Preemptive Use of High-Dose Fluticasone for Virus-Induced Wheezing in Young Children.
Preemptive Use of High-Dose Fluticasone for Virus-Induced Wheezing in Young Children.
复制标题
DOI：
10.1056/nejmoa0808907
复制
发表时间：
2009-01-22
影响因子：
158.5
通讯作者：
Platt, Robert W.
中科院分区：
文献类型：
--
作者：
Ducharme, Francine M.;Lemire, Chantal;Platt, Robert W.
背景：尽管病毒引起的喘息在学龄前儿童中很常见，但最佳的治疗方法仍然难以实现。方法：我们随机将129名1~6岁的儿童随机分成两组，每天服用750微克的丙酸氟替卡松(非瓣膜外剂量)或安慰剂，从上呼吸道感染开始，持续最多10天，持续6至12个月。主要结果是抢救性口服皮质类固醇的使用。次要结果包括症状、(β)(亚2)激动剂的使用、急性护理访问、住院、停止研究药物、生长和骨密度的变化、基础皮质醇水平以及不良事件。结果：在40周的中位数期间，氟替卡松组8%的上呼吸道感染导致救治全身皮质类固醇治疗，而安慰剂组为18%(优势比0.49；95%可信区间[CI]0.30至0.83)。与服用安慰剂的儿童相比，接受氟替卡松治疗的儿童身高平均(+/-SD)增加较小(6.23+/-2.62 cm[未调整值]；z评分，-0.19+/-0.42对6.56+/-2.90 cm[未调整值]；z评分，0.00+/-0.48；两组之间从基线到终点的z得分差异-0.24[95%CI，-0.40至-0.08]，以及体重(1.53+/-1.17公斤[未调整值]；z得分，-0.15+/-0.48比2.17+/-1.79公斤[未调整值]；z得分，0.11+/-0.43；从基线到终点的z得分差异，-0.26[95%CI，-0.41至-0.09])。两组在基础皮质醇水平、骨密度和不良事件方面无显著差异。结论：在中重度病毒诱发喘息的学龄前儿童中，与安慰剂相比，大剂量氟替卡松预防性治疗减少了抢救性口服皮质类固醇的使用。氟替卡松治疗与较小的身高和体重增加相关。考虑到过度使用的可能性，在明确长期不良反应之前，不应在临床实践中采用这种预防性方法。
Background: Although virus-induced wheezing is common in preschool-age children, optimal management remains elusive. We examined the efficacy and safety of preemptive treatment with high-dose fluticasone in reducing the severity of recurrent virus-induced wheezing in children.Methods: We randomly assigned 129 children who were 1 to 6 years of age to receive 750 microg of fluticasone propionate (ex-valve [manufacturer-measured] dose) or placebo twice daily, beginning at the onset of an upper respiratory tract infection and continuing for a maximum of 10 days, over a period of 6 to 12 months. The primary outcome was rescue oral corticosteroid use. Secondary outcomes included symptoms, use of (beta)(sub 2)-agonists, acute care visits, hospitalizations, discontinuation of the study drug, change in growth and bone mineral density, basal cortisol level, and adverse events.Results: Over a median period of 40 weeks, 8% of upper respiratory tract infections in the fluticasone group led to treatment with rescue systemic corticosteroids, as compared with 18% in the placebo group (odds ratio, 0.49; 95% confidence interval [CI], 0.30 to 0.83). Children who were treated with fluticasone, as compared with those who were given placebo, had smaller mean (+/-SD) gains from baseline in height (6.23+/-2.62 cm [unadjusted value]; z score, -0.19 +/-0.42 vs. 6.56+/-2.90 cm [unadjusted value]; z score, 0.00+/-0.48; difference between groups in z score from baseline to end point, -0.24 [95% CI, -0.40 to -0.08]) and in weight (1.53+/-1.17 kg [unadjusted value]; z score, -0.15+/-0.48 vs. 2.17+/-1.79 kg [unadjusted value]; z score, 0.11+/-0.43; difference between groups in z score from baseline to end point, -0.26 [95% CI, -0.41 to -0.09]). There were no significant differences between the groups in basal cortisol level, bone mineral density, or adverse events.Conclusions: In preschool-age children with moderate-to-severe virus-induced wheezing, preemptive treatment with high-dose fluticasone as compared with placebo reduced the use of rescue oral corticosteroids. Treatment with fluticasone was associated with a smaller gain in height and weight. Given the potential for overuse, this preventive approach should not be adopted in clinical practice until long-term adverse effects are clarified.