Rowe-Jones Julian M, Medcalf Mark, Durham Stephen R, Richards David H, Mackay Ian S
Otorhinolaryngology - Head & Neck / Facial Plastic Surgery Department, Royal Surrey County Hospital, Guildford, United Kingdom.
Rhinology. 2005 Mar;43(1):2-10.
One hundred nine patients with chronic rhinosinusitis underwent functional endoscopic sinus surgery. Seventy seven patients had polyposis. The population was studied prospectively for 5 years postoperatively. Seventy two patients attended the 5 year follow-up visit. At 1, 2, 3, 4 and 5 years of follow-up all outcome measures except olfactory detection thresholds (visual analogue scores, endoscopic findings, nasal mucociliary clearance times, total nasal volumes) were significantly improved compared to preoperative baseline values. Olfactory detection thresholds were significantly improved at 1 and 2 years postoperation. Patient symptom scores were improved in a greater percentage of patients than more objective outcome measures. Thirty eight patients required a total of 88 postoperative rescue medication courses with prednisolone and antibiotic. Twelve patients failed the study as they required at least 1 rescue medication course a month for 2 consecutive months. We demonstrated an 89% 5 year "survival" rate with regards to the risk of failure. The patients were also entered into a randomised, stratified, prospective, double-blind, placebo controlled study of fluticasone propionate aqueous nasal spray 200 mcg twice daily, commencing 6 weeks after FESS, with a 5 year follow-up. The change in overall visual analogue score was significantly better in the FPANS group at 5 years. The changes in endoscopic oedema and polyp scores and in total nasal volumes were significantly better in the FPANS group at 4 years but not 5 years. Last value carried forward analysis demonstrated that changes in endoscopic polyp score and in total nasal volume was significantly better in the FPANS group at 5 years. Significantly more prednisolone rescue medication courses were prescribed in the placebo group. Of the 12 patients who failed the study, 10 were in the placebo group. This difference nearly achieved significance.
109例慢性鼻窦炎患者接受了功能性鼻内镜鼻窦手术。77例患者患有鼻息肉病。对该人群进行了术后5年的前瞻性研究。72例患者参加了5年随访。在随访的1、2、3、4和5年时，与术前基线值相比，除嗅觉检测阈值外的所有结局指标（视觉模拟评分、内镜检查结果、鼻黏膜纤毛清除时间、总鼻腔容积）均有显著改善。嗅觉检测阈值在术后1年和2年时有显著改善。与更客观的结局指标相比，更多患者的症状评分得到了改善。38例患者术后共需要88个疗程的泼尼松龙和抗生素救援药物。12例患者退出研究，因为他们连续2个月每月至少需要1个疗程的救援药物。关于失败风险，我们证明了5年“生存率”为89%。患者还进入了一项随机、分层、前瞻性、双盲、安慰剂对照研究，即每天两次使用200微克丙酸氟替卡松水鼻喷雾剂，在功能性鼻内镜鼻窦手术后6周开始，随访5年。5年后，丙酸氟替卡松水鼻喷雾剂组的总体视觉模拟评分变化明显更好。4年后，丙酸氟替卡松水鼻喷雾剂组在内镜下水肿和息肉评分以及总鼻腔容积方面的变化明显更好，但5年后并非如此。末次观察值结转分析表明，5年后丙酸氟替卡松水鼻喷雾剂组在内镜下息肉评分和总鼻腔容积方面的变化明显更好。安慰剂组开出的泼尼松龙救援药物疗程明显更多。在退出研究的12例患者中，10例在安慰剂组。这种差异几乎达到了显著性。
