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球囊导管鼻窦切开术的安全性及治疗结果:对115例患者进行的多中心24周分析

Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients.

作者信息

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

机构信息

Maryland Sinus Center, Bethesda, MD 20817, USA.

出版信息

Otolaryngol Head Neck Surg. 2007 Jul;137(1):10-20. doi: 10.1016/j.otohns.2007.02.006.

Abstract

OBJECTIVE

The aim of this study was to further evaluate the safety and effectiveness of balloon catheter devices to dilate obstructed sinus ostia/perform sinusotomy.

METHODS

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).

RESULTS

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%).

CONCLUSION

Balloon catheter technology appears safe and effective in relieving ostial obstruction. Patients were pleased and indicated that they experienced symptomatic improvement.

摘要

目的

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。

方法

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。

结果

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。

结论

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。

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