O'Hagan Edel T, McIntyre Daniel, Nguyen Tu, Chow Clara K
Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, Westmead, New South Wales, Australia
Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, Westmead, New South Wales, Australia.
Heart. 2023 Aug 11;109(17):1273-1280. doi: 10.1136/heartjnl-2022-321496.
Fixed-dose combination (FDC) therapy may provide a solution to treatment gaps by overcoming reasons for therapeutic inertia. To synthesise and report on available evidence on standard or low-dose combination medicines that combine at least three antihypertensive medicines. A literature search was conducted via Scopus, Embase, PubMed and the Cochrane clinical trials database. Studies were eligible for inclusion if they were randomised clinical trials that included adults (>18 years) and examined the impact of at least three antihypertensive medications on blood pressure (BP). A total of 18 trials (n=14 307) were identified that examined combinations of three or four antihypertensive medicines. Ten trials investigated the effect of a standard dose triple combination polypill, four the effect of a low-dose triple and four the effect of a low-dose quadruple combination polypill. The mean difference (MD) in systolic BP ranged from -10.6 to -41.4 for the standard dose triple combination polypill in comparison with 2.1 to -34.5 for dual combination; -9.8 to -20.6 for a low-dose combination polypill in comparison with a MD of -0.9 to -5.2 for placebo; -9.0 to -29.3 for a low-dose combination polypill compared with -2.0 to -20.6 for monotherapy or usual care. All trials reported similar rates of adverse events. Ten studies reported medication adherence, six reported >95% adherence. Triple and quadruple combination antihypertensive medications are effective. Studies of low-dose triple and quadruple combinations involving treatment naïve populations suggest initiating such combinations are safe and effective as first-line therapy for stage 2 hypertension (BP >140/90 mm Hg).
固定剂量复方（FDC）疗法或许能通过克服治疗惰性的原因来解决治疗缺口问题。综合并报告关于至少包含三种抗高血压药物的标准或低剂量复方药物的现有证据。通过Scopus、Embase、PubMed和Cochrane临床试验数据库进行文献检索。如果研究是随机临床试验，纳入了成年人（>18岁）并考察了至少三种抗高血压药物对血压（BP）的影响，则这些研究符合纳入标准。共确定了18项试验（n = 14307），这些试验考察了三种或四种抗高血压药物的组合。十项试验研究了标准剂量三联复方制剂的效果，四项研究了低剂量三联复方制剂的效果，四项研究了低剂量四联复方制剂的效果。与双联复方制剂收缩压平均差（MD）范围为2.1至 -34.5相比，标准剂量三联复方制剂的收缩压平均差范围为 -10.6至 -41.4；与安慰剂MD为 -0.9至 -5.2相比，低剂量复方制剂的收缩压平均差为 -9.8至 -20.6；与单药治疗或常规治疗MD为 -2.0至 -20.6相比，低剂量复方制剂的收缩压平均差为 -9.0至 -29.3。所有试验报告的不良事件发生率相似。十项研究报告了药物依从性，六项报告依从性>95%。三联和四联复方抗高血压药物是有效的。涉及初治人群的低剂量三联和四联复方制剂研究表明，起始使用此类复方制剂作为2级高血压（BP>140/90 mmHg）的一线治疗是安全有效的。
