Vitale Cristiana, Fini Massimo, Spoletini Ilaria, Lainscak Mitja, Seferovic Petar, Rosano Giuseppe Mc
Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy.
Department of Medical Sciences, IRCCS San Raffaele, Roma, Italy.
Int J Cardiol. 2017 Apr 1;232:216-221. doi: 10.1016/j.ijcard.2017.01.018. Epub 2017 Jan 10.
Elderly and women have been often under-represented in randomised clinical trials (RCTs) testing the effect of treatments on cardiovascular diseases (CVDs) even though these diseases highly affect both of them.
Taking into account these issues, the aim of this review is to critically analyse the topic of under-representation of elderly and women in cardiovascular RCTs.
Compared to their younger counterparts, elderly have a higher incidence of disease-related morbidities, take more medicines and account for more adverse drug related events. Similarly, women present several differences in CVD pathophysiology, clinical manifestations and outcomes in comparison to their male counterparts. For these reasons, the results of RCTs obtained in younger men cannot be simply translated in elderly and women. Unfortunately, although international guidelines have been published to increase the enrolment of elderly and women, their recruitment is still insufficient. Thus, the inclusion of these subgroups in cardiovascular RCTs is a key aspect to acquire evidence-based knowledge in the understanding and management of CVDs in elderly and women.
尽管心血管疾病（CVD）对老年人和女性影响极大，但在测试治疗对心血管疾病疗效的随机临床试验（RCT）中，老年人和女性的代表性常常不足。
考虑到这些问题，本综述的目的是批判性地分析老年人和女性在心血管随机对照试验中代表性不足的问题。
与年轻人群相比，老年人与疾病相关的发病率更高，用药更多，药物相关不良事件也更多。同样，与男性相比，女性在心血管疾病的病理生理学、临床表现和预后方面存在一些差异。因此，在年轻男性中获得的随机对照试验结果不能简单地推广到老年人和女性身上。不幸的是，尽管已经发布了国际指南以增加老年人和女性的入组率，但他们的招募情况仍然不足。因此，将这些亚组纳入心血管随机对照试验是在了解和管理老年人及女性心血管疾病方面获得循证知识的一个关键方面。
