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系统评价:血管紧张素转换酶抑制剂或血管紧张素 II 受体阻滞剂治疗缺血性心脏病的疗效比较。

Systematic review: comparative effectiveness of angiotensin-converting enzyme inhibitors or angiotensin II-receptor blockers for ischemic heart disease.

机构信息

University of Connecticut/Hartford Hospital Evidence-based Practice Center, 80 Seymour Street, Hartford, CT 06102, USA.

出版信息

Ann Intern Med. 2009 Dec 15;151(12):861-71. doi: 10.7326/0003-4819-151-12-200912150-00162.

DOI:10.7326/0003-4819-151-12-200912150-00162
PMID:20008762
Abstract

BACKGROUND

Patients with ischemic heart disease and preserved ventricular function experience considerable morbidity and mortality despite standard medical therapy.

PURPOSE

To compare benefits and harms of using angiotensin-converting enzyme (ACE) inhibitors, angiotensin II-receptor blockers (ARBs), or combination therapy in adults with stable ischemic heart disease and preserved ventricular function.

DATA SOURCES

MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews (earliest date, July 2009) were searched without language restrictions.

STUDY SELECTION

Two independent investigators screened citations for trials of at least 6 months' duration that compared ACE inhibitors, ARBs, or combination therapy with placebo or active control and reported any of several clinical outcomes.

DATA EXTRACTION

Using standardized protocols, 2 independent investigators extracted information about study characteristics and rated the quality and strength of evidence. Disagreement was resolved by consensus.

DATA SYNTHESIS

41 studies met eligibility criteria. Moderate- to high-strength evidence (7 trials; 32 559 participants) showed that ACE inhibitors reduce the relative risk (RR) for total mortality (RR, 0.87 [95% CI, 0.81 to 0.94]) and nonfatal myocardial infarction (RR, 0.83 [CI, 0.73 to 0.94]) but increase the RR for syncope (RR, 1.24 [CI, 1.02 to 1.52]) and cough (RR, 1.67 [CI, 1.22 to 2.29]) compared with placebo. Low-strength evidence (1 trial; 5926 participants) suggested that ARBs reduce the RR for the composite end point of cardiovascular mortality, nonfatal myocardial infarction, or stroke (RR, 0.88 [CI, 0.77 to 1.00]) but not for the individual components. Moderate-strength evidence (1 trial; 25 620 participants) showed similar effects on total mortality (RR, 1.07 [CI, 0.98 to 1.16]) and myocardial infarction (RR, 1.08 [CI, 0.94 to 1.23]) but an increased risk for discontinuations because of hypotension (P < 0.001) and syncope (P = 0.035) with combination therapy compared with ACE inhibitors alone.

LIMITATIONS

Many studies either did not assess or did not report harms in a systematic manner. Many studies did not adequately report benefits or harms by various patient subgroups.

CONCLUSION

Adding an ACE inhibitor to standard medical therapy improves outcomes, including reduced risk for mortality and myocardial infarctions, in some patients with stable ischemic heart disease and preserved ventricular function. Less evidence supports a benefit of ARB therapy, and combination therapy seems no better than ACE inhibitor therapy alone and increases harms.

PRIMARY FUNDING SOURCE

Agency for Healthcare Research and Quality.

摘要

背景

尽管采用了标准的医学治疗,患有缺血性心脏病和心室功能保留的患者仍会经历相当大的发病率和死亡率。

目的

比较在稳定型缺血性心脏病和心室功能保留的成人中使用血管紧张素转换酶(ACE)抑制剂、血管紧张素 II 受体阻滞剂(ARB)或联合治疗的益处和危害。

数据来源

MEDLINE、EMBASE、Cochrane 对照试验中心注册库和 Cochrane 系统评价数据库(最早日期为 2009 年 7 月),无语言限制地进行了搜索。

研究选择

两名独立的研究者筛选了至少持续 6 个月的试验引文,这些试验比较了 ACE 抑制剂、ARB 或联合治疗与安慰剂或阳性对照的效果,并报告了几种临床结局。

数据提取

使用标准化协议,两名独立的研究者提取了研究特征的信息,并对证据的质量和强度进行了评级。通过共识解决了分歧。

数据综合

41 项研究符合入选标准。中等至高强度证据(7 项试验;32559 名参与者)表明,ACE 抑制剂降低了全因死亡率(RR,0.87 [95%CI,0.81 至 0.94])和非致死性心肌梗死(RR,0.83 [CI,0.73 至 0.94])的相对风险,但增加了晕厥(RR,1.24 [CI,1.02 至 1.52])和咳嗽(RR,1.67 [CI,1.22 至 2.29])的相对风险与安慰剂相比。低强度证据(1 项试验;5926 名参与者)表明,ARB 降低了心血管死亡率、非致死性心肌梗死或中风的复合终点(RR,0.88 [CI,0.77 至 1.00])的风险,但对单个成分没有影响。中等强度的证据(1 项试验;25620 名参与者)表明,在全因死亡率(RR,1.07 [CI,0.98 至 1.16])和心肌梗死(RR,1.08 [CI,0.94 至 1.23])方面也有类似的效果,但与 ACE 抑制剂单药治疗相比,联合治疗因低血压(P < 0.001)和晕厥(P = 0.035)而停药的风险增加。

局限性

许多研究要么没有系统地评估或报告危害,要么没有这样做。许多研究没有充分报告按不同患者亚组的益处或危害。

结论

在稳定型缺血性心脏病和心室功能保留的患者中,加用 ACE 抑制剂可改善预后,包括降低死亡率和心肌梗死的风险。ARB 治疗的益处证据较少,联合治疗似乎并不优于 ACE 抑制剂单药治疗,且增加了危害。

主要资金来源

医疗保健研究与质量局。

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