口服中成药治疗2型糖尿病性骨质疏松临床疗效的网状Meta分析

Network Meta-analysis of the clinical efficacy of oral Chinese patent medicine in the treatment of type 2 diabetic osteoporosis

目的:运用网状Meta分析对不同中成药治疗2型糖尿病性骨质疏松(T2DOP)的疗效和安全性进行评价。方法:系统检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Web of Science、Cochrane Library数据库中收录的中成药治疗T2DOP的随机对照试验(RCTs),检索时限均为建库起至2023年12月。运用Cochrane风险偏倚工具对纳入文献进行质量评价,采用Stata 15.0软件进行数据分析。结果:纳入17篇RCTs,包含金天格胶囊、糖脉康颗粒、仙灵骨葆胶囊、六味地黄丸、左归丸、骨疏康胶囊。网状Meta分析结果显示,(1)总有效率方面,排名第1的干预措施为骨疏康胶囊+常规西药;(2)改善腰椎骨矿物质密度(BMD)方面,排名第1的干预措施为糖脉康颗粒+常规西药;(3)改善股骨颈BMD方面,排名第1的干预措施为金天格胶囊+常规西药;(4)改善血清血清骨钙素(BGP)水平方面,排名第1的干预措施为骨疏康胶囊+常规西药。(5)在安全性方面,除左归丸及骨疏康胶囊未见报道相关不良反应,其余4种中成药均有报道,不良反应大多较轻,以消化道症状为主。结论:中成药联合常规西药治疗T2DOP能够提高综合疗效,疗效安全可靠,可优先选择骨疏康胶囊或糖脉康颗粒或金天格胶囊联合常规西药治疗。但由于缺少各药间直接对比,且纳入文献总体质量不高,结果还需更多的RCTs验证。

Objective:To evaluate the efficacy and safety of different oral Chinese patent medicines in the treatment of type 2 diabetic osteoporosis(T2DOP)by network Meta-analysis.Methods:We searched CNKI,Wanfang,VIP,SinoMed,PubMed,Web of Science,and the Cochrane Library for randomized controlled trials(RCTs)about oral Chinese patent medicines in the treatment of T2DOP.The retrieval time was from the establishment of each database to December 2023.The literature was evaluated using Cochrane bias risk assessment criteria and Stata 15.0 software for statistical analysis.Results:Seventeen RCTs were included,containing Jintiange capsule,Tangmaikang granules,Xianling Gubao capsule,Liu Wei Di Huang pills,Zuogui pills,and Gushukang capsule.The results of network Meta-analysis showed that:(1)In terms of total effective rate,the 1st ranked intervention was Gushukang capsule+conventional western medicine;(2)In terms of improving bone mineral density(BMD)of lumbar spine,the 1st ranked intervention was Tangmaikang granules+conventional western medicines;(3)In terms of improving BMD of femoral neck,the 1st ranked intervention was Jintiange capsules+conventional western medicines;(4)In terms of improving serum bone gla-protein(BGP)level,the 1st ranked intervention was Gushukang capsules+conventional western medicines.(5)In terms of safety,there have been no reports of adverse reactions related to Zuogui pills and Gushukang capsule.However,for the remaining four types of Chinese patent medicines,some cases of adverse reactions have been reported,with most symptoms being mild and primarily associated with the digestive tract.Conclusion:The combination of Chinese patent medicines and conventional western medicines in the treatment of T2DOP can enhance the overall therapeutic efficacy,ensuring safety and reliability.Gushukang capsule or Tangmaikang granule or Jintiange capsule may be prioritized when used in conjunction with conventional western medicine.However,due to limited direct comparisons among these drugs and the generally low quality of included literature,further validation through more RCTs is necessary to strengthen the evidence.