環(huán)孢素A治療難治性免疫性復(fù)發(fā)性流產(chǎn)隨機(jī)對(duì)照研究
發(fā)布時(shí)間:2018-12-06 07:33
【摘要】:目的探討環(huán)孢素A(CsA)在難治性免疫性復(fù)發(fā)性流產(chǎn)(RSA)治療中的作用。方法選擇濰坊市人民醫(yī)院產(chǎn)科2011年1月至2014年1月收治的難治性免疫性RSA(從未妊娠成功)的患者作為研究對(duì)象。共有168例患者納入該研究,均已連續(xù)流產(chǎn)至少4次且可查到由免疫異常導(dǎo)致;颊弑浑S機(jī)分配到兩組中。從月經(jīng)結(jié)束開始,CsA組(n=85)使用基本治療(葉酸、黃體酮、靜脈注射免疫球蛋白制品、丈夫淋巴細(xì)胞免疫治療)+CsA 2~4 mg/kg,每日2次,服藥期間查CsA最低濃度維持在80~150 mg/L;安慰劑組(n=83)使用基本治療+安慰劑。主要結(jié)果設(shè)定為分娩1個(gè)健康的無(wú)先天性異常的嬰兒。結(jié)果 CsA組中73例(85.88%)成功分娩健康嬰兒,安慰劑組中這一數(shù)值為57例(68.68%)[P=0.01,OR=2.78;95%CI(1.29~5.97)]。妊娠4~8周,CsA組β-人絨毛膜促性腺激素(β-HCG)水平高于安慰劑組,差異有統(tǒng)計(jì)學(xué)意義(P0.001)。結(jié)論 CsA可能對(duì)于難治性免疫性RSA有治療作用。
[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.
【作者單位】: 山東省濰坊市人民醫(yī)院產(chǎn)科;山東大學(xué)醫(yī)學(xué)院;
【基金】:濰坊市衛(wèi)生局科研項(xiàng)目計(jì)劃(2013-136)
【分類號(hào)】: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.
【作者單位】: 山東省濰坊市人民醫(yī)院產(chǎn)科;山東大學(xué)醫(yī)學(xué)院;
【基金】:濰坊市衛(wèi)生局科研項(xiàng)目計(jì)劃(2013-136)
【分類號(hào)】:R714.21
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