inclisiran治疗高胆固醇血症的安全性和有效性：一项系统评价和荟萃分析。
Safety and efficacy of inclisiran in treating hypercholesterolemia: A systemic review and meta-analysis.
作者信息
Cheng Zhiling, Gao Meiling, Liu Yang, Yan Wei, Zhang Zhihan, Jiao Ning, Li Congxin
机构信息
Department of Pharmacy, Hebei Medical University Third Hospital, No. 139 Ziqiang Road, Qiaoxi District, Shijiazhuang, Hebei, China; Hebei Medical University, No. 361 Zhongshan East Road, Chang'an District, Shijiazhuang, Hebei, China.
Department of Pharmacy, Hebei Medical University Third Hospital, No. 139 Ziqiang Road, Qiaoxi District, Shijiazhuang, Hebei, China.
出版信息
Nutr Metab Cardiovasc Dis. 2025 May;35(5):103779. doi: 10.1016/j.numecd.2024.10.017. Epub 2024 Oct 26.
AIMS
To evaluate the efficacy and safety of inclisiran in the treatment of hypercholesterolemia.
DATE SYNTHESIS
Randomized controlled trials comparing inclisiran with a placebo were searched until April 2024. Overall, 8 studies involving 4947 patients were included. Inclisiran reduced low-density lipoprotein cholesterol (mean difference [MD]: -46.95 %; 95 % confidence interval [CI]: -53.26 to -40.46; P < 0.05), proprotein convertase subtilisin/kexin type 9 (MD: -70.80 %; 95 % CI: -76.52 to -65.08; P < 0.05), serum total cholesterol (MD: -29.47 %; 95 % CI: -32.56 to -26.39; P < 0.05), non-high-density lipoprotein cholesterol (MD: -40.46 %; 95 % CI: -45.24 to -35.68; P < 0.05), apolipoprotein B (MD: -36.77 %; 95 % CI: -40.94 to -32.61; P < 0.05), and lipoprotein(a) (MD: -20.04 %; 95 % CI: -24.2 to -15.87; P < 0.05) levels but increased high-density lipoprotein cholesterol level (MD: 6.09 %; 95 % CI: 3.63 to 8.55; P < 0.05). The incidences of adverse events, serious adverse events, headache, nasopharyngitis, and muscular adverse reactions were not significantly different between the inclisiran and placebo groups. Inclisiran reduced the incidence of cardiovascular adverse reactions (odds ratio [OR] = 0.79; 95 % CI: 0.65 to 0.96; P = 0.02) and increased the incidence of injection-site reactions (OR = 4.79; 95 % CI: 2.18 to 10.52; P < 0.05).
CONCLUSION
Inclisiran is effective in treating hypercholesterolemia and has a good safety profile.
目的
评估inclisiran治疗高胆固醇血症的疗效和安全性。
数据综合分析
检索截至2024年4月比较inclisiran与安慰剂的随机对照试验。总体而言，纳入了8项涉及4947例患者的研究。inclisiran降低了低密度脂蛋白胆固醇（平均差[MD]：-46.95%；95%置信区间[CI]：-53.26至-40.46；P<0.05）、前蛋白转化酶枯草溶菌素/kexin 9型（MD：-70.80%；95%CI：-76.52至-65.08；P<0.05）、血清总胆固醇（MD：-29.47%；95%CI：-32.56至-26.39；P<0.05）、非高密度脂蛋白胆固醇（MD：-40.46%；95%CI：-45.24至-35.68；P<0.05）、载脂蛋白B（MD：-36.77%；95%CI：-40.94至-32.61；P<0.05）和脂蛋白(a)（MD：-20.04%；95%CI：-24.2至-15.87；P<0.05）水平，但提高了高密度脂蛋白胆固醇水平（MD：6.09%；95%CI：3.63至8.55；P<0.05）。inclisiran组与安慰剂组在不良事件、严重不良事件、头痛、鼻咽炎和肌肉不良反应的发生率方面无显著差异。inclisiran降低了心血管不良反应的发生率（比值比[OR]=0.79；95%CI：0.65至0.96；P=0.02），并增加了注射部位反应的发生率（OR=4.79；95%CI：2.18至10.52；P<0.05）。
结论
inclisiran治疗高胆固醇血症有效且安全性良好。
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