带量采购背景下针对肝细胞癌患者应用国产仑伐替尼后相关不良反应的临床管理

Clinical Management of Adverse Effects Associated with Domestic Lenvatinib in Hepatocellular Carcinoma Patients under Volume-Based Procurement Policy

摘要: 目的：系统回顾国产仑伐替尼一线治疗不可切除肝细胞癌(HCC)的不良反应谱，并总结分级管理策略。方法：纳入2023年1月至2025年1月我院单药口服国产仑伐替尼的55例HCC患者，依据CTCAE 5.0标准记录不良反应，结合多学科团队(MDT)制定分级干预及剂量调整方案。结果：52例(94.55%)出现不良反应，其中≥3级占34.55%。最常见事件为高血压(58.18%，≥3级21.82%)，其次为消化道反应(36.36%，≥3级5.45%)、蛋白尿(30.91%，≥3级9.09%)、转氨酶升高(34.55%，≥3级5.45%)等；未出现4级或致死性事件。经对症处理、减量或短暂停药后均获缓解并恢复治疗。结论：国产仑伐替尼在本研究队列中观察到的不良反应类型及发生率与原研药关键临床试验数据趋势一致。在本研究中，通过包含早期监测、及时分级干预及MDT协作的管理模式，所有不良反应均得到有效控制，提高了患者耐受性与持续用药率。

Abstract: Objective: To systematically review the spectrum of adverse reactions to domestic Lenvatinib in the first-line treatment of unresectable Hepatocellular Carcinoma (HCC), and summarize the hierarchical management strategies. Methods: 55 patients with HCC who received single-agent domestic Lenvatinib from January 2023 to January 2025 were included. Adverse reactions were recorded according to CTCAE 5.0 standards, and a hierarchical intervention and dose adjustment plan was formulated in conjunction with a Multidisciplinary Team (MDT). Results: 52 cases (94.55%) developed adverse reactions, of which 34.55% were grade ≥ 3. The most common event was hypertension (58.18%, grade ≥ 3 21.82%), followed by gastrointestinal reaction (36.36%, grade ≥ 3 5.45%), proteinuria (30.91%, grade ≥ 3 9.09%), transaminases increased (34.55%, grade ≥ 3 5.45%), etc.; no grade 4 or fatal events occurred. After symptomatic treatment, dose reduction or temporary drug discontinuation, all patients were relieved and treatment was resumed. Conclusions: The types and incidence of adverse reactions of domestically produced Lenvatinib observed in this study cohort are consistent with the data from pivotal clinical trials of the original drug. In this study, through a management model incorporating early monitoring, timely graded intervention, and MDT collaboration, all adverse reactions were effectively controlled, improving patient tolerance and continuous medication rate.