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目的观察吸入噻托溴铵干粉治疗慢性阻塞性肺疾病(COPD)的疗效及安全性。方法 64例COPD稳定期患者分成2组,试验组(32例)吸入噻托溴铵干粉1粒,每日1次,对照组(32例)予口服多索茶碱0.2 g,吸入福莫特罗粉剂1吸,均每日2次。2组均治疗1年,于治疗前、治疗后6 mo和12 mo测定第1秒用力呼气容积(FEV_1)、用力肺活量(FVC)、FEV_1占预计值百分比(FEV_1%)、FEV_1/FVC等指标,并评价呼吸困难等级,观察不良反应。结果治疗后6 mo,2组FEV_1、FVC和FEV_1%均明显改善(P<0.05),试验组改善幅度大于对照组,差异显著(P<0.05)。2组FEV_1/FVC也有改善,但组间无显著差异(P>0.05)。治疗后12 mo,试验组FEV_1 FVC和FEV_1%仍有改善(P<0.01),而对照组无改善反而减退(P<0.05),2组差异非常显著(P<0.01)。试验组呼吸困难评级下降幅度大于对照组(P<0.01),不良反应少于对照组(P<0.01)。结论规则使用噻托溴铵1年可提高COPD患者肺功能,缓解症状,无严重药物不良反应发生。
Objective To observe the efficacy and safety of inhaled tiotropium bromide in the treatment of chronic obstructive pulmonary disease (COPD). Methods Sixty-four patients with stable COPD were divided into two groups. The experimental group (32 patients) received tiotropium bromide once daily (n = 32) and the control group (n = 32) received oral doxofylline 0.2 g. Pulmonary powder 1 suction, 2 times a day. The FEV 1, FVC, FEV 1%, FEV 1 / FVC, etc. were measured before treatment, 6 and 12 months after treatment, respectively. Indicators, and evaluation of dyspnea level, observe the adverse reactions. Results At 6 months after treatment, the FEV_1, FVC and FEV_1% of the two groups were significantly improved (P <0.05). The improvement of the experimental group was greater than that of the control group (P <0.05). There was also improvement in FEV_1 / FVC in both groups, but there was no significant difference between the two groups (P> 0.05). At 12 months after treatment, FEV_1 FVC and FEV_1% of the experimental group still improved (P <0.01), while the control group did not improve but declined (P <0.05). The difference between the two groups was significant (P <0.01). The decline of dyspnea rating in the experimental group was greater than that in the control group (P <0.01), and the adverse reaction was less than that in the control group (P <0.01). CONCLUSIONS: The use of tiotropium for 1 year may improve lung function, relieve symptoms and avoid serious adverse drug reactions in COPD patients.