摘要
目的评价囊性纤维化(CF)和铜绿假单胞菌(PA)气道感染患者吸入氨曲南赖氨酸(AZLI)的有效性和安全性。方法 AZLI用药组给予75 mg AZLI(3次/d,连续28 d)对照组给予5 mg乳糖(3次/d),给药完成后监测14 d。主要观测指标为患者呼吸系统症状改善,其他指标包括肺功能(FEV1)、痰PA密度、非呼吸系统CFQ-R量表改善。监测不良反应。结果经过28 d的治疗,与安慰剂对照组比较,AZLI组平均CFQ-R呼吸评分、FEV1和痰PA密度显著改善。观测到的情绪、呼吸系统症状、体力等明显改善。不良事件伴随CF肺疾病症状。结论合并PA气道感染、中重度肺疾病、近期未应用抗假单孢菌属抗生素或阿奇霉素的CF患者,应用AZLI治疗28 d可明显改善呼吸系统症状和肺功能,且耐受性良好。
Objective To assess the short-term efficacy and safety of inhaled aztreonam lysine（AZLI） in patients with cystic fibrosis（CF） and pseudomonas aeruginosa（PA） airway infection.Methods AZLI group received 75 mg of AZLI（three times daily for 28 days）.The control group received 5 mg of lactose（three times daily） and was monitored for 14 days.The primary efficacy end point was the change in patient-reported respiratory symptoms.Secondary end points included changes in pulmonary function（FEV 1）,sputum PA density, and non-respiratory CFQ-R scales.Adverse events were monitored as well.Results After 28-day treatment,compared with the placebo group,AZLI improved significantly in terms of the mean CFQ-R respiratory score,FEV 1,and sputum PA density.Significant improvements in emotional functioning,health perceptions,physical functioning,and vitality CFQ-R scales were observed.Adverse events were consistent with symptoms of CF lung disease.Conclusion In patients with CF,PA airway infection,moderate-to-severe lung disease,and no recent use of antipseudomonal antibiotics or azithromycin,28-day treatment with AZLI can significantly improve respiratory symptoms and pulmonary function,which is also well tolerated.
出处
《实用临床医药杂志》
CAS
2012年第3期38-40,共3页
Journal of Clinical Medicine in Practice
关键词
氨曲南
囊性纤维化
抗生素
假单胞菌
呼吸系统
Objective To assess the short-term efficacy and safety of inhaled aztreonam lysine（AZLI） in patients with cystic fibrosis（CF） and pseudomonas aeruginosa（PA） airway infection.Methods AZLI group received 75 mg of AZLI（three times daily for 28 days）.The control group received 5 mg of lactose（three times daily） and was monitored for 14 days.The primary efficacy end point was the change in patient-reported respiratory symptoms.Secondary end points included changes in pulmonary function（FEV 1）,sputum PA density, and non-respiratory CFQ-R scales.Adverse events were monitored as well.Results After 28-day treatment,compared with the placebo group,AZLI improved significantly in terms of the mean CFQ-R respiratory score,FEV 1,and sputum PA density.Significant improvements in emotional functioning,health perceptions,physical functioning,and vitality CFQ-R scales were observed.Adverse events were consistent with symptoms of CF lung disease.Conclusion In patients with CF,PA airway infection,moderate-to-severe lung disease,and no recent use of antipseudomonal antibiotics or azithromycin,28-day treatment with AZLI can significantly improve respiratory symptoms and pulmonary function,which is also well tolerated.
