噻托溴铵粉雾剂治疗慢性阻塞性肺病的有效性及安全性

Evaluation of efficacy and safety of once-daily inhaled tiotropium in chronic obstructive pulmonary disease

目的观察噻托溴铵粉雾剂治疗慢性阻塞性肺病(COPD)的有效性及安全性。方法采用随机、双盲、双模拟阳性药平行对照、多中心临床研究的方法。对223例COPD稳定期Ⅰ、Ⅱ和Ⅲ级患者,分别吸入噻托溴铵粉雾剂(试验组)和异丙托溴铵定量气雾剂(对照组),治疗28 d,测定患者用药前后不同时间的肺功能。结果 1.治疗28 d,对照组和试验组的临床改善率分别为47.71%(P<0.05)和59.46%(P<0.05)。2.各组给药后30、60、120 m in、28 d,FEV1与基线相比,差别均有统计学意义(P<0.05)。治疗后28 d,试验组FEV1、FVC与对照组相比,差别有统计学意义(P<0.01)。结论规律吸入噻托溴铵粉雾剂可显著改善COPD患者的临床症状,无严重药物不良反应。

Objective To evaluate the efficacy and safety of once-daily inhaled tiotrop ium in chron ic obstructive pu lmonary d is-ease.M ethod A mu lti-center,random ized,doub le b lind,doub le dummy and parallel comparison clin ical trailwas conducted in 223 pa-tients ranging from stab le to m ild,to severe stagesw ith COPD.They were random ly d ivided into two groups： tiotrop ium（18μg qd）,and ipratrotium（40μg,tid） for 28 days.The lung function testwas perform ed before and after drug adm in istration at 30,60,120 m inutes,and 14 days,28 days respectively.The forced exp iratory volum e in first second（FEV1） and forced vital capacity（FVC） were compared w ith baseline values between the two groups.M eanwh ile,the symptom s and the drug adverse effects of the patientswere recorded and eval-uated.R esu lts ①Both groups exh ib ited sign ificant improvem ents in clin ical param eters at the end of the therapy（tiotrop ium： 59.46%,P0.05;ipratrop ium： 47.71%,P0.05）.The improvem ents d id not d iffer between the two groups（p0.05）.②Compared w ith baseline,the FEV1and FVC at 30,60 and 120 m inutes after inhalation sign ificantly increased in the two groups（P0.05）.③The FVE1 and FVC also sign ificantly increased in the tiotrop ium group 14 days and 28 days after the regu lar treatm ent.The FVE1and FVC slightly decreased in the ipratrop ium group 14 days and 28 days after the regu lar treatm ent.C onclu sion Tiotrop ium in the treatm ent of stab le COPD provided clin ically m ean ingfu l,statistically sign ificant and sustained improvem ents in pu lmonary function w ithout add itional adverse effects.