不同噻托溴铵给药方案对成年哮喘患者的疗效比较

Efficacy Observation of Different Tiotropium Bromide Medication Scheme on Adult Asthma Patients

目的：探讨不同噻托溴铵给药方案对成年哮喘患者的疗效。方法：,选择2014年1—12月间在呼吸科治疗的成年哮喘患者为研究对象,使用安慰剂作为对照,按随机交叉双盲试验分为安慰剂组（90例）、观察1组（90例）、观察2组（89例）,以4周为一治疗期,观察1组患者给予噻托溴铵5μg（每日晚间给药1次）,观察2组患者给予2.5μg（每日早、晚给药各1次）,安慰剂组患者每日早、晚给予安慰剂1次。主要终点是每个治疗周期结束后,患者从第一秒用力呼气容积（FEV1）的0~24 h曲线下面积（AUC0~24 h）;次要终点是前1晚吸入药物后24 h内测量的第一秒用力呼吸容积峰值[FEV1（0~24 h）峰值],每晚服药后测量FEV1谷值与早、晚的呼气流量峰值（PEFam和PEFpm）,比较ACQ-7问卷平均分数情况。结果：2种噻托溴铵的给药方案都可使支气管显著舒张达24 h。观察1组和观察2组患者FEV1AUC0~24 h、FEV1（0~24 h）峰值及FEV1谷值与安慰剂组比较,均明显改善;观察1组和观察2组患者的24 h后FEV1与安慰剂比较,均显著改善;观察1组与观察2组患者每个疗程的PEFam和PEFpm与安慰剂比较,均明显增强;观察1组和观察2组患者的ACQ-7问卷平均分数与安慰剂比较,均有明显改善,差异均有统计学意义（P〈0.05）。结论：每日给药5μg噻托溴铵可作为一种支气管舒张剂,以24 h作为一个给药周期,为哮喘患者提供有效治疗。

OBJECTIVE： To investigate the efficacy of different tiotropium bromide medication scheme on adult asthma patients. METHODS： The adult asthma patients admitted into department of respiration from Jan. to Dec.2014 were selected as the research objects,the placebo was set as control. According to the randomized cross-over double-blind trials,the patients were divided into placebo group（ 90 cases）,observation group one（ 90 cases） and observation group two（ 89 cases）,with 4 weeks as a period of treatment,the observation group one were given tiotropium bromide（ 5 μg each time in evening）, the observation group two received 2. 5 μg（ each time of administration in morning and evening）,and the placebo group were treated with placebo each time in the morning and evening. The primary end point,after the end of each treatment period,from 0 to 24 h,was the forced expiratory volume in one second（ FEV1） and the area under the curve of the drug（ AUC0-24 h）. The secondary end point,after taking drugs in the last night within 24 h,was the forced expiratory volume in measuring the peak [FEV1（ 0-24 h）peak],every night after taking drugs,the measurement of FEV1 trough and peak expiratory flow would be conducted（ PEFam and PEFpm）. And the average score of ACQ-7 questionnaires were compared. RESULTS： Two kinds of tiotropium bromide medication schemes can promote the significant relaxation of bronchial to reach 24 h. Compared with placebo group,FEV1AUC0-24 hand FEV1（ 0-24 h）peak and FEV1 trough in observation group one and observation group two were significantly improved; after 24 h,FEV1 in observation group one and observation group two were also significantly improved; and the PEFamand PEFpmboth had an obvious improvement in each treatment course and the average score of ACQ-7 questionnaires were significantly increased in observation group one and observation group two,the differences were statistically significant（ P〈0. 05）. CONCLUSIONS： The daily administration of 5 μg tiotropium bromide can be used as a bronchodilator,taking 24 h as a delivery cycle,to provide effective treatment for the patients with asthma.