异丁司特对类固醇抵抗型变应性鼻炎患者生活质量的影响

Effect of Ibudilast on the quality of life of patients with steroid resistant allergic rhinitis:a randomized,double blind,controlled study

目的观察异丁司特对类固醇抵抗型变应性鼻炎(allergic rhinitis,AR)患者生活质量的影响。方法进行随机、双盲、安慰剂的平行对照研究,应用SF-36生活质量量表(中文版)进行调查。类固醇抵抗型AR患者66例,年龄20～60岁。随机分为2组:异丁司特组34例,男18例,女16例;安慰剂组32例,男17例,女15例。两种药物服用方法均为每天2次,每次2粒(片),共服用21天,于服药前及服药后第7、14、21天记录症状和体征记分,于服药前、服药后第21天采用SF-36量表分别进行生活质量评价,评价内容包含36个项目,主要包括患者自己对功能状态、幸福和健康的评价。结果治疗前两组患者症状记分、生活质量记分差异无统计学意义。服药21天后异丁司特组AR症状和体征明显改善,生活质量明显提高(P均<0.001),安慰剂组未见明显改善。结论异丁司特能有效改善类固醇抵抗型AR患者的临床症状和体征,同时能提高患者的生活质量,安慰剂组虽然也能短时间内改善部分患者症状,但不能提高患者的生活质量记分。

OBJECTIVE To assess the effect of Ibudilast on the quality of life （QOL） of patients with steroid resistant allergic rhinitis. METHODS A randomized, double-blind, placebo-controlled study was carried out with Ibudilast in 66 patients with the steroid resistant allergic rhinitis. QOL was measured with Short-Form Health Survey （SF-36） questionnaire （Chinese version）. Ibudilast （10mg twice daily, 34 patients）, placebo （32 patients） was given for 3 weeks. The SF-36 questionnaire was administered at the start of treatment and after 3 weeks of treatment. Sings and Symptom-medication scores were measured daily during the study. RESULTS There were no significant differences between the Ibudilast and placebo group in terms of sings and symptoms or QOL scores before study. After 3 weeks of treatment, symptoms scores were significantly decreased and QOL scores significantly improved in the Ibudilast group compared with those in placebo group （both P 〈0.001, t test）. All of the 8 QOL dimensions were significantly improved （from P=0.001 to P 〈0.001, F test） after 3 weeks of Ibudilast treatment. There was no improvement in the placebo group. CONCLUSION Ibudilast not only can decrease sign and symptom scores, but also can improve the QOL in patients with steroid resistant allergic rhinitis. Placebo can relieve the signs and symptoms, but can not improve the QOL.