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妥洛特罗贴剂治疗老年人慢性阻塞性肺疾病急性加重期的临床研究 被引量:3

Clinical trials of tulobuteroi patch in the treatment of acute exacerbation of chronic obstructive pulmonary disease in the elderly
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摘要 目的 评价妥洛特罗贴剂治疗老年慢性阻塞性肺疾病(cOPD)急性加重期的疗效和安全性。方法165例老年中、重度COPD急性加重期患者随机分为试验组83例和对照组82例。试验组给予妥洛特罗贴剂(1mg/贴)2贴/d,同时吸入丙酸氟替卡松250μg/次,2次/d;对照组吸入沙美特罗/氟替卡松(50μg/250μg),2次/d。两组基础治疗相同,疗程10~14d。结果治疗后第1秒用力呼吸容积、呼吸峰流量、6min步行距离、症状评分试验组分别为[(1.30±0.31)L、(245.3±56.I)L/min、(263.0±53.2)m、(33.2±12.1)分],对照组分别为[(1.21±0.23)L、(213.9±58.4)L/min、(230.0±45.6)m、(37.8±14.5)分](t=2.120、3.521、4.279、2.212,均P〈0.05)。治疗后使用缓解药、夜间憋醒次数、住院时间试验组分别为[(2.5±0.6)次/d、(1.8±0.5)次/周、(12.9±1.6)d],对照组分别为[(2.9±0.8)次/d、(2.2±0.7)次/周、(14.1±1.8)d](t=3.610、4.219、4.524,均P〈O.05);试验期间试验组发生了8例(9.6oA)不良事件,对照组发生了7例(8.5%)不良事件(P〉0.50),两组均未发生严重不良事件。结论妥洛特罗贴剂是一种安全、有效治疗COPD每日急性加重期的新剂型药物。 Objective To evaluate the efficacy and safety of tulobuterol patch in the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD)in the elderly. Methods Totally 165 elderly patients with moderate to severe AECOPD were divided into trial group and control group randomly. 83 patients of trial group were treated with tulobuterol patch, 2 mg once a day, and fluticasone inhalation 250μg twice a day; 82 patients of control group were treated with inhalation of salmeterol/fluticasone 250 μg/50 μg twice a day. Basic therapy was the same in two groups. Results After 10-14 days' treatment, forced expiratory volume in one second(FEV1), peak expiratory flow (PEF), 6-min walking distance and symptom scores were ( 1.30 ± 0.31) L, (245.3 ±56.1) L/min, (263.0±53.2)m, (33.2±12.1)scoresintrial group, and (1.21±0.23)L, (213.9±58.4) L/min, (230.0±45.6)m, (37.8±14.5) scores in control group, respectively. The lung function,6 minute walk distance and symptom score were improved (t=2. 120, 3. 521, 4. 279, 2. 212,all P〈0.05). The frequencies of rescue medication, waking-up suffocating at night and the days of hospital stay were deceased significantly in trial group as compared with control group[(2.5±0.6) time/d, (1.8±0.5) time/week, (12.9±1.6)d vs. (2.9 0.8) time/d, (2.2±0.7) time/week, (14.1±1.8) d, t=3. 610, 4. 219, 4. 524, all P〈0.05]. The incidence of adverse reactions was not significant difference between twogroups[8 cases(9.6%)vs. 7 eases(8.5G), P〉0.05] and the adverse reactions were mild. Conclusions Tulobuterol patch is a newly formulated, effective and safe medication for the treatment of acute exacerbation of AECOPD.
出处 《中华老年医学杂志》 CAS CSCD 北大核心 2012年第8期679-682,共4页 Chinese Journal of Geriatrics
关键词 肺疾病 慢性阻塞性 有效性研究 Pulmonary disease,chronic obstructive Validation studies
作者简介 通信作者:程剑剑,Email:cheng030701@sohu.com
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