Willey R F, Godden D J, Carmichael J, Preston P, Frame M H, Crompton G K
Eur J Respir Dis Suppl. 1982;122:138-42.
The efficacy and side-effects of a new corticosteroid, budesonide, was assessed by comparison with beclomethasone dipropionate in double-blind, cross-over study of 30 patients with chronic asthma. The treatment regimens were budesonide 200 micrograms twice daily by conventional pressurized aerosol with a tube spacer attached and beclomethasone 100 micrograms four times daily via a conventional inhaler. Each treatment was given for four weeks. Results were analyzed using Student's t-test for paired comparisons. No significant differences were found for morning and evening peak flow rates, symptom scores, bronchodilator inhaler usage or forced vital capacity. Forced expiratory volume in one second after 4 weeks on each treatment was significantly higher following budesonide therapy (p less than 0.05), but the absolute changes were small and unlikely to be of clinical relevance. There were no major side-effects during either treatment period, but compared with pre-treatment levels serum creatinine and lactic dehydrogenase levels rose significantly during treatment with budesonide (p less than 0.01 and p less than 0.05 respectively). None of these results reflected clinically important biochemical or haematological changes. There was a significant reduction in neutrophil counts following treatment with beclomethasone (p less than 0.05). In the short term treatment of chronic asthma, budesonide administered twice daily is as effective as four times daily beclomethasone. A twice daily dosage regimen should improve patient compliance with therapy.
在一项针对30例慢性哮喘患者的双盲交叉研究中,通过与二丙酸倍氯米松比较,评估了一种新型皮质类固醇布地奈德的疗效和副作用。治疗方案为:使用带储雾罐的传统压力定量气雾剂,布地奈德每日两次,每次200微克;通过传统吸入器,二丙酸倍氯米松每日四次,每次100微克。每种治疗均持续四周。使用配对比较的学生t检验分析结果。早晚峰值流速、症状评分、支气管扩张剂吸入器使用情况或用力肺活量均未发现显著差异。每种治疗4周后,布地奈德治疗后的一秒用力呼气量显著更高(p<0.05),但绝对变化很小,不太可能具有临床意义。两个治疗期间均未出现重大副作用,但与治疗前水平相比,布地奈德治疗期间血清肌酐和乳酸脱氢酶水平显著升高(分别为p<0.01和p<0.05)。这些结果均未反映出具有临床重要意义的生化或血液学变化。二丙酸倍氯米松治疗后中性粒细胞计数显著降低(p<0.05)。在慢性哮喘的短期治疗中,布地奈德每日两次给药与二丙酸倍氯米松每日四次给药效果相同。每日两次的给药方案应能提高患者的治疗依从性。