国产布地奈德气雾剂治疗支气管哮喘疗效评价  

Evaluation of the effects of the domestic inhaled budesonide on patients with asthma

作　　者：王炜芳[1] 刘又宁[1] 胡红[1] 段蕴铀[2] 宋鹏[2] 曹兆龙[3] 金华 

机构地区：[1]解放军总医院呼吸科,北京100853 [2]海军总医院呼吸科,北京100037 [3]北京大学医学部附属人民医院呼吸科,北京100044 [4]天衡药物研究院,北京100071

出　　处：《军医进修学院学报》2004年第1期35-37,共3页Academic Journal of Pla Postgraduate Medical School

摘　　要：目的 :评价国家四类新药国产布地奈德气雾剂治疗轻、中度支气管哮喘的疗效及其安全性。方法 :采用多中心、随机、单盲、平行对照方法 ,对 132哮喘患者进行 4周 6 0 0 μg/d国产或进口布地奈德气雾剂治疗。FEV1、PEF为主要疗效指标。结果 :有效性评价 :治疗 4周后 ,①肺功能的改善 :FEV1、PEF较治疗前两组均有显著性提高(P <0 .0 1) ,提高值两组间无显著性差异 (P >0 .0 5 )。②气道高反应性 :PD3 5 Rrs与治疗前相比两组均有显著增加(P <0 .0 5 ) ,增加值两组间无显著差别 (P >0 .1)。安全性评价 :主要不良反应是咽部不适和声嘶。两组发生率无显著性差异 (P >0 .0 5 )。结论 :国产布地奈德气雾剂可明显改善轻、中度支气管哮喘患者的肺功能及气道高反应性 ,疗效及安全性均与进口布地奈德气雾剂相当。Objective:The study was designed to evaluate the efficacy and safety of the domestic inhaled budesonide in the treatment of mild to moderate asthma. Methods:In a multicentric, randomized, single-blind, parallel-controlled study, 132 patients with mild to moderate asthma were randomly selected to receive either of the following treatments for 4 weeks: 600mg/d of the domestic or the imported inhaled budesonide. The forced expiratory volume in one second (FEV 1) and the peak expiratory flow (PEF) were measured as the primary effective values. Results:The efficacy analysis: After a four-week treatment,①Lung function improvement:In both groups significant improvements in FEV 1 and PEF were found (P<0.01). Changes of FEV 1, PEF between two groups had no significant difference(P>0.05).②Airway hyperresponsiveness: PD 35 -Rrs in both groups improved significantly(P<0.05), and changes of PD 35 -Rrs between two groups had no significant difference(P>0.1). Safety evaluation: the main side effects of both medicines were throat irritation and hoarseness. The incidence rates of adverse events were similar between two groups (P>0.05). Conclusion: The domestic inhaled budesonide is an effective medicine to improve the lung function and airway hyperresponsiveness in the mild to moderate asthmatic patients. It is as effective and safe as the imported ones.

关 键 词：国产布地奈德气雾剂 治疗 支气管哮喘 肺功能 诊断 

分 类 号：R562.25[医药卫生—呼吸系统] R974.3[医药卫生—内科学]