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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-024-02896-w

摘要内容如下：

固定剂量联合（FDC）疗法，也称为多药丸疗法，针对动脉粥样硬化性心血管疾病（ASCVD）的危险因素，已被提议作为降低全球ASCVD负担的策略。在此，我们对2016-2022年的相关研究进行了系统检索，以评估FDC疗法预防ASCVD的效果。选择的研究包括评估至少使用一种降血压药物和一种降脂药物的FDC疗法的随机试验。研究数据是独立提取的，证据质量由多个评价者进行评估，当统计异质性为低至中度时，使用固定效应荟萃分析对效应估计进行汇总。分析的主要结果是全因死亡率、致死性和非致死性ASCVD事件、不良事件、收缩压、低密度脂蛋白胆固醇和依从性。在26项试验（n=27，317名参与者，43.2%为女性，平均年龄52.9-76.0岁）中，FDC治疗与较低的低密度脂蛋白胆固醇和收缩压相关，在一级预防和混合二级预防人群中，依从性和不良事件发生率较高。对于主要为一级预防人群的研究，FDC治疗与全因死亡率风险降低11%相关（5.6%对6.3%；相对风险（风险比）为0.89；95%置信区间0.78至1.00；I2=0%；4项试验和16，278名参与者），致死性和非致死性ASCVD事件的风险增加了29%（6.1%对8.4%；相对风险（风险比）为0.71；95%置信区间0.63至0.79；I2=0%；五项试验和15503名参与者）。一项在专门二级预防人群中进行的充分有力的试验显示，FDC疗法将主要不良心血管事件的风险降低了24%。这些发现支持采用和实施多药丸来降低全因死亡率和ASCVD的风险。

英文原文如下：

Abstracts

Fixed-dose combination (FDC) therapy, also known as polypill therapy, targets risk factors for atherosclerotic cardiovascular disease (ASCVD) and has been proposed as a strategy to reduce global ASCVD burden. Here we conducted a systematic search for relevant studies from 2016-2022 to assess the effects of FDC therapy for prevention of ASCVD. The studies selected include randomized trials evaluating FDC therapy with at least one blood pressure-lowering drug and one lipid-lowering drug. The study data were independently extracted, the quality of evidence was appraised by multiple reviewers and effect estimates were pooled using a fixed-effect meta-analysis when statistical heterogeneity was low to moderate. The main outcomes of the analysis were all-cause mortality, fatal and nonfatal ASCVD events, adverse events, systolic blood pressure, low-density lipoprotein cholesterol and adherence. Among 26 trials (n = 27,317 participants, 43.2% female and mean age range 52.9-76.0), FDC therapy was associated with lower low-density lipoprotein cholesterol and systolic blood pressure, with higher rates of adherence and adverse events in both primary and mixed secondary prevention populations. For studies with a mostly primary prevention population, FDC therapy was associated with lower risk of all-cause mortality by 11% (5.6% versus 6.3%; relative risk (risk ratio) of 0.89; 95% confidence interval 0.78 to 1.00; I2 = 0%; four trials and 16,278 participants) and risk of fatal and nonfatal ASCVD events by 29% (6.1% versus 8.4%; relative risk (risk ratio) of 0.71; 95% confidence interval 0.63 to 0.79; I2 = 0%; five trials and 15,503 participants). One adequately powered trial in an exclusively secondary prevention population showed that FDC therapy reduced the risk of major adverse cardiovascular events by 24%. These findings support adoption and implementation of polypills to lower risk for all-cause mortality and ASCVD.

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