[关键词]
[摘要]
目的 评估在中国获批的5种一线系统治疗方案用于不可切除肝细胞癌的整体效益风险,为临床决策提供参考。方法 采用R4.2软件对4项临床试验进行网状Meta分析,间接比较得出5种治疗方案的效应值。结合效益风险指标,应用多准则决策分析模型建立价值树。应用Hiview 3.2软件计算5种治疗方案用于不可切除肝细胞癌的效益值、风险值以及效益风险值,并进行敏感性分析评价结果的稳健性。借助Oracle Crystal Ball软件运行蒙特卡洛模拟,计算5种治疗方案两两比较的效益风险差值、95%可信区间以及出现差异的概率。结果 阿替利珠单抗与贝伐珠单抗(AB)、信迪利单抗与贝伐珠单抗生物类似物(SB)、多纳非尼(DN)、仑伐替尼(LF)、索拉非尼(SL)用于不可切除肝细胞癌的效益值分别是35、59、14、25、0;风险值分别是55、40、59、39、50;效益风险值分别是45、50、37、32、25。敏感性分析表明结果较稳健。蒙特卡洛模拟优化模型结果显示,5种治疗方案之间效益风险差有确定差异的是: AB vs SL,SB vs SL和DN vs SL。结论 在当前权重下,SB方案可使患者获益最大,为最优治疗方案,其次是AB、DN、LF和SL。临床医师可综合评估患者个体特征及风险耐受度制定决策方案。
[Key word]
[Abstract]
Objective To evaluate the overall benefit-risk of five systemic treatments for uHCC and provide references for clinical decision-making. Methods R4.2 software was used to conduct a network Meta-analysis of four clinical trials, and the effective values offive treatments were obtained by indirect comparison. Combined with the benefit risk index, the multi-criteria decision analysis model was used to establish the value tree. Hiview 3.2 software was applied to calculate the benefit value, risk value and benefit-risk value of five treatments for uHCC, and a sensitivity analysis was conducted to evaluate the robustness of the results. Monte Carlo simulation was performed with Oracle Crystal Ball software to calculate the benefit risk difference, 95%CI, and probability of differences between five treatments compared in pairs. Results The efficacy values of atezolizumab plus bevacizumab (AB), sintilimab plus a bevacizumab biosimilar (SB), donafenib (DN), lenvatinib (LF), and sorafenib (SL) for uHCC were 35, 59, 14, 25, and 0, respectively. The risk values were 55, 40, 59, 39, and 50, respectively. The benefit-risk values were 45, 50, 37, 32, and 25, respectively. Sensitivity analysis indicated that the results were relatively robust. The results of the Monte Carlo simulation optimization model showed that there were definite differences in the benefit-risk difference between the five treatments: AB vs SL, SB vs SL and DN vs SL. Conclusions Under the current weighting, the application of SB regimen can benefit patients the most, followed by AB, DN, LF and SL. Clinicians can comprehensively evaluate the individual characteristics and risk tolerance of patients to develop decision-making plans.
[中图分类号]
R979.1
[基金项目]
国家自然科学基金面上项目(82174529);河南省中医学“双一流”创建科学研究专项( HSRP-DFCTCM-2023-4-03)