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/Abstract

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RCT 7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。

关键词: 乌头, 雷公藤, 中轴脊柱关节炎, 效益-风险评价

Abstract: 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 multi-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 RCTs 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.

Key words: Aconitum, Tripterygium, axial spondyloarthritis, benefit-risk assessment

中图分类号:

R994.11

张晓朦, 林志健, 张冰, 李敏. 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[J]. 中国药物警戒, 2018, 15(2): 103-109.

ZHANG Xiao-meng, LIN Zhi-jian, ZHANG Bing, LI Min. Comparison of Aconitum with Tripterygium in Treatment of Axial Spondyloarthritis: A Benefit-risk Assessment[J]. Chinese Journal of Pharmacovigilance, 2018, 15(2): 103-109.

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