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经鼻内镜手术后表面活性物质与高渗盐水冲洗的单盲随机对照试验。

Single-blind randomized controlled trial of surfactant vs hypertonic saline irrigation following endoscopic endonasal surgery.

机构信息

Department of Otolaryngology-Head and Neck Surgery, University of North Carolina-Chapel Hill, Chapel Hill, NC 27599, USA.

出版信息

Int Forum Allergy Rhinol. 2013 Apr;3(4):276-80. doi: 10.1002/alr.21116. Epub 2012 Nov 20.

DOI:10.1002/alr.21116
PMID:23169768
Abstract

BACKGROUND

Recent discussion has revolved around formulations of irrigation in the postoperative functional endoscopic sinus surgery patient, specifically the efficacy of emulsion based nasal irrigations.

METHODS

Forty adult candidates for endoscopic endonasal surgery with chronic rhinosinusitis (CRS) were prospectively randomized. The 22-item Sino-Nasal Outcome Test (SNOT-22) and 31-item Rhinosinusitis Outcome Measure (RSOM-31) quality of life assessments, as well as a phenyl ethyl alcohol (PEA) smell threshold test were obtained preoperatively and over 3 postoperative visits in a 4-month period. Repeated measures analyses and Fisher's exact tests were used to assess statistical differences.

RESULTS

Of the 40 patients enrolled, 33, 32, and 26 patients were seen at postoperative visits 1, 2, and 3, respectively. The surfactant (S) and hypertonic saline (HS) irrigation groups both showed significant decreases in scores for both the SNOT-22 and RSOM-31 over time (both p < 0.0001), but no difference was seen between the 2 groups (p = 0.09, p = 0.5). PEA thresholds showed overall improvement in both groups 3 to 4 months after surgery: 62% (8/13) of HS patients and 50% (6/12) of S patients, but did not differ between the groups (p = 0.3). The S group reported significantly more side effects (52% vs 6%, p = 0.002) and had more patients stop the solution (20% vs 0%) and fewer S patients finished the study compared to the HS group.

CONCLUSION

There were no significant differences in overall subjective symptoms related to sinonasal disease between S and HS irrigation, but tolerability appeared to be an issue. More patients reported side effects with S irrigation, and 20% receiving S irrigation stopped the solution, compared to none receiving HS irrigation.

摘要

背景

最近的讨论围绕着术后功能性内窥镜鼻窦手术患者的冲洗液配方展开,特别是乳剂鼻腔冲洗的效果。

方法

40 名接受内镜鼻内手术的慢性鼻-鼻窦炎(CRS)成年患者被前瞻性随机分组。22 项 Sino-Nasal Outcome Test(SNOT-22)和 31 项 Rhinosinusitis Outcome Measure(RSOM-31)生活质量评估,以及苯乙醇(PEA)嗅觉阈值测试,分别在术前和术后 4 个月的 3 次就诊中获得。采用重复测量分析和 Fisher 精确检验评估统计学差异。

结果

40 名入组患者中,分别有 33、32 和 26 名患者在术后 1、2 和 3 次就诊中被观察到。表面活性剂(S)和高渗盐水(HS)冲洗组的 SNOT-22 和 RSOM-31 评分均随时间显著降低(均 p<0.0001),但两组之间无差异(p=0.09,p=0.5)。两组患者的 PEA 阈值在术后 3 至 4 个月均有整体改善:HS 组有 62%(8/13)的患者,S 组有 50%(6/12)的患者,但两组之间无差异(p=0.3)。S 组报告的副作用明显更多(52% vs 6%,p=0.002),有更多的患者停止使用溶液(20% vs 0%),且 S 组完成研究的患者明显少于 HS 组。

结论

S 和 HS 冲洗在与鼻-鼻窦疾病相关的总体主观症状方面无显著差异,但耐受性似乎是一个问题。S 冲洗组报告的副作用更多,有 20%的患者停止使用溶液,而接受 HS 冲洗的患者则无一人停止使用。

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