贝前列素钠治疗外周动脉疾病的快速卫生技术评估

Rapid Health Technology Assessment on Beraprost Sodium in the Peripheral Artery Disease

目的本研究通过对贝前列素钠治疗外周动脉疾病(peripheral artery disease,PAD)进行快速卫生技术评估(health technology assessment,HTA),评价贝前列素钠治疗PAD临床应用的有效性、安全性和经济性,为临床用药决策提供循证医学证据。方法计算机检索PubMed、Embase、Cochrane Library、中国知网、万方数据库、中国生物医学文献数据库和卫生技术评估(HTA)机构官方网站,收集前列素钠治疗PAD的系统评价(systematicreview,SR)/Meta分析、经济学评价和HTA报告,检索时限均为建库至2022年12月。由2位研究者独立根据纳入排除标准进行文章筛选、质量评价及数据提取,并对数据结果进行分析。结果共纳入7项研究,包括6项SR/Meta分析和1项经济学研究,未检索到HTA报告。分析结果显示,在有效性方面,6项SR/Meta分析结果均显示贝前列素钠对比其它阳性药物或安慰剂在提高PAD患者的最大步行距离(maximum walking distance,MWD)和无痛步行距离(pain-free walkingdistance,PFWD)方面均有一定优势。安全性方面,贝前列素钠的安全性劣于安慰剂、西洛他唑和阿司匹林,优于沙格雷酯。用药期间未见严重不良反应,安全性较好。经济学研究显示,与西洛他唑和沙格雷酯相比,贝前列素钠可延长患者的质量调整生命年(quality-adjusted life years,QALY)和节约医疗成本,更具有成本-效用优势。结论贝前列素钠治疗PAD具有较好的有效性、安全性和经济性。

OBJECTIVE To evaluate the effectiveness,safety and economy of beraprost sodium in the treatment of peripheral artery disease(PAD),and to provide evidence-based medical evidence for clinical decision.METHODS Computer searches of PubMed,Embase,Cochrane Library,China Knowledge Network,Wanfang database,Chinese biomedical literature database and official websites of health technology assessment(HTA)institutions were conducted to collect systematic review(SR)/Meta-analysis,economic evaluation and HTA of beraprost sodium for PAD.reports,all searched for the period of establishment to Dec.2022.Two investigators independently performed article screening,quality evaluation,and data extraction based on inclusion and exclusion criteria,and analyzed the data results.RESULTS A total of 7 studies were included,including 6 SR/Meta analyses and 1 economics study,and no HTA reports were retrieved.In terms of efficacy,all six SR/Meta analyses showed that beraprost sodium was superior to other positive drugs or placebo in increasing the maximum walking distance(MWD)and pain-free walking distance(PFWD)in patients with PAD.All of them have some advantages.In terms of safety,beraprost sodium was inferior to placebo,and superior to sarpogrelate.No serious adverse reactions were observed during dosing,and the safety profile was better.Economic studies have shown that beraprost sodium has a cost-utility advantage in terms of prolonging quality-adjusted life years(QALY)and saving healthcare costs compared with cilostazol and sarpogrelate.CONCLUSION Beraprost sodium has good efficacy,safety and economy in the treatment of PAD.