达拉非尼胶囊联合曲美替尼片致发热综合征的分析

doi:10.19803/j.1672-8629.20250603

摘要/Abstract

摘要： 目的分析达拉非尼联合曲美替尼治疗黑色素瘤致发热综合征的发生特点及规律，为临床安全用药提供参考。方法收集13例北京大学肿瘤医院（以下简称“某院”）应用达拉非尼联合曲美替尼方案治疗BRAF V600突变的黑色素瘤术后辅助或不可切除晚期患者的病例资料，同时检索从建库起至2024年6月30日中国知网、万方数据、Web of Science、Elsevier、PubMed数据库收载的相关个案报道，汇总相关数据进行分析。结果纳入分析的患者共33例，其中某院相关病例13例，国内外文献相关报道20例。男性18例，女性15例，年龄为35~77岁。首次中位发热时间16.5（1~240）d，3例患者发热后未进行处理自行好转，30例患者经中断药物治疗或非甾体抗炎药及类固醇处理后不再发热，随后20例患者以单药达拉非尼、达拉非尼联合曲美替尼原剂量或减量重启治疗，继续治疗后仍有18例患者再次出现发热。其中有20例患者经历2次及以上发热，3例患者因发生严重不良反应致永久停药。结论达拉非尼联合曲美替尼致首次发热的时间大多在用药后前30 d内（69.69%），60.60%患者经历2次及以上发热，本研究发现中断治疗、减少药物剂量、加用非甾体抗炎药或类固醇药物是改善发热综合征的关键管理策略。

关键词: 达拉非尼, 胶囊, 曲美替尼, 片剂, 发热综合征, 药品不良反应, BRAF V600

Abstract: Objective To analyze the patterns and characteristics of pyrexia syndrome induced by dabrafenib combined with trametinib in order to provide references for safe medication. Methods A total of 23 patients with BRAF V600-Mutant melanoma were collected, who had received dabrafenib plus trametinib, either as postoperative adjuvant therapy or for unresectable advanced diseases. Meanwhile, other case reports published between inception and June 30, 2024 were retrieved from CNKI, Wanfang, Web of Science, Elsevier and PubMed databases before being analyzed. Results A total of 33 patients were enrolled in our study, including 18 males and 15 females ages 35 to 77. The median duration of the first fever was 16.5(1-240) d. Three of the patients with fever improved without treatment while the rest were treated until fever was gone. Twenty of these patients resumed treatment with single-agent dabrafenib or dabrafenib combined with trametinib at the original dose or at a reduced dose, but fever recurred in 18 of them. Twenty of these patients experienced two or more febrile episodes and medication was permanently discontinued in three of them due to serious adverse drug reactions. Conclusion Dabrafenib combined with trametinib is likely to cause fever within 30 days of medication (69.69%), and 60.60% of patients experience two or more febrile episodes. Discontinuation of treatment, reduced drug dosage, and the use of non-steroidal anti-inflammatory drugs or steroids are key management strategies against pyrexia syndrome.

Key words: Dabrafenib, Capsules, Trametinib, Tablets, Pyrexia Syndrome, Adverse Drug Reaction, BRAF V600

中图分类号:

田春雨, 夏玉朝, 张艳华, 尹月. 达拉非尼胶囊联合曲美替尼片致发热综合征的分析[J]. 中国药物警戒, 2026, 23(2): 192-196.

TIAN Chunyu, XIA Yuchao, ZHANG Yanhua, YIN Yue. Pyrexia Syndrome Caused by Dabrafenib Capsules Combined with Trametinib Tablets[J]. Chinese Journal of Pharmacovigilance, 2026, 23(2): 192-196.

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https://zgywjj.magtechjournal.com/CN/Y2026/V23/I2/192

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