目的 評估在中國獲批的5種一線系統(tǒng)治療方案用于不可切除肝細胞癌的整體效益風(fēng)險，為臨床決策提供參考。方法 采用R4.2軟件對4項臨床試驗進行網(wǎng)狀Meta分析，間接比較得出5種治療方案的效應(yīng)值。結(jié)合效益風(fēng)險指標(biāo)，應(yīng)用多準(zhǔn)則決策分析模型建立價值樹。應(yīng)用Hiview 3.2軟件計算5種治療方案用于不可切除肝細胞癌的效益值、風(fēng)險值以及效益風(fēng)險值，并進行敏感性分析評價結(jié)果的穩(wěn)健性。借助Oracle Crystal Ball軟件運行蒙特卡洛模擬，計算5種治療方案兩兩比較的效益風(fēng)險差值、95%可信區(qū)間以及出現(xiàn)差異的概率。結(jié)果 阿替利珠單抗與貝伐珠單抗（AB）、信迪利單抗與貝伐珠單抗生物類似物（SB）、多納非尼（DN）、侖伐替尼（LF）、索拉非尼（SL）用于不可切除肝細胞癌的效益值分別是35、59、14、25、0；風(fēng)險值分別是55、40、59、39、50；效益風(fēng)險值分別是45、50、37、32、25。敏感性分析表明結(jié)果較穩(wěn)健。蒙特卡洛模擬優(yōu)化模型結(jié)果顯示，5種治療方案之間效益風(fēng)險差有確定差異的是： AB vs SL，SB vs SL和DN vs SL。結(jié)論 在當(dāng)前權(quán)重下，SB方案可使患者獲益最大，為最優(yōu)治療方案，其次是AB、DN、LF和SL。臨床醫(yī)師可綜合評估患者個體特征及風(fēng)險耐受度制定決策方案。

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.

R979.1

國家自然科學(xué)基金面上項目（82174529）；河南省中醫(yī)學(xué)“雙一流”創(chuàng)建科學(xué)研究專項（ HSRP-DFCTCM-2023-4-03）