足剂量氨氯地平单药治疗与小剂量氨氯地平单药或联合治疗高血压患者降压疗效的荟萃分析

Full-dose amlodipine monotherapy compared with low-dose amlodipine monotherapy or combination therapy in the management of hypertension: a meta-analysis

目的通过荟萃分析评估足剂量氨氯地平10 mg单药治疗与小剂量氨氯地平5 mg单药治疗或与其他小剂量抗高血压药物联合应用的降压效果。方法对PubMed、EMBASE、Cochrane和中文数据库SinoMed、CNKI及万方医学数据库中的对照试验进行了检索。从符合标准的随机对照试验(RCT)中提取数据进行随机效应荟萃分析;计算加权均数差(WMD)和95%置信区间(95%CI)。进一步分析潜在的异质性来源。结果研究纳入了11项RCT的原发性高血压患者3 422例。氨氯地平5 mg联合治疗与氨氯地平10 mg单药治疗降低收缩压(WMD-0.23 mm Hg;95%CI-2.42~1.95;P=0.83)和舒张压(WMD 0.48 mm Hg;95%CI-0.31~1.27;P=0.23)疗效相当。与氨氯地平5 mg治疗相比,氨氯地平10 mg可显著降低收缩压(WMD-4.99 mm Hg;95%CI-5.38^-4.61;P<0.001)和舒张压(WMD-2.95 mm Hg;95%CI-3.49^-2.42;P<0.001)。亚组分析显示,在亚洲患者中,氨氯地平10 mg单药治疗较氨氯地平5 mg单药治疗(WMD-9.39比-4.60 mm Hg;P<0.001)具有更大的降压效果,降低收缩压效果略优于氨氯地平5 mg联合其他小剂量抗高血压药物(WMD-3.15 mm Hg,P=0.008),降低舒张压效果与其相当(WMD-0.99 mm Hg;P>0.05)。结论原发性高血压患者氨氯地平10 mg单药治疗的降压效果与氨氯地平5 mg联合其他小剂量降压药的降压效果相当。

Objective This meta-analysis evaluated the blood pressure(BP)-lowering effects of full-dose amlodipine(10 mg;AML10) as monotherapy compared with low-dose amlodipine(5 mg;AML5) either as monotherapy or in combination with low-dose other antihypertensive drugs. Methods Searches of PubMed, EMBASE, Cochrane, SinoMed, CNKI and Wanfang Medicine database of controlled trials were conducted. Data from randomized controlled trials(RCT) meeting eligibility criteria were extracted for random-effects meta-analysis;weighted mean differences(WMD) and 95% confidence intervals(95% CI) were calculated. Further analysis was performed to investigate potential sources of heterogeneity. Results Data from 11 RCT of 3 422 patients with essential hypertension were included. Compared with AML5 combination therapy, AML10 monotherapy provided equivalent reductions in systolic BP(WMD-0.23 mm Hg;95% CI-2.42 to 1.95;P=0.83) and diastolic BP(WMD 0.48 mm Hg;95% CI-0.31 to 1.27;P=0.23). Compared with AML5 monotherapy, AML10 monotherapy provided significantly larger reductions in systolic BP(WMD-4.99 mm Hg;95% CI-5.38 to-4.61;P<0.001) and diastolic BP(WMD-2.95 mm Hg;95% CI-3.49 to-2.42;P<0.001). Subgroup analyses showed a larger BP-lowering effect for AML10 monotherapy versus AML5 monotherapy(WMD-9.39 vs-4.60 mm Hg;P<0.001), and a slightly larger systolic BP-lowering effect(WMD-3.15 mm Hg;P=0.008) and an equivalent diastolic BP-lowering effect(WMD-0.99 mmHg;P>0.05) versus AML5 combination therapy in Asian patients. Conclusions The BP-lowering effect of AML10 monotherapy was equivalent to that of AML5 administered in combination with low-dose other antihypertensive drugs in patients with essential hypertension. AML10 provided larger BP-lowering effect both in systolic and diastolic blood pressure than AML5, especially in Asian patients.