Jones Andrew Simpson, Young Pamela Elizabeth, Hanafi Zul Bin, Makura Zorustra George Grange, Fenton John Elian, Hughes Joseph Peter
Department Medicine, Head and Neck Group, University of Liverpool, Clinical Sciences Center, University Hospital Aintree, Long Lane, Liverpool L9 7AL, United Kingdom.
Head Neck. 2003 May;25(5):361-7. doi: 10.1002/hed.10264.
Previous work from this department has shown that resistive tracheostomy filters increase the partial pressure of oxygen in capillary blood and also provide a significant amount of heat/moisture exchange. Until now it has not been shown whether there is any long-term beneficial effect and in particular whether raised tissue oxygenation is maintained using a practical filter device.
We carried out a 6-month randomized control trial including 50 laryngectomees. Twenty-five patients were treated with the Liverpool Heat Moisture Exchange device incorporating an airway resistor (Trachinaze). Another 25 patients were treated with a placebo device. Relevant subjective and objective data were collected before and at the end of the study. The objective measurements were capillary oxygen tension (which parallels blood arterial tension), carbon dioxide tension, FEV(1), FVC, and PIF. Patients were reviewed at intervals throughout the study. Data were analyzed using the Mann-Whitney U test and the paired t test to test the difference between the active device and placebo at 6 months.
Subjective lower airway parameters, including cough, number of chest infections, mucus production, and shortness of breath at rest, were significantly improved in the active group compared with the placebo group. The objective parameters FEV(1), FVC, and PIF were not significantly different. Capillary oxygen tension, however, was highly significantly raised in the active group at 6 months.
Trachinaze is highly superior to placebo at improving subjective pulmonary parameters, including shortness of breath. It is also superior in its ability to maintain an increased peripheral tissue oxygen tension over a 6-month period.
该科室之前的研究表明，电阻式气管造口过滤器可提高毛细血管血中的氧分压，还能进行大量的热/湿交换。到目前为止，尚未证明其是否有任何长期有益效果，特别是使用实用的过滤装置能否维持组织氧合增加。
我们进行了一项为期6个月的随机对照试验，纳入50例喉切除患者。25例患者使用带有气道电阻器的利物浦热湿交换装置（Trachinaze）进行治疗。另外25例患者使用安慰剂装置进行治疗。在研究开始前和结束时收集相关的主观和客观数据。客观测量指标包括毛细血管氧分压（与动脉血氧分压平行）、二氧化碳分压、第一秒用力呼气容积（FEV₁）、用力肺活量（FVC）和吸气峰流速（PIF）。在整个研究过程中定期对患者进行复查。使用Mann-Whitney U检验和配对t检验分析数据，以检验6个月时活性装置与安慰剂之间的差异。
与安慰剂组相比，活性组的主观下呼吸道参数，包括咳嗽、胸部感染次数、黏液分泌和静息时气短等，均有显著改善。客观参数FEV₁、FVC和PIF无显著差异。然而，活性组在6个月时毛细血管氧分压显著升高。
Trachinaze在改善包括气短在内的主观肺部参数方面明显优于安慰剂。在维持外周组织氧分压升高达6个月的能力方面也更具优势。
