目的 通过分析索拉非尼不良反应的发生原因及规律、临床表现及转归情况,旨在为临床安全用药提供参考依据。方法 检索2006年至2016年国际学术期刊有关索拉非尼不良反应个案报道,筛选后采用回顾性研究方法,对患者基本情况、疾病信息、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93例,其中新的不良反应22例。分析显示,男性患者多于女性,61~80岁所占比例最高为45.16%,ADR主要发生在用药1个月之内(占71.11%)。皮肤及附件损害的不良反应最多,占总ADR临床表现的51.52%;消化系统的ADR损害其次,占22.73%,但其死亡病例最多(19例中6例死亡)。案例报道的ADR相关性评价较高。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,及时处理对症治疗。
Abstract
OBJECTIVE To analyze the regularity, clinical reactions and outcomes of the adverse reaction of sorafenib to provide reference for safe medication in clinical practice. METHODS The case reports of sorafenib ADR which were published at international medical academic periodicals during 2006-2016 were collected and analyzed statistically in respect of gender, age, disease informations, clinical manifestation and RESULTS of treatment. RESULTS A total of 93 adverse reactions were identified and included in the analysis, 22 cases were unexpected ADR. The ADR happened in male was more than in female, and the age of 61-80 was the most common population (45.16%). The ADR was mostly happened in 1 month (71.11%) after therapy. Lesions of skin and its appendants were the most commonly reported ADRs (51.52%), followed by the lesions of digestive system (22.73%) ,which reported the most of the death cases (n=19 , 6 death). The ADR correlation rate was high in these case reports. CONCLUSION Multiple organ systems are involved in the ADRs of sorafenib, amd careful clinical observation and symptomatic treatment in time are necessary.
关键词
索拉非尼 /
不良反应 /
回顾性分析
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Key words
sorafenib /
adverse drug reaction /
retrospective analysis
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参考文献
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