初次与二期气管食管穿刺后发声假体耐久性的比较：一项回顾性单中心队列的器械层面复发事件分析
Voice prosthesis durability after primary versus secondary tracheoesophageal puncture: a device-level recurrent-event analysis of a retrospective single-centre cohort.
文献信息
| PMID | 42966807 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Rafael De Cicco |
| 作者单位 | Department of Head and Neck Surgery, Instituto do Câncer Arnaldo Vieira de Carvalho, São Paulo, Brazil. rafaeldecicco@gmail.com. |
| 期刊 | European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery |
| SCI 分区 | Q1 |
| IF | 2.3 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
目的： 比较初次与二期气管食管穿刺（TEP）后发声假体的耐久性，并探讨放疗暴露和器械顺序是否与器械存活相关。
方法： 回顾性单中心队列，纳入2006年至2025年间连续治疗的38例患者（18例初次TEP，20例二期TEP）。每个假体贡献一个从置入到下次更换的间期；并发症驱动的更换为事件，常规更换、尺寸调整和仍在位的器械作为删失处理。放疗暴露为单一互斥变量（无/单纯放疗/放化疗）。Cox回归使用按患者聚类的稳健标准误；患者层面发生率使用负二项回归。
结果： 共分析130个器械间期（57次失败），随访137.0人年。首次失败的中位时间分别为21.6个月与13.6个月（log-rank p = 0.09）。二期置入与失败无关（校正HR 1.05；95% CI 0.51-2.18）。相对于无放疗，放化疗与失败相关（HR 6.69；95% CI 1.25-35.83）；单纯放疗则无关。器械顺序不能预测失败（第四或更晚 vs. 第一：HR 0.81；95% CI 0.43-1.50）。更换率分别为每人年0.36和0.45。渗漏导致57次失败中的45次（78.9%）。
结论： TEP的时机与发声假体耐久性无关。放化疗与器械存活期缩短相关，但置信区间较宽；该研究未针对等效性进行把握度设计，且不能排除适应证混杂。器械顺序不能预测后续失败。这些发现具有探索性。
英文摘要
PURPOSE: To compare voice prosthesis durability between primary and secondary tracheoesophageal puncture (TEP), and to examine whether radiotherapy exposure and device order are associated with device survival.
METHODS: Retrospective single-centre cohort of 38 consecutive patients (18 primary, 20 secondary TEP) treated between 2006 and 2025. Each prosthesis contributed one interval from insertion to the next replacement; complication-driven replacement was the event, and routine renewals, size adjustments and devices in situ were censored. Radiotherapy exposure was a single mutually exclusive variable (none / radiotherapy alone / chemoradiotherapy). Cox regression used robust standard errors clustered by patient; patient-level rates used negative-binomial regression.
RESULTS: In total, 130 device intervals were analysed (57 failures) over 137.0 person-years. Median time to first failure was 21.6 versus 13.6 months (log-rank p = 0.09). Secondary insertion was not associated with failure (adjusted HR 1.05; 95% CI 0.51-2.18). Relative to no radiotherapy, chemoradiotherapy was associated with failure (HR 6.69; 95% CI 1.25-35.83); radiotherapy alone was not. Device order did not predict failure (fourth or later vs. first: HR 0.81; 95% CI 0.43-1.50). Replacement rates were 0.36 and 0.45 per person-year. Leakage caused 45 of 57 failures (78.9%).
CONCLUSIONS: The timing of TEP was not associated with voice prosthesis durability. Chemoradiotherapy was associated with shorter device survival, with a wide confidence interval; the study was not powered for equivalence, and confounding by indication cannot be excluded. Device order did not predict subsequent failure. These findings are exploratory.