Centre for Perinatal Health Services Research, Building DO2, University of Sydney, NSW, 2006, Australia.
BMC Pregnancy Childbirth. 2005 Mar 18;5(1):7. doi: 10.1186/1471-2393-5-7.
There is now good evidence that antiplatelet agents (principally low dose aspirin) prevent pre-eclampsia, a leading cause of morbidity and mortality for pregnant women and their babies. A Cochrane Review identified moderate, but clinically important, reductions in the relative risks of pre-eclampsia (19%), preterm birth (7%) and perinatal mortality (16%) in women allocated antiplatelets, rather than placebo or no antiplatelet.Uncertainty remains, however, about whether some women (in terms of risk) benefit more than others, what dose of aspirin is best and when in pregnancy treatment should ideally start. Rather than undertake new trials, the best way to answer these questions is to utilise existing individual patient data from women enrolled in each trial. METHODS/DESIGN: Systematic review with meta-analysis based on individual patient data. This involves the central collection, validation and re-analysis of thoroughly checked data from individual women in all the available randomised trials.The objective is to confirm that antiplatelet agents, given during pregnancy, will reduce the incidence of pre-eclampsia. The review will then determine the size of this effect, and whether antiplatelets delay the onset of pre-eclampsia or its impact on important outcomes for women and their babies. It will also explore whether the effect of antiplatelets differs by womens' risk profile; when commenced during pregnancy; and/or by dose. DISCUSSION: The PARIS (Perinatal Antiplatelet Review of International Studies) Collaboration has been formed to undertake the review. This will be the first individual patient data review in the perinatal field. Final results should be available by 2006-7.
目前有充分证据表明，抗血小板药物（主要是小剂量阿司匹林）可预防先兆子痫，先兆子痫是导致孕妇及其胎儿发病和死亡的主要原因。一项Cochrane系统评价发现，与服用安慰剂或不服用抗血小板药物的女性相比，服用抗血小板药物的女性先兆子痫的相对风险适度但具有临床意义地降低了19%，早产风险降低了7%，围产期死亡率降低了16%。然而，关于某些女性（根据风险而言）是否比其他女性受益更多、最佳阿司匹林剂量是多少以及理想的治疗应在孕期何时开始，仍存在不确定性。回答这些问题的最佳方法不是开展新的试验，而是利用参与每项试验的女性现有的个体患者数据。
方法/设计：基于个体患者数据的系统评价与荟萃分析。这涉及对所有可用随机试验中个体女性经过全面检查的数据进行集中收集、验证和重新分析。目的是确认孕期使用抗血小板药物可降低先兆子痫的发生率。然后，该评价将确定这种效果的大小，以及抗血小板药物是否会延迟先兆子痫的发作或其对女性及其胎儿重要结局的影响。它还将探讨抗血小板药物的效果是否因女性的风险状况、孕期开始时间和/或剂量而异。
已成立PARIS（围产期抗血小板国际研究综述）协作组来开展此项评价。这将是围产期领域的首次个体患者数据评价。最终结果应在2006 - 2007年可得。
