MitraClip器械治疗中重度二尖瓣反流患者的快速卫生技术评估  

MitraClip device for patients with severe mitral valve regurgitation:a rapid health technology assessment

作　　者：樊志磊 连代 袁家琪 翁俊岭 魏艳[1,2] 陈英耀 FAN Zhilei;LIAN Dai;YUAN Jiaqi;WENG Junling;WEI Yan;CHEN Yingyao(School of Public Health,Fudan University,Shanghai 200032,P.R.China;National Health Commission Key Laboratory of Health Technology Assessment,Fudan University,Shanghai 200032,P.R.China)

机构地区：[1]复旦大学公共卫生学院,上海200032 [2]国家卫生健康委员会卫生技术评估重点实验室,上海200032

出　　处：《中国循证医学杂志》2023年第1期41-49,共9页Chinese Journal of Evidence-based Medicine

基　　金：复旦大学横向项目(编号:WAF201277)。

摘　　要：目的快速评估MitraClip器械治疗中重度二尖瓣反流(MR)患者的安全性、有效性与经济性。方法计算机检索PubMed、EMbase、The Cochrane Library、CNKI、WanFang Data、CBM和CRD数据库,搜集MitraClip对比传统方式治疗中重度MR患者的高等级临床证据和经济学评价文献,检索时限均为建库至2022年5月。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,进行定性分析和汇总描述。结果共纳入33个研究,包括4个HTA报告、3个RCT、16个系统评价或Meta分析,10个成本-效果分析。结果显示,与手术比较,多数研究显示MitraClip组术后残余MR程度更高,输血事件和住院天数更少,但30天不良事件和死亡率、1年及以上生存率两者未见显著差异。部分研究显示MitraClip有更高的再次二尖瓣手术率和中重度MR复发率。与药物比较,所有研究显示MitraClip有中长期生存率获益并能降低心脏住院事件的发生。现有经济学评价显示,基于现有证据临床获益在大多数卫生服务和支付体系下具有成本-效果。结论现有高等级证据显示MitraClip有效性和安全性较好,在其他国家相对传统治疗更具有成本-效果。但在中国人群中的真实疗效和基于国情的成本-效果仍需要完整HTA流程予以验证。Objective To utilize a rapid health technology assessment to evaluate the efficacy,safety and costeffectiveness of the MitraClip device for patients with severe mitral regurgitation(MR).Methods PubMed,EMbase,The Cochrane Library,CNKI,WanFang Data,CBM and the CRD databases were electronically searched to collect clinical evidence and economic evaluations on the efficacy,safety and cost-effectiveness of the MitraClip device for patients with severe MR from inception to May 2022.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies;then,descriptive analyses and data summaries were performed.Results A total of 33 studies,involving 4 HTA reports,3 RCTs,16 systematic reviews or meta-analyses,and 10 economic evaluations were included.In the evidence comparing MitraClip and surgery,most of the literature showed that the MitraClip group had higher postoperative residual MR,fewer blood transfusion events,and fewer hospital days.We found no significant treatment effects on 30-day adverse events and mortality,and the 1-year and above survival rate.In the evidence of MitraClip versus medical therapy alone,all included studies showed that MitraClip benefited mid-term and long-term survival and reduced the incidence of subsequent cardiac hospitalizations.Economic evaluations showed that the clinical benefits were cost-effective in the setting of their health service systems.Conclusion The available high-grade clinical evidence shows that MitraClip is effective and safe to some extent,and has cost-effectiveness compared with traditional treatment in other countries.However,the real-world effectiveness and cost-effectiveness of the MitraClip need to be tested in the Chinese population and health-care setting.

关 键 词：MITRACLIP 二尖瓣反流 经导管二尖瓣缘对缘修复术 快速卫生技术评估 

分 类 号：R654.2[医药卫生—外科学]