一项关于依那西普治疗伴有固有免疫紊乱的难治性复发性流产的随机对照试验。
A randomized controlled trial of etanercept in the treatment of refractory recurrent spontaneous abortion with innate immune disorders.
机构信息
Department of Obstetrics, Qingdao Jinhua Hospital, Qingdao, 266200, China; Department of Obstetrics, Weifang People's Hospital, Weifang, 261041, China.
Department of Nephrology, The Affiliated Hospital of Qingdao University, Qingdao, 266003, China.
出版信息
Taiwan J Obstet Gynecol. 2019 Sep;58(5):621-625. doi: 10.1016/j.tjog.2019.07.007.
OBJECTIVE
To evaluate the effectiveness of etanercept in the treatment of refractory recurrent spontaneous abortion with innate immune disorders.
MATERIALS AND METHODS
A randomized controlled trial in patients with refractory innate immune RSA was conducted in our hospital. 188 patients were selected, all with at least 4 consecutive miscarriages and caused by innate immunity disorders. Patients were randomly allocated into 2 groups. One group (n = 95) used etanercept 25 mg per week starting from the first day after menstruation, while the other (n = 93) with placebo. Delivery of a healthy baby without malformations was regarded as the primary outcome.
RESULTS
In etanercept group, 85 (89.47%) patients delivered a healthy baby, while in placebo group, this number was only 67 (72.04%) [P = 0.01, OR = 3.30; 95% CI(1.49～7.32)]. Significantly lower levels of TNF-α and NK cell activity were observed in gestation weeks 4-10 in etanercept group versus placebo group (P < 0.05).
CONCLUSION
The results provide a proof of principle that etanercept can be an attractive therapeutic strategy for refractory innate immune RSA.
目的
评估依那西普治疗固有免疫紊乱所致难治性复发性自发性流产的疗效。
材料和方法
对我院收治的固有免疫 RSA 难治性患者进行随机对照试验。选择至少连续 4 次流产且由固有免疫紊乱引起的 188 例患者。患者被随机分为 2 组。一组（n=95）从月经后第一天开始每周使用依那西普 25mg，另一组（n=93）使用安慰剂。分娩出无畸形的健康婴儿被视为主要结局。
结果
依那西普组 85（89.47%）例患者分娩出健康婴儿，而安慰剂组这一数字仅为 67（72.04%）例[P=0.01，OR=3.30；95%CI（1.49～7.32）]。依那西普组妊娠 4-10 周 TNF-α和 NK 细胞活性明显低于安慰剂组（P<0.05）。
结论
结果初步证明依那西普可作为治疗难治性固有免疫 RSA 的一种有吸引力的治疗策略。
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