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心肌梗死后长期抗凝治疗多中心试验未参与者的特征及预后

Characteristics and prognosis of non-participants of a multi-centre trial of long-term anticoagulant treatment after myocardial infarction.

作者信息

van Bergen P F, Jonker J J, Molhoek G P, van der Burgh P H, van Domburg R T, Deckers J W, Hofman A

机构信息

ASPECT Coordinating Centre, Rotterdam, Netherlands.

出版信息

Int J Cardiol. 1995 Apr;49(2):135-41. doi: 10.1016/0167-5273(95)02298-b.

Abstract

Participants of a randomised trial may differ from eligible non-participants as a result of selection. We studied the distribution of prognostic factors and survival in eligible patients of a multi-centre trial of long-term oral anticoagulant treatment after myocardial infarction. All hospital survivors of myocardial infarction in one participating clinical centre of a multi-centre, randomised, double-blind, placebo-controlled trial of long-term anticoagulant treatment after myocardial infarction were screened for entry criteria. Subsequently, prognostic factors and survival of participants were compared with eligible but not randomised patients. The 350 participants were younger and were more often of male gender and more often smokers compared with 587 non-participants. Non-participants had more frequently suffered a previous myocardial infarction and were treated more often with diuretics and ACE-inhibitors, suggesting a higher proportion of patients with chronic heart failure in this group. Age, previous myocardial infarction and the use of diuretics at discharge were independent predictors of mortality, consent showed no association. Our findings indicate that participants of a clinical trial have a better prognosis during the first years following myocardial infarction compared to eligible non-participants as a result of a higher prevalence of cardiovascular risk factors associated with mortality in the non-participants.

摘要

由于选择因素,随机试验的参与者可能与符合条件的非参与者有所不同。我们研究了心肌梗死后长期口服抗凝治疗多中心试验中符合条件患者的预后因素分布和生存率。在一项多中心、随机、双盲、安慰剂对照的心肌梗死后长期抗凝治疗试验的一个参与临床中心,对所有心肌梗死住院幸存者进行了入选标准筛查。随后,将参与者的预后因素和生存率与符合条件但未随机分组的患者进行了比较。与587名非参与者相比,350名参与者更年轻,男性比例更高,吸烟者更多。非参与者既往心肌梗死的发生率更高,利尿剂和ACE抑制剂的使用频率更高,这表明该组慢性心力衰竭患者的比例更高。年龄、既往心肌梗死和出院时使用利尿剂是死亡率的独立预测因素,而是否同意参与试验与死亡率无关。我们的研究结果表明,由于非参与者中与死亡率相关的心血管危险因素患病率较高,心肌梗死后头几年临床试验的参与者相比符合条件的非参与者预后更好。

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