| 严家菊,张玉萍,杨大伟,叶晓磊,刘猛,卞涛.安徽省六安市第二人民医院4种国产PD-1抑制剂的临床应用评价与分析[J].中国药事,2023,(5):596-605 |
| 安徽省六安市第二人民医院4种国产PD-1抑制剂的临床应用评价与分析 |
| Evaluation and Analysis of Clinical Application of Four Domestic PD-1 Inhibitors in the Second People’s Hospital of Lu’an City in Anhui Province |
| 投稿时间：2022-06-14 |
| DOI：10.16153/j.1002-7777.2023.05.014 |
| 中文关键词: 国产PD-1免疫检查点抑制剂 临床应用 超说明书用药 免疫相关不良事件 相关性评价 |
| 英文关键词: domestic PD-1 immune checkpoint inhibitor clinical application off -label medication use immunerelated adverse events correlation evaluation |
| 基金项目:吴阶平医学基金(编号 320.6750.2020-10-72) |
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| 中文摘要: |
| 目的：分析六安市第二人民医院临床常用的国产PD-1免疫检查点抑制剂的临床应用合理性及安全性。方法：回顾性分析2020年1月至2021年12月接受国产PD-1免疫检查点抑制剂治疗的117例恶性肿瘤患者的临床资料，依据药品说明书及现有临床试验证据，统计并分析患者基本信息、用药信息及免疫相关不良事件(Immune-related Adverse Events，irAEs)发生情况等，评价其临床用药合理性和安全性，并探讨irAEs与性别、年龄、基础疾病及肿瘤类型等因素之间的关系。结果：共纳入117例应用国产 PD-1抑制剂的住院患者，其中涉及到超适应症用药的有42例(35.90%)，包括卡瑞利珠单抗26例、信迪利单抗13例、特瑞普利单抗2例和替雷利珠单抗1例。42例超适应症用药病例中评价为限制使用、特殊使用和不推荐使用的分别占14.29%(6/42)、52.38%(22/42)和33.33%(14/42)。本研究irAEs的总发生率为40.17%(47例患者、66例次)，严重irAEs占10.26%(12/117)，常见irAEs主要包括皮肤毒性 (16.24%)、肺毒性(13.68%)及内分泌毒性(12.82%)等，多为1~2级毒性反应(81.82%)；其中有 27例未停用PD-1抑制剂，11例永久停用，5例暂停使用，经对症处理后均出现好转。但有2例重启后再激发irAEs，另外有4例因肺毒性导致全身器官衰竭而死亡。经单因素分析提示患者合并慢性疾病和既往胸部放疗史对irAEs的发生有一定影响，且差异有统计学意义(P＜0.05)。结论：PD-1抑制剂在我院超说明书用药占比较大，且存在无循证医学证据支持的用药情况，需要加强管理。irAEs发生较多，多为1~2 级，但临床用药过程中仍需警惕严重irAEs的发生，对irAEs做到早发现、早对症处理，以保障临床合理安全用药。 |
| 英文摘要: |
| Objective: To analyze the rationality and safety of clinical application of domestic PD-1 immune checkpoint inhibitors commonly used in the Second People's Hospital of Lu'an City. Methods: The clinical data of 117 patients with malignant tumor who received domestic PD-1 immune checkpoint inhibitors from January 2020 to December 2021 were retrospectively analyzed. According to drug instructions and existing clinical trial evidence, the basic information of patients, medication information and occurrence of immune-related Adverse Events were statistically analyzed to evaluate the rationality and safety of clinical medication. The relationship between irAEs and factors such as gender, age, preexisting diseases and cancer types of patients were explored. Results: Among the 117 patients using domestic PD-1 immune checkpoint inhibitors, 42 patients (35.90%) were involved in off -label medication, including Camrelizumab (n=26), Sintilimab (n=13), Toripalimab (n=2), Tislelizumab (n=1). Among the 42 cases of off -label medication, 14.29% (6/42) , 52.38% (22/42) and 33.33% (14/42) were evaluated as restricted, special and non-recommended uses respectively. The overall incidence of irAEs in this study was 40.17% (47 patients, 66 cases), serious irAEs accounted for 10.26% (12/117). Common irAEs usually manifest as skin toxicity (16.24%), lung toxicity (13.68%) and endocrine toxicity (12.82%), most of them were grade 1 or 2 toxic reactions (81.82%). Among all irAEs, PD-1 inhibitors were not discontinued in 27 cases, permanently discontinued in 11 cases, and discontinued in 5 cases, and all cases improved after symptomatic treatment. However, 2 patients re-stimulated irAEs after re-dosing and 4 patients died due to systemic organ failure caused by pulmonary toxicity. Univariate analysis suggested that patients with chronic disease and previous history of chest radiotherapy had a certain infl uence on the occurrence of irAEs, and the diff erence was statistically significant (P＜0.05). Conclusion: In our hospital, the off-label medications of PD-1 inhibitors account for a relatively large proportion, and there are medications not supported by evidence-based medical evidence, which needs to be strengthened in management. Grade 1-2 irAEs occurred frequently. However, in the process of clinical medication, we still need to be vigilant about the occurrence of serious irAEs, and to achieve early detection and early symptomatic treatment of irAEs, so as to ensure clinical medication rationality and safety. |
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