目的 從衛(wèi)生體系角度出發(fā)，評(píng)價(jià)曲妥珠單抗聯(lián)合化療對(duì)比單純化療治療HER-2陽(yáng)性晚期胃癌的成本效果。方法 參考1項(xiàng)Ⅲ期臨床試驗(yàn)數(shù)據(jù)（ToGA研究）構(gòu)建分區(qū)生存模型，通過(guò)擬合最佳參數(shù)來(lái)外推生存曲線(xiàn)模擬患者終生，以質(zhì)量調(diào)整生命年（QALY）來(lái)計(jì)算增量成本-效果比（ICER），通過(guò)單因素敏感性分析和概率敏感性分析驗(yàn)證基礎(chǔ)分析結(jié)果的穩(wěn)健性。結(jié)果 基礎(chǔ)分析結(jié)果顯示：曲妥珠單抗聯(lián)合化療較單純化療增加0.19 QALY的同時(shí)，需增加成本65 352.42元，大于支付意愿閾值（WTP）。單因素敏感性分析顯示：對(duì)模型最敏感的3個(gè)因素為：無(wú)進(jìn)展生存期（PFS）和進(jìn)展期（PD）的效用值和曲妥珠單抗的成本。概率敏感性分析顯示：當(dāng)WTP＜320 000.00元時(shí)，曲妥珠單抗聯(lián)合化療組具有經(jīng)濟(jì)性的概率低于45.6%。結(jié)論 曲妥珠單抗聯(lián)合化療方案治療HER-2陽(yáng)性晚期胃癌目前不具有經(jīng)濟(jì)性。

Objective To evaluate the cost-effectiveness of trastuzumab combined with chemotherapy versus chemotherapy for HER- 2-positive advanced gastric cancer from a health system perspective. Methods A partition survival model was constructed by referring to a phase III clinical trial data (ToGA study). The survival curve was extrapolated by fitting the best parameters to simulate the patient 's life, and the incremental cost-effectiveness ratio (ICER) was calculated by quality-adjusted life years (QALY). The robustness of the basic analysis results was verified by single factor sensitivity analysis and probability sensitivity analysis.Results Basic analysis showed that trastuzumab combined with chemotherapy increased 0.19 QALY compared with chemotherapy alone, and increased the cost by 65 352.42 yuan, which was greater than the willingness to pay threshold (WTP). Univariate sensitivity analysis showed that the three most sensitive factors to the model were progression-free survival (PFS) and progression (PD) and the cost of trastuzumab. Probabilistic sensitivity analysis showed that when WTP was less than 320 000.00 yuan, the probability of economy in trastuzumab combined with chemotherapy group was less than 45.6%. Conclusion Trastuzumab combined with chemotherapy in the treatment of HER-2 positive advanced gastric cancer is not economical.

R979.1