补肾健脾方治疗封闭抗体阴性复发性流产的临床研究

Efficacy of Chinese Herb Medicine Bushen Jianpi Recipe on Recurrent Miscarriage in Blocking Antibody-negative Patients

目的：研究补肾健脾方对于封闭抗体阴性的复发性流产的临床疗效及安全性。方法：中医辨证为脾肾两虚型的封闭抗体阴性的复发性流产患者共61例,随机分为中医治疗组（35例）及对照组（26例）。中医治疗组给予补肾健脾方结合HCG及黄体酮的联合治疗方案,对照组在确定妊娠后给予HCG结合黄体酮的常规保胎方案。结果：中医治疗组妊娠31例,成功26例,成功妊娠率为83.9%;对照组妊娠22例,成功妊娠13例,成功妊娠率为59.1%,中医治疗组成功妊娠率显著高于对照组（P〈0.05）。中医治疗组先兆流产症状及中医证候改善率均显著高于对照组（P〈0.05）。结论：补肾健脾方中医治疗方案可显著提高封闭抗体阴性复发性流产患者的成功妊娠率,其疗效与中医证候的改善显著相关。

Objective： To investigate the efficacy of Chinese herb medicine Bushen Jianpi Recipe on recurrent miscarriage in blocking antibody-negative patients. Methods： A total of 61 recurrent miscarriage patients with negativity of blocking antibodies were recruited and randomly divided into two groups： traditional Chinese medicine treatment group（ n = 35） and control group（ n= 26）. Patients in traditional Chinese medicine treatment group received Chinese herbal medicine Bushen Jianpi Recipe in combination with HCG-and progesterone-based tocolytic therapy. Patients in control group received HCG-and progesterone-based tocolytic therapy alone after the confirmation of pregnancy. Results： A total of 31 subjects in traditional Chinese medicine treatment group became pregnant. Among them,successful pregnancies were observed in 26 cases. In control group,fecundability was observed in 22 subjects,among which a total of 13 cased were successfully pregnant. Successful pregnancy ratio 83. 9% in traditional Chinese medicine treatment group was significantly higher than that in control group（ 59. 1%）. Furthermore,the ratio of improvement in symptoms of threatened abortion together with the manifestations defined according to traditional Chinese medicine in treatment group was significantly higher when compared with that in control group. Conclusion： The therapy of Chinese herb medicine Bushen Jianpi Recipe in combination with HCG-and progesterone-based tocolytic treatment resulted in a significantly higher ratio of successful pregnancy in recurrent miscarriage patients with negativity of blocking antibodies. The therapeutic effect of Chinese herb medicine Bushen Jianpi Recipe was in close association with the improvement in manifestations defined according to traditional Chinese medicine.