- 期刊
Prednisolone Oral Solution plus Inhaled Procaterol for Acute Asthma in Children: A double-blind Randomized Controlled trial
Prednisolone口服水劑併用吸入式Procaterol治療急性氣喘病童：一雙盲隨機對照試驗
摘要
背景：爲了瞭解在急性氣喘發作之病童，合併使用類固醇水劑與吸入式procaterol是否可有效緩解症狀。 方法：本文收集了四十三位六至十二歲之氣喘急性發作病童並以雙盲隨機對照之方式將之分爲二組，一組給予類固醇水劑加上錠劑安慰劑，另一組給予類固醇錠劑加上水劑安慰劑一共治療七天，兩組皆合併每天使用吸入式procaterol。比較前後的尖峰吐氣流速值、肺功能、肺部指數分數、症狀分數及試驗主持人和病人及家屬的整體評估。 結果：兩組的尖峰吐氣流速值在治療前後均有顯著增加但治療前後的變化在兩親間沒有差異（57.27±31.44L/min及54.29±30.04L/min，差異2.99±30.76L/min，平均值土標準差，P=0.752）。另外在肺部指數分數及症狀分數方面兩組均有顯著進步但治療前後的變化沒有組間差異（P=0.091及0.827）。肺功能含FEVI, FEV1/FVC, FEF25-75%也都有明顯改善但治療前後的變化在兩組間亦無差異(P=0.162, 0.48, 0.081)。在試驗主持人和病人及家屬的整體評估上也都有相當程度的緩解。 結論：在治療急性氣喘發作病童上，使用Prednisolone sodium phosphate水劑合併吸入式procaterol和錠劑合併吸入式procaterol的療效相似。
並列摘要
Background: To evaluate the efficacy of prednisolone sodium phosphate oral solution plus inhaled procaterol in the treatment of acute asthma in children. Methods: Forty-three patients aged 6 to 12 years with an acute exacerbation of asthma were double-blind randomized into one of two treatment groups in a 1:1 ratio:1) prednisolone oral solution placebo tablets procaterol MDI or 2) prednisolone tablets placebo oral solution procaterol MDI, all given three times daily for 7 days. Peak expiratory flow rate (PEFR), 24-hour reflective asthma symptom scores, spirometry and pulmonary index score (PIS) were recorded before and after treatment. Net changes in PEFR, symptom score, PIS, Forced Expiratory Volume in the first second (FEV1), FEV1/forced vital capacity (FVC), forced expiratory flow between 25 and 75 percent of the forced vital capacity (FEF(subscript 25-75%)) (before and after treatment) and global assessment by the investigator and the subjects or their parents were analyzed. Results: The two groups were statistically similar at baseline values of these parameters. After a 7-day course of treatment, the net change of PEFR before and after treatment was significantly improved in both groups, but there was no significant difference in the net change of PEFR between the two groups (57.27 ±31.44 L/min vs. 54.29±30.04 L/min, difference 2.99±30.76L/min, mean SD, P=0.752). The net change in PIS and total symptom score did not differ between the two groups (P=0.091 and 0.827, respectively). Similarly, the FEV1, FEV1/FVC and FEF25-75% all improved with either treatment, and neither group was significantly superior to the other group (P=0.162, 0.48 and 0.081, respectively). Global assessment by the investigator and the subjects or their parents at the end of study indicated an essentially comparable result. Conclusions: Prednisolone sodium phosphate oral solution plus inhaled procaterol is as efficacious as prednisolone tablets plus inhaled procaterol in the management of acute asthma in children.