Department of Otolaryngology-Head and Neck Surgery, Schulich School of Medicine and Dentistry, The University of Western Ontario, London, Ontario, Canada.
Laryngoscope. 2011 Dec;121(12):2702-5. doi: 10.1002/lary.22396. Epub 2011 Oct 13.
OBJECTIVES/HYPOTHESIS: Evidence is lacking to guide the postoperative management of Samter's triad patients with chronic rhinosinusitis with polyposis (CRSwP) undergoing endoscopic sinus surgery (ESS). The purpose of this study was to compare three different standardized medication regimens prescribed to these patients after ESS.
Three-arm, randomized, double-blinded, controlled trial.
Patients with Samter's triad undergoing ESS were postoperatively randomized into three medication regimens, those being saline irrigation alone (control group A), saline irrigation plus separate budesonide nasal spray (group B), and saline irrigation mixed with budesonide nasal spray (group C). Outcome measures were Sino-Nasal Outcome Test scores, Lund-Mackay computed tomography scores, and Lund-Kennedy endoscopic scores taken at preoperative baseline, and then at 6 months and 1 year postoperatively. Side effect profiles were also measured (adrenocorticotropic hormone blood level ranges and intraocular pressure at the same interval points). Analysis of variance and χ(2) analyses were conducted using a Bonferroni correction method and routine descriptive statistics. Inter- and intragroup comparisons were made.
Sixty subjects were recruited. All groups were equivalent at baseline in all outcomes. All intragroup analyses showed statistically and clinically significant improvement in disease status as compared to baseline (P < .0167), with a sustained but lessened improvement at 1 year. However, no statistically or clinically significant differences were observed between groups at any time point (P > .05). There was no treatment effect noted.
In this study, nasal steroids did not confer any additional benefit over saline alone as post-ESS care for the Samter's triad CRSwP patient population.
目的/假设：缺乏证据来指导 Samter 三联征伴鼻息肉型慢性鼻窦炎（CRSwP）患者行内镜鼻窦手术后（ESS）的术后管理。本研究的目的是比较 ESS 后为这些患者开的三种不同标准化药物治疗方案。
三臂、随机、双盲、对照试验。
行 ESS 的 Samter 三联征患者术后随机分为三组，即单独盐水冲洗（对照组 A）、盐水冲洗加布地奈德鼻喷雾剂（B 组）和盐水冲洗混合布地奈德鼻喷雾剂（C 组）。测量的结果包括鼻-鼻窦结局测试评分、Lund-Mackay 计算机断层扫描评分和 Lund-Kennedy 内镜评分，在术前基线时测量，然后在术后 6 个月和 1 年时测量。还测量了副作用情况（促肾上腺皮质激素的血水平范围和眼压在相同的间隔点）。使用 Bonferroni 校正法和常规描述性统计进行方差分析和 χ(2)分析。进行了组间和组内比较。
共招募了 60 名受试者。所有组在所有结果上基线时均相当。所有组内分析均显示与基线相比疾病状况有统计学和临床意义上的改善（P<.0167），但在 1 年时改善程度有所降低但仍持续。然而，在任何时间点组间均无统计学或临床显著差异（P>.05）。未观察到治疗效果。
在这项研究中，与单独使用盐水冲洗相比，鼻用类固醇并不能为 Samter 三联征 CRSwP 患者人群提供任何额外的益处。
