目的 探讨妇科再造胶囊联合炔雌醇环丙孕酮治疗月经不调（肾虚证）的有效性、安全性及对性激素和血液流变学指标的影响。方法 纳入2023年1～12月于南阳市中心医院妇产科就诊的月经不调女性患者160例，随机分为对照组和治疗组，每组各80例。对照组口服炔雌醇环丙孕酮片，月经第5天开始服药，1片/d。治疗组在对照组的基础上口服妇科再造胶囊，2次/d，6粒/次。21 d为1个疗程，两组治疗3个疗程。观察两组患者临床疗效，比较治疗前后两组患者月经症状量表（MDQ）评分和中医证候积分，激素黄体生成素（LH）、雌二醇（E₂）和孕酮（P）水平，血液流变学指标血浆黏度（PV）、全血低切黏度（LSWBV）和全血高切黏度（HSWBV）水平。结果 治疗后，治疗组总有效率为92.50%，显著高于对照组的总有效率（81.25%，P＜0.05）。治疗后，两组MDQ评分、中医证候积分、LH、PV、LSWBV及HSWBV均比治疗前显著降低，而E₂和P水平均显著升高，同组治疗前后比较差异具有统计学意义（P＜0.05）。治疗后，治疗组患者MDQ评分、中医证候积分、LH、PV、LSWBV及HSWBV均显著低于对照组，而E₂和P水平均显著升高，两组比较差异具有统计学意义（P＜0.05）。结论 妇科再造胶囊联合炔雌醇环丙孕酮治疗月经不调（肾虚证）的临床疗效显著，且安全性较高，可能与改善性激素及血液流变学指标等有关。

Objective To investigate the efficacy and safety of Fuke Zaizao Capsules combined with ethinylestradiol and cyproterone acetate in treatment of irregular menstruation (kidney deficiency syndrome) and the influence on sex hormones and hemorheology indexes. Methods Patients (160 cases) with irregular menstruation (kidney deficiency syndrome) in Nanyang Central Hospital from January 2023 to December 2023 were randomly divided into control and treatment group, and each group had 80 cases. Patients in the control group were po administered with Ethinylestradiol and Cyproterone Acetate Tablets from the 5th day of menstruation, 1 tablet/d. Patients in the treatment group were po administered with Fuke Zaizao Capsules on the basis of the control group, 6 grains/time, twice daily. 21 days was a course of treatment, and patients in two groups were treated for 3 courses. After treatment, the clinical evaluations were evaluated, and the MDQ scores and TCM syndrome scores, the levels of E₂, P and LH, and the hemorheological indexes PV, LSWBV and HSWBV levels in two groups before and after treatment were compared. Results After treatment, the total effective rate in the treatment group was 92.50%, which was significantly higher than that in the control group (81.25%, P < 0.05). After treatment, the MDQ score, TCM syndrome score, LH, PV, LSWBV and HSWBV in two groups were significantly lower than before treatment, while the E₂ and P levels were significantly higher, the difference between before and after treatment in the same group was statistically significant (P < 0.05). After treatment, the MDQ score, TCM syndrome score, LH, PV, LSWBV and HSWBV in the treatment group were significantly lower than those in the control group, while the E₂ and P levels were significantly higher, the difference between the two groups was statistically significant (P < 0.05). Conclusion Fuke Zaizao Capsules combined with ethinylestradiol andcyproterone acetate in the treatment of irregular menstruation (kidney deficiency syndrome) with a significant clinical efficacy and safety, which may be related to the improvement of sex hormones and hemorheology indexes.

R984

河南省医学科技攻关计划项目（LHGJ20200525）