Ige O M, Sogaolu O M
Department of Medicine, College of Medicine, University of Ibadan, Ibadan, Nigeria.
Afr J Med Med Sci. 2004 Jun;33(2):155-60.
The study compared clinical efficacy and safety of beclomethasone dipropionate (BDP) given at a dose of 400microg in the mornings and evenings and delivered via pressurised metered dose inhaler (pMDI) with budesonide given via a dry-powder, inspiratory flow driven device at a daily dose of 400microg in the evening. The study was conducted as a week screening. 8-week open comparative clinical trial. At the commencement of the therapy, the baseline characteristics of the patients randomised into the two drug groups were comparable. Efficacy was assessed by changes in symptoms, number of times beta2-agonist was used and results of pulmonary function tests (PEF and FEV1) while safety was assessed by adverse event experiences. At the end of the study, 24 patients (12 in each group) were evaluated. Both drugs were effective in reducing asthma symptoms and frequency of beta2-agonist usage, as well as improving the lung function tests (FEV1 and PEF). However, budesonide given via Turbuhaler provided better effects in all parameters. The drugs were well tolerated and no adverse event was noticed in any of the patients. We therefore concluded that budesonide Turbuhaler administered once daily at a dose of 400microg is more efficacious than beclomethasone 400microg twice daily administered via pressurized metered dose inhaler.
该研究比较了丙酸倍氯米松(BDP)每日早晚各400微克通过压力定量吸入器(pMDI)给药与布地奈德每日晚上通过干粉吸入、气流驱动装置给药400微克的临床疗效和安全性。该研究作为一周筛选、为期8周的开放对比临床试验进行。在治疗开始时,随机分为两个药物组的患者的基线特征具有可比性。通过症状变化、β2受体激动剂使用次数以及肺功能测试结果(呼气峰流速和第一秒用力呼气容积)评估疗效,通过不良事件经历评估安全性。在研究结束时,对24名患者(每组12名)进行了评估。两种药物在减轻哮喘症状、减少β2受体激动剂使用频率以及改善肺功能测试(第一秒用力呼气容积和呼气峰流速)方面均有效。然而,通过都保吸入器给药的布地奈德在所有参数上效果更好。这些药物耐受性良好,所有患者均未出现不良事件。因此,我们得出结论,每日一次给予400微克的布地奈德都保吸入器比每日两次通过压力定量吸入器给予400微克的丙酸倍氯米松更有效。