Objective:To analyze that if the quality of ethics review is closely related to the protection of human subjects' right and interest. Methods:This article has analyzed all the issues raised by local Ethics Committee in the process of review in recent two years since guideline of ethical review of drug clinical trials was published, summed up the most common problems occurred in protocols and informed consents. Results:Total 94 new drug or medical device clinical trial projects were reviewed by the local ethics committee, among which 29 projects were ap-proved through regular full board meeting, the approval rate in the initial review was 31%. The most common prob-lems in protocols include: the research backgrounds, design, and risk-benefit ratio; Main issues raised on in-formed consent focused on the contents, language and signature terms. Conclusions:The protection of subjects needs more improvement of capability of investigator, sponsor, drug clinical trial institution and the ethics commit-tee.

It is the intent of this investigation to gain an insight into the relationship of serum total adiponectin with polycystic ovary syndrome (PCOS) and insulin resistance. Fifty-eight PCOS patients were enrolled (29 with high serum insulin level and 29 without), at the same time, 29 non-PCOS women with normal weight were included as control. The influencing factors of total adiponectin, PCOS and insulin resistance were analyzed. The serum total adiponectin of PCOS patients and all participants were found to be negatively related to waist hip ratio (r = -0.39, r = -0.36) and InHOMA-IR (r = -0.53, r = -0.45), respectively. Adiponectin was not a protective factor of PCOS (P > 0.1), but it was that of PCOS-insulin resistance (OR = 0.81; 95% CI: 0.67-0.97; P = 0.02). LH/FSH (OR = 1.51; 95% CI: 1.16-1.96; P = 0.01) and InHOMA-IR (OR = 1.26; 95% CI: 1.10-1.44; P = 0.01) were risk factors of PCOS, and waist hip ratio was that of PCOS-insulin resistance (OR = 8.57; 95% CI, 2.14-34.30, P = 0.01). Adiponectin might influence fasting insulin and InHOMA-IR (B = -0.22, P = 0.001; B = -0.02, P = 0.002). These data signify that adiponectin is not directly related with PCOS, but it is related with PCOS-HL Adiponectin might participate in the pathophysiologic mechanism of PCOS by influencing insulin sensitivity.
Adiponectin ; blood ; Adult ; Female ; Humans ; Insulin Resistance ; physiology ; Polycystic Ovary Syndrome ; blood ; physiopathology ; Waist-Hip Ratio ; Young Adult

This paper is aimed to analyze the correlation between serum free testosterone (FT) and total testosterone (TT) to acquire a cutoff about using total testosterone to diagnose hyperandrogenism in Chengdu females. We investigated 1854 women by cluster sampling method, detected their serum FT levels and TT levels, scored relative items, analyzed the correlation and made the ROC curve to get a cutoff of TT levels. Serum FT had a linear correlation with serum TT (r = 0.597, r2 = 0.356, P < 0.001). The cutoff value was 0.635 ng/mL. The specificity and sensitivity were 76.3% and 77.24%, respectively. No correlation found between serum FT and Ferriman-Gallway Score (P = 0.392). Positive correlations were seen between serum FT and Plewig-Kligman Score (r = 0.137, P < 0.001), serum TT and Ferriman-Gallway Score (r = 0.069, P = 0.003) and serum TT and Plewig-Kligman Score (r = 0.092, P < 0.001). There is a linear correlation between serum FT and TT. We can diagnose hyperandrogenism according to the serum TT cutoff value (0.635 ng/mL). Its clinical symptoms are not paralleled with the biochemical test results.
Adolescent ; Adult ; Child ; China ; Female ; Humans ; Hyperandrogenism ; blood ; Middle Aged ; Reference Values ; Sampling Studies ; Testosterone ; blood ; Young Adult