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.

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

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

Objective　To identify the relationship between polycystic ovarian syndrome and hyperinsulinemia. Methods　Age, body height, body weight, serum estradiol, progesterone, testosterone, follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin(PRL), triiodothyronine (T3), tetraiodothyronine (T4), insulin, oral glucose tolerance test (OGTT), and cortisol were measured in 28 patients with polycystic ovarian syndrome (PCOS).Results　Sxiteen patients (57.1% of total) had hyperinsulinemia. Among them one patient was found diabetic. No difference was noted in age, height, body weight, body mass index, serum estradiol, progesterone, testosterone, FSH, LH, PRL, T3, T4, cortisol, and glucose of OGTT between hyperinsulinemia and non-hyperinsulinemia patients. However the LH/FSH ratio(2.4±1.5) in hyperinsulinemia patients was significantly higher than 1.2±0.6 in non-hyperinsulinemia patients （P=0.0125）. In addition, the results showed that the fasting serum insulin, insulin after OGTT,the insulin/glucose ratio at 30, 120 minutes, 180 minutes, the area under curve of and the insulin, insulin resistant index (IRI) were higher in hyperinsulinemia pateints than in non-hyperinsulinemia patients respectively. Furthermore, the fasting insulin level, insulin/glucose ratio were found to be negatively related to insulin sensitivity index and positively related with β-cell functioning index. Conclusion　Hyperinsulinemia and insulin resistance accompany with some of the PCOS patients in China. Further investigations will be necessary to clarify the relevant mechanisms.