Wright Erin D, Agrawal Sumit
Department of Surgery, Division of Otolaryngology, University of Alberta, Edmonton, Alberta, Canada.
Laryngoscope. 2007 Nov;117(11 Pt 2 Suppl 115):1-28. doi: 10.1097/MLG.0b013e31814842f8.
OBJECTIVES/HYPOTHESIS: The objective of this randomized, double-blind, placebo-controlled study was to assess the effect of perioperative systemic steroids on subjective and objective surgical outcomes for patients undergoing endoscopic sinus surgery (ESS) for chronic rhinosinusitis with polyposis (CRSwP). The secondary objective was to begin validation of the newly developed Perioperative Sinus Endoscopy (POSE) scoring system.
Patients who had failed maximal medical therapy and were scheduled to undergo ESS were eligible for the study. Participants were randomized to receive either 30 mg of prednisone or placebo for 5 days preoperatively and 9 days postoperatively. Operative and baseline clinical data were collected using the Lund-McKay staging system including its Sinus Symptom Questionnaire as well as additional data regarding mucosal health, the technical difficulty of surgery, and endoscopic data using the Lund-Kennedy Endoscopic Score (LKES) and POSE scale. Data were also collected at 2 weeks, 1 month, 3 months, and 6 months postoperatively. A sample size of 24 was calculated to detect a clinically relevant difference between groups of 40%. Routine statistical comparisons were performed as were repeated measures analysis of variance with Bonferroni adjustment because of the multiple comparisons performed. To address the secondary objective, data were also collected at all postoperative time points using the POSE instrument, which was designed with the intention of enhancing face validity and responsiveness to change. Comparisons were performed between the POSE and LKES, including assessment of sensitivity to change, correlation between the two scales, and correlation with symptom scores.
Twenty-six patients participated in the study. Operative data demonstrated a significantly higher percentage of severely inflamed sinonasal mucosa in patients not pretreated with systemic steroids, which was associated with technically more difficult surgery in the estimation of the operating surgeon. In terms of postoperative symptoms, there was no difference between treatment groups, with both placebo and prednisone significantly improved over baseline up to 4 weeks postoperatively. Endoscopic assessment of patients postoperatively demonstrated a treatment effect (P < .05), with clinically healthier cavities seen in patients treated with prednisone up to 6 months postoperatively as compared with baseline (P < .001), although the strongest effect was seen at the 2-week time point. In comparing the two endoscopic scales, the POSE and LKES correlated highly (R > 0.70; P < .001) both in terms of absolute score and change in score. There is some evidence that the POSE score may be more sensitive to change than the LKES, and the POSE scores did correlate more strongly with symptom scores than the LKES, although both endoscopic scores correlated only weakly with symptom scores.
The data presented in this study support the practice of administering preoperative systemic steroids to patients undergoing ESS for CRSwP. Furthermore, in the practice of surgeons who provide intensive postoperative care post-ESS, including debridement and medical therapy based on the endoscopic findings, there is evidence to support administering systemic steroids in the postoperative period. The POSE scoring system compares favorably with the LKES and may confer advantages in terms of face/content validity and responsiveness to change and is worthy of further validation.
目的/假设:本随机、双盲、安慰剂对照研究的目的是评估围手术期全身使用类固醇对患有鼻息肉的慢性鼻窦炎(CRSwP)患者接受鼻内镜鼻窦手术(ESS)的主观和客观手术结果的影响。次要目的是开始验证新开发的围手术期鼻窦内镜检查(POSE)评分系统。
接受最大程度药物治疗失败且计划接受ESS的患者符合本研究条件。参与者被随机分为术前5天和术后9天接受30mg泼尼松或安慰剂治疗。使用Lund-McKay分期系统(包括其鼻窦症状问卷)收集手术和基线临床数据,以及关于黏膜健康、手术技术难度的额外数据,并用Lund-Kennedy内镜评分(LKES)和POSE量表收集内镜数据。术后2周、1个月、3个月和6个月也收集数据。计算得出样本量为24,以检测组间40%的临床相关差异。由于进行了多次比较,因此进行了常规统计比较,并采用Bonferroni校正的重复测量方差分析。为实现次要目的,还使用POSE仪器在所有术后时间点收集数据,该仪器旨在提高表面效度和对变化的反应性。对POSE和LKES进行了比较,包括对变化的敏感性评估、两个量表之间的相关性以及与症状评分的相关性。
26名患者参与了本研究。手术数据显示,未接受全身类固醇预处理的患者中,鼻窦黏膜严重炎症的百分比显著更高,据手术医生估计,这与手术技术难度更大有关。在术后症状方面,治疗组之间没有差异,安慰剂组和泼尼松组在术后4周内均较基线有显著改善。术后对患者的内镜评估显示出治疗效果(P <.05),与基线相比,接受泼尼松治疗的患者术后6个月鼻窦腔在临床上更健康(P <.001),尽管在2周时间点效果最强。在比较两个内镜量表时,POSE和LKES在绝对评分和评分变化方面均高度相关(R > 0.70;P <.001)。有证据表明,POSE评分可能比LKES对变化更敏感,并且POSE评分与症状评分的相关性比LKES更强,尽管两个内镜评分与症状评分的相关性都较弱。
本研究中的数据支持对接受CRSwP的ESS患者术前使用全身类固醇的做法。此外,对于在ESS术后提供强化护理(包括根据内镜检查结果进行清创和药物治疗)的外科医生来说,有证据支持在术后使用全身类固醇。POSE评分系统与LKES相比具有优势,可能在表面效度/内容效度和对变化的反应性方面具有优势,值得进一步验证。