State Key Laboratory of Respiratory Disease/Guangzhou Institute of Respiratory Disease, Guangzhou Medical University, Guangzhou, Guangdong 510120, China.
Chin Med J (Engl). 2013;126(19):3603-7.
A pharmacokinetic study in an Asian population showed that tiotropium 5 µg via Respimat leads to the same plasma levels compared to 18 µg via HandiHaler. The objective of the trial was to compare the efficacy and safety of longterm treatment (1 year) with tiotropium bromide (5 µg) via Respimat® with placebo in patients with chronic obstructive pulmonary disease (COPD).
A total of 3991 patients were randomized in this double-blind, placebo controlled, parallel group study, while in China 338 patients (309 males, 29 females) received either tiotropium bromide (n = 167) or placebo (n = 171). Tiotropium bromide solution or matching placebo was delivered via Respimat® at a dosage of 5 µg (2×2.5 µg/puff) once daily for 48 weeks. Co-primary endpoints were trough forced expiratory volume in one second (FEV1) and the time to first exacerbation.
Statistically significant improvements in trough FEV1 and trough forced vital capacity (FVC) in the tiotropium group were achieved at weeks 4, 24, and 48 compared with those in the placebo group. A statistically significant difference (P = 0.0027) in favour of tiotropium was also observed for the time to first exacerbation. The total numbers of exacerbations during treatment were 90 and 128 in the tiotropium and placebo groups, respectively, with a rate ratio of 0.69 (P = 0.0164). The difference between the treatment groups in the adjusted mean changes from baseline of St. George Respiratory Questionnaire (SGRQ) total score was -3.9 (95% CI: -7.5, -0.2) and was of statistical significance (P = 0.0367). The incidences of serious adverse events (SAEs) in the tiotropium and placebo groups were 16.2% and 17.0%, respectively. Seven deaths occurred whilst patients were on treatment, four in the tiotropium group and three in the placebo group, all of which were assessed as non-related study drugs by the investigators.
Tiotropium significantly improved lung function and quality of life, delayed the time to first exacerbation, reduced the number of exacerbations. Overall, tiotropium was well tolerated.
一项在亚洲人群中的药代动力学研究表明，经 Respimat 给予的噻托溴铵 5μg 可达到与经 HandiHaler 给予的 18μg 相同的血浆水平。本试验的目的是比较长效治疗（1 年）时，经 Respimat®给予的噻托溴铵（5μg）与安慰剂在慢性阻塞性肺疾病（COPD）患者中的疗效和安全性。
这项双盲、安慰剂对照、平行分组研究共纳入了 3991 例患者，其中在中国纳入了 338 例患者（309 例男性，29 例女性），他们被随机分配至噻托溴铵组（n=167）或安慰剂组（n=171）。噻托溴铵溶液或匹配的安慰剂经 Respimat®每日 1 次给予 5μg（2×2.5μg/喷），共治疗 48 周。主要复合终点为谷值用力呼气量（FEV1）和首次加重时间。
与安慰剂组相比，噻托溴铵组在第 4、24 和 48 周时的谷值 FEV1 和谷值用力肺活量（FVC）均获得了统计学显著的改善。在首次加重时间方面，噻托溴铵组也具有统计学显著的优势（P=0.0027）。治疗期间，噻托溴铵组和安慰剂组的加重例数分别为 90 例和 128 例，治疗组比为 0.69（P=0.0164）。调整基线 St. George 呼吸问卷（SGRQ）总评分后的治疗组间平均变化差值为-3.9（95%CI：-7.5，-0.2），差异具有统计学意义（P=0.0367）。噻托溴铵组和安慰剂组的严重不良事件（SAE）发生率分别为 16.2%和 17.0%。7 例患者在治疗期间死亡，其中 4 例在噻托溴铵组，3 例在安慰剂组，研究者均评估为与研究药物无关。
噻托溴铵可显著改善肺功能和生活质量，延迟首次加重时间，减少加重次数。总的来说，噻托溴铵具有良好的耐受性。
