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基于办公室的球囊鼻窦扩张术:一项前瞻性多中心研究的1年随访

Office-Based Balloon Sinus Dilation: 1-Year Follow-up of a Prospective, Multicenter Study.

作者信息

Sikand Ashley, Silvers Stacey L, Pasha Raza, Shikani Alan, Karanfilov Boris I, Harfe Dan T, Sillers Michael J

机构信息

Ear, Nose & Throat Consultants of Nevada, Las Vegas, Nevada, USA

Madison ENT & Facial Plastic Surgery, New York, New York, USA.

出版信息

Ann Otol Rhinol Laryngol. 2015 Aug;124(8):630-7. doi: 10.1177/0003489415573830. Epub 2015 Mar 4.

Abstract

OBJECTIVE

Balloon sinus dilation (BSD) instruments afford the opportunity for office-based sinus procedures in properly selected patients with chronic rhinosinusitis (CRS). This study evaluated patient-reported outcomes 1 year after office-based BSD.

METHODS

Adult patients with medically refractory CRS were prospectively enrolled into a multicenter, single-arm study and treated with office-based BSD under local anesthesia. Follow-up on 203 patients was conducted at 2, 8, and 24 weeks postsurgery using validated outcome measures for quality of life (SNOT-20) and computed tomography imaging (Lund-Mackay score). After 24 weeks, patients were re-enrolled for 1-year follow-up to evaluate changes in SNOT-20 scores and revisions.

RESULTS

All patients who re-enrolled (n = 122) completed the study, with an average follow-up of 1.4 years. Neither preoperative SNOT-20 nor Lund-Mackay CT scores were predictive of re-enrollment and return for follow-up. Compared to baseline, improvements in SNOT-20 scores remained statistically significant (P < .001) and clinically meaningful (mean decrease ≥ 0.8). In patients followed to 1.4 years, 9 of 122 (7.4%) had revision surgery.

CONCLUSION

Following office-based BSD, significant improvements in quality of life observed at 24 weeks were maintained 1 year postsurgery. These extended results provide further evidence of office-based BSD as an effective, minimally invasive procedure for appropriately selected patients with CRS.

摘要

目的

对于经过适当挑选的慢性鼻-鼻窦炎(CRS)患者,球囊鼻窦扩张术(BSD)器械为门诊鼻窦手术提供了机会。本研究评估了门诊BSD术后1年患者报告的结局。

方法

将药物治疗无效的成年CRS患者前瞻性纳入一项多中心、单臂研究,并在局部麻醉下接受门诊BSD治疗。使用经过验证的生活质量结局指标(SNOT-20)和计算机断层扫描成像(Lund-Mackay评分),在术后2、8和24周对203例患者进行随访。24周后,让患者重新入组进行1年随访,以评估SNOT-20评分的变化和再次手术情况。

结果

所有重新入组的患者(n = 122)均完成了研究,平均随访时间为1.4年。术前SNOT-20评分和Lund-Mackay CT评分均不能预测重新入组和随访返回情况。与基线相比,SNOT-20评分的改善在统计学上仍具有显著意义(P < .001)且具有临床意义(平均下降≥0.8)。在随访至1.4年的患者中,122例中有9例(7.4%)接受了再次手术。

结论

门诊BSD术后,24周时观察到的生活质量显著改善在术后1年得以维持。这些长期结果进一步证明门诊BSD是一种对适当挑选的CRS患者有效的微创治疗方法。

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