Dixon Anne E, Castro Mario, Cohen Rubin I, Gerald Lynn B, Holbrook Janet T, Irvin Charles G, Mohapatra Shyam, Peters Stephen P, Rayapudi Sobharani, Sugar Elizabeth A, Wise Robert A
Department of Medicine, University of Vermont, Burlington, Vt.
Department of Medicine, Washington University School of Medicine, St Louis, Mo.
J Allergy Clin Immunol. 2015 Mar;135(3):701-9.e5. doi: 10.1016/j.jaci.2014.06.038. Epub 2014 Aug 28.
Chronic sinonasal disease is common in asthmatic patients and associated with poor asthma control; however, there are no long-term trials addressing whether chronic treatment of sinonasal disease improves asthma control.
We sought to determine whether treatment of chronic sinonasal disease with nasal corticosteroids improves asthma control, as measured by the Childhood Asthma Control Test and Asthma Control Test in children and adults, respectively.
A 24-week multicenter, randomized, placebo-controlled, double-blind trial of placebo versus nasal mometasone in adults and children with inadequately controlled asthma was performed. Treatments were randomly assigned, with concealment of allocation.
Two hundred thirty-seven adults and 151 children were randomized to nasal mometasone versus placebo, and 319 participants completed the study. There was no difference in the Childhood Asthma Control Test score (difference in change with mometasone - change with placebo [ΔM - ΔP], -0.38; 95% CI, -2.19 to 1.44; P = .68; age 6-11 years) or the Asthma Control Test score (ΔM - ΔP, 0.51; 95% CI, -0.46 to 1.48; P = .30; age ≥12 years) in those assigned to mometasone versus placebo. In children and adolescents (age 6-17 years) there was no difference in asthma or sinus symptoms but a decrease in episodes of poorly controlled asthma defined by a decrease in peak flow. In adults there was a small difference in asthma symptoms measured by using the Asthma Symptom Utility Index (ΔM - ΔP, 0.06; 95% CI, 0.01 to 0.11; P < .01) and in nasal symptoms (sinus symptom score ΔM - ΔP, -3.82; 95% CI, -7.19 to -0.45; P = .03) but no difference in asthma quality of life, lung function, or episodes of poorly controlled asthma in adults assigned to mometasone versus placebo.
Treatment of chronic sinonasal disease with nasal corticosteroids for 24 weeks does not improve asthma control. Treatment of sinonasal disease in asthmatic patients should be determined by the need to treat sinonasal disease rather than to improve asthma control.
慢性鼻-鼻窦炎在哮喘患者中很常见,且与哮喘控制不佳有关;然而,尚无长期试验探讨慢性鼻-鼻窦炎的治疗是否能改善哮喘控制。
我们试图确定用鼻用糖皮质激素治疗慢性鼻-鼻窦炎是否能改善哮喘控制,分别通过儿童哮喘控制测试和成人哮喘控制测试来衡量。
对哮喘控制不佳的成人和儿童进行了一项为期24周的多中心、随机、安慰剂对照、双盲试验,比较安慰剂与鼻用莫米松。治疗随机分配,分配过程保密。
237名成人和151名儿童被随机分为鼻用莫米松组和安慰剂组,319名参与者完成了研究。在6至11岁的儿童中,接受莫米松治疗与接受安慰剂治疗的儿童哮喘控制测试得分没有差异(莫米松组变化值 - 安慰剂组变化值[ΔM - ΔP],-0.38;95%置信区间,-2.19至1.44;P = 0.68);在12岁及以上的成人中,哮喘控制测试得分也没有差异(ΔM - ΔP,0.51;95%置信区间,-0.46至1.48;P = 0.30)。在儿童和青少年(6至17岁)中,哮喘或鼻窦症状没有差异,但通过峰流速降低定义的哮喘控制不佳发作次数减少。在成人中,使用哮喘症状效用指数测量的哮喘症状有微小差异(ΔM - ΔP,0.06;95%置信区间,0.01至0.11;P < 0.01),鼻窦症状也有差异(鼻窦症状评分ΔM - ΔP,-3.82;95%置信区间,-7.19至-0.45;P = 0.03),但在接受莫米松治疗与接受安慰剂治疗的成人中,哮喘生活质量、肺功能或哮喘控制不佳发作次数没有差异。
用鼻用糖皮质激素治疗慢性鼻-鼻窦炎24周并不能改善哮喘控制。哮喘患者鼻-鼻窦炎的治疗应根据治疗鼻-鼻窦炎的需要来决定,而不是为了改善哮喘控制。