【目的】 分析寿胎丸加味方治疗多囊卵巢综合征（PCOS）合并复发性流产（RSA）的临床疗效。【方法】 将丽水市中医院 2021年 1月至 2022年 1月接诊的 96例 PCOS合并 RSA肾虚血瘀证患者随机分为观察组和对照组，每组各 48例。对照组给予 黄体酮、阿司匹林、低分子肝素的西医常规治疗，观察组在对照组的基础上给予寿胎丸加味方治疗，疗程为 1 个月并随 访 1年。观察2组患者治疗前后中医证候积分、卵巢储备功能指标（窦卵泡数、平均卵巢体积）、凝血和纤溶指标[纤维蛋白原 （FIB）、活化部分凝血活酶时间（APTT）、凝血酶原时间（PT）、D-二聚体（D-D）]的变化情况，比较 2组患者的临床疗效、不 良反应总发生率和妊娠结局。【结果】（1）疗效方面，治疗 1个月后，观察组的总有效率为 95.83%（46/48），对照组为 72.92% （35/48）；组间比较，观察组的总体疗效（Ridit检验）和总有效率（χ2 检验）均明显优于对照组（P < 0.05）。（2）中医证候积分方 面，治疗后，2组患者的自然堕胎史、少腹疼痛、神疲乏力、头晕耳鸣等中医证候积分均较治疗前下降（P < 0.05），且观察 组的下降幅度均明显优于对照组（P < 0.05）。（3）卵巢储备功能方面，治疗后，2组患者的窦卵泡数、平均卵巢体积等卵巢储 备功能指标均较治疗前改善（P < 0.05），且观察组的改善幅度均明显优于对照组（P < 0.05）。（4）凝血和纤溶指标方面，治疗后， 2组患者的FIB、APTT、PT、D-D等凝血和纤溶指标均较治疗前改善（P < 0.05），且观察组的改善幅度均明显优于对照组（P < 0.05）。 （5）不良反应方面，观察组的不良反应总发生率为6.25%（3/48），对照组为10.42%（5/48），组间比较，差异无统计学意义（P > 0.05）。 （6）妊娠结局方面，观察组的足月分娩率为 87.50%（42/48），高于对照组的 45.83%（22/48），早产率和流产率分别为 8.33% （4/48）、4.17%（2/48），均低于对照组的27.08%（13/48），差异均有统计学意义（P < 0.05或P < 0.01）。【结论】 寿胎丸加味方可 有效改善PCOS合并RSA患者卵巢功能，纠正血液高凝状态，缓解腹部疼痛等症状，降低早产率、流产率，且治疗期间患者 未出现明显不良反应。

Objective To observe the clinical efficacy of modified Shoutai Pills in the treatment of polycystic ovary syndrome（PCOS）complicated with recurrent spontaneous abortion（RSA）. Methods Ninety-six patients with PCOS complicated with RSA of kidney deficiency and blood stasis syndrome admitted to Lishui Hospital of Traditional Chinese Medicine from January 2021 to January 2022 were randomly divided into the observation group and the control group，with 48 cases in each group. The control group was treated with progesterone，aspirin and low molecular weight heparin，while the observation group was treated with modified Shoutai Pills on the basis of treatment for the control group. The course of treatment covered one month and then the follow-up lasted for one year. The changes of traditional Chinese medicine（TCM）syndrome scores，ovarian reserve function indicators of antral follicle count and mean ovarian volume，and coagulation and fibrinolysis indicators of fibrinogen（FIB）， activated partial thromboplastin time（APTT），prothrombin time（PT），and D-dimer（D-D）level before and after the treatment in the two groups were observed. After treatment， the clinical efficacy， total incidence of adverse reactions and pregnancy outcome of the two groups of patients were compared. Results（1）After one month of treatment，the total effective rate of the observation group was 95.83%（46/48），and that of the control group was 72.92%（35 / 48）；the comparison between the two groups showed that the overall efficacy（tested by Ridit test）and the total effective rate（tested by chi-square test）of the observation group were significantly superior to those of the control group（P < 0.05）.（2）After treatment，the scores of spontaneous abortion frequency and TCM symptoms such as pain in the lower abdomen，fatigue and weakness，and dizziness and tinnitus in the two groups were decreased 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 < 0.05）.（3）After treatment， ovarian reserve function indicators of antral follicle count and mean ovarian volume in the two groups were improved compared with those before treatment（P < 0.05），and the improvement in the observation group was significantly superior to that in the control group（P < 0.05）.（4）After treatment，coagulation and fibrinolysis indicators such as FIB，APTT， PT， and D -D in the two groups were improved compared with those before treatment（P < 0.05）， and the improvement in the observation group was significantly superior to that in the control group（P < 0.05）.（5）The total incidence of adverse reactions in the observation group was 6.25%（3/48），while that in the control group was 10.42%（5 / 48）， and the comparison between the two groups showed that the difference was not statistically significant（P > 0.05）.（6）The rate of full-term delivery in the observation group was 87.50%（42/48），higher than that in the control group [45.83%（22/48）]；the preterm birth rate and abortion rate of the observation group were 8.33%（4/48）and 4.17%（2/48），respectively，lower than those of the control group [all being 27.08% （13 / 48）]， with the differences being statistically significant（P < 0.05 or P < 0.01）. Conclusion Modified Shoutai Pills can effectively improve the ovarian function of patients with PCOS complicated with RSA，correct the hypercoagulable state，relieve abdominal pain and other symptoms，reduce the rate of preterm birth and abortion， and no obvious adverse reactions occurred in the patients during treatment.

R271.9

国家自然科学基金资助项目（编号：82074259）；浙江省丽水市科技计划项目（编号：2021SJZC037）