时间标签:数据日期 2026-10-31 · 生成时间 2026-11-01 05:30(Asia/Shanghai)| 检索窗口 PubMed edat 2026/10/28–2026/10/31 | 情报发生日期 2026-10-31
研究问题
A further open question is whether the disproportionality signal itself is age-dependent: that is, whether older patients are overrepresented in myocarditis reports beyond what differential exposure would predict.
方法
For myocarditis-specific analyses (Sections –3.4, , , , , ), the pooled unique-case total (4,107) was obtained by an OR-combined query of the three myocarditis Preferred Terms at the whole-cohort level, de-duplicating reports containing more than one of these terms.;The Hacettepe University Health Sciences Research Ethics Board reviewed the study protocol and granted a formal waiver of ethics approval (decision no.;SBA 26/540, reference E-16969557-050.04-00005080458, dated 17 July 2026), confirming that ethics committee review was not required given the anonymous, publicly available nature of the data.;Reporting followed the STROBE checklist for observational studies ().
核心结论
For myocarditis specifically, the OR-combined unique-case query identified 4,107 reports across the same period.;Total ICI cardiac AE records increased from 85 in 2014 to 2,670 in 2024, a 31-fold rise.;The pooled ROR for myocarditis across all ICIs combined was 34.21 (95% CI 32.95–35.51), well above the conventional signal threshold and in line with the magnitude reported by Reeves et al. ‖ 结论:Sensitivity analysis across the full range of de-duplication assumptions yields ≥65 proportions between 52.1% and 83.1%, with a plausible range of 62.6–63.4% (); the qualitative conclusion that ICI myocarditis reporting is concentrated in older adults holds throughout.
局限
Because FAERS does not provide true exposure denominators by age, treatment duration, indication, tumor type, ICI combination regimen, or comorbidity status, the age-stratified reporting odds ratios reported here should be interpreted as age-stratified reporting signals rather than as direct evidence that older age independently increases the true clinical risk of ICI myocarditis.;With this caveat in mind, and to keep demonstrated findings clearly separated from biological hypotheses and clinical implications, the remainder of this discussion is organized in three layers: (i) findings directly demonstrated by our FAERS data (age concentration of myocarditis reports, age-stratified reporting
对本项目的价值
★☆☆☆☆ 相关范围内,作为背景与横向对照收录。最大样本量约 18,261。
全文来源
PMC JATS 全文(正文 46,967 字符,已过标题/DOI 逐字归属校验)
原文题录
- 英文标题:Age-stratified reporting of immune checkpoint inhibitor-associated myocarditis: disproportionality is amplified in older adults, with implications for geriatric oncology.
- 期刊与标识:Front Cardiovasc Med · PMID 42947724 · DOI 10.3389/fcvm.2026.1948161
A 级证据分级:A 级(同行评议人体研究)
本文属人体研究证据,但需注意:观察性或小样本干预的结论不等于已证实临床获益;效应量与长期安全性仍需更大规模、更长随访的试验验证。
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