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APPENDIX

M. Weis Bentzon

In the main article groups of patients are compared. For each patient a linear regression model is used to characterize the change in urinary oestriol excretion from the 26th week of pregnancy.

Expressed in statistical terms the model is

article image

where ij is the logarithm of the value of the urinary oestriol excretion and xij the number of weeks for patient number i measurement number j. αi and βi are constants and εij are random variables with the same variance σ2.

The α's and β's are found to vary significantly from patient to patient within the groups to be compared. The question then arises: How should the β's in the different groups be compared?

For each patient an estimate bi of βi is calculated as

article image

The group is characterised by the weighted average of the bi's

article image

If the β's are supposed to vary at random

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OPENING SPEECH

Dr. Chang Wei-hsun

On behalf of the Director-General, it gives me great pleasure to welcome you to this Meeting on Pharmacological Models to Assess Toxicity and Side Effects of Fertility Regulating Agents. I would like particularly to express the Organization's gratitude for the extensive working papers that have been prepared to form the basis of presentations during the next four days.

Maybe I should begin by situating the subject matter of this meeting within the general framework of WHO's activities in the field of health and family planning. Within this area, as in other aspects of the Organization's work, WHO's main responsibilities are to assist national authorities in organizing health services, including the training of health personnel. From the beginning, the Member States of WHO have recognized the fact that research must play a part in attaining these objectives.

This research covers the definition of priority health problems, the development of appropriate therapeutic

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Seasonal variations of plasma normetanephrine levels in Los Angeles

Run Yu and Meng Wei

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THERAPY OF ENDOCRINE DISEASE: A systematic review and meta-analysis of α-lipoic acid in the treatment of diabetic peripheral neuropathy

Tingting Han, Jiefei Bai, Wei Liu, and Yaomin Hu

Objective

To evaluate the effects and safety of 300–600 mg α-lipoic acid (ALA) given i.v. for diabetic peripheral neuropathy (DPN).

Methods

We searched the databases of Medline, Embase, and Cochrane central register of Controlled Trials and Chinese biological medicine for clinical trials of ALA in the treatment of DPN. Data were extracted to examine methodological quality and describe characteristics of studies. The primary outcomes were efficacy, median motor nerve conduction velocity (MNCV), median sensory nerve conduction velocity (SNCV), peroneal MNCV, and peroneal SNCV. Secondary outcomes were adverse events.

Results

Fifteen randomized controlled trials met the inclusion criteria. The treatment group involved the administration of ALA 300–600 mg i.v. per day. And the control group used the same interventions except for ALA. Compared with the control group, nerve conduction velocities increased significantly in the treatment group. The weighted mean differences in nerve conduction velocities were 4.63 (95% confidence interval 3.58–5.67) for median MNCV, 3.17 (1.75–4.59) for median SNCV, 4.25 (2.78–5.72) for peroneal MNCV, and 3.65 (1.50–5.80) for peroneal SNCV in favor of the treatment group. The odds ratio in terms of efficacy was 4.03 (2.73–5.94) for ALA. Furthermore, no serious adverse events were observed during the treatment period.

Conclusions

The results of this meta-analysis provide evidence that treatment with ALA (300–600 mg/day i.v. for 2–4 weeks) is safe and that the treatment can significantly improve both nerve conduction velocity and positive neuropathic symptoms. However, the evidence may not be strong because most of the studies included in this meta-analysis have poor methodological quality.

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Local action of exogenous growth hormone and insulin-like growth factor-I on dihydroxyvitamin D production in LLC-PK1 cells

S Wei, H Tanaka, and Y Seino

Previous in vivo studies have shown that growth hormone (GH) affects vitamin D and mineral metabolism. Insulin-like growth factor-I (IGF-I) was recently reported to be a regulator of renal 1,25-dihydroxyvitamin D3 (1,25-(OH)2D3) production, suggesting that it mediates the effects of GH on vitamin D metabolism. However, there is no direct evidence to support this. The present study was designed to investigate the in vitro effects of GH and IGF-I on the renal production of 1,25-(OH)2D3 and 24,25-dihydroxyvitamin D3 (24,25-(OH)2D3) in a pig kidney cell line, LLC-PK1. Confluent cells were preincubated in serum-free medium with hormone (GH or IGF-I) or vehicle, and then incubated with 25-[3H]OHD3. The levels of 1,25-[3H](OH)2D3 and 24,25-[3H](OH)2D3 produced were determined after lipid extraction and HPLC purification. Production of 1,25-(OH)2D3 and 24,25-(OH)2D3 was increased after both IGF-I and GH preincubation in a dose-dependent manner. Significant increases were found after preincubation with 13 nmol/l IGF-I (1,25-(OH)2D3, 1.8-fold: 24,25-(OH)2D3, 1.5-fold)or 0.9 or 9 nmol/lGH (1,25-(OH)2D3, 1.3-fold and 1.5-fold; 24.25-(OH)2D3, 1.4-fold and 1.5-fold respectively). Furthermore, the effect of 9 nmol/l GH on 1.25-(OH)2D3 and 24,25-(OH)2D3 production was blocked in the presence of IGF-I receptor monoclonal antibody. These results confirm that IGF-I acts on renal tubules, resulting in induction of 1,25-(OH)2D3 and 24,25-(OH)2D3 production, and the findings suggest that GH stimulates 1.25-(OH)2D3 and 24,2 5-(OH)2D3 production by increasing local IGF-I production in the kidney.

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Pulmonary metastases in differentiated thyroid cancer: efficacy of radioiodine therapy and prognostic factors

Hong-Jun Song, Zhong-Ling Qiu, Chen-Tian Shen, Wei-Jun Wei, and Quan-Yong Luo

Context

Data from a large cohort of patients with pulmonary metastases from differentiated thyroid cancer (DTC) were retrospectively analyzed.

Objective

To assess the effect of radioiodine therapy and investigate the prognostic factors of survival for patients with pulmonary metastasis secondary to DTC.

Methods

A total of 372 patients with pulmonary metastasis from DTC treated with 131I entered the study. According to the results of 131I whole-body scan (WBS), pulmonary metastases were classified as 131I-avid and non-131I-avid. For patients with 131I-avid lung metastases, treatment response was measured by three parameters: serum thyroglobulin (Tg) levels, chest computed tomography (CT) and post-therapeutic 131I-WBS. Overall survival was calculated by the Kaplan–Meier method. Factors predictive of the outcome were determined by multivariate analyses.

Results

Among patients demonstrating 131I-avid pulmonary metastases (256/372, 68.8%), 156 cases (156/256, 60.9%) showed a significant decrease in serum Tg levels after 131I therapy and 138 cases (138/229, 60.3%) showed a reduction in pulmonary metastases on follow-up CT. A complete cure, however, was only achieved in 62 cases (62/256, 24.2%). Multivariate analysis showed that only age, the presence of multiple distant metastases and pulmonary metastatic node size were significant independent variables between the groups of 131I-avid and non-131I-avid.

Conclusion

This study indicated that, most 131I-avid pulmonary metastases from DTC can obtain partial or complete remission after 131I therapy. Younger patients (<40 years old) with only pulmonary metastases and small (‘fine miliaric’ or micronodular) metastases appear to have relative favorite outcomes. Patients who do not respond to 131I treatment have a worse prognosis.

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Association study of the polymorphisms in the KISS1 gene with central precocious puberty in Chinese girls

Xiaohui Luan, Yuxun Zhou, Wei Wang, Hong Yu, Pin Li, Xiaohong Gan, Dongzhi Wei, and Junhua Xiao

Objective: The kisspeptin/GPR54 pathway has been proven to be crucial in the process of puberty onset, yet the polymorphisms in the KISS1 gene and their relationships with central precocious puberty (CPP) have not been investigated. This study was performed to reveal the relationship between the gene and the disease.

Design and Methods: 272 Chinese Han girls diagnosed to be CPP patients were recruited as Case Group I, 43 unrelated African women as Case Group II, and 288 unrelated normal Chinese Han girls as Control Group. Polymorphism scans of the KISS1 gene were performed for the first time by bidirectional resequencing of the whole gene in a subset of the patients, and then by ligase detection reaction some of the polymorphisms identified were typed in the two groups and the respective haplotypes were constructed. The relationships of the typed polymorphisms and the haplotypes with CPP were evaluated by an association study between genotypes and phenotypes.

Results: By resequencing, eight polymorphisms were identified, five of which were typed forming 18 haplotypes. Although one novel nonsynonymous single nucleotide polymorphism substituting one amino acid in kisspeptin (P110T) was found to be statistically related to the disease (P = 0.025), no further supporting evidence has yet been found. The other polymorphisms and all the haplotypes were not found to be related.

Conclusion: The polymorphism scanning and typing of KISS1 uncovered several potentially meaningful polymorphisms, but the conclusion was not solid and further studies are necessary for function validation of these polymorphisms.

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Expression of the CD11c gene in subcutaneous adipose tissue is associated with cytokine level and insulin resistance in women with polycystic ovary syndrome

Tao Tao, Shengxian Li, Aimin Zhao, Yanyun Zhang, and Wei Liu

Objective

Alterations in the phenotypes of macrophages in adipose tissue play a key role in inflammation and insulin resistance (IR). The phenotypes of macrophages in subcutaneous adipose tissue (SAT) and the relationship between proinflammation markers and IR in women with polycystic ovary syndrome (PCOS) remain unclear. The objectives of this study are to characterize the gene expression of macrophage markers and cytokines in the SAT of PCOS women and to estimate their relationships with circulating levels of cytokines and IR.

Methods

The cross-sectional study involves 16 PCOS women and 18 normal control women. Cytokines and macrophage markers in the circulation and SAT were determined using ELISA, quantitative PCR, or immunofluorescence staining. IR was estimated using the homeostasis model assessment (HOMA-IR).

Results

The gene expression levels of CD11c along with TNF α and leptin in SAT remained significantly higher in PCOS women than in normal women (P<0.05). However, no significant differences were found in CD68 mRNA expression in SAT between women with and without PCOS (P>0.05). Furthermore, CD11c mRNA abundance provided a stronger contribution to models predicting serum levels of TNFα (sTNFα) than did CD68 mRNA abundance. Lastly, increased sTNFα was associated with increased HOMA-IR in PCOS women, and this association was independent of both overall and visceral adiposity.

Conclusion

The high expression level of CD11c mRNA in SAT was proved to be an important feature in PCOS women. Furthermore, CD11c mRNA abundance made a stronger contribution to models predicting sTNFα in which existing proinflammatory properties might significantly contribute to the pathogenesis of IR in PCOS women.

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MECHANISMS IN ENDOCRINOLOGY: Parity and risk of type 2 diabetes: a systematic review and dose-response meta-analysis

Peiyun Li, Zhilei Shan, Li Zhou, Manling Xie, Wei Bao, Yan Zhang, Ying Rong, Wei Yang, and Liegang Liu

Objective

Epidemiologic studies regarding the association between parity and risk of type 2 diabetes have yielded inconsistent results. Therefore, we performed a systematic review and dose-response meta-analysis to determine the relation between parity and type 2 diabetes risk.

Methods

We searched PubMed and Embase for published epidemiologic studies that assessed the relation between parity and risk of type 2 diabetes up to 31 March 2016. A dose-response random-effects model was used to combine study-specific relative risks (RRs) and 95% confidence intervals (CIs). Potential sources of heterogeneity were explored by meta-regression and subgroup analyses.

Results

Seven cohort studies, 1 case-control study and 9 cross-sectional studies including 296 923 participants were eligible for inclusion. The combined RR for the highest versus lowest category of parity indicated a 54% increment in type 2 diabetes risk (95% CI: 29–83%). In the cubic spline model, a nonlinear association was found between parity and risk of type 2 diabetes (P = 0.02 for nonlinearity). Compared with nulliparous women, the estimated RR (95% CI) of type 2 diabetes for women with one to seven children was 1.01 (0.96–1.07), 1.08 (1.00–1.16), 1.20 (1.12–1.30), 1.32 (1.22–1.42), 1.37 (1.27–1.48), 1.39 (1.26–1.52) and 1.39 (1.23–1.57) respectively.

Conclusions

Higher parity is significantly associated with an increased risk of type 2 diabetes. Further studies are warranted to fully adjust for the potential confounders and explore the causality between parity and type 2 diabetes risk.

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Association between polycyclic aromatic hydrocarbons exposure and bone turnover in adults

Yuan-Yuei Chen, Tung-Wei Kao, Chung-Ching Wang, Chen-Jung Wu, Yi-Chao Zhou, and Wei-Liang Chen

Background

Cigarette smoking is a risk factor of osteoporosis and bone fracture. Tobacco smoke contains several polycyclic aromatic hydrocarbons. Thus, we hypothesized that environmental polycyclic aromatic hydrocarbon exposure is associated with bone loss and fracture risk. The present study examined the association between polycyclic aromatic hydrocarbon exposure and bone turnover in the general adult population.

Methods

A total of 1408 eligible participants from the National Health and Nutrition Examination Survey (NHANES 2001–2006) were included in this cross-sectional analysis. The levels of urinary N-telopeptide and serum bone-specific alkaline phosphatase, which are biomarkers of bone resorption and formation, respectively, were assessed. Meanwhile, polycyclic aromatic hydrocarbon exposure was evaluated using the concentrations of urinary polycyclic aromatic hydrocarbon metabolites. The association between polycyclic aromatic hydrocarbon exposures and N-telopeptide, and bone-specific alkaline phosphatase levels was assessed using a multivariate linear regression model.

Results

All polycyclic aromatic hydrocarbon metabolites except 3-phenanthrene were significantly associated with increased N-telopeptide levels (P < 0.05) after adjustment of relevant covariables. However, no significant relationship was observed between polycyclic aromatic hydrocarbon metabolites and bone-specific alkaline phosphatase levels. This relationship remained significant after the participants were assessed according to sex (P < 0.05). Additionally, all polycyclic aromatic hydrocarbon metabolites showed a positive association with N-telopeptide levels in participants aged <60 years (P < 0.05).

Conclusion

Polycyclic aromatic hydrocarbon exposure is associated with increased bone resorption among the general adult population in the United States. Further studies must assess the potential mechanisms associated with the adverse effects of polycyclic aromatic hydrocarbon exposure on bone loss.