基于Meta分析六味地黄丸联合降糖药治疗2型糖尿病的药物经济学评价

Pharmacoeconomic Evaluation of Liuwei Dihuang Pills Combined with Hypoglycemic Agents in the Treatment of Type 2 Diabetes Mellitus

目的:基于Meta分析方法对六味地黄丸联合降糖药治疗2型糖尿病(T2DM)的有效性、安全性和经济性进行评价。方法:计算机检索PubMed、Embase、the Cochrane Library、Springer、ProQuest、CNKI、WanFang Data及VIP数据库,搜集六味地黄丸与降糖药(二甲双胍、消渴丸)联用治疗T2DM的随机对照试验(RCT),检索时间均为从建库至2019年12月31日,由两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,采用RevMan 5.3软件进行Meta分析,利用成本-效果分析法进行经济性评价。结果:共纳入45个RCT,其中31个RCT的对照药为二甲双胍,14个RCT的对照药为消渴丸。Meta分析结果表明,与单独使用该两种降糖药相比,六味地黄丸分别联合该两种降糖药治疗的总有效率更高,对空腹血糖、餐后2 h血糖、糖化血红蛋白均有更佳的疗效,差异有统计学意义(P<0.05)。安全性分析表明,未见严重药品不良反应。成本-效果分析显示,六味地黄丸联合用药与单独使用二甲双胍相比,每提高1单位有效率,成本增加4.09~17.60元;与单独使用消渴丸相比,每提高1单位有效率,成本增加2.43元。结论:六味地黄丸联合降糖药治疗T2DM可增加疗效,未见严重安全性问题,但成本有所增加,仍需高质量研究提供证据支撑。

Objective:To evaluate the efficacy,safety and cost of Liuwei Dihuang pills combined with hypoglycemic agents in the treatment of type 2 diabetes mellitus(T2DM)based on meta-analysis.Methods:PubMed,Embase,the Cochrane Library,Springer,ProQuest,CNKI,WanFang Data and VIP databases were electronically searched to collect the randomized controlled trials(RCTs)of Liuwei Dihuang pills combined with metformin or Xiaoke pills in the treatment of T2DM from inception to December 31,2019.Two reviewers independently screened the literature,extracted the data and assessed the risk of bias of included studies.Meta-analysis was performed using RevMan 5.3 software,and cost-effectiveness analysis was used for economic evaluation.Results:A total of 45 RCTs were included,of which 31 were combined with metformin,and 14 were with Xiaoke pills.Meta-analysis showed that Liuwei Dihuang pills combined with metformin or Xiaoke pills were more effective than metformin or Xiaoke pills alone,and had better curative effect on FBG,2hPG and HbA1c.The differences were statistically significant(P<0.05).Safety analysis showed no serious adverse reactions.The cost-effectiveness analysis showed that the cost of the combination of Liuwei Dihuang pills increased by 4.09-17.60 yuan for each unit of efficacy increase when compared with that of metformin alone,and by 2.43 yuan for per unit of efficacy increase when compared with that of Xiaoke pills alone.Conclusion:Liuwei Dihuang pills combined with metformin or Xiaoke pills in the treatment of T2DM can increase the efficacy without serious safety problems,while with increased cost,and more high quality researches are still needed to provide more evidence support.