| Objective:To observe the clinical effects and explore the mechanism of metformin, Diane-35combined with Traditional Chinese Medieine (TCM)"Bushen Huoxue Tiaozhou(BSHXTZ)" in treating polycystic ovary syndrome (PCOS) diagnosed as deficiency of kidney and blood stasis syndrome, so as to provide a scientific basis for integrative treatment of PCOS.Methods:64patients with PCOS diagnosed as deficiency of kidney and blood stasis syndrome were divided into two groups randomly (1:1),32cases in the western medicine treatment group (hereinafter referred to as the western medicine group) and32cases in the traditional joint treatment group (hereinafter referred to as the joint group). Patients in both groups were given Diane-35and metformin, and the traditional Chinese medicine "Bushen Huoxue Tiao zhou" was also given to the patients in the joint group. After a treatment period of3menstrual cycles, A B-mode sonographic monitoring of ovulation was performed in the month after withdrawal. Anovulatory patients with fertility requirements were given letrozole for ovulation induction. The recovery of the menstruation and the improvement in body mass index(BMI), waist hip ratio (WHR), basal body temperature(BBT), and the pregnancy of infertility were observed in both groups before and after treatment. Sex hormone levels (FSH, LH, E2,T), fasting blood glucose (FBG), fasting plasma insulin (FINS) were determined.Ovarian volume, number of antral follicles and endometrial thickness were monitored.Withdrawal of this month, Ultrasound equipments were used to monitor the emergence of mature follicles and ovulation.Resu1ts:According to the exclusion criteria, a total of60patients meet the requirements finally.30cases were in the joint group (one patient withdrew from the treatment due to economic reasons, one patient was removed from the study because of unwillingness to take TCM) and30cases were in the western medicine group (one case with severe gastrointestinal reactions after taking, exchanged with other drugs and withdrew from the study, one case was removed from the study due to interruption of contact).The total effective rate of the joint group was93.3%, significantly higher than that of the western medicine group73.3%(P<0.05). Comparison of FSH,E2contents before and after treatment were not statistically significantly (P>0.05) in each group, comparison of FSH, E2contents between two groups also were not statistically significant(P>0.05). Levels of LH, T and the ratio of LH/FSH reduced markedly after treatment, showing significant difference as compared with those of in both groups (P<0.05) before treatment. Levels of LH, T and the ratio of LH/FSH were statistically significant(P<0.05) between two groups before and after treatment. Comparision of WHR contents in the western medicine group was no significant difference (P>0.05) before and after treatment. Level of WHR after treatment were significantly lower than that of before treatment (P<0.05) in the joint group. Comparision of WHR were statistically significant (P<0.05) between two groups before and after treatment. Levels of BMI, FINS, Homastasis Model Assessment score for insulin resistance (Homa-IR) after treatment were obviously decreased (P<0.05) compared with those of before treatment in both groups. Comparison of BMI, Homa-IR between groups were statistically significant (P<0.05), FINS was not statistically significant between groups (P>0.05). In addition, decrease in average of ovarian volume became evidently in both groups after treatment, the average numbers of antral follicles was reduced significantly, endometrial thickness became thick obviously, which were improved significantly (P<0.05) after treatment and showing statistical significance (P <0.05) between two groups. About the improvement of clinical symptoms related aspects, although menstrual abnormalities and infertility between two groups were not significant difference (P>0.05), but the improvement of BBT single-phase and restore ovulatory menstruation in joint group were better than that in the western medicine group (P<0.05). The total pregnancy rate was not significant difference (P<0.05) between two groups, but the percent of pregnancy in the joint group was higher than that in the western medicine group.Conclusion:Diane-35, metformin combined with Traditional Chinese Medieine (TCM)"Bushen Huoxue Tiaozhou (BSHXTZ)" in treating polycystic ovary syndrome (PCOS) diagnosed as deficieney of kidney and blood stasis syndrome can improve clinical symptoms, reproductive endocrine and metabolic disorders effectively, reduce the ovarian volume, promote endometrium growth, promote the growth, development and the discharge of ovarian follicle.The treatment effect of the traditional joint were significantly better than pure western medicine. In addition, there are certain advantages in improving the pregnancy rate of infertile patients with polycystic ovary syndrome and restoring their reproductive functions. This method has certain clinical value. |
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