索拉非尼致不良反应文献分析

Analysis of Literature on Adverse Drug Reactions of Sorafenib

关键词:  索拉非尼  不良反应  肿瘤

Key words:  sorafenib  adverse drug reactions  tumor

摘要:

目的 探讨索拉非尼致不良反应发生的特点和规律。方法 检索2006—2011年国际学术期刊有关索拉非尼致不良反应的个案报道，并按患者性别、年龄、原患疾病、给药剂量、累及器官或系统及临床表现、评价与转归等方面进行统计分析。结果 共收集索拉非尼致不良反应86例，新的药品不良反应28例，严重的药品不良反应34例，新的严重的药品不良反应20例。皮肤及其附件发生不良反应最多，有36例，占41.86%，其次为内分泌系统(18例，20.93%)；消化系统发生新的、严重的不良反应最多，有11例(死亡5例)，占不良反应例数的12.79%，其次为多脏器反应(10例，11. 63%)。结论 索拉非尼引起的不良反应可累及全身多个系统，在临床用药过程中应加强监测。

Abstract:

OBJECTIVE To investigate the characteristics and regularity of ADR induced by sorafenib. METHODS The case reports of soeafenib ADR which were published at international medical academic periodicals during 2006-2011 were collected and analyzed statistically in respect of gender, age, case history, dosage, clinical manifestation and results of treatment. RESULTS A total of 86 adverse reactions were identified and included in the analysis, 28 cases were unexpected ADR, 34 cases of serious ADR and 20 cases of unexpected serious ADR. Lesion of skin and its appendants were the most commonly reported ADR(n=36, 41.86%), followed by lesion of endocrine system(n=18, 20.93%); unexpected and/or serious ADR were reported more frequently in digestive system (n=11, 12.79%, 5 death), followed by multiple organ response (n=10, 11.63%) CONCLUSION Sorafenib is associated with a significant risk of various ADR in body. In order to reduce the incidence of ADR, careful clinical observation is necessary.