Bolger William E, Brown Christopher L, Church Christopher A, Goldberg Andrew N, Karanfilov Boris, Kuhn Frederick A, Levine Howard L, Sillers Michael J, Vaughan Winston C, Weiss Raymond L
Maryland Sinus Center, Bethesda, MD 20817, USA.
Otolaryngol Head Neck Surg. 2007 Jul;137(1):10-20. doi: 10.1016/j.otohns.2007.02.006.
The aim of this study was to further evaluate the safety and effectiveness of balloon catheter devices to dilate obstructed sinus ostia/perform sinusotomy.
Through a prospective, multicenter evaluation, safety was assessed by rate of adverse events, patency was determined by endoscopic examination, and sinus symptoms were determined by the Sino-Nasal Outcome Test (SNOT 20).
At the conclusion of the 24-week analysis, endoscopy determined that the sinusotomy was patent in 80.5% (247 of 307) sinuses and nonpatent in 1.6% (5 of 307), and could not determine ostial patency status in 17.9% (55 of 307). Of the ostia visualized on endoscopy, 98% were patent (247 of 252), while 2% (5 of 252) were considered nonpatent. SNOT 20 scores showed consistent symptomatic improvement over baseline. Revision treatment was required in 3 sinuses (3 of 307 sinuses, 0.98%) in 3 patients (3 of 109 patients, 2.75%).
Balloon catheter technology appears safe and effective in relieving ostial obstruction. Patients were pleased and indicated that they experienced symptomatic improvement.
本研究旨在进一步评估球囊导管装置扩张阻塞性鼻窦开口/进行鼻窦切开术的安全性和有效性。
通过前瞻性多中心评估，通过不良事件发生率评估安全性，通过内镜检查确定通畅情况，通过鼻窦结局测试（SNOT 20）确定鼻窦症状。
在24周分析结束时，内镜检查确定鼻窦切开术在80.5%（307个鼻窦中的247个）的鼻窦中通畅，在1.6%（307个中的5个）的鼻窦中不通畅，在17.9%（307个中的55个）的鼻窦中无法确定开口通畅状态。在内镜检查中可见的开口中，98%（252个中的247个）通畅，而2%（252个中的5个）被认为不通畅。SNOT 20评分显示症状较基线持续改善。3例患者（109例患者中的3例，2.75%）的3个鼻窦（307个鼻窦中的3个，0.98%）需要进行翻修治疗。
球囊导管技术在缓解开口阻塞方面似乎是安全有效的。患者感到满意，并表示症状有所改善。
