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英克司兰治疗动脉粥样硬化性心血管疾病伴高胆固醇血症的快速卫生技术评估
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| 篇名： | 英克司兰治疗动脉粥样硬化性心血管疾病伴高胆固醇血症的快速卫生技术评估 |
| TITLE： | Rapid health technology assessment of inclisiran in the treatment of atherosclerotic cardiovascular disease with hypercholesterolemia |
| 摘要： | 目的 评估英克司兰在动脉粥样硬化性心血管疾病伴高胆固醇血症治疗中的有效性、安全性和经济性。方法采用快速卫生技术评估（HTA）方法。通过检索PubMed、Embase、theCochraneLibrary、中国知网、万方等中英文数据库和HTA官方网站，收集英克司兰相关HTA报告、系统评价（SR）/Meta分析和药物经济学研究，检索时限为建库起至2025年4月。通过文献筛选、数据提取及文献质量评价，对研究结果进行描述性分析和汇总。结果最终纳入22篇文献，包括HTA报告1篇，SR/Meta分析15篇，药物经济学研究6篇。有效性方面，与对照组相比，英克司兰能够显著降低低密度脂蛋白胆固醇、前蛋白转化酶枯草溶菌素9、总胆固醇、甘油三酯、载脂蛋白B和脂蛋白（a）水平，升高高密度脂蛋白胆固醇水平，降低心血管不良事件风险。安全性方面，英克司兰组总不良事件、严重不良事件和非严重不良事件的发生风险与对照组差异无统计学意义，但是注射部位反应发生率升高，且多为轻度。经济性方面，国内外研究结论存在差异，更多研究表明英克司兰不具备经济性优势，需适当降价才能符合成本-效果标准。结论英克司兰治疗动脉粥样硬化性心血管疾病伴高胆固醇血症疗效显著、安全性良好，但其经济性有待进一步提高。 |
| ABSTRACT： | OBJECTIVE To evaluate the efficacy， safety and economy of inclisiran in the treatment of atherosclerotic cardiovascular disease with hypercholesterolemia. METHODS A rapid health technology assessment （HTA） approach was employed. HTA reports， systematic reviews（SR）/meta-analyses， and pharmacoeconomic studies related to inclisiran were systematically identified through comprehensive searches of Chinese and English databases， including PubMed， Embase， the Cochrane Library， CNKI and Wanfang database， supplemented by HTA institutional repositories. The search timeframe spanned from database inception to April 2025. The results of the studies were descriptively analysed and summarized through literature screening， data extraction and literature quality assessment. RESULTS The final analysis included 22 studies， comprising one HTA report， 15 SR/meta-analyses， and 6 pharmacoeconomic evaluations. Regarding therapeutic efficacy， compared with control group， inclisiran could significantly reduce the levels of low-density lipoprotein cholesterol， proprotein convertase subtilisin/kexin type 9， total cholesterol， triacylglycerol， apolipoprotein B， and lipoprotein（a）， increase the level of high-density lipoprotein cholesterol， and reduce the risk of adverse cardiovascular events. In terms of safety， the inclisiran group showed no significant difference compared with the control group in the risk of total adverse events， serious adverse events， or non-serious adverse events； however， an increased incidence of injection site reactions was observed， most of which were mild. In terms of cost-effectiveness， there were discrepancies in research conclusions both domestically and internationally. More studies indicated that inclisiran did not demonstrate cost-effectiveness advantage and would require an appropriate price reduction to meet cost-effectiveness criteria. CONCLUSIONS Inclisiran demonstrates favorable efficacy and acceptable safety in treating atherosclerotic cardiovascular disease with hypercholesterolemia， though its economic profile requires improvement. |
| 期刊： | 2025年第36卷第19期 |
| 作者： | 高杏；刘天雅；张倩；张波；李薇；刘玲 |
| AUTHORS： | GAO Xing，LIU Tianya，ZHANG Qian，ZHANG Bo，LI Wei，LIU Ling |
| 关键字： | 英克司兰；动脉粥样硬化性心血管疾病；高胆固醇血症；快速卫生技术评估 |
| KEYWORDS： | inclisiran； atherosclerotic cardiovascular disease； hypercholesterolemia； rapid health technology assessment |
| 阅读数： | 8 次 |
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