含乌头、雷公藤中药制剂治疗中轴脊柱关节炎的效益与风险对比研究

摘要

目的 定量对比含乌头制剂与雷公藤制剂治疗中轴脊柱关节炎(axial spondyloarthritis,ax-SpA)的效益与风险差异,为临床用药提供参考.方法 建立中药治疗ax-SpA的效益-风险多准则决策模型评价体系,综合中国知网数据库中含乌头、雷公藤制剂对比西药治疗ax-SpA的随机对照试验(RCT)结果,分别计算乌头、雷公藤治疗ax-SpA的效益值、风险值及效益-风险总值,并采用蒙特卡洛模拟两者出现差异的概率.结果 共纳入“含乌头制剂VS.西药”治疗ax-SpA的RCT 14项,“含雷公藤制剂VS.西药”治疗ax-SpA的RCT7项.量化对比含乌头、雷公藤制剂用药效益与风险,两者治疗ax-SpA的效益差为3[95％CI(-2.19,8.16)],应用含乌头制剂产生效益高于含雷公藤制剂的概率为86.53％;两者风险差为[80,95％CI(73.24,86.48)],含乌头制剂用药风险100％低于含雷公藤制剂.当治疗获益与用药风险对ax-SpA患者各贡献50％时,两者效益-风险总值差为41[95％CI(35.67,46.23)],产生差异概率为100％.结果稳定.结论 基于现有证据表明,含乌头制剂治疗ax-SpA的效益-风险明显优于含雷公藤制剂,对用药风险接受能力较差的ax-SpA患者不建议使用雷公藤.%Objective Quantitatively comparing the benefit and risk of Aconitum and Tripterygium in the treatment of axial spondyloarthritis (ax-SpA),which can provide guidance for rational use of medicines in clinic.Methods The data,which from random clinical trials (RCTs) that Aconitum or Tripterygium vernus western medicines in the treatment of ax-SpA,was extracted and merged by RevMan 5.2 software.Based on the benefit-risk assessment framework of herbs for treating ax-SpA that was built by the multr-criteria decision analysis model in Hiview 3 software,the benefit value,the risk value and the total benefit-risk value of Aconitum and Tripterygium were calculated.And the probability of difference value caused by the two therapies were conducted by Monte Carlo simulation.Results 14 RCTs of Aconitum and 7 R CTs of Tripterygium that each vernus western medicines in the treatment of ax-SpA were included.Comprehensively and quantitatively compared the benefit and risk of Aconitum and Tripterygium in the treatment of ax-SpA,the difference of efficacy between Aconitum and Tripterygium was 3[95％CI (7.39,16.45)],which probability was 86.53％;and the difference of risk was 80 [95％CI (73.24,86.48)],which probability was 100％.When benefit and risk were the same important for ax-SpA patients,the total benefit-risk value of using Aconitum was 65,while that of Tripterygium was 24,their difference was 41 [95％CI(35.67,46.23)] and the probability of the former superior to the latter was 100％.The results were stable which tested by sensitivity analysis.Conclusion Based on the available evidence,the benefit-risk of Aconitum for ax-SpA patients is significantly superior to that of Tripterygium.If ax-SpA patients that cannot accept the medication risk,the application of Tripterygium is not recommended.