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一项前瞻性随机单盲临床试验,比较功能性内窥镜鼻窦手术后 Sterimar™ 和 Sinus Rinse™ 鼻腔冲洗产品的疗效和耐受性。

A prospective randomised single-blinded clinical trial comparing the efficacy and tolerability of the nasal douching products Sterimar™ and Sinus Rinse™ following functional endoscopic sinus surgery.

机构信息

Academic unit of Clinical and Experimental Sciences, Department of Otorhinolaryngology - Head and Neck Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK.

出版信息

Clin Otolaryngol. 2013 Aug;38(4):297-305. doi: 10.1111/coa.12132.

Abstract

OBJECTIVES

To compare the efficacy and tolerability of two commonly used nasal douching products, low-volume high-pressure Sterimar™ and high-volume low-pressure Sinus Rinse™ following functional endoscopic sinus surgery.

DESIGN

Prospective randomised single-blinded study.

SETTING

Tertiary referral centre.

PARTICIPANTS

Thirty-one patients, undergoing functional endoscopic sinus surgery for chronic rhinosinusitis with and without polyps, were recruited for the study. The patients acted as their own comparators self-administering each douche three times daily into one randomly allocated nostril for a period of 12 weeks following the surgery.

MAIN OUTCOME MEASURES

The primary outcome measure was a blinded objective endoscopic assessment of each operated side using a modified Lund-Kennedy endoscopic assessment tool undertaken at 2, 4 and 12 weeks postoperatively. As secondary outcome measures, the patients were asked to express a preference between the two products based on perceived effectiveness and ease of use.

RESULTS

Compared with the preoperative scores, there was a statistically significant improvement in the SNOT-22 score at all three postoperative time points (P < 0.001). Compared with week 2, there was a statistically significant reduction in the modified Lund-Kennedy endoscopic scores (P < 0.05) for both Sterimar™ and Sinus Rinse™ at weeks 4 and 12. When comparing Sterimar™ with SinuRinse™, there was a statistically significant lower modified Lund-Kennedy score at 2 and 4 weeks postoperatively for the side treated with Sinus Rinse™ (P ≤ 0.05), indicating a more favourable outcome. However, this difference was not apparent at 12 weeks postoperatively (P = 0.66). At all time points, patients perceived Sinus Rinse™ to be more effective than Sterimar™ (P < 0.0001), but there was no significant difference in the patients' preference for either product (P > 0.05).

CONCLUSION

High-volume low-pressure saline irrigation is recommended as an efficacious, easy to use and well-tolerated adjunct to endoscopic sinonasal toilet in the early postoperative period following functional endoscopic sinus surgery.

摘要

目的

比较两种常用鼻腔冲洗产品,即低容量高压 Sterimar™和高容量低压 Sinus Rinse™,在功能性鼻窦内窥镜手术后的疗效和耐受性。

设计

前瞻性随机单盲研究。

地点

三级转诊中心。

参与者

31 名患者,因慢性鼻-鼻窦炎伴或不伴息肉而行功能性鼻窦内窥镜手术,被招募参与本研究。这些患者在手术后每天自我冲洗三次,将每种冲洗液注入随机分配的一个鼻腔,持续 12 周,充当自身对照。

主要观察指标

主要观察指标是使用改良 Lund-Kennedy 内窥镜评估工具对每一侧手术侧进行盲法客观内窥镜评估,分别在术后 2、4 和 12 周进行。作为次要观察指标,患者被要求根据感知效果和易用性表达对两种产品的偏好。

结果

与术前评分相比,所有术后时间点的 SNOT-22 评分均有统计学显著改善(P < 0.001)。与术后 2 周相比,Sterimar™和 Sinus Rinse™的改良 Lund-Kennedy 内窥镜评分在术后 4 周和 12 周均有统计学显著降低(P < 0.05)。当比较 Sterimar™与 SinuRinse™时,在术后 2 周和 4 周时,用 Sinus Rinse™冲洗的一侧的改良 Lund-Kennedy 评分显著降低(P ≤ 0.05),表明结果更有利。然而,这种差异在术后 12 周时并不明显(P = 0.66)。在所有时间点,患者均认为 Sinus Rinse™比 Sterimar™更有效(P < 0.0001),但对两种产品的偏好无显著差异(P > 0.05)。

结论

高容量低压盐水冲洗被推荐为功能性鼻窦内窥镜手术后早期鼻腔鼻窦冲洗的有效、易于使用且耐受性良好的辅助治疗方法。

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