目的 分析信迪利單抗所致藥品不良反應(yīng)發(fā)生的規(guī)律及其臨床特點(diǎn)，為臨床安全用藥提供參考。方法 通過(guò)檢索Pubmed數(shù)據(jù)庫(kù)、中國(guó)知網(wǎng)、萬(wàn)方數(shù)據(jù)庫(kù)，收集信迪利單抗的不良反應(yīng)的個(gè)案報(bào)道，并對(duì)患者的性別、年齡、原患疾病、給藥方案以及不良反應(yīng)的發(fā)生時(shí)間、臨床表現(xiàn)及預(yù)后等進(jìn)行統(tǒng)計(jì)分析。結(jié)果 檢索文獻(xiàn)得到20例患者，患者多為男性，原患疾病多為肺癌。20例均采用常規(guī)劑量治療，單藥治療的為9例，聯(lián)合其他藥物化療的共11例。信迪利單抗所致不良反應(yīng)發(fā)生時(shí)間跨度較大，最快出現(xiàn)在用藥后3 d，最遲出現(xiàn)在用藥后405 d，用藥后30～180 d發(fā)生者最多為12例。信迪利單抗致不良反應(yīng)累及多個(gè)系統(tǒng)，免疫相關(guān)性內(nèi)分泌疾病7例，表現(xiàn)為甲狀腺功能減退、甲狀腺功能亢進(jìn)、自身免疫性糖尿病；1例放射召回性肺炎為新發(fā)的不良反應(yīng)。16例患者通過(guò)停藥、給予糖皮質(zhì)激素、免疫抑制劑、保肝藥等治療后好轉(zhuǎn)。結(jié)論 臨床醫(yī)師和藥師需加強(qiáng)藥物治療的安全性監(jiān)測(cè)，以便早期識(shí)別，保障患者用藥安全。

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.

R979.1