信迪利单抗不良反应文献分析

Literature analysis of adverse reactions of sintilimab

目的分析信迪利单抗所致药品不良反应发生的规律及其临床特点,为临床安全用药提供参考。方法通过检索Pubmed数据库、中国知网、万方数据库,收集信迪利单抗的不良反应的个案报道,并对患者的性别、年龄、原患疾病、给药方案以及不良反应的发生时间、临床表现及预后等进行统计分析。结果检索文献得到20例患者,患者多为男性,原患疾病多为肺癌。20例均采用常规剂量治疗,单药治疗的为9例,联合其他药物化疗的共11例。信迪利单抗所致不良反应发生时间跨度较大,最快出现在用药后3 d,最迟出现在用药后405 d,用药后30~180 d发生者最多为12例。信迪利单抗致不良反应累及多个系统,免疫相关性内分泌疾病7例,表现为甲状腺功能减退、甲状腺功能亢进、自身免疫性糖尿病;1例放射召回性肺炎为新发的不良反应。16例患者通过停药、给予糖皮质激素、免疫抑制剂、保肝药等治疗后好转。结论临床医师和药师需加强药物治疗的安全性监测,以便早期识别,保障患者用药安全。

Objective To analyze the general patterns and characteristics of adverse reactions of sintilimab and provide a reference for safety of clinical medication.Methods By searching PubMed,CNKI,and Wanfang databases,the adverse reactions of sintilimab were collected,and patients’sex,age,basic diseases,combined medication,the occurrence time,clinical manifestation and prognosis were analyzed statistically.Results A total of 20 reports were retrieved,most of the patients were male,and most of the primary diseases were lung cancer.20 Cases were treated with conventional dose.9 cases were treated with single drug and 11 cases were treated with other drugs.Adverse reactions caused by sintilimab occurred in a wide range of time.Adverse reactions occurred as soon as 3 days after administration,as late as 405 days,and 12 cases occurred in 30 to 180 days.Sintilimab caused adverse reactions involving multiple systems.There were 7 cases of immune related endocrine diseases,including hypothyroidism,hyperthyroidism and autoimmune diabetes.One case of radiation recall pneumonitis was a new adverse reaction.16 Cases got better after stopping medication,giving glucocorticoids,immune osuppressants,liver protecting drugs and other symptomatic treatment.Conclusion Clinicians and pharmacists need to strengthen the safety monitoring of drug therapy,so as to early identification and ensure the safety of drug use.