Provox Life 热湿交换器用于未使用过 HME 的喉切除患者肺康复：一项随机对照试验

文献信息

中文摘要

目的： 评估 Provox Life 热湿交换器（HME）及附件能否使未使用过 HME 的喉切除患者建立 24 小时 HME 使用习惯，以及与标准护理相比，由此对肺部症状产生的效果能否维持 9 个月。
方法： 在这项前瞻性随机对照试验中，巴西两个中心的 79 例全喉切除术后未使用过 HME 的患者被随机分配至 Provox Life 组（n = 41）或不使用 HME 的对照组（n = 38）。在基线以及 3、6 和 9 个月时收集数据。主要终点是经验证的咳嗽和痰液评估问卷（CASA-Q）的咳嗽症状（COUS）域。次要终点包括其他 CASA-Q 域、用力咳痰、非自主咳嗽、睡眠质量（JSEQ）、生活质量（EQ-5D-5L）、气短、皮肤完整性、肺部并发症和患者满意度。
结果： HME 依从性接近持续使用（平均 23.3–23.9 小时/天）。Provox Life 组所有四个 CASA-Q 域（COUS、COUI、SPUS、SPUI）较基线均显著改善（9 个月时所有 p ≤ 0.001），变化超过已发表的最小临床重要差异；对照组保持稳定，除了在 T2 时痰液域出现短暂改善。在 9 个月时，Provox Life 组的用力咳痰显著低于对照组（每 24 小时 3.3 ± 2.2 次 vs. 6.6 ± 6.1 次；p = 0.023）。Provox Life 组睡眠质量（JSEQ）显著改善（p = 0.013），而对照组未改善。EQ-5D-5L 指数在 3 和 6 个月时改善，肺部并发症描述性更少，89.7% 的患者将其体验评为“非常好”。皮肤刺激发生率低，且两组相当。未发生器械相关严重不良事件。
结论： 在全喉切除术后未使用过 HME 的患者中，Provox Life 可实现接近持续的 HME 使用，并与肺部症状负担、痰液管理和睡眠质量的临床有意义改善相关。皮肤耐受性与标准护理相当。
证据等级： 1b 试验注册：ClinicalTrials.gov 标识符：NCT06084611。

英文摘要

OBJECTIVE: To evaluate whether Provox Life Heat and Moisture Exchangers (HMEs) and attachments enable HME-naïve laryngectomized patients to establish a 24-h HME routine, and whether the resulting effect on pulmonary symptoms is sustained over 9 months, compared with standard care.
METHODS: In this prospective, randomized controlled trial, 79 HME-naïve patients post-total laryngectomy at two Brazilian centers were randomized to the Provox Life group (n = 41) or a control group without HMEs (n = 38). Data were collected at baseline and at 3, 6, and 9 months. The primary endpoint was the Cough Symptoms (COUS) domain of the validated Cough and Sputum Assessment Questionnaire (CASA-Q). Secondary endpoints included other CASA-Q domains, forced expectorations, involuntary coughs, sleep quality (JSEQ), quality of life (EQ-5D-5L), shortness of breath, skin integrity, pulmonary complications, and patient satisfaction.
RESULTS: HME adherence was near-continuous (mean 23.3-23.9 h/day). All four CASA-Q domains (COUS, COUI, SPUS, SPUI) improved significantly from baseline in the Provox Life group (all p ≤ 0.001 at 9 months), with changes exceeding published minimal clinically important differences; controls remained stable except for transient sputum-domain gains at T2. At 9 months, forced expectorations were significantly lower in the Provox Life group versus controls (3.3 ± 2.2 vs. 6.6 ± 6.1 per 24 h; p = 0.023). Sleep quality (JSEQ) improved significantly with Provox Life (p = 0.013), but not in controls. The EQ-5D-5L index improved at 3 and 6 months, pulmonary complications were descriptively fewer, and 89.7% rated their experience "very good". Skin irritation was low and comparable between groups. No device-related serious adverse events occurred.
CONCLUSION: In HME-naïve patients after total laryngectomy, Provox Life enables near-continuous HME use and is associated with clinically meaningful improvements in pulmonary symptom burden, sputum management, and sleep quality. Skin tolerability is comparable to standard care.
LEVEL OF EVIDENCE: 1b Trial Registration: ClinicalTrials.gov identifier: NCT06084611.