Li Fu-Xiao, Cai Jia-Xin, Li Ji-Bin, Luo Kong-Jia, Wang Shi-Yu, Meng Wei-Hua, Sha Feng, Yang Zhi-Rong, Hackshaw Allan, Tang Jin-Ling
Department of Computational Biology and Medical Big Data, Shenzhen University of Advanced Technology, Shenzhen, China.
Nottingham Ningbo China Beacons of Excellence Research and Innovation Institute, University of Nottingham Ningbo China, Ningbo, China.
Cardiooncology. 2025 Mar 31;11(1):33. doi: 10.1186/s40959-025-00325-6.
Evidence suggests immune checkpoint inhibitor (ICI) can increase the risk of myocarditis. We investigated it in a large national cohort in China.
Patients with stage IIIB-IV non-small cell lung cancer (NSCLC) using data from China's National Anti-Tumor Drug Surveillance System between January 2013 and December 2021. Exposure density sampling was applied to control for immortal time bias. Multivariate Cox regression with time-dependent exposures was used to examine the association between ICI therapy and the incidence of myocarditis while controlling for confounders.
55,219 patients were included. The median age was 61 years, and 62% were males. At one-year follow-up (median 335 days), there were 26 cases of myocarditis among ICI users and 28 cases among ICI non-users (a cumulative incidence of 4.8 and 0.6 per 1000 person-years respectively). The adjusted hazard ratio (HR) of myocarditis for ICI users was 7.41 (95% confidence interval [CI]: 3.29-16.67). For programmed cell death protein 1 inhibitor users the HR was 8.39 (95% CI: 3.56-19.77). No significant interactions were observed in subgroup analysis. The results remained unchanged in sensitivity analyses.
This study showed that ICI therapy considerably increased the risk of myocarditis, supporting the need for closer monitoring of patients receiving ICI therapies.
有证据表明免疫检查点抑制剂（ICI）会增加心肌炎风险。我们在中国一个大型全国性队列中对此进行了调查。
利用2013年1月至2021年12月期间中国国家抗肿瘤药物监测系统的数据，纳入IIIB-IV期非小细胞肺癌（NSCLC）患者。采用暴露密度抽样以控制不朽时间偏倚。使用具有时间依赖性暴露的多变量Cox回归，在控制混杂因素的同时，检验ICI治疗与心肌炎发病率之间的关联。
共纳入55219例患者。中位年龄为61岁，男性占62%。在一年随访期（中位335天），ICI使用者中有26例心肌炎病例，ICI非使用者中有28例（累积发病率分别为每1000人年4.8例和0.6例）。ICI使用者发生心肌炎的调整后风险比（HR）为7.41（95%置信区间[CI]：3.29-16.67）。程序性细胞死亡蛋白1抑制剂使用者的HR为8.39（95%CI：3.56-19.77）。亚组分析未观察到显著的相互作用。敏感性分析结果保持不变。
本研究表明ICI治疗显著增加了心肌炎风险，支持对接受ICI治疗的患者进行更密切监测的必要性。
