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目的观察噻托溴胺粉雾剂吸入治疗稳定期慢性阻塞性肺疾病(COPD)的临床疗效。方法52例COPD稳定期患者,随机分为噻托溴胺组(T组)和异丙托溴胺组(I组)各26例。2组均采用常规避免吸烟、预防呼吸道感染、祛痰、止咳及按需吸入短效沙丁胺醇气雾剂等治疗。T组在上述综合性治疗的基础上,加用噻托溴胺粉雾剂吸入治疗,I组加用异丙托溴胺气雾剂吸入治疗。测定患者基线肺功能及首次用药后2 h与治疗后2、3、4周的肺功能第1秒用力呼气容积(FEV1)和用力肺活量(FVC)值,观察圣.乔治呼吸评分变化及药物不良反应。结果T组及I组患者首次用药后2 h的FEV1均较用药前升高〔(1 397±205)vs(1 273±187)ml,P<0.01;(1 387±217)vs(1 270±204)ml,P<0.01〕,2组FVC也明显升高〔(2 978±296)vs(2 696±297)ml,P<0.01;(2 939±353)vs(2 668±332)ml,P<0.01〕;用药2、3及4周后T组FEV1较治疗前明显增高〔(1 383±200)、(1 372±194)、(1 368±190)ml vs(1 273±187)ml,P均<0.05〕,FVC也明显增高〔(2 929±319)、(2 880±323)、(2 848±384)ml vs(2 696±297)ml,P均<0.05〕,而I组较治疗前无明显变化。FEV1及FVC较用药前升高值,在首次用药后2 h,T组与I组比较差异无统计学意义(P均>0.05);在用药2、3及4周后,T组均明显高于I组(P均<0.01)。试验结束时,T组圣.乔治呼吸评分有明显改善(P<0.05),I组无改善(P>0.05)。结论规律吸入噻托溴胺4周可显著改善COPD患者的症状和肺功能及圣.乔治呼吸评分。
Objective To observe the clinical efficacy of tiotropium bromide inhalation in the treatment of patients with chronic obstructive pulmonary disease (COPD). Methods Fifty-two patients with stable COPD were randomly divided into tiotropium group (T group) and ipratropium bromide group (Group I) with 26 cases each. Both groups were treated routinely with no smoking, respiratory tract infection, expectorant, cough and short-acting salbutamol inhalation on demand. T group on the basis of the above comprehensive treatment, add tiotropium powder aerosol inhalation therapy, I group with ipratropium bromide aerosol inhalation therapy. The baseline lung function and FEV1 and FVC of 2 h and 2, 3 and 4 weeks after the first administration were measured to observe the change of St. George’s respiratory score and the change of the drug Adverse reactions. Results The FEV1 in group T and group I at 2 h after the first administration was significantly higher than that before treatment [(1 397 ± 205) vs (2773 ± 187) ml, P <0.01; (1 387 ± 217) vs (2 978 ± 296) vs (2 696 ± 297) ml, P <0.01; (2 939 ± 353) vs (2 668 ± 332) ml, P <0.01). After 2, 3 and 4 weeks of treatment, the FEV1 in T group was significantly higher than that before treatment [(1 383 ± 200), (1 372 ± 194), (1 368 ± 190) ml vs (P <0.001), P <0.05] and FVC also increased significantly (P <0.05) , While I group had no significant change before treatment. FEV1 and FVC were higher than those before treatment, and there was no significant difference between T group and I group at 2 hours after the first administration (P> 0.05). After 2, 3 and 4 weeks, T group were significantly higher In group I (all P <0.01). At the end of the trial, St. George’s breathing score was significantly improved in group T (P <0.05), but no improvement in group I (P> 0.05). Conclusion Regular inhalation of tiotropium for 4 weeks significantly improved symptoms and pulmonary function and St. George’s respiratory score in COPD patients.