环孢素A治疗难治性免疫性复发性流产随机对照研究  

A randomized controlled trial of cyclosporine A in the treatment of refractory immune recurrent spontaneous abortion

作　　者：付锦华[1] 朱霄鹤[1] 孙红[1] 赵龙[2] 

机构地区：[1]山东省潍坊市人民医院产科,山东潍坊261041 [2]山东大学医学院,山东济南250012

出　　处：《中国实用妇科与产科杂志》2016年第5期441-445,共5页Chinese Journal of Practical Gynecology and Obstetrics

基　　金：潍坊市卫生局科研项目计划(2013-136)

摘　　要：目的探讨环孢素A（CsA）在难治性免疫性复发性流产（RSA）治疗中的作用。方法选择潍坊市人民医院产科2011年1月至2014年1月收治的难治性免疫性RSA（从未妊娠成功）的患者作为研究对象。共有168例患者纳入该研究，均已连续流产至少4次且可查到由免疫异常导致。患者被随机分配到两组中。从月经结束开始、CsA组（n=85）使用基本治疗（叶酸、黄体酮、静脉注射免疫球蛋白制品、丈夫淋巴细胞免疫治疗）＋CsA2～4mg/kg，每日2次，服药期间查CsA最低浓度维持在80～150mg／L；安慰创组（n=83）使用基本治疗＋安慰剂。主要结果设定为分娩1个健康的无先天性异常的婴儿。结果CsA组中73例f85．88％）成功分娩健康婴儿，安慰剂组中这一数值为57例（68．68％）[P=0．01，OR=2．78；95％CI（1．29～5．97）]。妊娠4～8周，CsA组β-人绒毛膜促性腺激素（β-HCG）水平高于安慰剂组，差异有统计学意义（P〈0．001）。结论CsA可能对于难治性免疫性RSA有治疗作用。Objective To evaluate the effectiveness of CsA in the treatment of refractory immune RSA. Methods A randomized controlled trial was conducted in patients with refractory immune RSA in our hospital. Totally 168 patients were selected from January 2011 to January 2014 in Shanghai Weifang People＇s Hospital, all with at least 4 consecutive miscarriages and caused by dysimmunity. Patients were randomly allocated into 2 groups. In one group （n=85） CsA 2 ～ 4 mg/kg bid was started from the first day after menstruation, while in the other （n=83） placebo was used. During the cure we examined the concentration of cyclosporine A and kept it at the 80 ～ 150 mg/L. Delivery of a healthy baby without malformations was regarded as the primary outcome. Results In the CsA group, 73 （85.88%） patients delivered a healthy baby, while in the placebo group, this number was only 57（68.68%） [P=0.01,OR =2.78; 95% CI （1.29- 5.97）]. Significantly higher levels of β-HCG were observed in gestation weeks 4 to 8 in CsA group than in placebo group （P 〈 0.001）. Conclusion The results indicate that CsA is probably effective in the treatment of refractory immune RSA.

关 键 词：环孢素A 复发性流产 免疫抗体 Β-人绒毛膜促性腺激素 妊娠结局 

分 类 号：R714.21[医药卫生—妇产科学]