Kothiwala Mamta, Samdani Sunil, Grover Mohnish, Gurjar Vishram
Department of ENT and Head and Neck Surgery, SMS Medical College and Hospital, Dr Kothiwala Neurosurgery and ENT Clinic, B-48, Shyam colony (near rammandir sitabadi), Tonk road, 302019 Jaipur, Rajasthan India.
Indian J Otolaryngol Head Neck Surg. 2022 Oct;74(Suppl 2):1399-1407. doi: 10.1007/s12070-021-02509-9. Epub 2021 Apr 15.
Chronic rhinosinusitis (CRS) is a chronic inflammatory process of nasal mucosa and paranasal sinuses, lasting more than 12 weeks, without complete resolution of symptoms. CRS is treated medically, followed by Endoscopic sinus surgery (ESS) if necessary, and supplemented by post-operative topical treatment with highly variable clinical outcomes. However, till date there is no consensus on the composition and duration of maximal medical treatment. Despite proven role of topical steroids, the mode of delivery, dose and duration of topical intranasal corticosteroids still remains debatable. Studies found that high volume sinonasal irrigation (> 50 ml) using budesonide is most efficient method but still there is not sufficient data to prove this and results are variable with multiple modifiable factors therefore, this study has been conducted. (1) To determine the difference in mean decrease in Lund-Kennedy endoscopic scores and SNOT-22 scores among post ESS patients with high volume budesonide nasal irrigation nasal cavity and control nasal cavity of chronic rhinosinusitis patients. (2) To determine safety by measuring serum cortisol levels and intra ocular pressure. This is hospital based interventional, randomised, double blind, control trial study. A total of 66 patients of CRS with previous failed medical therapy were included. Same patients nasal cavities were divided into control and case nasal cavities, to avoid demographic bias. All subjects had a baseline SNOT-22 scores (Sino Nasal Outcome Test scores), Lund Kennedy endoscopy score, NCCT PNS score. All patients were undergone ESS procedure. After nasal pack removal, nasal cavities were randomly assigned 1:1 to receive normal saline irrigation (control group) or 1 mg of budesonide irrigation (case group) for transnasal irrigation twice daily for 12 weeks. A total of 66 patients with 132 nasal cavities were included in the study. Out of which 16 were female and 50 were male with mean age 33 year and mean duration of symptoms was 38.19 months. Mean duration of follow up was for 3 months. Mean decrement in SNOT-22 score in control nasal cavity from 52.54(16.309) to 30.06 (18.16) and in endoscopic score from 6.53 (1.33) to 3.93 (1.6) which is statically significant ( value < 0.05) in both scores. Mean decrement in SNOT-22 score in case nasal cavity from 53.73 (15.75) to 21.15 (13.52) and in endoscopic score from 6.74 (1.8) to 2.77 (1.4) which is statically significant ( value < 0.05) in both scores. Decrement in SNOT-22 scores and endoscopy scores in case nasal cavity in comparision to control nasal cavity were compared by student 't' test and found to be statically significant ( value equals to 0.0001). In subjective outcomes 57.57% shows total improvement in control nasal cavities while 72.73% case nasal cavities shows total improvement. Our study shows high volume budesonide irrigation is safe and superior over normal saline irrigation and results were statistically comparable. Still further studies with larger sample size and longer duration of irrigation needed.Based on available evidence, high volume budesonide irrigation is statically safe and superior over normal saline irrigation.
慢性鼻-鼻窦炎(CRS)是一种鼻腔黏膜和鼻窦的慢性炎症过程,持续时间超过12周,症状未完全缓解。CRS采用药物治疗,必要时进行鼻内镜鼻窦手术(ESS),术后辅以局部治疗,但临床疗效差异很大。然而,迄今为止,关于最大药物治疗的组成和持续时间尚无共识。尽管局部用类固醇的作用已得到证实,但鼻内局部用皮质类固醇的给药方式、剂量和持续时间仍存在争议。研究发现,使用布地奈德进行大容量鼻窦冲洗(>50 ml)是最有效的方法,但仍缺乏足够的数据来证明这一点,而且由于存在多个可改变的因素,结果也存在差异,因此开展了本研究。(1)确定ESS术后慢性鼻-鼻窦炎患者中,大容量布地奈德鼻腔冲洗组与对照组鼻腔的Lund-Kennedy内镜评分和SNOT-22评分的平均下降差异。(2)通过测量血清皮质醇水平和眼压来确定安全性。这是一项基于医院的干预性、随机、双盲对照试验研究。共纳入66例先前药物治疗失败的CRS患者。为避免人口统计学偏差,将同一患者的双侧鼻腔分别分为对照侧鼻腔和病例侧鼻腔。所有受试者均有基线SNOT-22评分(鼻窦结局测试评分)、Lund Kennedy内镜评分、鼻窦计算机断层扫描(NCCT)鼻窦评分。所有患者均接受了ESS手术。鼻腔填塞物取出后,鼻腔随机分为1:1,分别接受生理盐水冲洗(对照组)或1 mg布地奈德冲洗(病例组),每天经鼻冲洗2次,持续12周。本研究共纳入66例患者的132个鼻腔。其中女性16例,男性50例,平均年龄33岁,平均症状持续时间为38.19个月。平均随访时间为3个月。对照侧鼻腔的SNOT-22评分从52.54(16.309)降至30.06(18.16),内镜评分从6.53(1.33)降至3.93(1.6),两个评分均具有统计学意义(P值<0.05)。病例侧鼻腔的SNOT-22评分从53.73(15.75)降至21.15(13.52),内镜评分从6.74(1.8)降至2.77(1.4),两个评分也均具有统计学意义(P值<0.05)。通过学生t检验比较病例侧鼻腔与对照侧鼻腔的SNOT-22评分和内镜评分的下降情况,发现具有统计学意义(P值等于0.0001)。在主观结果方面,对照侧鼻腔57.57%显示完全改善,而病例侧鼻腔72.73%显示完全改善。我们的研究表明,大容量布地奈德冲洗是安全的,优于生理盐水冲洗,结果具有统计学可比性。仍需要进行更大样本量和更长冲洗时间的进一步研究。基于现有证据,大容量布地奈德冲洗在统计学上是安全的,优于生理盐水冲洗。