舒尼替尼致不良反应的文献分析
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篇名: 舒尼替尼致不良反应的文献分析
TITLE:
摘要: 目的:为舒尼替尼临床安全使用提供参考。方法:以“舒尼替尼”“不良反应”等为检索词,检索2006年1月-2017年3月PubMed、维普、中国知网和万方数据库关于舒尼替尼致不良反应(ADR)文献的个案报道和病例系列报道,筛选后采用回顾性研究的方法,对患者基本情况、疾病信息、ADR累及器官/系统及临床表现、ADR关联性评价及转归进行统计分析。结果:共纳入文献57篇,涉及66个病例,其中新的不良反应15例;患者中男性34例 (51.52%)、女性32例 (48.48%) ,男女比例为 1.06 ∶ 1,平均年龄(63.4±10.5)岁。舒尼替尼主要用于治疗肾透明细胞癌,占65.15%;其次是胃肠间质瘤,占21.21%。用药8~14 d和22~28 d时ADR发生率最高(27.27%、22.73%)。ADR累及器官/系统以内分泌系统为主(25.76%),主要临床表现为甲状腺功能减退;其次为皮肤及其附件(21.21%)和血液淋巴系统(16.67%),主要临床表现为手足综合征和血小板减少症(以4度骨髓抑制为主)。因果关系评价为肯定 9 例,很可能57例。舒尼替尼致ADR停药后自然好转的有14例(21.21%);停药并经药物治疗后好转的有27例(40.91%);需经手术治疗,严重延长病程或治疗后仍有后遗症的有17例(25.76%);死亡的有8例(12.12%)。结论:舒尼替尼所致的不良反应涉及全身多个器官/系统,不乏严重致死病例;在临床用药过程中应加强观察监测,及时处理ADR,保障患者安全。
ABSTRACT: OBJECTIVE: To provide reference for safe use of sunitinib in clinic. METHODS: Using “sunitinib”“ADR” as retrieval words, retrieved from PubMed, VIP, CNKI and Wanfang database during Jan. 2006-Mar. 2017, case reports and case series reports about sunitinib-induced ADR were collected and screened. In retrospective study, general information of patients, disease information, involved organs or systems, clinical manifestations, ADR association evaluation and outcomes were analyzed statistically. RESULTS: A total of 57 literatures were included, involving 66 cases, among which there were 15 new ADR. There were 34 male (51.52%) and 32 female (48.48%), with ratio of 1.06 ∶ 1. Average age of patients was(63.4±10.5) years old. Sunitinib was mainly used for suprarenal epithelioma, accounting for 65.15%; followed by gastrointestinal stromal tumors, accounting for 21.21%. The incidence of ADR was the highest during 8-14 d (27.27%) and 22-28 d (22.73%) of medication. Organs/systems involved in ADR mostly were endocrine system (accounting for 25.76%). Main clinical manifestation was hypothyroidism, followed by diseases of skin and subcutaneous tissue (21.21%), diseases of the blood lymphatic system (16.67%) which mainly manifested as hand foot syndrome and thrombocytopenia (mainly being 4 degree bone marrow suppression). There were 9 cases of definite causal relationship and 57 cases of probable causal relationship. Fourteen cases of sunitinib-induced ADR were recovered after drug withdrawal (21.21%); 27 cases were recovered after drug withdrawal and drug therapy (40.91%); 17 cases had sequel after surgery, prolonging disease course and therapy (25.76%); there were 8 death cases (12.12%). CONCLUSIONS: Sunitinib-induced ADR involve various organs/systems, and there are fatal cases. In the process of clinical medication, we should strengthen the observation and monitoring, timely ADR disposal to guarantee the safety of patients.
期刊: 2017年第28卷第35期
作者: 廖彬池,杜婧
AUTHORS: LIAO Binchi,DU Jing
关键字: 舒尼替尼;不良反应;文献分析
KEYWORDS: Sunitinib; ADR; Literature analysis
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