Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, Egypt.
Pediatrics Department, Faculty of Medicine, Tanta University, Tanta, Egypt.
Eur J Hosp Pharm. 2020 May;27(3):151-156. doi: 10.1136/ejhpharm-2018-001707. Epub 2018 Nov 10.
Asthma is one of the most prevalent chronic respiratory diseases, which often leads to an emergency department visit. Prednisolone is the most commonly used corticosteroid in treatment of asthma exacerbation. Oral dexamethasone demonstrates bioavailability similar to that of oral prednisolone but has a longer half-life.
To evaluate in adouble-blind, randomised clinical trial the efficacy of different doses of dexamethasone versus prednisolone in controlling asthma exacerbations in children.
We recruited 60 patients with asthma exacerbation, aged 2-11 years. Participants were randomly divided into three groups (20 patients each). Group I received a single dose of oral dexamethasone 0.3 mg/kg (maximum 12 mg), group II received 0.6 mg/kg/day of oral dexamethasone for 2 days (maximum 16 mg/day) and group III received 1.5 mg/kg/day oral prednisolone for 5 days (maximum 60 mg/day). Our primary outcomes were changes in Paediatric Respiratory Assessment Measure (PRAM), eosinophilic count and serum immunoglobulin E on day 5. Secondary endpoints were reporting any adverse effects and relapse rate during the 5 days. After 30 days, the Asthma Therapy Assessment Questionnaire (ATAQ) was given to the parents of the recruited patients.
Among the three study groups, there was a highly statistically significant difference in IgE level, saturated oxygen, peak expiratory flow, forced expiratory volume in 1 s/forced vital capacity, PRAM and Modified Pulmonary Index Score; however, the eosinophilic count was significantly lower within the same group. Vomiting, gastrointestinal tract cramps, ATAQ and relapse rate showed a non-statistically significant difference.
Single-dose dexamethasone was at least as effective as 5-day course of prednisolone in controlling asthma, while dexamethasone for 2 days was non-inferior to 5 days of prednisolone in children with asthma exacerbation.
哮喘是最常见的慢性呼吸道疾病之一,常导致患者前往急诊部就诊。在哮喘加重的治疗中,泼尼松龙是最常使用的皮质类固醇。口服地塞米松的生物利用度与口服泼尼松龙相似,但半衰期更长。
在一项双盲、随机临床试验中评估不同剂量的地塞米松与泼尼松龙治疗儿童哮喘加重的疗效。
我们招募了 60 名哮喘加重的患者,年龄在 2-11 岁之间。参与者被随机分为三组(每组 20 名患者)。第 I 组接受单次口服地塞米松 0.3mg/kg(最大剂量 12mg),第 II 组接受 0.6mg/kg/天的口服地塞米松治疗 2 天(最大剂量 16mg/天),第 III 组接受 1.5mg/kg/天的口服泼尼松龙治疗 5 天(最大剂量 60mg/天)。我们的主要结局是第 5 天 Paediatric Respiratory Assessment Measure(PRAM)、嗜酸性粒细胞计数和血清免疫球蛋白 E 的变化。次要终点是报告 5 天内的任何不良反应和复发率。30 天后,给招募患者的家长发放哮喘治疗评估问卷(ATAQ)。
在三组研究中,IgE 水平、血氧饱和度、呼气峰流速、用力呼气 1 秒/用力肺活量、PRAM 和改良肺指数评分有高度统计学意义的差异;然而,同一组的嗜酸性粒细胞计数明显较低。呕吐、胃肠道痉挛、ATAQ 和复发率差异无统计学意义。
单次剂量地塞米松在控制哮喘方面至少与 5 天泼尼松龙疗程一样有效,而地塞米松治疗 2 天与泼尼松龙治疗 5 天在儿童哮喘加重中无差异。