Department of Cardiology, Sichuan Tianfu New District People's Hospital, Chengdu, China.
Department of Cardiology, Sichuan Provincial People's Hospital, Chengdu, China.
Medicine (Baltimore). 2024 May 31;103(22):e38360. doi: 10.1097/MD.0000000000038360.
The effect of proprotein convertase subtilisin kexin type (PCSK9) inhibitors on blood lipids and major adverse cardiovascular events (MACEs) is still controversial for acute coronary syndrome (ACS) patients. This study aimed to evaluate the efficacy and safety of PCSK9 inhibitors for ACS patients.
We searched the following databases until March 2023: PubMed, Embase, Cochrane, Web of Science, CNKI, Chongqing VIP Database and Wan Fang Database. Finally, all randomized controlled trials, retrospective studies and prospective studies were included in the analysis.
A total of 20 studies involving 48,621 patients were included in this meta-analysis. The results demonstrated that PCSK9 inhibitors group was more beneficial for ACS patients compared to control group (receiving statins alone or placebo). The meta-analysis showed: there was no significant difference in high density lipoprotein cholesterol between PCSK9 inhibitors group and control group (standard mean difference = 0.17, 95% confidence interval [CI]: -0.02 to 0.36, P = .08), while the level of low density lipoprotein cholesterol in PCSK9 inhibitors group was lower than that in control group (standard mean difference = -2.32, 95% CI: -2.81 to -1.83, P < .00001). Compared with the control group, the PCSK9 inhibitors group also decreased the levels of total cholesterol and triglycerides (mean difference = -1.24, 95% CI: -1.40 to -1.09, P < .00001, mean difference = -0.36, 95% CI: -0.56 to -0.16, P = .0004). Moreover, compared with the control group, PCSK9 inhibitors group could reduce the incidence of MACEs (relative risk [RR] = 0.87, 95% CI: 0.83-0.91; P < .00001). However, this study showed that the incidence of drug-induced adverse events in PCSK9 inhibitors group was higher than that in the control group (RR = 1.15, 95% CI: 1.05-1.25, P < .0001).
Although this study demonstrates that PCSK9 inhibitors have higher drug-induced adverse events, they can not only reduce low-density lipoprotein cholesterol levels but also reduce the incidence of MACEs simultaneously. However, these findings needed to be further verified through large sample, multicenter, double-blind randomized controlled trials.
对于急性冠状动脉综合征（ACS）患者，前蛋白转化酶枯草溶菌素 9（PCSK9）抑制剂对血脂和主要不良心血管事件（MACEs）的影响仍存在争议。本研究旨在评估 PCSK9 抑制剂在 ACS 患者中的疗效和安全性。
我们检索了以下数据库，截至 2023 年 3 月：PubMed、Embase、Cochrane、Web of Science、CNKI、重庆 VIP 数据库和万方数据库。最后，所有随机对照试验、回顾性研究和前瞻性研究都被纳入了分析。
共有 20 项研究纳入了本荟萃分析，涉及 48621 名患者。结果表明，与对照组（单独使用他汀类药物或安慰剂）相比，PCSK9 抑制剂组对 ACS 患者更有益。荟萃分析显示：PCSK9 抑制剂组与对照组高密度脂蛋白胆固醇水平无显著差异（标准均数差=0.17，95%置信区间：-0.02 至 0.36，P=0.08），而 PCSK9 抑制剂组低密度脂蛋白胆固醇水平低于对照组（标准均数差=-2.32，95%置信区间：-2.81 至-1.83，P<0.00001）。与对照组相比，PCSK9 抑制剂组还降低了总胆固醇和甘油三酯水平（均数差=-1.24，95%置信区间：-1.40 至-1.09，P<0.00001，均数差=-0.36，95%置信区间：-0.56 至-0.16，P=0.0004）。此外，与对照组相比，PCSK9 抑制剂组可降低 MACEs 的发生率（相对风险[RR]=0.87，95%置信区间：0.83-0.91；P<0.00001）。然而，本研究显示，PCSK9 抑制剂组药物不良反应的发生率高于对照组（RR=1.15，95%置信区间：1.05-1.25，P<0.0001）。
尽管本研究表明 PCSK9 抑制剂的药物不良反应发生率较高，但它们不仅可以降低低密度脂蛋白胆固醇水平，还可以同时降低 MACEs 的发生率。然而，这些发现需要通过大样本、多中心、双盲随机对照试验进一步验证。
