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阿司匹林和安慰剂在早产先兆子痫高危妊娠中的比较研究
Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia


Daniel L. Rolnik ... 心脑血管疾病 妇产科和儿科 • 2017.08.17
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阿司匹林能够降低子痫前期早产的风险:又一次成功的“老药新用”

 

赵扬玉,乔杰*

国家妇产科疾病临床医学研究中心;教育部辅助生殖重点实验室;北京大学第三医院

*通讯作者

 

关于阿司匹林的历史还需追溯至3,500多年前,古代民间普遍将柳树皮作为治疗疾病的偏方。1763年,英国牧师Edward Stone首次报道利用柳树皮成功治愈疟疾引起了世界轰动,从此,科学家们开始对柳树皮中的成分进行研究。从水杨苷(1828)到水杨酸的发现(1838),再到乙酰水杨酸的应用(1852),最终,名为“阿司匹林”的成品药于1897年问世,由此开启了它经久不衰的辉煌历史1。2017年8月17日(2017年6月28日在线发表),英国国王学院医院的Kypros Nicolaides教授与其团队在《新英格兰医学杂志》上发表了关于阿司匹林对子痫前期早产结局的研究结果,是阿司匹林老药新用的又一成功例证2

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摘要


背景

早产先兆子痫是母亲和婴儿围生期死亡及并发症的重要原因,目前尚未确定妊娠期摄入小剂量阿司匹林是否可以降低早产先兆子痫风险。

 

方法

在这项多中心、双盲、安慰剂对照研究中,我们将1,776例早产先兆子痫高危单胎妊娠女性随机分组,分别接受每日150 mg阿司匹林或安慰剂,从孕11~14周直至孕36周。主要结局是孕37周前分娩伴有先兆子痫。我们根据意向性治疗原则进行分析。

 

结果

试验期间共有152人撤回同意,4人失访。在余下的参与者中,798例入组阿司匹林组,822例入组安慰剂组。阿司匹林组有13例(1.6%)参与者出现早产先兆子痫,安慰剂组有35例(4.3%)(阿司匹林组比值比,0.38;95%置信区间,0.20~0.74;P=0.004)。将撤回同意或失访参与者考虑在内进行敏感性分析,结果没有实质性改变。本试验依从性较好,79.9%的参与者报告服用了≥85%的要求药片数量。新生儿不良结局或其他不良事件发生率无显著组间差异。

 

结论

与安慰剂相比,小剂量阿司匹林在早产先兆子痫高危女性中引起了较低的早产先兆子痫发生率(由欧盟第七框架计划[European Union Seventh Framework Program]和胎儿医学基金会[Fetal Medicine Foundation]资助;在EudraCT注册号是2013-003778-29,在Current Controlled Trials注册号是ISRCTN13633058)。





作者信息

Daniel L. Rolnik, M.D., David Wright, Ph.D., Liona C. Poon, M.D., Neil O’Gorman, M.D., Argyro Syngelaki, Ph.D., Catalina de Paco Matallana, M.D., Ranjit Akolekar, M.D., Simona Cicero, M.D., Deepa Janga, M.D., Mandeep Singh, M.D., Francisca S. Molina, M.D., Nicola Persico, M.D., Jacques C. Jani, M.D., Walter Plasencia, M.D., George Papaioannou, M.D., Kinneret Tenenbaum-Gavish, M.D., Hamutal Meiri, Ph.D., Sveinbjorn Gizurarson, Ph.D., Kate Maclagan, Ph.D., and Kypros H. Nicolaides, M.D.
From King’s College Hospital (D.L.R., L.C.P., N.O., A.S., R.A., K.H.N.), Homerton University Hospital (S.C.), North Middlesex University Hospital (D.J.), and University College London Comprehensive Clinical Trials Unit (K.M.), London, University of Exeter, Exeter (D.W.), Medway Maritime Hospital, Gillingham (R.A.), and Southend University Hospital, Westcliff-on-Sea (M.S.) — all in the United Kingdom; Chinese University of Hong Kong, Hong Kong (L.C.P.); Hospital Clínico Universitario Virgen de la Arrixaca, Murcia (C.P.M.), Hospital Universitario San Cecilio, Granada (F.S.M.), and Hospiten Group, Tenerife (W.P.) — all in Spain; Ospedale Maggiore Policlinico, Milan (N.P.); University Hospital Brugmann, Université Libre de Bruxelles, Brussels (J.C.J.); Attikon University Hospital, Athens (G.P.); Rabin Medical Center, Petach Tikva (K.T.-G.), and HyLabs Diagnostics, Rehovot (H.M.) — both in Israel; and University of Iceland, Reykjavik (S.G.). Address reprint req uests to Dr. Nicolaides at the Harris Birthright Research Centre for Fetal Medicine, Fetal Medicine Research Institute, King’s College Hospital, Denmark Hill, London SE5 8BB, United Kingdom, or at kypros@fetalmedicine.com.

 

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