The First Clinical Medical College of Henan University of Traditional Chinese Medicine, Zhengzhou, 450046, China.
Personal Department, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, China.
Chin J Integr Med. 2024 Jun;30(6):559-564. doi: 10.1007/s11655-023-3704-2. Epub 2023 Sep 12.
To evaluate the benefit-risk of 3 commonly used Chinese medicine injections, Aidi Injection (ADI), Cinobufagin Injection (CINI) and Compound Kushen Injection (CKI), in the treatment of primary liver cancer (PLC), so as to provide a reference for clinical decision-making.
Randomized controlled trials (RCTs) of ADI, CINI and CKI in the treatment of PLC published in the databases of China National Knowledge Infrastructure, Wanfang, China Science and Technology Journal Database, SinoMed, PubMed, Cochrane Library, and Web of Science were retrieved from January 2020 to October 2022. The data of benefit and risk indicators were combined to obtain the effect value. The multi-criteria decision analysis (MCDA) model was applied to build the decision tree. The benefit value, risk value and benefit risk value of the 3 injections in PLC treatment were calculated. Monte Carlo simulation was carried out to calculate the 95% confidence interval and probability of differences among the 3 injections, so as to optimize the evaluation results.
A total of 71 RCTs were included. The benefit values of ADI, CINI and CKI combined with transcatheter arterial chemoembolization (TACE) were 42, 38 and 36, respectively. The risk values were 42, 25 and 37, respectively. The benefit risk values were 42, 31 and 37, respectively. The benefit risk differences of ADI vs. CINI, ADI vs. CKI, and CKI vs. CINI were 11 (-0.86, 17.75), 5 (-5.01, 11.09), and 6 (-1.87, 12.63), respectively. The probability that ADI superior to CINI, ADI superior to CKI, and CKI superior to CINI was 96.26%, 77.27%, and 92.62%, respectively.
Based on the results of MCDA model, CINI combined with TACE has the greatest risk in the treatment of the PLC. Considering the efficacy and safety, the possible priority of the 3 Chinese medicine injections combined with TACE in the treatment of PLC is ADI, CKI and CINI.
评价艾迪注射液、华蟾素注射液和复方苦参注射液 3 种常用中药注射剂治疗原发性肝癌的获益-风险,为临床决策提供参考。
计算机检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、Cochrane 图书馆、Web of Science 中 2020 年 1 月至 2022 年 10 月关于艾迪注射液、华蟾素注射液和复方苦参注射液治疗原发性肝癌的随机对照试验(RCT),提取疗效指标和风险指标数据并结合后计算效应值,采用多准则决策分析(MCDA)模型构建决策树,计算 3 种注射剂治疗原发性肝癌的获益值、风险值和获益风险值,采用蒙特卡罗模拟计算 3 种注射剂间差异的 95%置信区间和概率,以优化评价结果。
共纳入 71 项 RCT,艾迪注射液、华蟾素注射液和复方苦参注射液联合经导管动脉化疗栓塞术(TACE)的获益值分别为 42、38、36,风险值分别为 42、25、37,获益风险值分别为 42、31、37;艾迪注射液对比华蟾素注射液、艾迪注射液对比复方苦参注射液、复方苦参注射液对比华蟾素注射液的获益风险差值分别为 11(-0.86,17.75)、5(-5.01,11.09)、6(-1.87,12.63),艾迪注射液优于华蟾素注射液、艾迪注射液优于复方苦参注射液、复方苦参注射液优于华蟾素注射液的概率分别为 96.26%、77.27%、92.62%。
基于 MCDA 模型结果,华蟾素注射液联合 TACE 治疗原发性肝癌风险最大,考虑疗效和安全性,3 种中药注射剂联合 TACE 治疗原发性肝癌的可能优先顺序为艾迪注射液、复方苦参注射液、华蟾素注射液。