BMJ:孕早期补高剂量叶酸能否阻止高危孕妇发生先兆子痫?

2018-11-02 贾朝娟 环球医学

先兆子痫是威胁母亲和产儿生命与健康的重要原因,因此研究如何避免其发生成为众多学者的使命。2018年9月,发生在《BMJ》的一项随机双盲多中心对照试验,调查了补充高剂量叶酸预防先兆子痫的有效性。

先兆子痫是威胁母亲和产儿生命与健康的重要原因,因此研究如何避免其发生成为众多学者的使命。2018年9月,发生在《BMJ》的一项随机双盲多中心对照试验,调查了补充高剂量叶酸预防先兆子痫的有效性。

目的:在至少有1个风险因素(既往患有高血压、妊娠前糖尿病(1型或2型)、双胞胎、既往妊娠期间先兆子痫或体重指数≥35)的女性中,考察补充高剂量叶酸预防先兆子痫的有效性。

设计:随机III期、双盲国际多中心临床试验。

数据来源:5个国家(阿根廷、澳大利亚、加拿大、牙买加和英国)的70个产科中心。

受试者:2011到2015年间,2464名至少有1个先兆子痫风险因素的妊娠妇女被随机分配(叶酸组1144名,安慰剂组1157名);2301名纳入到意向治疗分析。

干预:从妊娠第8周到妊娠16周开始,直到分娩,符合条件的女性被随机分配至接受每日高剂量叶酸组(口服片剂1.0 mg,4片)或安慰剂组。临床医生、参与者、评审员和研究人员对治疗分组设盲。

主要结局测试指标:主要结局是先兆子痫,定义为妊娠20周后出现高血压,且出现大量蛋白尿或HELLP综合征(溶血、肝酶升高和血小板减少)。

结果:叶酸组1144名女性,169名(14.8%)出现先兆子痫,安慰剂组1157名中有156名(13.5%)(相对风险 1.10,95%置信区间0.90~1.34;P=0.37)。对于任何其他孕妇或新生儿的不良结局,没有证据表明两组之间存在差异。

结论:孕早期补充4.0 mg/日叶酸,并不能预防高危患者发生先兆子痫。

原始出处:

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    2019-09-21 gaoxiaoe
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    2019-03-07 amy0550
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