鼻腔局部应用类固醇药物治疗慢性鼻窦炎/鼻息肉和变应性鼻炎的安全性系统评价

Systematic Review of the Safety of Steroids for Chronic Sinusitis/Nasal Polyps and Allergic Rhinitis

目的 系统评价鼻腔局部应用二丙氯米松、布地奈德、丙酸氟替卡松、莫米松对成人、儿童的安全性。方法 全面系统收集全世界有关鼻腔局部应用皮质类固醇药物的安全性的随机对照试验。按纳入、排除标准纳入合格的研究。两个研究者独立对纳入文献进行质量评价。资料统计分析用RevMan 4 .2软件。结果 共纳入 7篇随机对照研究 ,共 82 6例。与二丙氯米松比较 ,成人局部使用丙酸氟替卡松发生急性鼻窦炎、鼻出血的危险性增加 ,但无统计学差异其值分别为OR 16 18,95 %CI (0 87,30 1 6 2 )和OR 7 76 ,95 %CI (0 38,15 7 14 )。治疗组和对照组均未发现鼻腔粘膜萎缩。成人局部使用布地奈德与安慰剂比较 ,鼻干、鼻出血的危险性增加 ,但无统计学意义 ,其值分别为OR 3 38,95 %CI (0 6 6 ,17 8)和OR 2 2 0 ,95 %CI (0 39,12 32 )。与Pollinex R比较 ,成人局部使用布地奈德头痛的危险性增加 ,但无统计学意义 [OR 1 71,95 %CI (0 5 2 ,5 6 2 ) ]。与安慰剂比较 ,儿童使用丙酸氟替卡松 ,出现鼻出血、头痛的危险性降低 ,但无统计学差异 ,其值分别为OR 0 85 ,95 %CI (0 2 0 ,3 6 6 )和OR 0 2 5 ,95 %CI (0 0 2 ,2 83) ;血浆中皮质类固醇浓度降低的危险性增加 ,但无统计学意义 [OR 1 5 6 ,95 %CI (0 0 6 。

Objective To evaluate the safety of intranasal use of beclomethasone dipropionate, budesonide, fluticasone propionate and mometasone for adults and children with chronic sinusitis/nasal polyps and allergic rhinitis. Methods Randomized controlled trials were located. Study quality was evaluated by two researchers independently. RevMan 4.2 was used for meta-analysis. Results Seven RCTs involving 826 patients were included. Compared with placebo, local use of fluticasone proprionate in adults showed no statistically significant trend to increase incidence of acute sinusitis (OR 16.87, 95% CI 0.87 to 301.62), but no significant difference was seen for epistaxis (OR 7.76, 95% CI 0.38 to 157.14): 1 trial, 60 patients. In another trial, no cases of nasal atrophy were reported in either fluticasone or placebo groups. No significant differences were seen between local use of budesonide and placebo in adults for dryness of nasal mucosa (OR 3.38, 95%CI 0.66 to 17.18) and epistaxis (OR 2.20, 95%CI 0.39 to 12.32) : 1 trial, 193 participantions. No significant difference was seen between budesonide and pollinex for headache (OR 1.71, 95%CI 0.52 to 5.62). No differences were seen between placebo and fluticasone propionate in children for epistaxis (OR 0.85, 95%CI 0.20 to 3.66), headache (OR 0.25, 95%CI 0.02 to 2.83), plasma cortisol concentration (OR 1.56, 95%CI 0.06 to 38.69) and dryness of nasal mucosa (OR 4.76, 95%CI 0.25 to 89.54). Beclomethasone dipropionate in children showed no statistical differences for dryness of nasal mucosa (OR 0.51, 95%CI 0.14 to 1.87), epistaxis (OR 0.68, 95%CI 0.26 to 1.73) and rhinitis (OR 0.47, 95%CI 0.04 to 5.36). No decrease of plasma cortisol concentration was detected in either group. Mometasone and placebo showed no significant differences in children for epistaxis (OR 1.57, 95%CI 0.41 to 5.95), rhinitis (OR 0.33, 95%CI 0.01 to 8.22) or headache (OR 0.33, 95%CI 0.01 to 8.22). Decrease of plasma cortisol concentration was not detected. Conclusions According to this systematic review, long term intranasal use of steroid for adults and children may be safe based on the two high quality, four moderate quality trials and one with strong bias. High quality studies with larger sample sizes and in other languages are needed to provide stronger evidence.