Nankani J N, Northfield M, Beran Y M, Richardson P D
Astra Pharmaceuticals Ltd., Kings Langley, England.
Curr Med Res Opin. 1990;12(3):198-206. doi: 10.1185/03007999009111502.
An open, multi-centre, general practice study was carried out in 1661 asthmatic patients to assess the efficacy, in terms of symptom relief and changes in lifestyle, of budesonide and to record objective lung function changes and any adverse events. After a 1-week run-in period on any pre-trial anti-asthma medication, patients received either 200 micrograms or 400 micrograms budesonide twice daily by metered dose inhaler for 4 weeks. Peak expiratory flow rate (PEFR) was measured by the doctor on entry, after the run-in, and at the end of the study and patients were asked to complete diary cards on a daily basis to record compliance, bronchodilator usage and the severity of cough, wheeze and sleep disturbance, and weekly to record 5 lifestyle assessments, e.g. physical activity. Analysis of data from the clinic visits and 1375 completed diary cards showed that PEFR increased significantly from 321 +/- 3 l/min at the end of the run-in to 368 +/- 3 l/min at the end of the trial; 77% of patients had an improved PEFR. Bronchodilator use decreased significantly from 4.2 +/- 0.1 times/day during the run-in period to 3.0 +/- 0.1 times/day at the end of the study; 65% of patients used less bronchodilator. Significant improvements were recorded in all the symptoms and lifestyle indices monitored; 76% of patients improved in at least 5 of the 11 assessments. Treatment-emergent adverse events occurred in 103 (6%) of patients: none was classified as serious or unexpected. No sub-group of patients was identified in which the results were at variance from the full sample. It is concluded that budesonide improves patients' lifestyle and ability to carry out normal activities, as well as improving PEFR and reducing bronchodilator use, in mild to moderately severe asthmatics treated in general practice.
一项开放性、多中心的全科医学研究纳入了1661例哮喘患者，以评估布地奈德在缓解症状和改善生活方式方面的疗效，并记录客观肺功能变化及任何不良事件。在对任何试验前的抗哮喘药物进行为期1周的导入期后，患者通过定量吸入器每日两次接受200微克或400微克布地奈德治疗，为期4周。医生在入组时、导入期结束后及研究结束时测量呼气峰值流速（PEFR），并要求患者每天填写日记卡，记录依从性、支气管扩张剂使用情况以及咳嗽、喘息和睡眠障碍的严重程度，每周记录5项生活方式评估指标，如体力活动情况。对门诊就诊数据和1375份完整日记卡的分析表明，PEFR从导入期结束时的321±3升/分钟显著增加至试验结束时的368±3升/分钟；77%的患者PEFR有所改善。支气管扩张剂的使用从导入期的每日4.2±0.1次显著减少至研究结束时的每日3.0±0.1次；65%的患者支气管扩张剂使用量减少。所有监测的症状和生活方式指标均有显著改善；76%的患者在11项评估中的至少5项中有所改善。103例（6%）患者出现治疗中出现的不良事件：无一例被归类为严重或意外事件。未发现结果与全样本有差异的患者亚组。结论是，在全科医学治疗的轻至中度哮喘患者中，布地奈德可改善患者的生活方式和进行正常活动的能力，同时改善PEFR并减少支气管扩张剂的使用。
