在心血管疾病的随机对照试验中,病的代表性不足
Steven G Coca1, Harlan M Krumholz, Amit X Garg
1Clinical Epidemiology Research Center, Veterans Affairs Medical Center, West Haven, Conn 06516, USA.
JAMA
|September 21, 2006
概括
患有病的患者往往被排除在主要心血管试验之外. 这限制了对治疗如何影响这一高风险群体的理解.
科学领域:
- 心脏病学 心脏病学
- 腎臟病學 (nephrology) 是一種醫學.
- 临床试验 临床试验
背景情况:
- 患有病的患者面临心血管死亡的高风险.
- 为这一群体确定有效的干预措施是关键的卫生优先事项.
研究的目的:
- 评估将患有病的患者纳入心血管疾病干预的随机对照试验 (RCT).
- 评估这些试验中关于功能和治疗效果的报告.
主要方法:
- 在MEDLINE的系统搜索中,确定了1985年至2005年期间在主要医学期刊上发表的RCT.
- 包括专注于慢性充血性心力衰竭和急性心肌梗塞的试验,其中包括I/II类推.
- 关于患者特征,功能和结果的数据由两位评论员独立抽象.
主要成果:
- 在153项审查的试验中,56%排除了患有病的患者.
- 排除在多中心,北美试验中更为常见,以及那些测试氨酸氨酸氨系统对抗剂或抗凝剂的试验.
- 只有5%的试验报告了病患者的比例,10%报告了基线功能. 根据脏疾病进行子组分析很少 (3%).
结论:
- 主要的心血管试验经常排除患有病的患者.
- 对这一子组的功能和治疗效果的报告不足,阻碍了临床决策.
- 需要改进试验设计和报告,以应对患有病的患者心血管风险.
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