| Objective:To observe the clinical efficacy of Bushen Huoxue Decoction combined with Diane-35 in the treatment of PCOS-HA.to explore its mechanism of action and effectiveness.and to provide a diagnostic basis for the clinical diagnosis and treatment of PCOS-HA.Methods:In this study,65 patients with polycystic ovary syndrome with hyperandrogenemia of kidney deficiency and blood stasis type identified by Chinese and Western medicine were selected from the Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine between 08,2020 and 12,2021.The patients were divided into two groups by the random number method of SPSS 26.0 software.Treatment group: from the fifth day of menstrual cycle,they were given Bushen Huoxue Decoction twice a day,180 ml/time,taken warmly half an hour after meals in the morning and evening,plus Diane-35,once a day,1 tablet/time;Control group: from the fifth day of menstrual cycle,they were given Diane-35,once a day,1tablet/time.Both groups were taken for 21 consecutive days,and 3 menstrual cycles were considered as 1 course of treatment.Changes in TCM syndrome score,changes in menstrual cycle and menstrual volume,changes in LH value,FSH value,LH/FSH and T value during follicular phase,changes in acne,hirsutism and BMI and WHR values of patients as well as changes in ovarian volume and number of small follicles were observed before and after treatment.The liver and kidney function tests were performed before and after treatment,and the adverse reactions and discomfort experienced by the patients were recorded,and the final data were statistically obtained by SPSS 26.0 software.Results:1.After treatment.the total effective rate of the treatment group was 96.67% and the total effective rate of the control group was 80.00%.the efficacy of the treatment group was better than that of the control group.and the difference was statistically significant(P<0.05).2.Comparison of TCM syndrome points and menstruation: The treatment methods of both groups were effective in improving TCM syndrome points.menstrual cycle and menstrual volume.and the decrease was more obvious in the treatment group than in the control group.and the difference was statistically significant(P<0.05).3.Comparison of sex hormone levels: The treatment methods of both groups were effective in improving serum sex hormone levels during the follicular phase.and the treatment group was more effective than the control group.with statistically significant differences(P <0.05).The two groups were effective in improving serum FSH values.but the improvement of FSH values in both groups after treatment was not significant compared with that before treatment.with no statistically significant differences(P>0.05).4.Comparison of physical signs: The treatment methods of both groups were effective in improving acne.hirsutism.BMI and WHR.and the treatment group was more effective than the control group.and the difference was statistically significant(P<0.05).The two groups were effective in improving BMI values and WHR values.but the improvement of BMI values and WHR values in both groups after treatment was not significant compared with that before treatment.and the difference was not statistically significant(P>0.05).5.Comparison of ovarian volume and number of small follicles: Both treatment methods were effective in improving ovarian volume and number of small follicles in both groups.and the treatment group was more effective than the control group.the difference was statistically significant(P<0.05).6.During this period.the patients did not experience adverse reactions and discomfort.and no significant abnormalities in liver and kidney function were observed.Conclusion:1.Bushen Huoxue Decoction combined with Diane-35 can improve patients’ TCM clinical symptoms.adjust patients’ menstrual cycle and menstrual flow.and is significantly better than the efficacy of Diane-35 alone.2.Bushen Huoxue Decoction combined with Diane-35 can improve patients’ basal body temperature.lower their body androgen levels.improve their hyperandrogenic signs.reduce ovarian volume and the number of small follicles.3.No significant liver and kidney impairment.adverse effects and side effects were observed in the treatment of PCOS-HA by combining Bushen Huoxue Decoction with Diane-35.with good safety.4.It is concluded from this study that the use of Bushen Huoxue Decoction combined with Diane-35 is more effective than Diane-35 alone in the treatment of PCOS-HA.and its treatment method is worth promoting and applying. |