- 期刊
Double-blind Placebo-controlled Study of Oxatomide in the Treatment of Childhood Asthma
Oxatomide在氣喘兒童之臨床評估
摘要
Oxatomide是口服的第一型組織胺拮抗劑，過去曾用於成人過敏性疾病之預防及治療，本研究是採雙盲試驗以及以安慰劑爲對照組做比較，以探討Oxatomide在改善兒童氣喘之療效及其安全性。 64位年齡介於5至16歲之氣喘病童，參與本研究計盡，病童隨意分成使用oxatomide（1-2mg/kg）的治療組或使用安慰劑之對照組兩組，每組各32位病童，利用雙盲試驗進行評估，評估之包括肺功能檢查，免疫、生化、血液檢查及病患臨床症狀評分等，結果顯示，使用oxatomide治療組在改善肺功能以及降低血清之嗜酸性白血球陽離子蛋白（E.C.P.）和改進臨床症狀評分等項較安慰劑組有統計學上之差異。而Total IgE及IgG4等項在統計學上兩組比較並無明顯的差異，肝功能，腎功能及血液學檢查兩組在治療前後亦無明顯之改變。在研究期間分別有2位（5.8%）及1位（2.9%）病童在接受oxatomide治療後，發現有嗜睡及體重增加之現象，但停藥後即消失。 研究的結果顯示，Oxatomide能改善氣喘兒童之肺功能及臨床症狀，同時也是相不安全的小兒氣喘治療藥物。
並列摘要
Oxatomide is an orally active H1-histamine receptor antagonist. It has been demonstrated to have therapeutic efficacy in the treatment of allergic diseases in adults. The aim of this study was to evaluate the efficacy and safety of oxatomide in the treatment of asthma in children. Sixty-four asthmatic children of both sexes, aged between 5 and 16 years, were enrolled in this double-blind, placebo-controlled trial with a duration of 4 months. Patients were randomized chosen to receive either oxatomide with a daily dose of 1 to 2mg/kg body weight or a placebo twice daily. Clinical evaluations including pulmonary function tests and immunological studies. The patients’ impression on the effect of treatment also were recorded during the study. The effects of bronchodilatation and normalizing pulmonary function were observed 2 months after oxatomide treatment. The levels of eosinophil cationic protein and total asthma symptom scores were significantly reduced during treatment with oxatomide. There was no significant change in total IgE or IgG4 before or after treatment in either the treatment or control groups. During the study, two (5.8%) oxatomide treated patients reported slight drowsiness and one (29%) reported body weight gain. Routine laboratory tests showed no significant alterations. In conclusion, oxatomide was generally well tolerated in this study and may have the potential of being an effective treatment for childhood asthma.