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[将慢性心力衰竭临床试验的良好结果转化为日常临床实践的困难]

[The difficulties of translating into daily clinical practice the favorable results of clinical trials in chronic heart failure].

作者信息

Licata G

机构信息

Istituto di Clinica Medica, Università degli Studi di Palermo.

出版信息

Ann Ital Med Int. 2000 Jan-Mar;15(1):28-38.

PMID:10842889
Abstract

Congestive heart failure is a growing public health problem and continues to be characterized by a poor prognosis. Its prevalence may be estimated at 0.4-2% of the general population with an incidence varying from 1-10% in elderly patients. This may be in part explained by the progressive aging of the population and the more effective therapeutic strategies for coronary heart disease and hypertension: since they increase the life-expectancy of patients, they favor the onset of this clinical syndrome at a more advanced age. The number of hospital admissions has also increased; mortality is 50% within 4 years of diagnosis, although patients with very severe cardiac decompensation die within 1 year. Despite the fact that with the use of the most advanced molecules created by pharmacological research (ACE inhibitors, beta-blockers, angiotensin-II-receptor antagonists) a significant reduction in morbidity and mortality as well as clear improvement of symptoms and quality of life have been obtained in diverse clinical trials, there is still no certain evidence that in the general population, mortality due to chronic heart disease has been reduced. In our opinion, several factors explain the gap between the favorable results of clinical trials and the lack of significant reduction in morbidity and mortality in clinical practice: A) the selection criteria utilized in clinical studies exclude, for the most part, patients present in general population; B) the average age of the patients included (60 years) is not representative of the overall population; C) patients with associated co-morbidity are generally excluded; D) the number of women enrolled in the trials is quite low; E) compliance is certainly better in the trials than in clinical practice; F) higher drug dosages are used in the trials than in clinical practice. To intervene in these areas and thus make the positive results obtained in the trials available to the general population is, in our opinion, the principal challenge of the future. For this task, the close collaboration and commitment of the internist, the geriatrist, the cardiologist and the family doctors is necessary so that the results reported in clinical trials may be translated into general medical practice.

摘要

充血性心力衰竭是一个日益严重的公共卫生问题,其预后仍然很差。据估计,其在普通人群中的患病率为0.4%-2%,在老年患者中的发病率为1%-10%。这在一定程度上可能是由于人口老龄化以及冠心病和高血压治疗策略的有效性提高:由于这些因素延长了患者的预期寿命,从而增加了该临床综合征在更高年龄阶段发病的几率。住院人数也有所增加;诊断后4年内的死亡率为50%,尽管心脏严重失代偿的患者在1年内死亡。尽管通过使用药理学研究开发的最先进药物(血管紧张素转换酶抑制剂、β受体阻滞剂、血管紧张素II受体拮抗剂),在各种临床试验中已实现发病率和死亡率的显著降低以及症状和生活质量的明显改善,但仍没有确凿证据表明普通人群中慢性心脏病导致的死亡率有所下降。我们认为,有几个因素可以解释临床试验的良好结果与临床实践中发病率和死亡率未显著降低之间的差距:A)临床研究中使用的选择标准在很大程度上排除了普通人群中的患者;B)纳入患者的平均年龄(60岁)不代表总体人群;C)通常排除有合并症的患者;D)试验中纳入的女性数量相当少;E)试验中的依从性肯定比临床实践中更好;F)试验中使用的药物剂量高于临床实践。我们认为,干预这些领域并将试验中取得的积极成果应用于普通人群是未来的主要挑战。要完成这项任务,内科医生、老年病医生、心脏病专家和家庭医生的密切合作与投入是必要的,以便将临床试验中报告的结果转化为普通医疗实践。

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