帕博利珠单抗用于PD-L1高表达患者致严重药品不良反应影响因素分析

目的 探讨帕博利珠单抗治疗晚期恶性肿瘤导致严重药品不良反应（adverse drug reaction，ADR）相关危险因素，为临床安全、有效使用帕博利珠单抗，预防ADR提供参考。方法 回顾性分析2018年1月—2020年6月医院所有使用过帕博利珠单抗患者的临床病例资料，对可能引起帕博利珠单抗严重ADR的危险因素进行多因素非条件Logistic回归分析。结果 138例使用帕博利珠单抗的患者单因素分析结果显示，患者药物过敏史、药物给药剂量和PD-L1表达程度差异有统计学意义（P<0.05）；对筛选出的影响因素进行非条件Logistic回归得出，患者PD-L1表达程度对帕博利珠单抗严重ADR发生均有显著影响（P<0.05）。结论 临床应用帕博利珠单抗导致严重ADR比例较高，特别是单次高剂量和PD-L1高表达的患者，应密切观察给药后ADR发生情况，积极对症治疗发生严重ADR的患者。

Analysis of Influencing Factors of Serious Adverse Drug Reactions Caused by Pembrolizumab in Treatment for Patients with High PD-L1 Expression

OBJECTIVE To explore the risk factors related to serious adverse drug reactions(ADR) caused by pembrolizumab in the treatment of advanced cancer, and to provide references for clinically safe and effective use of pembrolizumab and prevention of ADR. METHODS Retrospectively analyzed the clinical case data of all patients who had used pembrolizumab from January 2018 to June 2020, and conducted multivariate unconditional Logistic regression analysis on the risk factors that might cause severe ADR of pembrolizumab. RESULTS The results of univariate analysis of 138 patients using pembrolizumab showed that the history of drug allergy, drug administration dose and PD-L1 expression level were statistically significant(P<0.05). The selected influencing factors were carried out unconditional Logistic regression, the result showed that the expression level of PD-L1 in patients had a significant impact on the occurrence of severe ADR of pembrolizumab(P<0.05). CONCLUSION The clinical application of pembrolizumab leads to a higher proportion of severe ADR, especially in patients with a single high dose and high PD-L1 expression. The occurrence of ADR after administration should be closely observed, and patients with severe ADR should be actively treated symptomatically.