Kang Sheng, Wu Yang Feng, An Ning, Ren MingBao
Department of Epidemiology, Cardiovascular Institute and Fu Wai Heart Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
Clin Ther. 2004 Feb;26(2):257-70. doi: 10.1016/s0149-2918(04)90024-0.
A low-dose combination of perindopril and indapamide may effectively reduce blood pressure (BP) in hypertensive patients, but some factors related to study design might have contributed to the between-group differences in the rate of reduction of BP observed in some trials.
The aim of this study was to systematically assess the efficacy and safety profiles (through review of randomized, controlled trials) of the fixed, low-dose combination perindopril 2 mg and indapamide 0.625 mg given as 1 tablet daily as first-line antihypertensive therapy in patients with mild to moderate hypertension.
We searched MEDLINE (1966-April 2003), EMBASE (1980-March 2003), BIOSIS (1999-December 2002), and the Cochrane Library, using the medical subject headings with the search terms perindopril, indapamide, hypertension, randomized controlled trials, randomly, random, randomization, perindopril-indapamide, essential hypertension, and primary hypertension. Additional articles were obtained from the reference lists of relevant reviews and papers.
We reviewed 11 trials (5936 individuals). In 5 studies of perindopril-indapamide versus placebo, the between-group weighted mean differences (WMDs) for both systolic and diastolic BP (SBP and DBP, respectively) favored perindopril-indapamide (SBP, -9.03 mm Hg [95% CI, -9.54 to -8.52]; DBP, -5.09 mm Hg [95% Cl, -5.42 to -4.77]; both P < 0.01 for z score for overall effect). In 6 studies of perindopril-indapamide versus routine antihypertensives, the between-group WMDs for SBP and DBP favored perindopril-indapamide (SBP, -3.72 mm Hg [95% CI, -7.11 to 0.33], P = 0.03 for z score for overall effect; DBP, -1.71 mm Hg [95% CI, -2.27 to -1.16], P < 0.01 for z score for overall effect). Five studies compared perindopril-indapamide and placebo; in the remaining 3 studies, which assessed perindopril-indapamide versus routine antihypertensives, the between-group WMDs for SBP and DBP favored perindopril-indapamide (SBP, -4.00 mm Hg [95% CI, -6.54 to -1.47], P < 0.01; DBP, -1.02 mm Hg [95% CI, -1.73 to -0.31], P < 0.01). Adverse events and withdrawals were not significantly different between perindopril-indapamide, placebo, or routine antihypertensive drugs.
The studies in our analysis consistently demonstrated that a fixed, low-dose perindopril-indapamide combination has a favorable safety profile and may be efficacious as first-line treatment for patients with mild to moderate essential hypertension.
培哚普利与吲达帕胺的低剂量联合用药可能有效降低高血压患者的血压（BP），但某些与研究设计相关的因素可能导致了一些试验中观察到的组间血压降低率差异。
本研究旨在通过回顾随机对照试验，系统评估每日服用1片固定剂量的低剂量培哚普利2毫克和吲达帕胺0.625毫克作为一线降压治疗对轻至中度高血压患者的疗效和安全性。
我们检索了MEDLINE（1966年至2003年4月）、EMBASE（1980年至2003年3月）、BIOSIS（1999年至2002年12月）和Cochrane图书馆，使用医学主题词并结合检索词培哚普利、吲达帕胺、高血压、随机对照试验、随机地、随机、随机化、培哚普利-吲达帕胺、原发性高血压和高血压病。从相关综述和论文的参考文献列表中获取其他文章。
我们回顾了11项试验（5936名个体）。在5项培哚普利-吲达帕胺与安慰剂对比的研究中，收缩压和舒张压（分别为SBP和DBP）的组间加权平均差（WMD）均支持培哚普利-吲达帕胺（SBP，-9.03毫米汞柱[95%CI，-9.54至-8.52]；DBP，-5.09毫米汞柱[95%CI，-5.42至-4.77]；总体效应的z值检验P均<0.01）。在6项培哚普利-吲达帕胺与常规抗高血压药物对比的研究中，SBP和DBP的组间WMD支持培哚普利-吲达帕胺（SBP，-3.72毫米汞柱[95%CI，-7.11至0.33]，总体效应的z值检验P = 0.03；DBP，-1.71毫米汞柱[95%CI，-2.27至-1.16]，总体效应的z值检验P<0.01）。5项研究对比了培哚普利-吲达帕胺与安慰剂；在其余3项评估培哚普利-吲达帕胺与常规抗高血压药物的研究中，SBP和DBP的组间WMD支持培哚普利-吲达帕胺（SBP，-4.00毫米汞柱[95%CI，-6.54至-1.47]，P<0.01；DBP，-1.02毫米汞柱[95%CI，-1.73至-0.31]，P<0.01）。培哚普利-吲达帕胺、安慰剂或常规抗高血压药物之间的不良事件和退出研究情况无显著差异。
我们分析中的研究一致表明，固定剂量的低剂量培哚普利-吲达帕胺联合用药具有良好的安全性，可能作为轻至中度原发性高血压患者的一线治疗有效。
