目的 定量评估马钱子中药复方制剂（Chinese materia medica compound preparation of Strychni Semen， CPSS）单用和与常规化学药联用治疗类风湿关节炎（rheumatoid arthritis，RA）的效益与风险，为其临床合理用药提供参考。方法 计算机检索中国知网、维普、万方、中国生物医学文献数据库、Embase、Cochrane Library和PubMed等数据库中CPSS治疗RA的临床随机对照研究（randomized controlled trial，RCT），采用Review Manager 5.3软件进行数据合并，得出各指标效用值。然后，建立CPSS治疗RA的多准则决策分析（multi-criteria decision analysis，MCDA）模型评价体系，并采用Hiview3软件分别计算出CPSS单用和与常规化学药联用的效益值、风险值和效益风险总值。最后，借助Crystal Ball嵌入Excel软件进行蒙特卡洛模拟，计算出2种用药方案效益风险差异的95%可信区间（95% CI）及出现差异的概率，优化评估结果。结果 最终纳入27项RCT。MCDA模型量化评估结果显示，CPSS单用的效益低于其与常规化学药联用，效益差为−13[95% CI（−23，−3）]，差异大于0的概率为0.47%；但其用药风险显著降低，风险差为26[95% CI（13，42）]，差异大于0的概率为100%。当2种用药方案的一级指标效益和风险权重各占50%时，CPSS单用和与常规化学药联用的效益风险总值分别为40和34，差异为6[95% CI（−1，16）]，CPSS单用优于其联合常规化学药的概率为94.84%，评价结果稳定。结论 CPSS单用或联用常规化学药治疗RA使患者获益明显，可作为RA治疗手段的重要补充。但是，当患者对用药风险接受程度较低时，不建议中西医联合用药。

Objective To quantitatively evaluate and compare the benefit and risk of traditional Chinese medicine compound preparation of Strychni Semen (CPSS) alone and combined with conventional western medicine in the treatment of rheumatoid arthritis (RA), in order to provide reference for clinical rational drug use. Methods The clinical randomized controlled trial (RCT) of CPSS for RA in the databases of CNKI, VIP, Wanfang, CBM, Embase, Cochrane library, and PubMed were searched by computer, and Review Manager 5.3 was used to merge the data to obtain the utility value of each indicator. And then, the multi-criteria decision analysis (MCDA) model evaluation system for the treatment of RA with CPSS was established and Hiview3 was used to calculate the benefit value, risk value and total benefit-risk value of CPSS alone and in combination with conventional western medicine. Finally, with the help of Crystal Ball embedded in Excel for Monte Carlo simulation, the 95% CI and the probability of the difference between the benefit risks of the two medication options were calculated, and the evaluation results were optimized. Results A total of 27 RCTs were included in this study. The quantitative evaluation results of the MCDA model showed that the benefit of the CPSS alone was lower than its combination with conventional western medicine, the benefit difference was −13[95% CI (−23, −3)], and the probability of the difference being greater than zero was 0.47%; but the risk of its medication was significantly reduced, the risk difference was 26[95% CI (13, 42)], and the probability that the difference greater than zero was 100%. When the first-level indicator benefit and risk weights of the two regimens account for 50% each, the total benefit-risk value of the CPSS alone and in combination with conventional western medicines was 40 and 34, respectively, with a difference of 6[95% CI (−1, 16)], the overall situation of the single use of CPSS was superior to its combined conventional western medicine with a probability of 94.84%, and the evaluation result was stable. Conclusion The use of CPSS alone or in combination with western medicine to treat RA has obvious benefits for patients, and can be used as an important supplement to the treatment of RA. However, when the patient's acceptance of the risk of medication is low, the combination of Chinese and Western medicine is not recommended.

R285.64

四川省科技厅省青年科技创新研究团队专项（2017TD0001）