妥洛特罗贴剂治疗轻中度持续支气管哮喘患者的临床疗效观察

Evaluation of the Clinical Efficacy and Safety of Tulobuterol Tape in the Control of Mild to Moderate Asthma

目的观察妥洛特罗贴剂治疗轻中度持续支气管哮喘患者的疗效和安全性.方法106例轻中度持续支气管哮喘患者随机分为两边组:试验组和对照组,试验组给予妥洛特罗贴剂2 mg,每日1贴,同时吸入丙酸氟替卡松250～500μg/d,对照组吸入沙美特罗/氟替卡松250～500μg/d.结果试验组和对照组患者晨起呼气峰流速(PEF)在治疗的第1周末较基线值分别提高(35±6)L/min和(19±5)L/min(P<0.05),4周后两组的改善分别为(52±6)L/min和(30±5)L/min(P<0.05),治疗期间试验组每周均改善更明显,夜间PEF与晨起PEF结果相似.试验组和对照组症状评分在治疗第1周比较差异均有统计学意义(P<0.05),4周时试验组下降的程度与对照组比较差异有统计学意义(P<0.01).沙丁胺醇气雾剂的揿数在两组分别由治疗前的(3.12±2.93)揿和(3.07±2.75)揿下降至治疗结束时的(1.15±1.67)揿和(1.92±2.88)揿,两组比较差异有统计学意义(P<0.05),试验组的用药揿数显著少于对照组.夜间发作次数在两组分别由治疗前的(3.51±1.35)次和(3.62±1.24)次下降至治疗结束时的(0.53±0.67)次和(1.02±0.82)次,两组比较差异有统计学意义(P<0.05),试验组的夜间发作次数均显著少于对照组.治疗期间两组患者血压、心率和心电图均无明显改变.两组不良事件的发生率比较差异无统计学意义(P>0.05).结论使用妥洛特罗贴剂治疗轻中度持续支气管哮喘患者是安全有效的.

Objective Toevaluate the efficacyand the safetyofTulobuterol tape in the management ofmild to moderate asthma.Methods 106 patients with mild to moderate asthma were randomly divided into 2groups： experimental group and control group.Patients in the experimental group were given Tulobuterol tape 2mg once daily and fluticasone 250 ～500 μg daily,and patients in the control group were given salmeterol/fluticasone 250～500 μg daily.Results Compared with the base line,the morning evening peak expiratory flow（PEF） of patients in the experimental group and control group increased（35±6）L/min and（19±5） L/min 1week after treatment（P0.05）,and increased（52 ±6）L /min and（30±5）L/min 4weeks after treatment（P0.05）.The increase of PEF in the experimental group was more significant than in the control group,and the results of the evening PEF was similar to the moring PEF.There was a statistical difference in the symptoms scores of patients between the experimental group and control group 1 week after treatment（P 0.01）.The decrease of the symptoms scores of patients in the experimental group was more significant than in the control group（P0.01）.The drug use times of patients in the experimental group and control group were reduced from（3.12±2.93） and （3.07±2.75） times before treatment to（1.15 ±1.67） and（1.92 ±2.88） times after treatment,and there was a statistical difference between the two groups（P0.05）.The asthma attack times of patients in the experimental group and control group were reduced from（3.51±1.35） and（3.62 ±1.24） times before treatment to（0.53 ±0.67） and（1.02 ±0.82） times after treatment,and there was a statistical difference between the two groups （P0.05）.The blood pressure,heart rate,and ECG ofpatients in the twogroups did not change significantly,and there was no significant difference in the incidence of adverse eventbetween the two groups（P0.05）.Conclusion The treatment with Tulobuterol tape in patients with mild to moderate asthma should be considered as safe and effective.