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基层医疗中起始使用血管紧张素转换酶抑制剂治疗心力衰竭的安全性和成本:来自左心室功能障碍研究的个体患者数据分析

Safety and costs of initiating angiotensin converting enzyme inhibitors for heart failure in primary care: analysis of individual patient data from studies of left ventricular dysfunction.

作者信息

Mason J, Young P, Freemantle N, Hobbs R

机构信息

Medicines Evaluation Group, Centre for Health Economics University of York, York YO10 5DD.

出版信息

BMJ. 2000 Nov 4;321(7269):1113-6. doi: 10.1136/bmj.321.7269.1113.

Abstract

OBJECTIVE

To estimate the costs and consequences of diagnosing symptomatic heart failure with left ventricular systolic dysfunction and initiating angiotensin converting enzyme inhibitors in primary care.

DESIGN

Analysis of individual patient data from studies of left ventricular dysfunction (SOLVD) to identify complications during test dose and titration phases.

SETTING

Two randomised controlled trials in secondary care.

PARTICIPANTS

7487 patients taking a test dose of enalapril at enrolment to the treatment and prevention trials; 2569 patients with clinical signs of heart failure and established left ventricular dysfunction entered the treatment trial.

MAIN OUTCOME MEASURES

Discontinuation during the test dose period. Discontinuation or reduction of dose during the first year of treatment for heart failure. Costs of diagnosis and titration of treatment.

RESULTS

During the test dose phase, 585 patients (7.8%) reported side effects; 136 (1.8%) of these discontinued because of severe side effects. During the titration phase, compared with placebo, enalapril was associated with an increased risk of dose reduction due to hypotension (odds ratio 2.09, 95% confidence interval 1.15 to 3.82). However, overall, there was no difference in the rates of side effects leading to dose reduction or withdrawal between the enalapril and placebo groups. The costs of diagnosing heart failure with left ventricular systolic dysfunction and initiating and titrating an angiotensin converting enzyme inhibitor in primary care are pound300 to pound400.

CONCLUSIONS

Treatment with angiotensin converting enzyme inhibitors can be safely started for patients with heart failure and left ventricular systolic dysfunction in primary care.

摘要

目的

评估在基层医疗中诊断有症状的左心室收缩功能不全性心力衰竭并开始使用血管紧张素转换酶抑制剂的成本及后果。

设计

对左心室功能障碍研究(SOLVD)中的个体患者数据进行分析,以确定试验剂量和滴定阶段的并发症。

地点

两项二级医疗中的随机对照试验。

参与者

7487名在治疗和预防试验入组时服用依那普利试验剂量的患者;2569名有心力衰竭临床体征且已确诊左心室功能障碍的患者进入治疗试验。

主要观察指标

试验剂量期停药情况。心力衰竭治疗第一年的停药或减量情况。诊断和滴定治疗的成本。

结果

在试验剂量阶段,585名患者(7.8%)报告有副作用;其中136名(1.8%)因严重副作用停药。在滴定阶段,与安慰剂相比,依那普利因低血压导致剂量减少的风险增加(比值比2.09,95%置信区间1.15至3.82)。然而,总体而言,依那普利组和安慰剂组因副作用导致剂量减少或停药的发生率没有差异。在基层医疗中诊断左心室收缩功能不全性心力衰竭并开始及滴定血管紧张素转换酶抑制剂的成本为300至400英镑。

结论

在基层医疗中,对于心力衰竭和左心室收缩功能不全的患者,可以安全地开始使用血管紧张素转换酶抑制剂进行治疗。

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