THE EXCLUSION OF THE ELDERLY AND WOMEN FROM CLINICAL-TRIALS IN ACUTE MYOCARDIAL-INFARCTION
THE EXCLUSION OF THE ELDERLY AND WOMEN FROM CLINICAL-TRIALS IN ACUTE MYOCARDIAL-INFARCTION
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DOI：
10.1001/jama.1992.03490110055029
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发表时间：
1992-09-16
影响因子：
120.7
通讯作者：
AVORN, J
中科院分区：
文献类型：
--
作者：
GURWITZ, JH;COL, NF;AVORN, J
客观。-确定老年人被排除在急性心肌梗死治疗药物治疗试验之外的程度，确定与此类排除相关的因素，并探讨老年人被排除与女性代表性之间的关系。数据来源。我们对1960年1月至1991年9月的英文文献进行了系统检索，以确定用于治疗急性心肌梗死的特定药物治疗的所有相关研究。为此，我们检索了MEDLINE、主要心脏病学教科书、荟萃分析、综述、社论和所有已识别文章的参考书目。只有患者被随机分配接受特定治疗方案或安慰剂或非安慰剂对照方案的试验才被纳入审查。对研究的发表年份、支持来源、性能位置、患者随机接受的药物治疗、侵入性诊断测试或治疗程序的使用、排除标准、随机研究人群的规模和人口统计学特征以及主要结局指标进行了摘要。共有214项试验符合纳入标准，涉及150920例研究受试者。超过60%的试验排除了75岁以上的人。与1980年之前发表的研究相比，1980年之后发表的研究更可能有基于年龄的排除（调整后的比值比为4.92; 95%置信区间为2.33至10.54）。与其他研究相比，涉及侵入性操作的溶栓治疗试验更可能排除老年患者（校正比值比，2.45; 95%置信区间，1.10至5.47）。与没有这种排除的研究相比，基于年龄排除的研究中女性比例较小（18% vs 23%; P =.0002），研究人群的平均年龄与女性参与者的比例显著相关（P =.0001，R2 =.29）。在急性心肌梗死治疗药物的临床试验中，经常使用基于心脏病的排除。这种排除限制了将研究结果推广到急性心肌梗死发病率和死亡率最高的患者人群的能力。
Objective.-To determine the extent to which the elderly have been excluded from trials of drug therapies used in the treatment of acute myocardial infarction, to identify factors associated with such exclusions, and to explore the relationship between the exclusion of elderly and the representation of women.Data Sources.-We conducted a systematic search of the English-language literature from January 1960 through September 1991 to identify all relevant studies of specific pharmacotherapies employed in the treatment of acute myocardial infarction. To accomplish this, we searched MEDLINE, major cardiology textbooks, meta-analyses, reviews, editorials, and the bibliographies of all identified articles.Study Selection.-Only trials in which patients were randomly allocated to receive a specific therapeutic regimen or a placebo or nonplacebo control regimen were included for review.Data Extraction.-Studies were abstracted for year of publication, source of support, performance location, drug therapies to which patients were randomized, use of invasive diagnostic tests or therapeutic procedures, exclusion criteria, size and demographic characteristics of the randomized study population, and principal outcome measures.Data Synthesis.-A total of 214 trials met inclusion criteria, involving 150 920 study subjects. Over 60% of trials excluded persons over the age of 75 years. Studies published after 1980 were more likely to have age-based exclusions compared with studies published before 1980 (adjusted odds ratio, 4.92; 95% confidence interval, 2.33 to 10.54). Trials of thrombolytic therapy involving an invasive procedure were more likely to exclude elderly patients compared with other studies (adjusted odds ratio, 2.45; 95% confidence interval, 1.10 to 5.47). Studies with age-based exclusions had a smaller percentage of women compared with those without such exclusions (18% vs 23%; P=.0002), with the mean age of the study population significantly associated with the proportion of women participants (P=.0001, R2=.29).Conclusions.-Age-based exclusions are frequently used in clinical trials of medications used in the treatment of acute myocardial infarction. Such exclusions limit the ability to generalize study findings to the patient population that experiences the most morbidity and mortality from acute myocardial infarction.