α-硫辛酸单用及其与甲钴胺联用对比甲钴胺辅助治疗糖尿病周围神经病变的药物经济学评价

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英文篇名：Pharmacoeconomic Evaluation of α-Lipoic Acid Alone or Combined with Mecobalamin versus Mecobalamin in the Adjunctive Treatment of Diabetic Peripheral Neuropathy 作者：王红梅 ; 杨男 ; 许倩 ; 孔令希 ; 邱峰 ; 单雪峰 英文作者：WANG Hongmei;YANG Nan;XU Qian;KONG Lingxi;QIU Feng;SHAN Xuefeng;Dept.of Pharmacy,the First Affiliated Hospital of Chongqing Medical University;West China School of Pharmacy,Sichuan University; 关键词：α-硫辛酸注射液 ; 甲钴胺注射液 ; 糖尿病周围神经病变 ; Meta分析 ; 成本-效果分析 英文关键词：Lipoic acid injection;;Mecobalamin injection;;Diabetic peripheral neuropathy;;Meta-analysis;;Cost-effectiveness analysis 中文刊名：ZGYA 英文刊名：China Pharmacy 机构：重庆医科大学附属第一医院药学部;四川大学华西药学院; 出版日期：2019-03-15 出版单位：中国药房 年：2019 期：v.30;No.647 基金：重庆市科技计划项目(No.cstc2015shmszx120023) 语种：中文; 页：ZGYA201905023 页数：5 CN：05 ISSN：50-1055/R 分类号：119-123

摘要

目的:评估α-硫辛酸注射液单用及其与甲钴胺注射液联用对比甲钴胺注射液辅助治疗糖尿病周围神经病变(DPN)的临床效果及经济性。方法:计算机检索PubMed、Cochrane Library、Embase、中国知网、中文科技期刊数据库、中国生物医学文献数据库和万方数据,中文检索词包括"甲钴胺""α-硫辛酸""糖尿病周围神经病变",英文检索词包括"Thioctic acid""α-lipoic acid""Methylcobal""Mecobalamin""Diabetic peripheral neuropathy",检索时间为建库至2018年8月30日。收集相关随机对照试验(RCT),进行临床总有效率的Meta分析,同时从医疗保健服务提供者角度,采用成本-效果分析进行经济学评价,并通过成本和临床总有效率上下浮动15%进行敏感性分析。结果:共纳入13篇RCT,共计1 131例患者。Meta分析结果显示,两药联用治疗DPN的临床总有效率高于甲钴胺注射液单用[RR=1.41,95%CI(1.28,1.55),P<0.000 01],α-硫辛酸注射液单用治疗DPN的临床总有效率也高于甲钴胺注射液单用[RR=1.35,95%CI(1.25,1.47),P<0.000 01],差异均有统计学意义。成本-效果分析结果显示,甲钴胺注射液的成本-效果比(CER)为211.38元,两药联用及α-硫辛酸注射液单用的CER分别为1 484.42、1 383.49元,二者的增量成本-效果比(ICER)分别为4 589.52、4 638.82元,均小于2017年的人均国内生产总值(GDP)。敏感性分析表明成本-效果分析结果稳健。结论:与甲钴胺注射液比较,α-硫辛酸注射液与甲钴胺注射液联用辅助治疗DPN的临床总有效率更高,更具经济性。
        OBJECTIVE:To evaluate the clinical efficacy and economics of α-lipoic acid injection alone or combined with Mecobalamin injection versus Mecobalamin injection in the adjunctive treatment of diabetic peripheral neuropathy(DPN).METHODS: Retrieved from PubMed, Cochrane Library, Embase, CNKI, VIP, CBM and Wanfang database, using"mecobalamin"" α-lipoic acid"and"diabetic peripheral neuropathy"as Chinese retrieval words,"Thioctic acid"" α-lipoic acid""Methylcobal""Mecobalamin""Diabetic peripheral neuropathy"as English retrieval words,relevant randomized controlled trials(RCTs) were collected during the date of database establishment to Aug. 30 th,2018. Meta-analysis was conducted for total response rate. From the perspective of health care providers,cost-effectiveness analysis was used for economic evaluation and sensitivity analysis was conducted by a 15% fluctuation of cost and total response rate. RESULTS:Totally 13 RCTs were included,involving 1 131 patients. The results of Meta-analysis showed that the total response rate of two-drug combination therapy in the treatment of DPN was higher than that of mecobalamin alone [RR=1.41,95%CI(1.28,1.55),P<0.000 01];that of α-lipoic acid injection alone in the treatment of DPN was higher than that of mecobalamin injection alone [RR=1.35,95%CI(1.25,1.47),P<0.000 01],with statistical significance. Results of cost-effectiveness analysis showed that the cost-effectiveness ratio(CER) of Mecobalamin injection was 211.38 yuan,and CER of two-drug combination and α-lipoic acid injection alone were 1 484.42 and 1 383.49 yuan,respectively. The incremental cost-effectiveness ratio(ICER)were 4 589.52 and 4 638.82 yuan,which were all lower than per capita GDP in 2017. Sensitivity analysis showed that the cost-effectiveness analysis results kept stable. CONCLUSIONS:Compared with Mecobalamin injection,α-lipoic acid injection combined with Mecobalamin injection in the adjunctive treatment of DPN show high total response rate and economics.

引文

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