【目的】探讨自拟温肾健脾方治疗脾肾两虚型多囊卵巢综合征 （PCOS） 的疗效及其对糖脂代谢、肠道菌群的调节机制。【方法】选取2020年10月至2023年10月在昆山市中医医院就诊的105例脾肾两虚型PCOS患者为研究对象，根据治疗方法的不同，将患者分为观察组53例和对照组52例。对照组给予二甲双胍、炔雌醇环丙孕酮治疗，观察组在对照组的基础上给予自拟温肾健脾方治疗，疗程为3个月。观察2组患者治疗前后中医证候积分、卵泡个数、卵巢体积、糖脂代谢指标、肠道菌群的变化情况，并比较2组患者的临床疗效和不良反应总发生率。 【结果】（1） 疗效方面，治疗3个月后，观察组的总有效率为96.23% （51/53） ，对照组为76.92% （40/52） ，组间比较 （χ2检验） ，观察组的疗效明显优于对照组 （P＜0.01） 。 （2） 中医证候积分方面，治疗后，2组患者的腰膝酸软、形寒畏冷、头晕眼花、神疲乏力等中医证候积分均较治疗前降低 （P＜0.05） ，且观察组的降低幅度均明显优于对照组 （P＜0.01） 。 （3） 卵泡个数和卵巢体积方面，治疗后，2组患者的卵泡个数均较治疗前减少（P＜0.05） ，左、右侧卵巢体积均较治疗前缩小 （P＜0.05） ，且观察组对卵泡个数的减少幅度及对左、右侧卵巢体积的缩小幅度均明显优于对照组 （P＜0.01） 。 （4） 糖脂代谢方面，治疗后，2组患者的总胆固醇 （TC） 、甘油三酯 （TG） 、空腹血糖 （FPG） 、餐后2 h血糖 （2hPG） 、糖化血红蛋白 （HbA1c） 水平均较治疗前降低 （P＜0.05） ，且观察组的降低幅度均明显优于对照组 （P＜0.01） 。 （5） 肠道菌群方面，治疗后，2组患者的双歧杆菌、乳酸杆菌均较治疗前增高 （P＜0.05） ，肠球菌、肠杆菌均较治疗前降低 （P＜0.05） ，且观察组治疗后的双歧杆菌、乳酸杆菌均明显高于对照组，肠球菌、肠杆菌均明显低于对照组，差异均有统计学意义 （P＜0.01） 。 （6） 不良反应方面，观察组的不良反应总发生率为5.66% （3/53） ，对照组为7.69% （4/52） ，组间比较，差异无统计学意义 （P＞0.05） 。 【结论】自拟温肾健脾方可显著提高脾肾两虚型PCOS患者的临床疗效，缩小卵巢体积，减少卵泡数目，有效调节糖脂代谢及肠道微生态稳态失衡，且未引发严重不良反应，安全有效。

Objective To observe the efficacy of self-made Wenshen Jianpi Formula in the treatment of polycystic ovary syndrome （PCOS） with deficiency of spleen and kidney type，and to explore its mechanism of regulating glucose-lipid metabolism and intestinal flora. Methods A total of 105 PCOS patients with deficiency of spleen and kidney type who attended the clinic at Kunshan Hospital of Chinese Medicine from October 2020 to October 2023 were selected as the study object. According to the treatment methods， the patients were divided into the observation group（53 cases） and the control group（52 cases） . The control group was treated with metformin and ethinylestradiol and cyproterone，while the observation group was treated with self-made Wenshen Jianpi Formula on the basis of treatment for the control group，and the course of treatment lasted three months. The changes of traditional Chinese medicine（TCM） syndrome scores， number of follicles， ovarian volume， glucose-lipid metabolism indicators and intestinal flora in the two groups before and after treatment were observed. After treatment，the clinical efficacy and the total incidence of adverse reactions of the patients in the two groups were compared. Results （1） After three months of treatment，the total effective rate of the observation group was 96.23%（51/53），while that of the control group was 76.92% （40/52），and the intergroup comparison （by chi-square test） showed that the clinical efficacy of the observation group was significantly superior to that of the control group （P＜0.01） . （2）After treatment，the scores of TCM symptoms such as soreness and weakness in the waist and knee， physical intolerance of cold， vertigo and dizziness， lassitude and weakness in the two groups were decreased when compared with those before treatment （P＜0.05） ，and the decrease of the scores in the observation group was significantly superior to that in the control group （P＜0.01） . （3） After treatment，the number of follicles in the two groups was reduced （P＜0.05） and the volume of the left and right ovaries were reduced when compared with those before treatment （P＜0.05），and the reduction of follicles number as well as the bilateral ovarian volume in the observation group was significantly superior to that in the control group （P＜0.01） . （4） After treatment，the levels of total cholesterol（TC），triglycerides（TG），fasting plasma glucose（FPG），2-hour postprandial glucose （2hPG），and glycosylated hemoglobin （HbA1c） in the two groups were decreased when compared with those before treatment （P＜0.05）， and the decrease of the above glucose-lipid metabolism indicators in the observation group was significantly superior to that in the control group （P＜0.01） . （5） After treatment，the levels of Bifidobacteria and Lactobacilli in both groups were higher （P＜0.05） and the levels of Enterococci and Enterobacteria were lower than those before treatment （P＜0.05） ，and the observation group had higher levels of Bifidobacteria and Lactobacilli and lower levels of Enterococci and Enterobacteria than the control group after treatment，the differences being statistically significant （P＜0.01） . （6） The total incidence of adverse reactions in the observation group was 5.66%（3/53） and that in the control group was 7.69%（4/52），and the intergroup comparison showed that the difference was not statistically significant （P＞0.05） . Conclusion Self-made Wenshen Jianpi Formula can significantly enhance the clinical efficacy of PCOS patients with deficiency of spleen and kidney type，reduce the volume of ovaries，decrease the number of follicles，and regulate the imbalance of glucose-lipid metabolism and gut microflora homeostasis effectively，without serious adverse reactions，which is safe and effective.

R271.9

国家自然科学基金资助项目 （编号：81873825）；中国中医科学院科技创新重大攻关项目（编号：CI2021A02401）；苏州市科技局科技计划项目 （编号：SYSD2019225)