445例贝伐珠单抗注射液严重不良反应报告分析

doi:10.19803/j.1672-8629.20250843

摘要/Abstract

摘要： 目的探讨贝伐珠单抗注射液所致严重不良反应（Adverse Drug Reaction,ADR）特点,为临床用药安全提供参考。方法收集2019年1月1日至2025年12月31日河南省药品不良反应监测系统中关于贝伐珠单抗注射液发生严重ADR的报告共445例,对患者年龄、性别、严重ADR转归及严重损害情况、给药途径与剂量、联合用药情况、原患疾病、严重ADR累及系统-器官及临床表现、ADR严重程度分级进行统计分析。结果 445例严重ADR报告中,女性多于男性,男女比例为1∶ 1.75,高发年龄主要集中在51~60岁。转归结果为好转、痊愈的ADR共586例次（84.69%）。给药途径以静脉滴注为主（422例,94.83%）,用药剂量范围为25~1 100 mg。45例（10.11%）患者的原患疾病是说明书未记载的适应证。联合用药以抗代谢类药物、铂类和紫杉醇类为主（130例,72.22%）。严重ADR主要累及血液及淋巴系统疾病、胃肠系统疾病,临床表现主要为骨髓抑制（115例,18.31%）、白细胞计数降低（68例,10.83%）、恶心（45例,7.17%）、高血压（33例,5.25%）、呕吐（30例,4.78%）、血小板计数降低（29例,4.62%）。严重ADR分级以1~3级为主,无死亡病例。结论贝伐珠单抗注射液致严重ADR多见于中老年患者,且女性占比高,多数患者经临床干预后转归情况良好。临床应用中可能存在给药途径不规范及超说明书用药问题,严重ADR累及多个系统-器官。临床应充分认识其相关ADR特征,加强对常见严重ADR的监测与有效处理。

关键词: 贝伐珠单抗注射液, 新型抗肿瘤药物, 骨髓抑制, 药品不良反应, 超说明书用药

Abstract: Objective To explore the characteristics of serious adverse drug reactions (ADRs) induced by bevacizumab injection and provide references for safe medications. Methods A total of 445 reports of serious ADRs induced by bevacizumab injection collected in 2019-2025 were retrieved from the Adverse Drug Reaction Monitoring System of Henan Province. Statistical analysis was conducted of the patients' age, gender, outcomes and severity of serious ADRs, primary diseases, routes and dosages of administration, systems-organs involved and clinical manifestations, grading of ADRs, and combined medications. Results Among the 445 reports of serious ADRs, female patients outnumbered male ones at a ratio of 1.75∶1. The incidence was high among patients ages 51 to 60. In terms of patient outcomes, a total of 586 cases (84.69%) recovered or improved. Intravenous drip was the dominating administration route (422 cases, 94.83%), with the dosages ranging from 25 mg to 1,100 mg. The primary diseases were indications that were not recorded in package inserts in 45 patients (10.11%). Combined medications included antimetabolites, platinum compounds, and paclitaxel-based agents (130 cases, 72.22%). Serious ADRs primarily involved the circulatory and lymphatic system and the gastrointestinal system. The common clinical manifestations were bone marrow suppression (115 cases, 18.31%), decreased white blood cell count (68 cases, 10.83%), nausea (45 cases, 7.17%), hypertension (33 cases, 5.25%), vomiting (30 cases, 4.78%), and decreased platelet count (29 cases, 4.62%). The severity of serious ADRs was predominantly grade 1 to 3, with no fatal cases reported. Conclusion Serious ADRs induced by bevacizumab injection are more common in middle-aged and elderly patients, especially in females. Most of the patients have favorable outcomes after clinical interventions. Improper administration routes and off-label drug use may occur in clinical practice. Severe ADRs involve multiple systems and organs. Clinicians should be well aware of the characteristics of related ADRs and effectively manage common serious ADRs.

Key words: Bevacizumab Injection, New Antineoplastic Drugs, Myelosuppression, Adverse Drug Reaction, Off-Label Drug Use

中图分类号:

刘影, 薛红委, 庞楠, 杨中一, 柯文缘, 刘玲. 445例贝伐珠单抗注射液严重不良反应报告分析[J]. 中国药物警戒, 2026, 23(5): 547-552.

LIU Ying, XUE Hongwei, PANG Nan, YANG Zhongyi, KE Wenyuan, LIU Ling. Analysis of 445 Reports of Severe Adverse Drug Reactions to Bevacizumab Injection[J]. Chinese Journal of Pharmacovigilance, 2026, 23(5): 547-552.

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