Comparative Efficacy and Tolerability of Oral Bambuterol Once Daily (Evening) and Oral Salbutamol Four Times Daily in Patients with Asthma or COPD

評估Bambuterol和Salbutamol對於氣喘及COPD病人的臨床療效及耐受性

謝任豐(Jen-Feng Hsien) ； 許正園(Jeng-Yuan Hsu) ； 江自得(Chi-Der Chiang)

《胸腔醫學》 18卷1期 (2003/02) Pp. 20-27

摘要

目的：本研究目的是比較交叉使用每晚睡前一次口服Bambuterol(Bambec)10毫克，和每天四次口服Salbutamol (Ventolin)2毫克二週後兩者的療效和耐受性。
方法：選擇門診定期追蹤，依據美國胸腔學會標準，診斷為氣喘或慢性阻塞性肺病的病人，隨機地分為兩組，採交叉對照的方式進行，分別接受每晚睡前一次口服Bambuterol(Bambec)10毫克和每天四次口服Salbutamol (Ventolin)2毫克，二週之後兩組交換藥物再使用二週，完成之後比較兩組之肺功能、收縮壓、舒張壓、心跳速率、臨床療效（以肺功能及effective scale來評估）及副作用（以side effect scale來評估）。
結果：我們一共收集20位病人，每組各10人，第一組含氣喘3人, 慢性阻塞性肺病7人；第二組含氣喘4人，慢性阻塞性肺病6人之FEV1，FVC，FEF25%-75%，FEV1/FVC上升之值相當，早晨尖峰吐氣流量，夜間尖峰吐氣流量，早晨療效評分，夜間效果評分，心跳速率、臨床療效及副作用，兩者藥物使用後對收縮壓、舒張壓、心跳速率、臨床療效及副作用，都無顯著差異。
結論：對每天四次口服Salbutamol氣喘或慢性阻塞性肺病病人而言，每晚睡前一次口服Bambuterol是另一種安全又有效的選擇。本研究之限制在於樣本數太少(small sample size)而且樣本組成均質性不足(heterogeneity)，這是近一步相關研究時必須改進之處。

關鍵字

支氣管擴張劑,交叉對照

並列摘要

Bambuterol is an oral terbutaline carbamate product with a prolonged bronchodilator action that allows a once- daily administration in the evening.
The objective of this research was to compare the efficacy and tolerability of 10 mg oral bambuterol (Bambec) once daily (in the evening) with 2 mg oral albutamol (Ventolin) administered four times daily in 20 patients. Those were 18 to 60 years old and diagnosed with asthma or COPD, as defined by the American Thoracic Society. Three patients with asthma and 7 patients with COPD comprised group 1,and four patients with asthma and 6 patients with COPD formed group 2.
The investigation was designed as a cross-over, randomized study with a 1-week run-in period and 4 weeks of treatment. Lung function (FEV1, FVC, FEF25%-75%, FEV1/FVC) and systemic variables (heart rate, blood pressure) were monitored prior to the administration of the drug. Both treatments showed a good safety profile, and they were well tolerated. There were few side effects and no significant difference between the treatments in any of the efficacy variables (FEV1, FVC, FEF25%-75%, FEV1/FVC, PEFR morning, PEFR evening, and effect score).
In conclusion, once-daily (evening) oral bambuterol is a convenient, effective, safe alternative to oral salbutamol four times daily in patients with COPD or asthma. The limitations of the study include a small sample size and the heterogeneity of disease and age in the two groups.

並列關鍵字

Bambuterol ； Salbutamol ； bronchodilator ； cross-over ； bambutarol