OBJECTIVE:To provide reference for safe use of sunitinib in clinic. METHODS:Using"sunitinib""ADR"as re-trieval 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 in-formation,involved organs or systems,clinical manifestations,ADR association evaluation and outcomes were analyzed statistical-ly. 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 in-volved 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 sur-gery,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 ob-servation and monitoring,timely ADR disposal to guarantee the safety of patients.%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.
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