Volovitz B, Soferman R, Blau H, Nussinovitch M, Varsano I
Department of Pediatrics C, Schneider Children's Medical Center of Israel, Petah Tikva.
J Allergy Clin Immunol. 1998 Apr;101(4 Pt 1):464-9. doi: 10.1016/S0091-6749(98)70405-1.
There are no data currently available on the correct schedule for the initiation of treatment with nebulized suspension of budesonide in children with recurrent wheezing episodes. We compared the efficacy and safety of starting with a high dose followed by a stepwise decrease to a continuous low dose.
In a double-blind design, 42 children aged 6 months to 3 years were randomly allocated to receive either a high starting dose of 1 mg budesonide twice daily followed by a stepwise decrease of 25% every second day for 1 week (group A) or a low dose of 0.25 mg twice daily for 1 week (group B). Efficacy was assessed with daily symptom scores and the systemic effect of the corticosteroids with the adrenocorticotropic hormone test.
The two groups were comparable for all parameters evaluated. During the first week of treatment, there was a significant decrease in asthmatic symptomatology only in group A: a 59% decrease for wheezing (p = 0.0001), 39% for diurnal cough (p = 0.036), and 39% for nocturnal cough (p = 0.04). Mean time to clinical response was 3.0 days in group A and 5.7 days in group B (p = 0.02). This early improvement was sustained for the rest of the follow-up period. The high dose starting schedule was not associated with any change in serum cortisol level.
The administration of nebulized suspension of budesonide at a high starting dose schedule followed by a rapid (1 week) stepwise decrease yields a significant early improvement in asthma symptoms and causes no change in serum cortisol levels.
目前尚无关于复发性喘息发作儿童使用布地奈德雾化混悬液开始治疗的正确疗程的数据。我们比较了先采用高剂量随后逐步减量至持续低剂量的疗效和安全性。
采用双盲设计，将42名6个月至3岁的儿童随机分配，一组接受布地奈德起始高剂量每日两次，每次1毫克，随后每隔一天逐步减量25%，持续1周（A组），另一组接受低剂量每日两次，每次0.25毫克，持续1周（B组）。通过每日症状评分评估疗效，并通过促肾上腺皮质激素试验评估皮质类固醇的全身效应。
两组在所有评估参数方面具有可比性。在治疗的第一周，仅A组哮喘症状有显著减轻：喘息减轻59%（p = 0.0001），日间咳嗽减轻39%（p = 0.036），夜间咳嗽减轻39%（p = 0.04）。A组临床反应的平均时间为3.0天，B组为5.7天（p = 0.02）。这种早期改善在随访期的其余时间持续存在。高剂量起始方案与血清皮质醇水平的任何变化均无关。
以高剂量起始方案给予布地奈德雾化混悬液，随后快速（1周）逐步减量，可使哮喘症状在早期得到显著改善，且血清皮质醇水平无变化。
