环孢素A治疗难治性免疫性复发性流产随机对照研究
发布时间：2018-12-06 07:33
【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)+CsA 2~4 mg/kg,每日2次,服药期间查CsA最低浓度维持在80~150 mg/L;安慰剂组(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(85.88%)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(P0.001)。结论 CsA可能对于难治性免疫性RSA有治疗作用。
[Abstract]:Objective to investigate the role of cyclosporine A (CsA) in the treatment of refractory recurrent abortion with (RSA). Methods the patients with refractory immune RSA (never pregnancy) admitted from January 2011 to January 2014 in Weifang people's Hospital were selected as study objects. A total of 168 patients were enrolled in the study, all with at least 4 consecutive abortions and were found to be caused by immune abnormalities. The patients were randomly assigned to two groups. From the end of menstruation, the CsA group (nnt85) received basic treatment (folic acid, progesterone, intravenous immunoglobulin product, husband lymphocyte immunotherapy) twice a day with CsA 2 + 4 mg/kg,. The minimum concentration of CsA during medication was maintained at 80 mg/L;. The placebo group (nf83) received a basic therapeutic placebo. The main result was to give birth to a healthy baby without congenital abnormality. Results in the CsA group, 73 (85.88%) healthy infants were delivered successfully, 57 (68.68%) in the placebo group [CI (1.295.97)]. 尾-human chorionic gonadotropin (尾-HCG) levels in the CsA group were significantly higher than those in the placebo group at the 4th week of gestation (P0.001). Conclusion CsA may have therapeutic effect on refractory immune RSA.
【作者单位】： 山东省潍坊市人民医院产科;山东大学医学院;
【基金】：潍坊市卫生局科研项目计划(2013-136)
【分类号】：R714.21
[Abstract]:Objective to investigate the role of cyclosporine A (CsA) in the treatment of refractory recurrent abortion with (RSA). Methods the patients with refractory immune RSA (never pregnancy) admitted from January 2011 to January 2014 in Weifang people's Hospital were selected as study objects. A total of 168 patients were enrolled in the study, all with at least 4 consecutive abortions and were found to be caused by immune abnormalities. The patients were randomly assigned to two groups. From the end of menstruation, the CsA group (nnt85) received basic treatment (folic acid, progesterone, intravenous immunoglobulin product, husband lymphocyte immunotherapy) twice a day with CsA 2 + 4 mg/kg,. The minimum concentration of CsA during medication was maintained at 80 mg/L;. The placebo group (nf83) received a basic therapeutic placebo. The main result was to give birth to a healthy baby without congenital abnormality. Results in the CsA group, 73 (85.88%) healthy infants were delivered successfully, 57 (68.68%) in the placebo group [CI (1.295.97)]. 尾-human chorionic gonadotropin (尾-HCG) levels in the CsA group were significantly higher than those in the placebo group at the 4th week of gestation (P0.001). Conclusion CsA may have therapeutic effect on refractory immune RSA.
【作者单位】： 山东省潍坊市人民医院产科;山东大学医学院;
【基金】：潍坊市卫生局科研项目计划(2013-136)
【分类号】：R714.21
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