采用多准则决策分析（MCDA）评估治疗类风湿关节炎患者的中成药制剂青藤碱的获益-风险比。
Benefit-risk assessment of traditional Chinese medicine preparations of sinomenine using multicriteria decision analysis (MCDA) for patients with rheumatoid arthritis.
机构信息
The First College of Clinical Medical Sciences, China Three Gorges University, Yichang, 443003, Hubei, China.
Yichuan Community Health Service Center, Shanghai, 200065, China.
出版信息
BMC Complement Med Ther. 2023 Feb 6;23(1):37. doi: 10.1186/s12906-023-03864-6.
OBJECTIVE
A multicriteria decision analysis (MCDA) model was used to evaluate the benefits and risks of traditional Chinese medicine preparations of sinomenine alone or in combination with conventional drugs in the treatment of rheumatoid arthritis (RA) and to provide a basis for the rational clinical application of sinomenine.
METHODS
A study search was performed using six major databases, and Review Manager 5.3 was used for data analysis. Then, an MCDA model evaluation system was established for the treatment of RA with sinomenine preparations, and the benefit values, risk values, and total benefit-risk values of sinomenine preparations alone or in combination with conventional drugs were calculated using Hiview 3.2 software. Finally, Monte Carlo simulations were performed using Crystal Ball embedded in Excel software to calculate the 95% confidence intervals (95% CI), and the probability of the differences between the 2 drug regimens was determined to optimize the evaluation results.
RESULTS
Forty-four randomized controlled trials (RCTs) were included. Quantitative assessment of the MCDA model showed that the sinomenine preparation alone offered less benefits than when combined with conventional drugs with a benefit difference of 20 (95% CI 3.06, 35.71). However, the risk of the combination was significantly lower with a risk difference of 13(95% CI -10.26, 27.52). The total value of the benefit-risk of sinomenine alone and in combination with conventional drugs was 46 and 53 at 60% and 40% of the benefit-risk ratio of the two dosing regimens, respectively, with a difference of 7 (95% CI -4.26, 22.12). The probability that the comprehensive score of the combined regimen is greater than that of sinomenine alone is 90.1%, and the evaluation was steady.
CONCLUSION
The benefit-risk of the combined application regimen of sinomenine is greater than that of sinomenine alone.
目的
采用多准则决策分析（MCDA）模型评估单独使用或与常规药物联合使用青藤碱治疗类风湿关节炎（RA）的获益和风险，并为青藤碱的合理临床应用提供依据。
方法
检索 6 个主要数据库，采用 Review Manager 5.3 进行数据分析。然后，建立青藤碱制剂治疗 RA 的 MCDA 模型评价体系，采用 Hiview 3.2 软件计算青藤碱制剂单独或与常规药物联合使用的获益值、风险值和总获益风险值。最后，采用 Excel 软件中的 Crystal Ball 嵌入功能进行蒙特卡罗模拟，计算 95%置信区间（95%CI），确定 2 种药物方案差异的概率，优化评价结果。
结果
纳入 44 项随机对照试验（RCT）。MCDA 模型的定量评估结果显示，青藤碱制剂单独使用的获益低于与常规药物联合使用，获益差值为 20（95%CI 3.06，35.71）。但联合用药的风险明显降低，风险差值为 13（95%CI -10.26，27.52）。青藤碱单独使用和与常规药物联合使用的获益风险总数值分别为 46 和 53，当两种给药方案的获益风险比为 60%和 40%时，差值为 7（95%CI -4.26，22.12）。联合用药方案综合评分大于青藤碱单独使用的概率为 90.1%，评价结果稳定。
结论
青藤碱联合应用方案的获益风险大于青藤碱单独使用。
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