Hepatology:皮质类固醇剂量对免疫检查点抑制剂治疗肝炎的结局影响

2021-11-29 MedSci原创 MedSci原创

免疫检查点是完整T细胞功能所不可缺少的蛋白,当人体需要阻止免疫功能时,这类蛋白会起到重要的抑制T细胞功能的作用。

免疫检查点抑制剂 (ICIs) 已成为许多人治疗恶性肿瘤的主要治疗选择,免疫检查点抑制剂是靶向细胞毒性T淋巴细胞抗原 4 (CTLA-4)的单克隆抗体药物。免疫系统过度激活会导致免疫相关不良事件 (irAE)的发生。ICI相关性肝炎是一种表现为无症状的丙氨酸升高转氨酶 (ALT) 和天冬氨酸转氨酶 (AST) 的肝功能异常,3 级和 4 级肝炎定义为转氨酶升高分别为正常上限的5-20倍和>20倍。对此,共识指南推荐使用大剂量皮质类固醇(1-2 mg/kg/天甲基强的松龙等价物)治疗≥3 级免疫检查点抑制剂 (ICI) 相关性肝炎。因此,本项研究旨在探究皮质类固醇剂量对丙氨酸氨基转移酶 (ALT) 正常化时间、额外免疫抑制的需要和类固醇相关并发症的影响。

 

为此,研究人员对2010年至2020年间的215名接受ICI治疗的患者进行了一项回顾性队列研究,这些患者都出现了3级(ALT>200 U/L)ICI相关性肝炎。患者按初始皮质类固醇剂量的大小(≥1.5 mg/kg 或 <1.5 mg/kg 甲基强的松龙当量)进行分组。然后使用倾向评分以预测接受较高类固醇剂量的风险。

 

 研究结果显示:≥1.5 mg/kg组的 87 名患者接受了更高的初始(2.0 VS 0.8 mg/kg/天,p<0.001)类固醇剂量的治疗。在Cox逻辑回归模型分析中,高剂量组与低剂量组在发生类固醇难治性肝炎方面没有差异(OR 1.22,95% CI 0.79-1.89,p=0.365)。在类固醇反应性疾病患者中,≥1.5 mg/kg 组的皮质类固醇暴露时间更长(中位数为 60 天 VS 44 天,p=0.005)和更高的感染发生率(18.4% VS 7.0%,RR 2.6,95% CI 1.2-5.6,p=0.011)和更需要治疗的高血糖症(23.3% VS 7.8%,RR 3.0,95% CI 1.5-6.0,p=0.001)。

 

本项研究证实在患有高级别 ICI 肝炎的患者中,与更高剂量方案相比,用 1 毫克/公斤/天的甲基强的松龙等效物进行初始治疗可提供相似的肝炎结果,并降低了类固醇相关并发症的风险。

原始出处:

Michael Li. Et al. Effect of corticosteroid dosing on outcomes in high-grade immune checkpoint inhibitor hepatitis. Hepatology.2021.

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