参附注射液治疗心力衰竭的快速卫生技术评估  

Rapid Health Technology Assessment on Shenfu Injection in the Treatment of Cardiac Failure

作　　者：邵晖 张碧华[2] 叶爱军[2] 邱葵[3] SHAO Hui;ZHANG Bihua;YE Aijun;QIU Kui(Medical Insurance Office,Beijing Xuanwu Hospital of Traditional Chinese Medicine,Beijing 100050,China;Dept.of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Science,Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing 100730,China;Dept.of Pharmacy,Beijing Chaoyang Hospital Affiliate of Capital University of Medical,Beijing 100020,China)

机构地区：[1]北京市宣武中医医院医疗保险办公室,北京100050 [2]北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究所,北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京100730 [3]首都医科大学附属北京朝阳医院药事部,北京100020

出　　处：《中国医院用药评价与分析》2021年第5期595-599,共5页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:基于快速卫生技术评估(health technology assessment,HTA),评价参附注射液治疗心力衰竭的安全性、有效性和经济性,为该药的临床合理应用提供循证依据。方法:全面检索中国期刊全文数据库、万方医学网、中国生物医学文献数据库、EMBase、PubMed和the Cochrane Library等官方网站,纳入参附注射液治疗心力衰竭的HTA报告、系统评价/荟萃分析(Meta分析)和药物经济学研究,采用定性描述的方法对纳入的研究进行分析汇总,并对文献及其方法学进行质量评价。结果:共纳入14篇文献,其中13篇为系统评价/Meta分析,1篇为药物经济学研究,未检索到HTA报告。分析结果显示,采用参附注射液联合西药常规方案治疗心力衰竭,在提高临床有效率、改善中医证候积分、降低脑钠肽水平、提高左心室射血分数、增加心输出量、改善心脏泵血功能、降低N末端B型利钠肽原水平、提高6 min步行距离、改善左心室短轴缩短率和降低心力衰竭患者再入院率等方面具有优势;然而,在减小左心室舒张末期内径、降低死亡率等方面的研究结论不一致;同时,用药期间未见严重不良反应发生,安全性较好。结论:参附注射液治疗心力衰竭具有较好的有效性和安全性。未来可考虑对该药进一步开展规范化的临床疗效观察及药物经济学研究,进而补充其治疗心力衰竭的经济学评价证据。OBJECTIVE:Based on the rapid health technology assessment(HTA),to evaluate the efficacy,safety and economical efficiency of Shenfu injection in the treatment of cardiac failure,so as to provide evidence-based evidence for clinical rational drug application.METHODS:HTA reports,systematic reviews/Meta-analyses and pharmacoeconomic studies on Shenfu injection in the treatment of cardiac failure were involved by overall retrieving CNKI,Wanfang database,CBM,EMBase,PubMed and the Cochrane Library,qualitative description was adopted to conduct analysis and summary on the involved studies,and quality evaluation on the literature and its methodology were performed.RESULTS:Totally 14 studies were involved,13 of which were systematic reviews/Meta-analyses,1 was pharmacoeconomic study,no HTA report was retrieved.The analysis result indicated that the combination of Shenfu injection and western conventional therapy in the treatment of cardiac failure had obvious advantages in promoting clinical effective rate,improving TCM syndrome score,reducing brain natriuretic peptide level,improving left ventricular ejection fraction,increasing cardiac output,improving heart pump function,reduce N-terminal B-type pronatriuretic peptide level,promoting 6-min walking distance,improving left ventricular shortening fraction and reducing readmission rate of patients with cardiac failure;however,the research conclusions on reducing the left ventricular end diastolic diameter and mortality were inconsistent;meanwhile,no obvious adverse drug reactions occurred during medication,and the safety was good.CONCLUSIONS:Shenfu injection has good effectiveness and safety in the treatment of cardiac failure.In the future,it can be considered to further carry out standardized clinical efficacy observation and pharmacoeconomic research on this drug,and then supplement its economic evaluation evidence for the treatment of heart failure.

关 键 词：参附注射液 心力衰竭 卫生经济学 快速卫生技术评估 

分 类 号：R932[医药卫生—生药学]