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异体淋巴细胞免疫治疗不明原因复发性流产巢式病例对照研究
Allogeneic Lymphocyte Immunotherapy for Primary Unexplained Recurrent Miscarriage: a Randomized Nested Placebo-Controlled Trial
【摘要】 目的:探讨异体淋巴细胞免疫治疗(ALIT)对不明原因复发性流产(URM)的治疗价值。方法:采用前瞻性、随机、患者单盲、巢式病例对照研究方法,将南方医院生殖医学中心2008年7月至2012年4月符合条件的638例URM患者随机分为ALIT组(314例)和对照组(324例)。ALIT组进行ALIT 6~8次复查封闭抗体转阳后积极试孕;对照组仅予0.9%氯化钠液注射。比较两组的临床特征和妊娠结局。结果:①两组既往平均流产次数、既往流产平均孕周、体重指数和再次妊娠年龄比较,差异均无统计学意义(P>0.05)。②两组末次治疗后1年内受孕方式比例、异位妊娠率、再次流产率、流产胚胎异常染色体核型比例、严重母胎并发症发生率、粗活产率和校正活产率比较,差异均无统计学意义(P>0.05)。结论:ALIT不能对URM再次妊娠有明显的保胎作用。
【Abstract】 Objective: To explore whether primary unexplained recurrent miscarriage( URM) patients could benefit from allogeneic lymphocyte immunotherapy( ALIT). Methods: Between July 2008 and April 2012,638URM patients who met the enrollment criteria were recruited. They were randomly assigned to receive ALIT6-8 times( ALIT group,n =314) until the serum blocking factors turned positive before conception or the equivalent volume of the placebo normal saline infusion( control group,n =324). All their clinical characteristics and pregnancy outcomes within one year after therapy were collected and compared. Results: ①The demographic characteristics,including initiation attendant age,mean previous miscarriage number,mean termination gestational weeks of previous miscarriage,body mass index and current pregnancy age were similar between the two groups( P>0. 05). ②Both the ALIT and the control groups had similar conception route ratio,pregnancy rate,ectopic pregnancy rate,repeated miscarriage rate,abnormal conceptus chromosome ratio,severe pregnancy complications( pre-eclamsia,placental abruption,premature rupture of membranes,preterm births and fatal major defects) ratio,rough live birth rate and live birth rate adjusted by abnormal conceptus chromosome / fatal major defects( P >0. 05). Conclusions: ALIT could not improve the URM subsequent live birth rate as compared with placebo.
【Key words】 Recurrent unexplained miscarriage; Blocking factor; Allogeneic lymphocyte immunotherapy;
- 【文献出处】 实用妇产科杂志 ,Journal of Practical Obstetrics and Gynecology , 编辑部邮箱 ,2014年04期
- 【分类号】R714.21
- 【被引频次】34
- 【下载频次】283