补肾活血方案治疗排卵障碍性不孕不育的多中心随机双盲对照临床研究  

A multi-center,randomized,double-blind clinical study on Bushen Huoxue in treatment of ovulatory dysfunction caused infertility

作　　者：马堃[1] 刘雁峰[2] 何军琴[3] 李敏[1] 单婧[1] 

机构地区：[1]中国中医科学院,北京100700 [2]北京中医药大学东直门医院,北京100700 [3]首都医科大学附属北京妇产医院,北京100069

出　　处：《中国中药杂志》2015年第20期3911-3915,共5页China Journal of Chinese Materia Medica

基　　金：首都医学科技发展基金项目(SF-2009-I-02)

摘　　要：目的:采用多中心随机双模双模拟阳性药物对照设计,验证补肾活血方案治疗卵巢功能障碍性(排卵障碍性)不孕不育的贡献度,为临床治疗提供科学依据。方法:严格按照诊断标准、纳入标准和排除标准筛选病例,6种排卵障碍性不孕不育患者入组349例,随机分为试验组177例(补肾促卵冲剂组)和对照组172例(克罗米芬组),观察2组患者治疗前后的排卵率、妊娠率、总有效率、子宫内膜、优势卵泡及血清性激素水平的变化。结果:排卵率试验组为69.34%,对照组71.01%;妊娠率试验组为41.35%,对照组为29.23%;总有效率试验组为91.73%,对照组为80.77%。治疗后子宫内膜厚度有显著性差异(P<0.05)。试验组血清性激素PRL、E2治疗前后有显著性差异(P<0.05)。未发现试验药物不良反应,安全性指标无异常。结论:6种疾病采用补肾活血中药治疗前后,试验组与对照组相比,妊娠率有显著性差异(P<0.05),排卵率无显著性差异。试验组总有效率明显高于对照组,有显著性差异(P<0.05)。2组均可以促进卵泡发育及排出,试验组促进子宫内膜的生长,提高子宫内膜胚胎容受性,调节PRL,E2,优于对照组。Objective： The multi-center,randomized,double-blind,double-simulated and positive-control trial was used to verify the contribution degree of Bushen Huoxue for the treatment of ovulatory dysfunction caused infertility,which provided scientific basis for clinical treatment. Method： According to diagnostic,inclusion and exclusion criteria,we observed 349 patients which were divided into the treated group（ n = 177,treated with Bushen Huoxue ricipe） and control group（ n = 172,treated with clomiphene）. Ovulation rate,pregnancy rate,clinical effective rate of traditional Chinese medicine,endometrium and diameter of dominant follicle were observed.Serum reproductive endocrine hormones were assayed before and after treatment. Result： The treated group showed ovulation rate of69. 34%,with pregnancy rate of 41. 35%. The clinical effective rate of treated group and control group were 91. 73% and 80. 77%.There was remarkable difference in endometrium（ P〈0. 05） and remarkbale difference in sex hormones PRL and E2 in treated group at prior-treatment and post-treatment（ P〈0. 05）. No adverse effects were found in the experiment. Security indicators did not show abnormal change. Conclusion： The comparison between the two groups showed that the treated group was significantly different from control group in the pregnancy rate（ P〈0. 05）,without notable difference in ovulation rate. There was significant difference in clinical effective rate between the treated group and control group. Both the two groups could contribute to the mature development and discharge of the follicles. The growth of endometrium and endometrial receptivity in the treated group were higher than control group. The treated group has regulatory effect on PRL and E2.

关 键 词：补肾活血 排卵障碍 不孕不育 多中心随机双盲对照 临床研究 

分 类 号：R271.14[医药卫生—中医妇科学]