舒尼替尼致不良反应的文献分析

发布时间：2018-10-16 12:43

【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Pub Med、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 the safe use of sunitinib. Methods: using "sulnitinib" and "adverse reaction" as the key words, we searched the case reports and case series reports on the (ADR) literature of sulnitinib induced adverse reactions from January 2006 to March 2017 in Pub Med, Wiper, China Zhiwang and Wanfang database. After screening, the patients' basic condition, disease information, ADR involvement organ / system and clinical manifestation, ADR correlation evaluation and outcome were statistically analyzed by retrospective study. Results: a total of 57 articles were included, involving 66 cases, including 15 cases of new adverse reactions, of which 34 cases (51.52%) were male and 32 cases (48.48%) were female. The ratio of male to female was 1.06: 1, with an average age of (63.4 卤10.5) years. Sunitinib was mainly used in the treatment of renal clear cell carcinoma (65.15%), followed by gastrointestinal stromal tumor (21.21). The incidence of ADR was the highest (27.27% 22.73%) with endocrine system (25.76%). The main clinical manifestation was hypothyroidism. The second was skin and its appendages (21.21%) and hemolymph system (16.67%). The main clinical manifestations were hand and foot syndrome and thrombocytopenia (mainly 4-degree bone marrow suppression). Causality was evaluated as positive in 9 cases and most likely in 57 cases. There were 14 cases (21.21%) of the patients who naturally improved after the withdrawal of sulnitinib, 27 cases (40.91%) of the patients who stopped taking the drug and treated with drugs, 17 cases (25.76%) needed surgical treatment, 17 cases (25.76%) had severe prolongation of the course of disease or still had sequelae after treatment, and 8 cases (12.12%) died. Conclusion: the adverse reactions caused by sunitinib involve many organs / systems of the whole body, and there are many serious fatal cases. The observation and monitoring should be strengthened in the course of clinical administration to ensure the safety of patients with ADR,.
【作者单位】：国家食品药品监督管理总局高级研修学院;国家食品药品监督管理总局食品药品查验中心;
【分类号】：G353.1;R969.3

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