Kleerup E C, Tashkin D P, Cline A C, Ekholm B P
Department of Medicine, University of California School of Medicine, Los Angeles, USA.
Chest. 1996 Mar;109(3):702-7. doi: 10.1378/chest.109.3.702.
This study compares the safety and efficacy of HFA 134a salbutamol sulfate (Airomir in the 3M CFC-free system [3M Pharmaceuticals]) and CFC 11/12 salbutamol (Ventolin [Allen & Hanburys]) in a cumulative dose-response (1, 1, 2, 4, 8 inhalations at 30-min intervals) study in asthmatic patients.
Randomized, single-blind, two-period cross-over study.
Twenty-four stable mild to moderate asthmatics.
At all cumulative inhalations, the changes in FEV1 (absolute, percent, and percent predicted) and FVC were equivalent. There was also no significant difference in heart rate, serum potassium level, BP, 12-lead ECG, Holter monitor recordings, or adverse events. Both HFA 134a salbutamol sulfate and CFC 11/12 salbutamol displayed a significant dose-response for FEV1, FEF25-75%, FVC, serum potassium, heart rate, and systolic BP.
HFA 134a salbutamol sulfate and CFC 11/12 salbutamol produced clinically and statistically similar airway responses and side effects. These results indicate that HFA 134a salbutamol sulfate would be a safe and effective substitute for CFC 11/12 salbutamol.
本研究在哮喘患者中进行累积剂量反应（每隔30分钟吸入1、1、2、4、8次）研究，比较HFA 134a硫酸沙丁胺醇（3M无氟氯化碳系统[3M制药公司]中的Airomir）和CFC 11/12沙丁胺醇（喘乐宁[艾伦和汉伯里公司]）的安全性和有效性。
随机、单盲、两阶段交叉研究。
24名病情稳定的轻度至中度哮喘患者。
在所有累积吸入时，第一秒用力呼气量（绝对值、百分比和预测百分比）和用力肺活量的变化相当。心率、血清钾水平、血压、12导联心电图、动态心电图记录或不良事件方面也无显著差异。HFA 134a硫酸沙丁胺醇和CFC 11/12沙丁胺醇在第一秒用力呼气量、用力呼气中期流速、用力肺活量、血清钾、心率和收缩压方面均显示出显著的剂量反应。
HFA 134a硫酸沙丁胺醇和CFC 11/12沙丁胺醇产生了临床和统计学上相似的气道反应及副作用。这些结果表明，HFA 134a硫酸沙丁胺醇将是CFC 11/12沙丁胺醇的一种安全有效的替代品。
