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临床试验:它们对临床决策真的有用吗?

Clinical trials: are they really useful for clinical decision making?

作者信息

Conti C R

出版信息

Clin Cardiol. 1996 Oct;19(10):763-4. doi: 10.1002/clc.4960191002.

DOI:10.1002/clc.4960191002
PMID:8896907
Abstract

I have always maintained that clinical trials are important to provide prognostic information in patients with cardiac disease. However, clinical trials provide prognostic information for the population of patients under study. I still believe that clinical trials provide knowledge and information that improves patient care. As physicians, we should use the results of clinical trials as guidelines for decision making in individual patients. If we are to make clinical decisions based on results of clinical trials, then it is imperative that the patient would have been suitable for entry into that clinical trial. Thus, as always, additional factors remain important when one has to determine the appropriate therapy for any single patient. These factors include persistent symptoms despite aggressive therapy, objective evidence of end points such as recurrent myocardial ischemia, life-threatening arrhythmias, ventricular dsyfunction, and presence of absence of factors that would suggest one therapy or another-for example, coronary artery spasm. If the patient has coronary artery disease, the location and severity of the coronary artery stenosis certainly influences decisions about medical or revascularization therapy, as do the confidence and enthusiasm of the surgeon and the desires of the patient.

摘要

我一直认为,临床试验对于提供心脏病患者的预后信息非常重要。然而,临床试验为所研究的患者群体提供预后信息。我仍然相信,临床试验能提供改善患者护理的知识和信息。作为医生,我们应将临床试验结果作为个体患者决策的指导。如果我们要根据临床试验结果做出临床决策,那么患者必须适合进入该临床试验。因此,一如既往,在为任何单个患者确定适当治疗方案时,其他因素仍然很重要。这些因素包括尽管积极治疗仍存在持续症状、终点的客观证据,如复发性心肌缺血、危及生命的心律失常、心室功能障碍,以及存在或不存在提示某种治疗方法的因素——例如冠状动脉痉挛。如果患者患有冠状动脉疾病,冠状动脉狭窄的部位和严重程度肯定会影响药物治疗或血运重建治疗的决策,外科医生的信心和热情以及患者的意愿也会产生影响。

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引用本文的文献

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Decision making in clinical cardiology, clinical trials, and judgement.临床心脏病学中的决策制定、临床试验与判断
Clin Cardiol. 2007 Jul;30(7):317-8. doi: 10.1002/clc.20198.