何氏养巢颗粒联合针灸治疗卵巢储备功能减退伴不孕症肾虚证患者的随机双盲对照研究  

Effect of HE’s Yangchao Granule combined with acupuncture in treating infertile patients with diminished ovarian reserve with kidney deficiency syndrome: a randomized, double-blind, controlled trial

作　　者：王玲[1] 马景[1] 许嘉瑜 张涵[1] 龚燕[1] 杜婷婷 马扬 金硕 章勤[1] WANG Ling;MA Jing;XU Jiayu;ZHANG Han;GONG Yan;DU Tingting;MA Yang;JIN Shuo;ZHANG Qin(Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University,Hangzhou3310007,China)

机构地区：[1]浙江中医药大学附属杭州市中医院,杭州310007

出　　处：《北京中医药大学学报》2023年第9期1218-1226,共9页Journal of Beijing University of Traditional Chinese Medicine

基　　金：浙江省重点研发计划(No.2019C03086);浙江省中医药科技计划中医药现代化专项项目(No.20GZS20220221ZX012);浙江省中医药创新团队(No.2022SJCXTD);国家中医药管理局全国名老中医药专家传承工作室建设项目(国中医药人教函[2022]75号)。

摘　　要：目的 评估何氏养巢颗粒联合针灸治疗卵巢储备功能减退(DOR)伴不孕症肾虚证患者的疗效。方法 使用随机、双盲、对照的临床试验方法,纳入120例DOR伴不孕症肾虚证患者,按1∶1∶1∶1的比例随机分配到何氏养巢颗粒+假针灸组、安慰剂+针灸组、何氏养巢颗粒+针灸组、安慰剂+假针灸组,每组各30例。1个月经周期为1个疗程,所有患者接受3个疗程治疗,治疗结束后随访3个月。治疗前及每个疗程结束后月经周期第2~3天,静脉血检测患者抗米勒管激素(AMH)、卵泡刺激素(FSH)含量及FSH/黄体生成素(LH)值,超声检查窦卵泡计数(AFC)。治疗前及每个疗程结束后月经周期第5天,计算患者中医证候积分、月经失血图评分。治疗结束后3个月,进行妊娠情况随访。结果 3个疗程后,与安慰剂+假针灸组比较,何氏养巢颗粒+针灸组AMH升高(P<0.05)、AFC增多(P<0.05),FSH及FSH/LH值下降(P<0.05)。3个疗程后,与安慰剂+假针灸组比较,何氏养巢颗粒+针灸组、安慰剂+针灸组、何氏养巢颗粒+假针灸组月经失血图评分均升高(P<0.05),中医证候积分均下降(P<0.05)。结论 针药结合、单纯针灸、单纯何氏养巢颗粒在改善DOR伴不孕症肾虚证患者的中医症状、月经量方面均有一定疗效。针药结合可明显提高DOR伴不孕症肾虚证患者AMH含量、降低FSH含量及FSH/LH值、增加AFC数量,比单纯何氏养巢颗粒或针灸效果更佳。Objective To evaluate the efficacy of HE’s Yangchao Granule(HSYC)combined with acupuncture for infertile patients with diminished ovarian reserve(DOR)with kidney deficiency syndrome.Methods This was a randomized,double-blinded,controlled clinical trial.A total of 120 infertile patients with DOR with kidney deficiency syndrome were randomly assigned into the HSYC+sham-acupuncture group,placebo+acupuncture group,HSYC+acupuncture group,and placebo+sham-acupuncture group at a 1∶1∶1∶1 ratio,with 30 patients each group.One menstrual cycle was one course of treatment,and all participants received three courses of treatment and were followed for an additional three months.Before and after each treatment course,anti-Müllerian hormone(AMH),follicle stimulating hormone(FSH),and the value of FSH/luteinizing hormone(LH)were measured on the second or third day of menstruation through blood tests.Meanwhile,the antral follicle count(AFC)was examined by ultrasound.Before and after each treatment course,the traditional Chinese medicine(TCM)syndrome score and menstrual blood loss map score were calculated on the fifth day of menstruation.Besides,the pregnancy condition was followed three months after treatment.Results After three courses of treatment,compared with the placebo+sham-acupuncture group,AMH was increased(P<0.05),AFC was increased(P<0.05),FSH and FSH/LH were decreased(P<0.05)in the HSYC+acupuncture group.After three courses of treatment,compared with the placebo+sham-acupuncture group,the menstrual blood loss map score was increased(P<0.05),and the TCM syndrome score was decreased(P<0.05)in the HSYC+acupuncture,placebo+acupuncture,and HSYC+sham-acupuncture group.Conclusion The combination of HSYC and acupuncture,or acupuncture,or HSYC has a certain effect on improving the TCM symptoms and menstrual blood volume of infertile patients with DOR with kidney deficiency syndrome.The combination of HSYC and acupuncture can significantly increase the level of AMH,reduce the level of FSH and the value of FSH/LH,and incre

关 键 词：卵巢储备功能减退 不孕症 肾虚证 何氏养巢颗粒 针灸 

分 类 号：R271.9[医药卫生—中西医结合]