of the carbonizing process of the three traditional Chinese herbs.

Methods: The pyrolysis characteristics of the crude materials and their extracts were studied by thermogravimetry-mass spectrometry (TG-MS) in a carrier gas of argon, coupled with Fourier transform infrared spectrometry (FTIR) and scanning electron microscopy (SEM) methods. Correlation of the pyrolysis behaviors with the carbonizing process by stir-frying of traditional Chinese medicines was made.

Results: Within the temperature range of 200-300 °C, which is the testing range for the study of the carbonizing process of Chinese herbs, the temperatures indicated by the maximum weight loss rate peak of the above three extracts were taken as the upper-limit temperatures of the carbonizing process of the herbs, and which were 200, 240 and 247 °C for radix rhizoma rhei, cortex moudan radicis, and radix Sanguisorbae, respectively. The ion monitoring signal peaks detected by the TG-MS method corresponded with reports that the level of chemical components of traditional Chinese medicinal materials would decrease after the carbonizing process. It was confirmed by Fourier transform infrared spectrometry (FTIR) and scanning electron microscopy (SEM) methods that better results of "medicinal property preservation" could be obtained by heating at 200 °C for radix rhizoma rhei, at about 250 °C for cortex moudan radicis, and radix sanguisorbae, as the relative intensity values of the common peaks were among the middle of their three carbonized samples by programmed heating.

Conclusion: The upper-limit temperatures of the carbonizing process for radix rhizoma rhei, cortex moudan radicis and radix sanguisorbae were 200, 240 and 247 °C respectively. It is feasible to research the mechanism and technology of the carbonizing process of traditional Chinese medicinal materials using thermogravimetry, Fourier transform infrared spectrometry, and scanning electron microscopy methods.
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http://dx.doi.org/10.1016/S1875-5364(14)60010-8DOI Listing
January 2014

Efficacy of structured education in patients with type 2 diabetes mellitus receiving insulin treatment.

J Diabetes 2014 Jul 26;6(4):290-7. Epub 2013 Nov 26.

Peking University First Hospital, Beijing, China.

Background: The aim of the present study was to assess the efficacy of structured education in insulin-treated type 2 diabetes mellitus (T2DM) patients.

Methods: In a 16-week open-label randomized controlled study, 1511 T2DM patients with inadequate responses to two or more oral antidiabetic drugs (OADs) for >3 months (HbA1c >7.5%) were randomized (1:1) to either an education group (structured diabetes education plus insulin therapy) or a control group (usual care plus insulin therapy). Both groups discontinued previous OADs (except biguanides and α-glucosidase inhibitors) and started twice daily injections of 30% soluble-70% isophane recombinant insulin. The primary endpoint was the change in HbA1c from baseline. Efficacy and safety data were analyzed for within- and between-group differences.

Results: Of the initial 1511 patients, 1289 completed the study (643 in the control group; 646 in the education group). At the end of the study, significant reductions in HbA1c versus baseline were evident in both groups, but the reduction was greater in the education group (2.16% vs. 2.08%; P < 0.05). A higher proportion of patients in the education group achieved target HbA1c levels <7% (43.81% vs. 36.86%; P < 0.05) and ≤6.5% (28.48% vs. 22.71%; P < 0.05). In addition, patients in the education group showed greater increments in scores and improvement in the Morisky Medication Adherence Scale (P < 0.05). The overall incidence of hypoglycemic events was similar in the two groups.

Conclusions: Structured education can promote the ability of patients to self-manage and their compliance with medications, thereby achieving better outcomes.
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http://dx.doi.org/10.1111/1753-0407.12100DOI Listing
July 2014

ChAy/Bx, a novel chimeric high-molecular-weight glutenin subunit gene apparently created by homoeologous recombination in Triticum turgidum ssp. dicoccoides.

Gene 2013 Dec 4;531(2):318-25. Epub 2013 Sep 4.

Triticeae Research Institute, Sichuan Agricultural University, Wenjiang 611130, China; Key Laboratory of Crop Genetic Resources and Improvement, Ministry of Education, Sichuan Agricultural University, Ya'an 625014, China.

High-molecular-weight glutenin subunits (HMW-GSs) are of considerable interest, because they play a crucial role in determining dough viscoelastic properties and end-use quality of wheat flour. In this paper, ChAy/Bx, a novel chimeric HMW-GS gene from Triticum turgidum ssp. dicoccoides (AABB, 2n=4x=28) accession D129, was isolated and characterized. Sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) analysis revealed that the electrophoretic mobility of the glutenin subunit encoded by ChAy/Bx was slightly faster than that of 1Dy12. The complete ORF of ChAy/Bx contained 1,671 bp encoding a deduced polypeptide of 555 amino acid residues (or 534 amino acid residues for the mature protein), making it the smallest HMW-GS gene known from Triticum species. Sequence analysis showed that ChAy/Bx was neither a conventional x-type nor a conventional y-type subunit gene, but a novel chimeric gene. Its first 1305 nt sequence was highly homologous with the corresponding sequence of 1Ay type genes, while its final 366 nt sequence was highly homologous with the corresponding sequence of 1Bx type genes. The mature ChAy/Bx protein consisted of the N-terminus of 1Ay type subunit (the first 414 amino acid residues) and the C-terminus of 1Bx type subunit (the final 120 amino acid residues). Secondary structure prediction showed that ChAy/Bx contained some domains of 1Ay subunit and some domains of 1Bx subunit. The special structure of this HMW glutenin chimera ChAy/Bx subunit might have unique effects on the end-use quality of wheat flour. Here we propose that homoeologous recombination might be a novel pathway for allelic variation or molecular evolution of HMW-GSs.
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http://dx.doi.org/10.1016/j.gene.2013.08.073DOI Listing
December 2013

Glycosylation of recombinant human thyroid peroxidase ectodomain of insect cell origin has little effect on recognition by serum thyroid peroxidase antibody.

Chin Med J (Engl) 2013 ;126(15):2907-11

Department of Endocrinology, Peking University First Hospital, Beijing 100034, China.

Background: Thyroid peroxidase (TPO) is an important autoantigen in Hashimoto's thyroiditis (HT), and almost all epitopes are located in TPO ectodomain. The glycosylation of TPO might contribute to breaking self-tolerance, therefore, purified glycosylated recombinant TPO ectodomain is prerequisite of elucidating its role in the pathogenesis of HT. The aim of our study was to investigate whether the glycosylation has influence on the antigenic determinants of recombinant TPO.

Methods: Bac-to-Bac baculovirus expression system was used to generate recombinant human TPO ectodomain. The antigenicity was analyzed by antigen specific enzyme-linked immunosorbant assays (ELISAs). The glycosylation of recombinant human TPO ectodomain of High Five insect cell origin was detected by lectin-ELISAs.

Results: TPO ectodomain was recovered from the culture media as a soluble protein, and it was fused with a hexahistidine tag which allowed purification by nickel-affinity chromatography. The recombinant TPO ectodomain could be recognized by all the 54 HT patients and three TPO monoclonal antibodies. Fucose, sialic acid and galactose were all detected on the recombinant TPO ectodomain. Sera TPOAb binding decreased slightly after non-specific deglycosylation of TPO by periodic acid.

Conclusions: High Five insect cells derived recombinant human TPO ectodomain had N-glycosylation sites, which might have little effect on recognition by serum TPOAb.
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March 2014

Glycemic control among patients in China with type 2 diabetes mellitus receiving oral drugs or injectables.

BMC Public Health 2013 Jun 21;13:602. Epub 2013 Jun 21.

Department of Endocrinology and Metabolism, Peking University People's Hospital, No. 11 Xizhimen Nandajie, Beijing 100044, China.

Background: The prevalence of type 2 diabetes mellitus (T2DM) is increasing rapidly among Chinese adults, and limited data are available on T2DM management and the status of glycemic control in China. We assessed the efficacy of oral antidiabetes drugs (OADs), glucagon-like peptide-1 (GLP-1) receptor agonists, and insulin for treatment of T2DM across multiple regions in China.

Methods: This was a multicenter, cross-sectional survey of outpatients conducted in 606 hospitals across China. Data from all the patients were collected between April and June, 2011.

Results: A total of 238,639 patients were included in the survey. Eligible patients were treated with either OADs alone (n=157,212 [65.88%]), OADs plus insulin (n=80,973 [33.93%]), or OADs plus GLP-1 receptor agonists (n=454 [0.19%]). The OAD monotherapy, OAD + insulin, and OAD + GLP-1 receptor agonist groups had mean glycosylated hemoglobin (HbA1c) levels (±SD) of 7.67% (±1.58%), 8.21% (±1.91%), and 7.80% (±1.76%), respectively. Among those three groups, 34.63%, 26.21%, and 36.12% met the goal of HbA1c <7.0%, respectively. Mean HbA1c and achievement of A1c <7.0% was related to the duration of T2DM.

Conclusions: Less than one third of the patients had achieved the goal of HbA1c <7.0%. Glycemic control decreased and insulin use increased with the duration of diabetes.
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http://dx.doi.org/10.1186/1471-2458-13-602DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3729491PMC
June 2013

[Research on processing mechanism of Zushima which was stir-fried with licorice based on TG-DTG].

Zhongguo Zhong Yao Za Zhi 2012 Dec;37(23):3558-63

School of Traditional Chinese Medicine, Shanxi University of Traditional Chinese Medicine, Taiyuan 030024, China.

Objective: To investigate the processing mechanism of Zushima which was stir-fried with licorice.

Method: Study of pyrolysis characteristics for extraction of Zushima effective part, petroleum ether, chloroform, ethyl acetate, n-butanol parts and the mixture of Zushima effective parts and licorice solid powder according to the proportion of 10: 1, 10: 2, 10: 3 was carried out in the thermogravimetric analyzer, the simulation of air (N2-O2 4:1) was chosen as carrier gas and heating rate was 5 degrees C x min(-1).

Result: Compared with TG-DTG curve of Zushima effective parts, the major weightloss temperature range of petroleum ether extraction which has strong stimulation was 320-390 degrees C, 0.69% x min(-1) weightlessness rate peak gradually moved forward with the addition of licorice powder, finally it was merged with the peak around 265 degrees C. In addition, effective department of Zushima at 291, 516 degrees C for 2.38% x min(-1) and 2.42% x min(-1) thermal weightlessness rate peak shift to lower temperature, the moving range were about 20-26, 19-50 degrees C, the former was significantly reduced, the latter was significantly increased.

Conclusion: In the course of programmed temperature heating, petroleum ether department was easy to lose with the addition oflicorice solid powder. At the same time, the main efficacy components of Zushima had a slow loss rate, which supported the processing mechanisms of TG-DTG method to research traditional Chinese medicine, and verified irritating characteristics that stimulus reduced after stir-fried with licorice.
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December 2012

Comparison of parathyroid hormone (1-34) and elcatonin in postmenopausal women with osteoporosis: an 18-month randomized, multicenter controlled trial in China.

Chin Med J (Engl) 2013 Feb;126(3):457-63

Department of Endocrinology, Tongji Hospital of Tongji University, Shanghai 200065, China.

Background: Recombinant human parathyroid hormone (1-34) (rhPTH (1-34)) is the first agent in a unique class of anabolic therapies acting on the skeleton. The efficacy and safety of long-term administration of rhPTH (1-34) in Chinese postmenopausal women had not been evaluated. This study compared the clinical efficacy and safety of rhPTH (1-34) with elcatonin for treating postmenopausal women with osteoporosis in 11 urban areas of China.

Methods: A total of 453 postmenopausal women with osteoporosis were enrolled in an 18-month, multi-center, randomized, controlled study. They were randomized to receive either rhPTH (1-34) 20 µg (200 U) daily for 18 months, or elcatonin 20 U weekly for 12 months. Lumbar spine (L1-4) and femoral neck bone mineral density (BMD), fracture rate, back pain as well as biochemical markers of bone turnover were measured. Adverse events were recorded.

Results: rhPTH (1-34) increased lumbar BMD significantly more than did elcatonin after 6, 12, and 18 months of treatment (4.3% vs. 1.9%, 6.8% vs. 2.7%, 9.5% vs. 2.9%, P < 0.01). There was only a small but significant increase of femoral neck BMD after 18 months (2.6%, P < 0.01) in rhPTH groups. There were larger increases in bone turnover markers in the rhPTH (1-34) group than those in the elcatonin group after 6, 12, and 18 months (serum bone-specific alkaline phosphatase (BSAP) 93.7% vs. -3.6%; 117.8% vs. -4.1%; 49.2% vs. -5.8%, P < 0.01; urinary C-telopeptide/creatinine (CTX/Cr) 250.0% vs. -29.5%; 330.0% vs. -41.4%, 273.0% vs. -10.6%, P < 0.01). rhPTH (1-34) showed similar effect of pain relief as elcatonin. The incidence of clinical fractures was 5.36% (6/112) in elcatonin group and 3.2% (11/341) in rhPTH (1-34) group (P = 0.303). Both treatments were well tolerated. Hypercaluria (9.4%) and hypercalcemia (7.0%) in rhPTH (1-34) group were transient and caused no clinical symptoms. Pruritus (8.2% vs. 2.7%, P = 0.044) and redness of injection site (4.4% vs. 0, P = 0.024) were more frequent in rhPTH (1-34). Nausea/vomiting (16.1% vs. 6.2%, P = 0.001) and hot flushes (7.1% vs. 0.6%, P < 0.001) were more common in elcatonin group.

Conclusions: rhPTH (1-34) was associated with greater increases in lumbar spine BMD and bone formation markers. It could increase femoral BMD after 18 months of treatment. rhPTH could improve back pain effectively. The results of the present study indicate that rhPTH (1-34) is an effective, safe agent in treating Chinese postmenopausal women with osteoporosis.
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February 2013

Pharmacokinetics, safety, and tolerability of single- and multiple-dose exenatide once weekly in Chinese patients with type 2 diabetes mellitus.

J Diabetes 2013 Jun;5(2):127-35

Department of Pharmacy, Peking University First Hospital, Beijing, China.

Background: This open-label, single-period study assessed the pharmacokinetics, safety, tolerability, and pharmacodynamics of exenatide once weekly (q.w.), following single and multiple weekly subcutaneous (s.c.) injections in native Chinese patients with type 2 diabetes (T2D).

Methods: Patients (n = 25; mean [±SD] age 51.3 ± 8.2 years; body mass index 25.6 ± 2.4 kg/m(2) ; HbA1c 7.4 ± 1.2%; duration of diabetes 3.1 ± 3.1 years) previously treated with diet modification and exercise alone or incombination with stable metformin doses were enrolled in the study. Twenty-five patients received weekly doses of 2 mg, s.c., exenatide q.w. for 10 weeks, followed by 10 weeks observation. Pharmacokinetic parameters of exenatide, fasting plasma glucose (FPG), HbA1c, and body weight were summarized using descriptive statistics.

Results: Steady state plasma exenatide concentrations (299 pg/mL) were attained within 8 weeks. Exenatide q.w. was generally well tolerated, and the majority of adverse events reported were mild in severity. The most frequent study drug-related adverse events were diarrhea and vomiting. Decreases were observed from baseline to 10 weeks in FPG (~3.0 mmol/L), HbA1c (~1.0%), and body weight (~3.8 kg).

Conclusions: This is the first clinical trial of exenatide q.w. in native Chinese patients with T2D. The results suggest that exenatide q.w. has a pharmacokinetic profile in this patient population similar to that observed in other ethnic and racial populations, and appears to be safe and generally well tolerated, with the potential to improve glycemic control and decrease body weight without increasing the risk of hypoglycemia.
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http://dx.doi.org/10.1111/1753-0407.12020DOI Listing
June 2013

Efficacy and safety of glimepiride as initial treatment in Chinese patients with Type 2 diabetes mellitus.

Curr Med Res Opin 2013 Mar 24;29(3):169-74. Epub 2013 Jan 24.

Peking University First Hospital, Beijing, China.

Objective: To investigate the efficacy and safety of glimepiride as initial mono-therapy in type 2 diabetes patients in China.

Methods: This is a multi-center, open-label, single arm study. A total of 391 subjects were enrolled to receive glimepiride treatment for 16 weeks, the initiation dose was 1 mg/d, with titration to 2 mg/d and 4 mg/d according to the fasting blood glucose (FBG) level measured at each visit. The change in HbA1c, fasting plasma glucose (FPG), 2 h postprandial blood glucose (2hPPG), HOMA-IR, weight, waist circumference and the incidence of hypoglycemia were evaluated. An exploratory analysis was conducted to identify the potential population prone to achieve target glycemic control.

Results: HbA1c was reduced significantly from 8.6 ± 1.6% to 6.9 ± 0.9% (p < 0.001); 60.9% of the subjects achieved HbA1c <7% at study endpoint. The reduction in FPG and 2hPPG were 2.3 mmol/L and 4.4 mmol/L (p < 0.001) respectively. Insulin resistance was improved significantly with HOMA-IR decreasing from 2.5 ± 2.3 to 2.2 ± 1.9 (p = 0.009). The incidence of confirmed hypoglycemia (BG ≤ 3.9 mmol/L) was 3.1%.

Conclusions: Glimepiride treatment as initial mono-therapy could effectively improve blood glucose control in type 2 diabetic patients, with a favorable safety profile. Lack of control group was the major limitation of this study. ClinicalTrial.gov identifier: NCT00908921.
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http://dx.doi.org/10.1185/03007995.2013.765396DOI Listing
March 2013
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