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信迪利单抗致不良反应文献分析
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| 篇名： | 信迪利单抗致不良反应文献分析 |
| TITLE： | Literature analysis of adverse drug reactions induced by sintilimab |
| 摘要： | 目的 探讨信迪利单抗致药品不良反应（ADR）的发生情况及临床特点，为临床安全用药提供参考。方法计算机检索PubMed、Embase、中国知网、维普网及万方数据，收集信迪利单抗致ADR的个案报道并进行汇总分析。结果共纳入32篇文献，共计33例患者，其中男性25例（75.76％）、女性8例（24.24％），以40岁以上患者为主（81.82％）。30例患者用药剂量为信迪利单抗药品说明书推荐剂量（200mg），1例患者用药剂量为100mg；ADR最早发生在首次用药后1h，最晚为第14个用药周期后，其中有27例患者（81.82％）发生在用药后4个月内，尚无患者在用药12个月后发生ADR。ADR主要表现为心肌炎、糖尿病、免疫检查点抑制剂肺炎（CIP）、细胞因子释放综合征（CRS）、甲状腺功能减退性肌病（HM）等，其中CRS和HM为药品说明书未记载的ADR。经对症治疗后，有29例患者好转、4例患者死亡。结论信迪利单抗致ADR常发生在用药后4个月内，男性、40岁以上患者高发。对于使用信迪利单抗患者的用药监护，需注意心肌炎、糖尿病、CIP，以及信迪利单抗说明书中未记载的CRS和HM的发生。 |
| ABSTRACT： | OBJEC TIVE To investigate the status and clinical characteristics of adverse drug reactions （ADRs）induced by sintilimab in order to provide references for clinical rational drug use. METHODS The cases of ADR induced by sintilimab were retrieved from the databases of PubMed ，Embase，CNKI，VIP and Wanfang. RESULTS A total of 32 literature were included ， involving 33 patients among which there were 25 males（75.76％）and 8 females（24.24％）. The incidence of ADRs was higher in patients aged over 40 years（81.82％）. The dose of sintilimab was the drug instructions recommended dose （200 mg）for 30 patients and 100 mg for a patient. The earliest ADR occurred 1 h after the first medication ，the latest ADR occurred after 14 cycles of sintilimab. The 27 cases suffered from ADR cases （81.82％）within 4 months after medication ，and no reports of ADR occurred after 12 months of medication. The major manifestations of ADR were myocarditis ，diabetes mellitus ，checkpoint inhibitor pneumonitis（CIP），cytokine release syndrome （CRS）and hypothyroid myopathy （HM），etc. CRS and HM belonged to ADRs not recorded in the drug instructions. The 29 cases of recovery and 4 deaths occurred after symptomatic treatment. CONCLUSIONS ADR caused by sintilimab often occurs within 4 months after treatment ，and it is high in males and patients over 40 years old. In clinical application of sintilimab ，attention should be paid to the occurrence of myocarditis ，diabetes mellitus ，CIP，as well as CRS and HM not recorded in the drug instructions. |
| 期刊： | 2022年第33卷第16期 |
| 作者： | 赵菲菲，李满，杨楠，毛利紧，陈敬霞，郭峰 |
| AUTHORS： | ZHAO Feifei，LI Ma n，YANG Nan，MAO Lij in，CHEN Jingxia ，GUO Feng |
| 关键字： | 信迪利单抗；不良反应；安全性 |
| KEYWORDS： | sintilimab；adverse drug rea ctions；safety |
| 阅读数： | 324 次 |
| 本月下载数： | 9 次 |
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