盐酸左旋沙丁胺醇治疗轻、中度支气管哮喘的随机双盲对照多中心临床研究  

Randomized double-blind control multicenter clinical study of levalbuterol hydrochloride in the treament of mild-moderate asthma

作　　者：马锦芳[1] 赵子文 袁本通[3] 陈平雁[4] 郑劲平[1] 

机构地区：[1]广州医学院第一附属医院广州呼吸疾病研究所呼吸内科,广州510120 [2]广州市第一人民院呼吸科,广州510180 [3]深圳市第二人民医院呼吸科,广东深圳100730 [4]南方医科大学统计教研室,广州510515

出　　处：《中国临床药理学杂志》2009年第4期291-293,297,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价盐酸左旋沙丁胺醇(β2受体激动剂,治疗支气管哮喘药)治疗轻、中度支气管哮喘的有效性和安全性。方法用随机、双盲、对照临床研究,122例轻、中度支气管哮喘患者随机分为2组,试验组口服盐酸左旋沙丁胺醇片1.15mg,对照组口服硫酸沙丁胺醇2mg,每日3次,疗程(14±2)天。结果与治疗前相比,试验组的第1秒用力呼气容积占预计值(FEV1%)、第1秒用力呼气容积值(FEV1)和第1秒用力呼气容积与用力肺活量的比值(FEV1/FVC)均有明显升高,具有显著的统计学差异(P≤0.05);对照组治疗前后无明显变化。试验组与对照组的不良反应发生率分别为12.5%和15.3%,2组间比较无显著性差异。结论治疗轻中、度支气管哮喘2组具有相同的临床疗效和安全性;但试验组在肺功能改善方面明显优于对照组。Objective To evaluate the efficacy and safety of levalbuterol hydrochloride in the treatment of mild - moderate asthma. Methods Randomized double - blind, control clinical study was carried out. One hundred twenty -two mild -moderate asthma patients were randomized to enroll the study. Trial group was treated with oral levalbuterol hydrochloride tablets 1.15 mg thrice daily. Control group was treated with oral salbutamol sulphate tablets 2 mg thrice daily. The therapy window is （ 14±2） d. Results Comparison with baseline, the first forced expiratory volume vs predicted（ FEV1% ）, the first forced expiratory volume （ FEV1 ） and the first forced expiratory volume vs the forced vital capacity （FEV1/ FVC） were obviously improved in trial group. There is significantly statistics difference （P 〈 0. 05 ）. Control group has no significant variance pre and post treatment. Drug adverse reaction of trial group and control group is 12.5% and 15.3% ,respectively. There is no marked difference between two groups. Conclusion Two groups are equivalent in the treatment of mild to moderate asthma, moreover ,lung function has been more improved greatly in trial group compared with control group.

关 键 词：盐酸左旋沙丁胺醇 硫酸沙丁胺醇 支气管哮喘 

分 类 号：R562.25[医药卫生—呼吸系统] R974[医药卫生—内科学]