维莫非尼致皮肤系统不良反应的文献计量学研究分析

Bibliometric analysis of adverse drug reactions of vemurafenib

目的:分析维莫非尼所致皮肤系统不良反应发生情况及临床特点,为临床安全用药提供参考。方法:检索Web of Science、PubMed、中国知网数据库、维普数据库、万方数据关于维莫非尼皮肤系统不良反应(ADRs)的文献并进行分析总结。结果:维莫非尼致皮肤系统毒性的ADRs的个案报道共41例次;其年龄分布以41~70岁年龄段较多(25例,61.0%);多发生在用药后15 d内(22例,53.7%);维莫非尼致皮肤系统ADRs主要临床表现为脂膜炎(12例,29.3%)、白细胞破碎性血管炎(6例,14.6%)、肉芽肿性皮炎(5例,12.2%)、光敏性皮炎(4例,9.8%)、放射性皮炎(3例,7.3%)及皮肤角化过度(3例,7.3%);34例在出现ADRs后痊愈或好转,其中27例(65.9%)重新恢复维莫非尼治疗,7例停药,出现的ADRs分别为肉芽肿性皮炎(2例)、中毒性表皮坏死松解(1例)、皮肤血管炎(2例)及光敏性皮炎(2例)。重启治疗的患者中,21例维持原剂量,5例减至3/4原剂量,1例剂量减半,9例患者未再次发生ADRs。结论:临床使用维莫非尼时应加强用药监测,尤其警惕用药后15 d内ADRs的发生,及时发现潜在ADRs并采取适当防治措施,同时应慎重评估重启给药后的治疗风险。

Objective: To analyze the occurrence and clinical characteristics of skin adverse reactions caused by vemurafenib, and provide reference for clinical safe drug use. Methods: The literatures about skin adverse reactions of vemurafenib were retrieved from Web of Science, PubMed, CNKI, VIP database and Wanfang data, and then analyzed and summarized. Results: A total of 41 cases of ADRs induced by vemurafenib were reported. Most of them aged from 41 to 70 years old(n=25, 61.0%). Most of them occurred within 15 d after medication(n=22, 53.7%). The main clinical manifestations of skin system ADRs induced by vemurafenib were lipiditis(12 cases, 29.3%), leukocytoclastic vasculitis(n=6, 14.6%), granulomatous dermatitis(n=5, 12.2%), photosensitive dermatitis(n=4, 9.8%), radioactive dermatitis(n=3, 7.3%), and hyperkeratosis(n=3, 7.3%). Thirty-four cases were cured or improved after ADRs, of whom 27 cases(65.9%) resumed vemurafenib treatment, and 7 cases discontinued, including granulomatous dermatitis(2 cases), toxic epidermal necrolysis(1 case), cutaneous vasculitis(2 cases), and photosensitive dermatitis(2 cases). Among the 27 patients who restarted vemurafenib treatment, 21 cases maintained the original dose, 5 cases reduced the original dose to 3/4, 1 case reduced the original dose by half, and ADRs occurred again in 9 patients. Conclusion: Drug monitoring should be strengthened during the clinical use of vemurafenib, especially for the occurrence of ADR within 15 d after drug administration, potential ADRs should be detected in time, appropriate prevention and treatment measures should be taken, and the treatment risk after resumption of treatment should be carefully evaluated.