Pharyngoseal®可调节假体用于唾液瘘治疗：一项STROBE研究
Pharyngoseal® adjustable prosthesis for salivary fistula treatment, a STROBE study.
文献信息
| PMID | 42773008 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | C Fabre |
| 作者单位 | Service ORL-CCF, Centre Hospitalier Universitaire de Grenoble-Alpes (CHUGA), Grenoble, France; Université de Grenoble-Alpes (UGA), Grenoble, France. Electronic address: cfabre2@chu-grenoble.fr. |
| 期刊 | European annals of otorhinolaryngology, head and neck diseases |
| SCI 分区 | Q2 |
| IF | 1.7 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
目的： 评估可调节双凸缘Pharyngoseal®假体（Blom-Singer®，Collin Medical）作为喉切除术后唾液瘘或发声假体植入后扩大的气管食管瘘的临时解决方案或手术替代方案的有效性和可靠性。
材料与方法： 一项单中心回顾性观察性研究（2021-2025）纳入了所有在局部或全身麻醉下接受Pharyngoseal®植入的患者。主要目标是比较植入前后视觉模拟量表（VAS）的生活质量评分。次要终点包括唾液漏出减少（VAS）、植入物相关并发症以及恢复固体或液体经口进食。
结果： 共纳入10例患者：5例为全喉咽切除术后瘘，5例为超过现有发声假体最大尺寸的扩大气管食管瘘。7例患者正在等待手术闭合或被认为不适合手术闭合，3例处于姑息治疗中。共植入13个假体，其中11个（85%）在局部麻醉下植入，多数通过逆行入路（55%）。中位植入使用时间为45天[范围，31-153.5]。生活质量显著改善，VAS从8/10降至4/10（P=0.01），唾液漏出从7/10降至2.5/10（P<0.01）。2个假体不得不移除（20%）。3例患者（30%）瘘完全闭合。6例患者恢复固体经口进食，4例恢复液体进食。
结论： Pharyngoseal®植入物似乎是等待手术或姑息情况下唾液瘘管理的一种可靠选择。
英文摘要
OBJECTIVES: To assess the effectiveness and reliability of the adjustable double-flanged Pharyngoseal® prosthesis (Blom-Singer®, Collin Medical) as a temporary solution or alternative to surgery for post-laryngectomy salivary fistula or enlarged tracheoesophageal fistula after voice prosthesis implantation.
MATERIALS AND METHODS: A single-center retrospective observational study (2021-2025) included all patients who underwent Pharyngoseal® implantation under local or general anesthesia. The primary objective was to compare quality-of-life scores on a Visual Analogue Scale (VAS) before and after implantation. Secondary endpoints comprised reduction in salivary leakage (VAS), implant-related complications and resumption of solid or liquid oral feeding.
RESULTS: Ten patients were included: 5 with postoperative fistula after total pharyngolaryngectomy, and 5 with enlarged tracheoesophageal fistula exceeding the maximum dimensions of available voice prostheses. Seven patients were awaiting or deemed unsuitable for surgical closure, and 3 were in palliative care. Thirteen prostheses were implanted, including 11 (85%) under local anesthesia, mostly via a retrograde approach (55%). Median implant use was 45 days [range, 31-153.5]. There was significant improvement in quality of life, with VAS decreasing from 8/10 to 4/10 (P=0.01), and salivary leakage from 7/10 to 2.5/10 (P<0.01). Two prostheses had to be removed (20%). Fistula closure was complete for 3 patients (30%). Six patients resumed solid oral feeding and 4 resumed liquid feeding.
CONCLUSION: The Pharyngoseal® implant appeared to be a reliable option for salivary fistula management while awaiting surgery or in palliative situations.