Casali L, Rossi A, Manazza P, Colombo M L, Zoia M C
Institute of Phthisiology and Respiratory Diseases, University of Pavia, Italy.
Int J Clin Pharmacol Ther Toxicol. 1988 Feb;26(2):93-7.
In 12 adult patients with reversible bronchospasm (7 bronchial asthma and 5 chronic obstructive bronchitis) the bronchodilator activity and tolerability of 200 and 400 mcg of broxaterol hydrochloride (Z 1170) were compared to those of 200 mcg of salbutamol administered by metered-dose inhaler. A single dose of the drugs was compared in a double-blind balanced latin square cross-over design. FEV1, FVC, MMEF, MEF25, heart rate and blood pressure were measured just before and 7.5, 15, 30, 60, 120, 180 and 240 min after each treatment. At these times clinical evaluation was also carried out to ascertain the presence of side effects. In the doses employed, broxaterol and salbutamol caused significant increases over baseline FEV1, MMEF and MEF25 from 7.5 to 240 min and FVC from 7.5 to 120 min. The difference between the effects of the two doses of broxaterol on FVC, MMEF and MEF25 was significant at 15 min. No significant difference was observed in the activity curves of 400 mcg of broxaterol and salbutamol. The effects of salbutamol were significantly greater than those of 200 mcg of broxaterol on FEV1 at 7.5 and 15 min and on FVC, MMEF and MEF25 at 15 min. All three treatments were well tolerated. No significant changes were observed in heart rate or blood pressure and tremors were not reported in any patient.
在12例患有可逆性支气管痉挛的成年患者（7例支气管哮喘和5例慢性阻塞性支气管炎）中，将200微克和400微克盐酸溴沙特罗（Z 1170）的支气管扩张活性及耐受性与通过定量吸入器给予的200微克沙丁胺醇进行比较。采用双盲平衡拉丁方交叉设计比较药物的单次剂量。在每次治疗前以及治疗后7.5、15、30、60、120、180和240分钟测量第一秒用力呼气容积（FEV1）、用力肺活量（FVC）、最大呼气中期流速（MMEF）、25%用力呼气流量（MEF25）、心率和血压。在这些时间点还进行临床评估以确定副作用的存在。在所使用的剂量下，溴沙特罗和沙丁胺醇使FEV1、MMEF和MEF25从7.5分钟至240分钟以及FVC从7.5分钟至120分钟较基线有显著增加。两种剂量的溴沙特罗对FVC、MMEF和MEF25的作用在15分钟时差异显著。400微克溴沙特罗和沙丁胺醇的活性曲线未观察到显著差异。在7.5和15分钟时，沙丁胺醇对FEV1的作用显著大于200微克溴沙特罗，在15分钟时对FVC、MMEF和MEF25的作用也显著大于200微克溴沙特罗。所有三种治疗耐受性良好。未观察到心率或血压有显著变化，且无患者报告震颤。
