论文部分内容阅读
背景每日吸入皮质类固醇为轻度持续性哮喘的有效治疗,有些儿童即便每天用药控制也发生了病情加重,有许多症状消失后停药。我们对吸入性皮质类固醇二丙酸倍氯米松作为救治用药的有效性做了评估。方法历经44周,随机双盲、安慰剂对照研究,入选者:美国5个临床中心、年龄5～18岁、患轻度持续性哮喘的儿童和青少年。采用计算机生成随机序列,按临床中心及年龄组分层,将入选者随机分入4个治疗组:2次/d倍氯米松,救治时倍氯米松加沙丁胺醇(联合治疗组);2次/d倍氯米松,救治时安慰剂加沙丁胺醇(每日用倍氯米松组);2次/d安慰剂,救治时倍氯米松加沙丁胺醇(救治时用倍氯米松组);2次/d安慰剂,救治时安慰剂加沙丁胺醇(安慰剂组)。2次/d倍氯米松治疗为倍氯米松(40μg/喷)或安慰剂早晚各1喷。救治用倍氯米松为沙丁胺醇2喷(180μg)、倍氯米松或安慰剂2喷以缓解症状。主要结果为因症状加重首次需用口服皮质激素时间;次级结果测量为线性增长。分析治疗意向。结果本研究入选者为儿童及青少年843例,其中288例分入4个治疗组中:联合组(n=71)、每日用倍氯米松组(n=72)、救治用倍氯米松组(n=71)、安慰剂组(n=74),在非正式入选期间555例被排除。根据预定标准,与安慰剂组[49%,95%CI(37,61)]比较,每日[28%,95%CI(18,40),P=0.03]、联合组[31%,95%CI(21,43),P=0.07]、救治组[35%,(24,47),P=0.07]加重频率要低。与5.6%(1.6,14)联合(P=0.012)、2.8%(0,10)每日(P=0.009)及8.5%(2,15)救治组(P=0.024)比较,治疗失败的频率安慰剂23%[95%CI(14,43)]。与安慰剂组比较,联合治疗和每日线性增长要低1.1 cm(SD 0.3)(P<0.0001),而不含救治组(P=0.26)。仅有2例出现了严重负性事件;每日用倍氯米松组有1例患病毒性脑膜炎;联合组有1例患支气管炎。解释儿童轻度持续性哮喘救治时不能只用沙丁胺醇,为了防止病情恶化,每日吸入皮质类固醇为最有效的治疗。吸入性皮质类固醇作为救治时用药,与沙丁胺醇共用为控制轻度持续性哮喘儿童病情的有效缓解策略,与救治时仅用沙丁胺醇比较,其能更有效地减少恶化。可避免每日用吸入皮质类固醇治疗及诸如像生长障碍相关的副作用。
Background Daily inhaled corticosteroids are an effective treatment for mild persistent asthma. Some children experience exacerbations even after daily medication control and many have discontinued symptoms. We evaluated the effectiveness of inhaled corticosteroid beclomethasone dipropionate as a rescue medication. Methods Forty-eight weeks of randomized double-blind, placebo-controlled study enrolled: 5 US clinical centers, 5 to 18 years old, children and adolescents with mild persistent asthma. The randomized sequences were generated by computer. According to the clinical centers and age groups, the patients were randomly divided into four treatment groups: twice a day for beclometasone, beclometasone plus salbutamol for treatment (combination therapy group), twice / d Beclomethasone, placebo plus salbutamol at rescue (daily with beclomethasone); twice daily at placebo with beclometasone plus salbutamol when treated with beclometasone; and twice daily with comfort Agents were given placebo plus salbutamol (placebo). 2 times / d beclomethasone treatment of beclometasone (40μg / spray) or placebo morning and evening 1 spray. Salvia miltiorrhiza was treated with 2-spray salbutamol (180 μg), and beclometasone or placebo 2-spray to relieve the symptoms. The primary outcome was the first oral corticosteroid time required due to the worsening of symptoms; the secondary outcome was measured as linear growth. Analysis of treatment intentions. RESULTS: A total of 843 children and adolescents were enrolled in this study, of which 288 were assigned to 4 treatment groups: the combination group (n = 71), the daily beclomethasone group (n = 72) (n = 71) and placebo (n = 74), 555 were excluded during the informal enrollment. [28%, 95% CI (18, 40), P = 0.03], combination group [31%, 95%, 95% CI % CI (21,43), P = 0.07], and the treatment group [35%, (24,47), P = 0.07]. The frequency of treatment failure compared with 5.6% (1.6,14) (P = 0.012), 2.8% (0,10) daily (P = 0.009) and 8.5% (2,15) Placebo 23% [95% CI (14,43)]. Compared with the placebo group, combination therapy and daily linear growth was 1.1 cm (SD 0.3) lower (P <0.0001) than the placebo group (P 0.26). Only 2 patients experienced a serious negative event; 1 patient had viral meningitis in the daily beclometasone group and 1 patient had bronchitis in the combined group. Interpretation of children with mild persistent asthma treatment can not only use salbutamol, in order to prevent the deterioration of the daily inhalation of corticosteroids is the most effective treatment. Inhaled corticosteroids as a treatment medication, and salbutamol to control mild persistent asthma in children with effective mitigation strategies, compared with salvage alone salvage alone, it can more effectively reduce the deterioration. Daily inhaled corticosteroid therapy and side effects such as growth disorders can be avoided.