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目的研究噻托溴铵治疗稳定期慢性阻塞性肺疾病(COPD)的有效性和安全性。方法 2013年1月至12月按标准纳入60例稳定期COPD患者,按随机数字表法分成两组,每组各30例,治疗组给予噻托溴铵吸入,对照组给予氨茶碱口服治疗,比较两组治疗前、治疗12周后的患者自我评估测试(CAT)评分、肺功能、6 min步行距离、急性加重次数,并评价安全性评价指标。结果 60例患者均顺利完成12周治疗,无失访脱落病例。与治疗前比较,两组患者的CAT评分、急性加重次数、FEV1、FEV1/FVC、运动耐力评分均有改善(P均<0.05),治疗组改善显著优于对照组(P均<0.05)。观察组有4例(13.3%)、对照组有3例(10.0%)发生不良事件,但两组比较差异无统计学意义(P>0.05)。观察组不良事件主要为口干2例,头痛1例,血肌酐增高1例,无心血管系统的异常表现和心电图异常报告;对照组为口干1例,窦性心动过速1例,右束支传导阻滞1例。两组均无因不良事件而提前终止研究病例,均未出现严重不良事件。两组实验室检查结果均无异常。结论噻托溴铵可有效改善肺功能并缓解临床症状,安全有效。
Objective To study the efficacy and safety of tiotropium in the treatment of stable chronic obstructive pulmonary disease (COPD). Methods From January to December 2013, 60 patients with stable COPD were enrolled according to the standard. Patients were divided into two groups according to the random number table. Each group had 30 patients. The treatment group was treated with tiotropium inhalation. The control group was given aminophylline oral treatment The CAT score, lung function, walking distance and acute exacerbation of patients before treatment and 12 weeks after treatment were compared between the two groups, and the safety evaluation indexes were evaluated. Results 60 patients completed 12 weeks of treatment, no loss of detached cases. Compared with those before treatment, CAT scores, acute exacerbations, FEV1, FEV1 / FVC, and exercise endurance scores improved in both groups (P <0.05). The treatment group improved significantly better than the control group (all P <0.05). There were 4 cases (13.3%) in the observation group and 3 cases (10.0%) in the control group. There was no significant difference between the two groups (P> 0.05). Adverse events in the observation group were mainly 2 cases of dry mouth, 1 case of headache, 1 case of increased serum creatinine, no abnormalities of cardiovascular system and abnormal electrocardiogram. The control group was one case of dry mouth, 1 case of sinus tachycardia, Branch conduction block in 1 case. There was no premature termination of study cases due to adverse events in both groups, and no serious adverse events occurred in both groups. Two sets of laboratory tests were normal. Conclusion Tiotropium bromide can effectively improve lung function and relieve clinical symptoms and is safe and effective.