首页|程序性死亡受体1抑制剂治疗恶性黑色素瘤的不良反应及其影响因素分析

程序性死亡受体1抑制剂治疗恶性黑色素瘤的不良反应及其影响因素分析

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目的:分析程序性死亡受体1(PD-1)抑制剂治疗恶性黑色素瘤(malignant melanoma,MM)引起的不良反应临床特点及其危险因素,为安全用药提供参考。方法:采用回顾性分析法,收集我院126例MM患者使用PD-1抑制剂的临床资料,观察性别、年龄、疾病分期及有无基础疾病等一般资料对不良反应的影响,并对发生不良反应累及器官、临床表现、严重程度、发生时间、处理情况及转归等情况进行分析总结。结果:126例患者中有81例发生不同严重程度的不良反应,1~2级有64例(50。8%),3级以上有17例(13。5%),中位发生年龄56岁(6~84岁)。年龄、有无基础疾病、既往有无不良反应发生史及是否合并抗肿瘤药物增加了不良反应的发生,差异有显著意义(P<0。05)。发生率前5位的不良反应临床表现为甲状腺功能减退(27。78%)、三酰甘油(TG)升高(15。08%)、谷丙转氨酶(ALT)升高(13。49%)、恶心(11。90%)、瘙痒(11。90%)。不良反应发生时间较分散,其中肝毒性发生较早,甲状腺功能减退发生较晚。81例不良反应中有59例(73%)症状好转,24例(29。6%)患者接受糖皮质激素等免疫抑制剂处理,6例(7。41%)加用了其他免疫抑制剂。结论:PD-1抑制剂相关性不良反应多为轻度的,3级以上不良反应发生率低,可通过类固醇激素治疗后得到改善或治愈。高龄、合并基础疾病以及既往有药品不良反应史的患者可增加不良反应的发生,临床使用中应重点关注。
Analysis of adverse reactions and influencing factors of programmed death receptor 1 inhibitors in the treatment of malignant melanoma
Objective:To analyze the clinical features and risk factors of adverse reactions(ADRs)caused by programmed death receptor 1(PD-1)inhibitors in malignant melanoma(MM),and provide reference for safe drug use.Methods:A retrospective analysis was used to collect the clinical data of 126 MM patients treated with PD-1 inhibitors in our hospital.The influences of general information such as gender,age,disease stage with or without underlying diseases on ADRs were observed,and the involved organs,clinical manifestations,severity,occurrence time,treatment and outcome of ADRs were analyzed and summarized.Results:Among the 126 patients 81 had ADRs of different severity,grade 1~2 in 64 patients(50.8%),grade 3 of above in 17 patients(13.5%),and the median age was 56 years(6~84 y).Age,underlying disease,history of ADRs and combination of anti-tumor drugs increased the occurrence of adverse reactions(P<0.05).The top five clinical manifestations were hypothyroidism(27.78%),TG elevation(15.08%),ALT elevation(13.49%),nausea(11.90%),and itching(11.90%).The occurrence time of ADRs was scattered,among which hepatotoxicity occurred earlier and hypothyroidism occurred later.Of the 81 patients with adverse reactions,59(73%)had improved symptoms,24(29.6%)were treated with immunosuppressant such as glucocorticoids,and 6(7.41%)were treated with other immunosuppressant.Conclusion:PD-1 inhibitor-related ADRs are mostly mild,and the incidence of grade 3 or above ADRs is low,which can be improved or cured by steroid hormone treatment.Advanced age,underlying diseases,and a history of ADRs can increase the incidence of ADRs,which should be paid attention to in clinic.

malignant melanomaprogrammed cell death 1 receptoradverse drug reactionsroot cause analysis

尹月、邱新野、赵志刚、张艳华

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北京大学肿瘤医院暨北京市肿瘤防治研究所,恶性肿瘤发病机制及转化研究教育部重点实验室,北京 100142

首都医科大学附属北京佑安医院药学中心,北京 100069

首都医科大学附属北京天坛医院药剂科,北京 100050

恶性黑色素瘤 程序性死亡受体1 药物不良反应 影响因素分析

2024

中国新药杂志
中国医药科技出版社 中国医药集团总公司 中国药学会

中国新药杂志

CSTPCD北大核心
影响因子:1.039
ISSN:1003-3734
年,卷(期):2024.33(10)