沙丁胺醇吸入粉雾剂与气雾剂治疗支气管哮喘的随机对照多中心研究

发布时间：2018-01-25 22:11

本文关键词： 哮喘沙丁胺醇气雾剂粉雾剂随机对照试验多中心研究　出处：《中国新药与临床杂志》2015年02期 　论文类型：期刊论文

【摘要】：目的比较沙丁胺醇吸入粉雾剂与吸入气雾剂治疗中、重度支气管哮喘的临床疗效和安全性。方法采用随机、单盲、多中心阳性对照临床试验方法。共入选219例中、重度支气管哮喘患者,随机分为两组。试验组患者通过茜乐装置吸入沙丁胺醇吸入粉雾剂400μg(2吸),对照组通过储雾罐吸入沙丁胺醇气雾剂400μg(4吸)。检测两组吸药后15、30、45、60、120、180、240 min不同时间点第一秒用力呼气容积(FEV1)、用力肺活量(FVC)和最大呼气流速(PEF)值,计算FEV1、FVC和PEF曲线下面积,观察肺部症状及体征变化及不良事件发生情况。结果吸药后两组各时间点FEV1、FVC和PEF均较治疗前改善(P0.05),作用均可持续4 h,组间无显著差异(P0.05),两组FEV1、FVC和PEF曲线下面积亦无显著差异(P0.05)。两组患者吸药后咳嗽、呼吸困难及肺部干Up音均有不同程度的改善,组间无显著差异(P0.05)。两组不良事件的发生率相似,试验组为11.4%,对照组为13.4%,与药物相关不良事件的发生率分别为0.9%和对照组5.4%,组间差异均无显著意义(P0.05)。整个研究过程两组均无严重不良事件发生。结论同等剂量沙丁胺醇吸入粉雾剂与气雾剂通过茜乐干粉吸入器和储雾罐吸入,均可明显改善中、重度支气管哮喘患者的肺功能和肺部症状,安全性较好。
[Abstract]:Objective to compare the salbutamol inhalation powder and inhaled aerosol in the treatment, the clinical efficacy and safety of severe bronchial asthma. Methods a randomized, single blind, multicenter clinical trial of positive control. There were 219 cases, patients with severe bronchial asthma were randomly divided into two groups. Patients in the experimental group by Qian Le suction device salbutamol inhalation powder 400 g, the control group (2 suction) by chuwuguan inhalation of Salbutamol Aerosol 400 g (4 suction) in two groups were detected. 15,30,45,60120180240 after inhalation of min at different time points of the first second forced expiratory volume (FEV1), forced vital capacity (FVC) and peak expiratory flow rate (PEF) value calculation FEV1, FVC and PEF area under the curve, the incidence of pulmonary symptoms and signs of change and adverse events observed. Results after inhalation of two group at different time points FEV1, FVC and PEF were better than those before treatment (P0.05), can be continued for 4 h, and there was no statistical significance The difference (P0.05), two FEV1 group, there were no significant differences in FVC and PEF area under the curve (P0.05). The two groups of patients after inhalation of cough, dyspnea and lung stem were improved in different degree of Up sound, there was no significant difference between the two groups (P0.05). The incidence of adverse events was similar to that of the test group 11.4%, the control group was 13.4%, the incidence rates were 0.9% and 5.4% in the control group and drug related adverse events, there were no significant differences between the groups (P0.05). The whole research process of the two groups were no serious adverse events occurred. Conclusion the same dose of salbutamol inhalation powder and aerosol by Qian Le dry powder inhaler and chuwuguan inhalation can significantly improve pulmonary function, and pulmonary symptoms in patients with bronchial asthma, with good safety.

【作者单位】：呼吸疾病国家重点实验室呼吸疾病国家临床医学研究中心广州呼吸疾病研究所广州医科大学附属第一医院;北京大学人民医院;首都医科大学附属北京朝阳医院东院区;首都医科大学附属北京朝阳医院西院区;上海交通大学医学院附属瑞金医院;中国人民解放军沈阳军区总医院;中国人民解放军总医院;广州市第一人民医院;中国医学科学院基础医学研究所统计室;
【分类号】：R562.25
【正文快照】： 沙丁胺醇(salbutamol)属于肾上腺素β2受体2排除标准(1)临床试验之前4周内参与过药(β2受体)激动药,可快速舒张支气管平滑肌,已物临床研究者;(2)试验前两日内口服或24 h内广泛应用于临床,其吸入治疗为缓解支气管哮喘吸入长效β2受体激动药;(3)对制剂中的任何成症状的首选治疗

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