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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。
Objective To analyze the causes, laws, clinical manifestations and outcomes of sorafenib-induced adverse reactions in order to provide a reference for the clinical use of drugs. Methods To search for the reports of sorafenib adverse reactions in international academic journals from 2006 to 2016. The retrospective research methods were used to screen the basic information of patients, disease information, organs involved or systemic and clinical manifestations, evaluation and prognosis conduct statistical analysis. Results A total of 93 cases of sorafenib-induced adverse reactions were collected, including 22 new adverse reactions. Analysis showed that more male patients than women, the highest proportion of 61-80 years old was 45.16%, ADR occurred within 1 month (71.11%). Adverse effects of skin and accessory lesions were the most, accounting for 51.52% of the total clinical manifestations of ADR. Digestive system followed by ADR, accounting for 22.73% of the total, but the largest number of deaths were found (6 of 19 deaths). Case reports have a higher ADR relevance. Conclusion Sorafenib-induced adverse reactions can affect the whole body more than one system. In the process of clinical medication should be strengthened monitoring, timely treatment of symptomatic treatment.