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国产噻托溴铵粉雾剂治疗慢性阻塞性肺疾病的多中心临床研究

A randomized, double-blind, placebo-control study of once-daily inhaled tiotropium in chronic obstructive pulmonary disease

摘要:

目的 评价国产噻托溴铵粉雾剂治疗COPD的临床疗效和安全性.方法 采用多中心、随机、双盲、安慰剂平行对照的研究方法,对205例筛选合格的I、Ⅱ级COPD稳定期患者,采用随机数字表法给予国产噻托溴铵粉雾剂18μg,每日1次,或用安慰剂治疗12周.在筛选期、用药后6和12周分别测定肺功能.结果 103例入选噻托溴铵组,用药后12周临床症状的控制率为25.2%(26/103),有效率为65.1%(67/103);102例入选对照组,用药后12周临床控制率为5.1%(5/99),有效率为30.3%(30/99).噻托溴铵组用药后12周FEV1增加值和增加率[(0.2±0.3)L和(19.2±29.1)%]明显高于对照组[(0.0±0.2)L和(0.8±18.2)%],FVC增加值和增加率(0.2 L和11.6%)明显高于对照组(0.0 L和2.2%).噻托溴铵组不良反应主要为口干和咽喉不适等,发生率(7.8%,8/103)略低于对照组(12.8%,13/102),差异无统计学意义(X2=1.381,P>0.05).结论 国产噻托溴铵粉雾剂可显著改善COPD患者的临床症状和肺功能,临床应用有效、安全.

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abstracts:

Objective To compare the efficacy and safety between tiotropium capsule and placebo in a 12-week treatment in patients with chronic obstructive pulmonary disease (COPD). Methods A multi-center, randomized, double-blind, and placebo-control clinical trial was conducted in 205 patients with stable COPD. They were randomized into inhaled tiotropium 18 μg once daily or placebo, lasting for 12 weeks. The spiromentry was conducted at baseline, 6 and 12 weeks after treatment. Results A total of 205 patients with stable stage Ⅰ or Ⅱ COPD were randomized to tiotropium and placebo groups. The improvement rate of clinical symptom in the tiotropium group was 25. 2% (26/103 ) after a 12 week treatment, but that of the control group was 4. 9% (5/102). The forced expiratory volume in one second (FEV1 ) and forced vital capacity (FVC) in the tiotropium group increased (0. 2 ± 0. 3) L and (19. 2 ± 29. 1)% after the 12 week therapy, but only (0. 0 ±0. 2) L and (0. 8 ± 18. 2) % in the placebo group. The rate of adverse reaction in the tiotropium group was 7. 8% (8/103), but in the placebo group was 12. 8% (13/102). The difference between the 2 groups was not significant All adverse reactions were mild, including dry mouth and sore throat Conclusions This trial confirmed that tiotropium powder 18 μg once daily relieved dyspnea, prevented aggravation and improved pulmonary function, clinical symptoms and life quality. Tiotropium was a safe and effective once-daily anticholinergic bronchodilator as first-line maintenance therapy in COPD.

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