Geriatrics Department of Endocrinology and Metabolism, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.
Guangxi Key Laboratory of Precision Medicine in Cardio-cerebrovascular Diseases Control and Prevention, Nanning, Guangxi, China.
Medicine (Baltimore). 2023 Jan 20;102(3):e32728. doi: 10.1097/MD.0000000000032728.
This paper aimed to comprehensively evaluate the effectiveness and safety of Inclisiran in treating hyperlipidemia through an overview of systematic reviews (SRs).
The Cochrane Library, EMBASE, PubMed, CNKI, WANGFANG database, VIP database, ClinicalTrials.gov, and ICRT were searched electronically to collect SRs and meta-analysis of Inclisiran in hyperlipidemia treatment from the establishment of the database till May 2022. Two researchers independently screened the relevant literature, then the assessment of multiple systematic reviews tool was made into assess the methodological quality of the included studies. Data extracted were used to perform the study through RevMan5.3 software. The grading of recommendations assessment, development, and evaluation tool was used to grade the quality of the evidence of the outcomes included in the SRs. Prospero ID: CRD 42022326845.
A total of 10 relevant SRs were included, involving 7 randomized controlled trials. The assessment results of the assessment of multiple systematic reviews tool suggested that the quality of the SRs included needed to be improved. The reduced level of low-density lipoprotein cholesterol of the experimental group was lower than the control group, and the difference in the amount of effectiveness was statistically significant (MD = -50.13, 95%CI: -56.2 to -44.06, P < .00001). The grading of recommendations assessment, development, and evaluation results showed that out of 27 outcomes, 8 were high-quality, 3 were of medium quality, 6 were of low quality, and 10 were of the most inferior quality.
300mg Inclisiran with 2 injections a year has the best therapeutic effect, which can significantly reduce low-density lipoprotein cholesterol and total cholesterol, and increase high-density lipoprotein cholesterol levels in patients with hyperlipidemia. Inclisiran has a favorable safety profile, with no significant difference in the incidence of adverse reactions compared to a placebo. Most of the adverse effects were associated with the reaction on the injection site.
本文旨在通过系统评价综述全面评估 Inclisiran 治疗高脂血症的有效性和安全性。
计算机检索 Cochrane 图书馆、EMBASE、PubMed、中国知网、万方数据库、维普数据库、ClinicalTrials.gov 和 ICRT，收集从建库至 2022 年 5 月关于 Inclisiran 治疗高脂血症的系统评价和 Meta 分析，由 2 位研究者独立筛选文献，采用评估系统综述质量的工具对纳入研究进行方法学质量评价，提取资料后采用 RevMan5.3 软件进行分析。对纳入的系统评价进行推荐意见的评估、制定与评价工具（Grading of Recommendations Assessment, Development, and Evaluation，GRADE）分级，评价结局指标的证据质量。前瞻性注册编号：CRD 42022326845。
共纳入 10 篇系统评价，包含 7 项随机对照试验。评估系统综述质量的工具评价结果显示，纳入的系统评价质量需要改进。实验组的低密度脂蛋白胆固醇降低水平低于对照组，差异有统计学意义（MD=-50.13，95%CI：-56.2 至-44.06，P<0.00001）。GRADE 结果显示，27 个结局指标中，8 个为高质量，3 个为中质量，6 个为低质量，10 个为最低质量。
每年注射 2 次 300mg Inclisiran 的疗效最佳，可显著降低高脂血症患者的低密度脂蛋白胆固醇和总胆固醇水平，提高高密度脂蛋白胆固醇水平。Inclisiran 具有良好的安全性，不良反应发生率与安慰剂相比无显著差异。大多数不良反应与注射部位反应有关。
