噻托溴胺粉雾剂治疗稳定期慢性阻塞性肺病的有效性和安全性

Study on efficacy and safty of tiotropium powder in patients with stable COPD

目的:观察噻托溴胺粉雾剂治疗慢性阻塞性肺病(COPD)的有效性和安全性。方法:采用随机,双盲双模拟,阳性药对照的临床研究方法,入选40例轻-中度COPD缓解期患者,随机分为两组,分别吸入噻托溴胺粉雾剂(试验组)或吸入异丙托溴胺气雾剂(对照组),测定患者基线肺功能及首次用药后0.5,1,2 h及治疗后2,4周的肺功能FEV1和FVC值,观察临床症状变化及药物不良反应。结果:试验组及对照组患者首次用药后0.5,1及2 h的FEV1,FVC与基线值比,升高有极显著统计学差异(P<0.01);试验组用药2及4周后FEV1,FVC与基线值比显著升高(P<0.05),对照组则无显著差异(P>0.05)。两组比较,首次用药后0.5,1及2 h的FEV1,FVC升高值无显著统计学差异。用药2及4周后,试验组FEV1较基线值分别升高(95.8±184.1),(52.6±172.2)mL;FVC分别升高(132.6±272.2)mL,(138.4±256.0)mL,而对照组FEV1分别降低(82.5±160.0)mL,(57.0±155.8)mL,FVC分别降低(113.0±259.6)mL,(79.5±338.9)mL。两组相比差异有显著统计学意义(P<0.05)。试验结束时,试验组和对照组分别有89.5%及85%的患者症状缓解或稳定。试验组4例有口干,1例心悸。结论:规律使用噻托溴胺可显著改善COPD患者的症状,提高FEV1及FVC值,无严重药物不良反应。

Objective ： To evaluate the efficacy and salty of inhaled tiotropium powder in patients with stable COPD. Methods： Randomized double-blind, double-mimic positive-controlled study of inhaled tiotropium powder（ 18μg qd）compared with ipratropium in metered dose inhaled （40μg tid） was conducted in patients with stable chronic obstructive mild or morderate stable COPD were enrolled in the pulmonary disease （COPD）. Forty outpatients with study. The lung function test was performed before and at 0. 5, 1 and 2 hours and 2 and 4 weeks after drug administration. The forced expiratory volume in first second （FEV1 ） and forced vital capacity （FVC） were compared with baseline values, respectively, and between the 2 groups treated with tiotropium and ipratropium. At the same time, the symptoms and the drug adverse effects of the patients were also recorded and evaluated. Results： Compared with base- line, the FEV1 and FVC at 0.5, 1 and 2 hours after inhalation were significantly increased in both tiotropium and ipratropium groups（P 〈 0.01 ）. The FEV1 and FVC also significantly increased in tiotropium group, 2 and 4 weeks after regular treatment, FEV1 ＋ （95.8 ± 184. 1 ） and （52.6 ± 172.2） mL and FVC ＋ （ 132.6 ±272.2） and （ 138.4 ± 256.0） mL, respectively, but decreased in ipratropium group. FEV1-（82.5 ±160.0） and-（57.0±155.8）mLand FVC-（113.0±259.6） and-（79.5 ±338.9） mL, respectively （P 〈 0.05 between 2 groups）. Symptoms of cough,.sputum and breathlessness were released or stable in 89.5% of patients in tiotropium group and 85% of patients in ipratropium group at the end of the study. Dry mouth occured in 4 patients and palpitation in 1 patient in tiotropium group. Conclusion： The bronchodilatation activity of tiotrooium was stronger than that of ipratropium after 4 weeks regular use. It＇s adverse effects were mild and tolerable, Once daily usage of tiotropium was more convenient for patients than 3 times daily of ipratropium.