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比较布地奈德和生理盐水鼻腔冲洗在慢性鼻窦炎术后管理中的双盲随机对照试验

Double Blinded Randomized Controlled Trial Comparing Budesonide and Saline Nasal Rinses in the Post-operative Management of Chronic Rhinosinusitis.

作者信息

Ahamed Shameer, Samson Divyan, Sundaresan Rajan, Balasubramanya Bhavya, Thomas Regi

机构信息

Unit-1(Head&Neck, Skull base surgery) Department of ENT, Christian Medical College, Vellore, Tamil Nadu India.

出版信息

Indian J Otolaryngol Head Neck Surg. 2024 Feb;76(1):408-413. doi: 10.1007/s12070-023-04173-7. Epub 2023 Sep 1.

DOI:10.1007/s12070-023-04173-7
PMID:38440477
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10909031/
Abstract

Post-operative management of chronic rhinosinusitis is very crucial for outcomes following surgery, Normal saline nasal irrigation and steroid spray form the standard treatment of care in this period. However nasal irrigation may not be adequate and spray is usually started after 2 weeks of surgery which in any case does not deliver optimum dosage of drug to the paranasal sinus mucosa. Budesonide nasal irrigation in a high-volume low-pressure system could be the solution for a better outcome. A double blinded randomized control trial with 88 patients in 2 groups of 44 each received normal saline or Budesonide nasal irrigation (0.5 mg in 200 ml) twice daily. Patients were followed up at 2 weeks post-operatively and 3 months, a SNOT 22 and Lund Kennedy Endoscopic scores were assessed for subjective and objective assessment. Subset analysis of only CRS patients (55) were done, and results presented. Patient reported subjective score at 3 months post operatively, SNOT22 was significantly ( < 0.0001) improved with the use of Budesonide irrigation (26.69 ± 2.92) as compared to Normal saline (30.54 ± 2.81) and objective assessment score, LKES was significantly ( = 0.0031) better in Budesonide group (4.06 + 0.74) in comparison to Normal saline in the saline (4.50 + 0.67) respectively. The mean scores 3 months post op visit was significantly lower for both subjective SNOT ( < 0.001) and objective score LKES ( < 0.0001) in Budesonide groups. Budesonide nasal irrigation with positive pressure high volume device has better patient benefits and wound healing when compared to normal saline irrigation in the post-operative management of chronic rhinosinusitis.

摘要

慢性鼻窦炎的术后管理对于手术效果至关重要,在此期间,生理盐水鼻腔冲洗和类固醇喷雾是标准的治疗护理方法。然而,鼻腔冲洗可能并不充分,喷雾通常在术后2周开始,而这无论如何都无法将最佳剂量的药物输送到鼻窦黏膜。在高容量低压系统中进行布地奈德鼻腔冲洗可能是获得更好效果的解决方案。一项双盲随机对照试验中,88名患者被分为两组,每组44人,分别接受生理盐水或布地奈德鼻腔冲洗(200毫升中含0.5毫克),每日两次。术后2周和3个月对患者进行随访,评估SNOT 22和Lund Kennedy内镜评分以进行主观和客观评估。仅对慢性鼻窦炎患者(55例)进行亚组分析并呈现结果。患者术后3个月报告的主观评分显示,与生理盐水冲洗组(30.54±2.81)相比,使用布地奈德冲洗组(26.69±2.92)的SNOT22评分有显著改善(<0.0001);客观评估评分方面,布地奈德组(4.06 + 0.74)的LKES评分与生理盐水组(4.50 + 0.67)相比有显著改善(=0.0031)。布地奈德组术后3个月的主观SNOT评分(<0.001)和客观LKES评分(<0.0001)均显著低于生理盐水组。与生理盐水冲洗相比,在慢性鼻窦炎的术后管理中,使用正压高容量装置进行布地奈德鼻腔冲洗对患者更有益,且有助于伤口愈合。

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本文引用的文献

1
Budesonide vs Saline Nasal Irrigation in Allergic Rhinitis: A Randomized Placebo-Controlled Trial.布地奈德对比盐水鼻腔冲洗治疗变应性鼻炎的随机安慰剂对照试验。
Otolaryngol Head Neck Surg. 2020 Jun;162(6):979-984. doi: 10.1177/0194599820919363. Epub 2020 May 12.
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Executive summary of EPOS 2020 including integrated care pathways.EPOS 2020 执行摘要,包括综合护理路径。
Rhinology. 2020 Apr 1;58(2):82-111. doi: 10.4193/Rhin20.601.
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Budesonide nasal irrigation improved Lund-Kennedy endoscopic score of chronic rhinosinusitis patients after endoscopic sinus surgery.布地奈德鼻腔冲洗改善了慢性鼻窦炎患者鼻内镜鼻窦手术后的 Lund-Kennedy 内镜评分。
Eur Arch Otorhinolaryngol. 2019 May;276(5):1397-1403. doi: 10.1007/s00405-019-05327-6. Epub 2019 Feb 20.
4
Effect of Budesonide Added to Large-Volume, Low-pressure Saline Sinus Irrigation for Chronic Rhinosinusitis: A Randomized Clinical Trial.布地奈德在大容积、低压力盐水鼻窦灌洗治疗慢性鼻-鼻窦炎中的作用:一项随机临床试验。
JAMA Otolaryngol Head Neck Surg. 2018 Jul 1;144(7):605-612. doi: 10.1001/jamaoto.2018.0667.
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Corticosteroid nasal irrigations are more effective than simple sprays in a randomized double-blinded placebo-controlled trial for chronic rhinosinusitis after sinus surgery.在鼻窦手术后慢性鼻-鼻窦炎的一项随机双盲安慰剂对照试验中,皮质类固醇鼻腔冲洗比单纯喷雾更有效。
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How does sinus surgery affect topical irrigation distribution?鼻窦手术如何影响局部冲洗分布?
Curr Opin Otolaryngol Head Neck Surg. 2018 Feb;26(1):21-26. doi: 10.1097/MOO.0000000000000429.
7
Antibiofilm effects of topical corticosteroids and intranasal saline in patients with chronic rhinosinusitis with nasal polyps depend on bacterial species and their biofilm-forming capacity.局部用皮质类固醇和鼻腔生理盐水对慢性鼻-鼻窦炎伴鼻息肉患者的抗生物膜作用取决于细菌种类及其生物膜形成能力。
Eur Arch Otorhinolaryngol. 2017 Apr;274(4):1897-1903. doi: 10.1007/s00405-017-4454-6. Epub 2017 Jan 23.
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Topical Steroids.外用类固醇
Adv Otorhinolaryngol. 2016;79:121-30. doi: 10.1159/000445148. Epub 2016 Jul 28.
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Defining appropriateness criteria for endoscopic sinus surgery during management of uncomplicated adult chronic rhinosinusitis: a RAND/UCLA appropriateness study.定义成人单纯性慢性鼻-鼻窦炎治疗中鼻内镜鼻窦手术的适宜性标准:一项兰德公司/加州大学洛杉矶分校适宜性研究
Rhinology. 2016 Jun;54(2):117-28. doi: 10.4193/Rhino16.023.
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Safety of long-term high-volume sinonasal budesonide irrigations for chronic rhinosinusitis.长期大剂量鼻腔鼻窦布地奈德冲洗治疗慢性鼻-鼻窦炎的安全性。
Int Forum Allergy Rhinol. 2016 Mar;6(3):228-32. doi: 10.1002/alr.21700. Epub 2016 Jan 11.