补肾育阴调冲方治疗肾阴虚型卵巢储备功能下降不孕的随机双盲对照临床研究

A Randomized Double-Blind Controlled Clinical Study of Bushen Yuyin Tiaochong Decoction in the Treatment of Diminished Ovarian Reserve Infertility with Kidney-Yin Deficiency

目的评价补肾育阴调冲方治疗肾阴虚型卵巢储备功能下降(DOR)不孕的临床疗效。方法选取2020年10月至2023年4月江西中医药大学第二附属医院妇科门诊的60例肾阴虚型DOR不孕患者,采用随机数字表法将其分为安慰剂组和补肾育阴组各30例,2组患者均给予脱氢表雄酮(DHEA)口服治疗,安慰剂组加服安慰剂,补肾育阴组加服补肾育阴调冲方,2组疗程均为3个月。治疗前后观察中医证候积分及生育生活质量评分变化情况,ELISA法检测患者血清卵泡刺激素(FSH)、抗苗勒氏管激素(AMH)和雌二醇(E_(2))水平变化情况,治疗期间观察不良反应发生情况,治疗后记录2组患者的妊娠率。结果治疗后,补肾育阴组患者的中医证候总积分明显减少(P<0.01),优于安慰剂组(P<0.01);2组患者生育生活质量评分均显著增加(P<0.05,P<0.01),补肾育阴组优于安慰剂组(P<0.05);补肾育阴组双侧窦卵泡个数(AFC)显著增加(P<0.01),优于安慰剂组(P<0.01);2组患者血清AMH水平均显著增加(P<0.05,P<0.01),补肾育阴组高于安慰剂组(P<0.01);2组患者血清E_(2)水平显著降低(P<0.05,P<0.01),补肾育阴组低于安慰剂组(P<0.01);补肾育阴组患者血清FSH水平显著降低(P<0.01),优于安慰剂组(P<0.01);补肾育阴组的总妊娠率优于安慰剂组(P<0.05);治疗期间2组均未见明显不良反应。结论补肾育阴调冲方能显著提高DOR不孕患者的妊娠率,在改善卵巢功能的同时降低患者中医证候积分,提高生育生活质量,安全性高。

OBJECTIVE To evaluate the clinical effect of Bushen Yuyin Tiaochong Decoction in the treatment of diminished ovarian reserve(DOR)infertility with kidney-yin deficiency.METHODS 60 DOR infertility patients with kidney-yin deficiency from the gynecology outpatient department of the Second Affiliated Hospital of Jiangxi University of Chinese Medicine from October 2020 to April 2023 were selected and divided into the placebo group and the kidney-tonifying group using the random number table method,with 30 cases in each group.Patients in both groups were given oral treatment with dehydroepiandrosterone(DHEA).The placebo group was additionally given placebo.The Bushen Yuyin group was additionally given Bushen Yuyin Tiaochong Decoction.The treatment course for both groups was 3 months.Changes in TCM syndrome scores and reproductive life quality scores were observed before and after treatment.Changes in serum follicle-stimulating hormone(FSH),anti-Mullerian hormone(AMH)and estradiol(E_(2))levels in patients were detected by ELISA.The occurrence of adverse reactions during treatment was observed,and the pregnancy rates of the two groups of patients after treatment were recorded.RESULTS After treatment,the total TCM syndrome scores of patients in the Bushen Yuyin group were significantly reduced(P<0.01),which was better than that of the placebo group(P<0.01);the reproductive life quality scores of patients in both groups were significantly increased(P<0.05,P<0.01),the Bushen Yuyin group was better than the placebo group(P<0.05);the number of AFC in the Bushen Yuyin group was significantly increased(P<0.01),which was better than the control group(P<0.01);the serum AMH levels of patients in both groups were significantly increased(P<0.05,P<0.01),and the Bushen Yuyin group was higher than that of the placebo group(P<0.01);the serum E_(2) level of patients in both groups was significantly decreased(P<0.05,P<0.01),the Bushen Yuyin group was lower than the placebo group(P<0.01);the serum FSH level of patients in Bushen Yuyin group was significantly decreased(P<0.01),which was better than that of the placebo group(P<0.01);the total pregnancy rate of the Bushen Yuyin group was better than that of the placebo group(P<0.05);no significant adverse reactions were observed in both groups during the treatment period.CONCLUSION Bushen Yuyin Tiaochong Decoction can significantly improve the pregnancy rate of DOR infertile patients,enhance ovarian function while reducing TCM syndrome scores,improve the quality of reproductive life,and is highly safe.