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噻托溴铵每日一次给药对稳定期慢性阻塞性肺疾病的肺量计疗效:一项为期13周的多中心试验。美国噻托溴铵研究组。

The spirometric efficacy of once-daily dosing with tiotropium in stable COPD: a 13-week multicenter trial. The US Tiotropium Study Group.

作者信息

Casaburi R, Briggs D D, Donohue J F, Serby C W, Menjoge S S, Witek T J

机构信息

Harbor-UCLA Research and Education Institute (Dr. Casaburi), Torrance, CA 90509, USA.

出版信息

Chest. 2000 Nov;118(5):1294-302. doi: 10.1378/chest.118.5.1294.

Abstract

STUDY OBJECTIVE

To compare the bronchodilator efficacy and safety of tiotropium and placebo.

DESIGN

A 3-month, randomized, double-blind, placebo-controlled, multicenter trial.

SETTING

Outpatient.

PATIENTS

Four hundred seventy patients with stable COPD (mean FEV(1) = 38.6% predicted).

INTERVENTIONS

Tiotropium 18 microg (N = 279) or placebo (N = 191) given once daily via a lactose-based dry-powder inhaler device.

MEASUREMENTS AND RESULTS

Spirometry was evaluated on days 1, 8, 50, and 92. Data were expressed as the mean trough (ie, before morning dose; 23 to 24 h after previous dose) and average response observed in the 3 h after the dose was received. Tiotropium produced significant improvement in trough FEV(1) and FVC, averaging 12% greater than baseline on day 8; these improvements were maintained on days 50 and 92. The average postdose FEV(1) was 16% greater than baseline on day 1 and 20% greater than baseline on day 92; FVC was 17% greater than baseline on day 1 and 19% greater than baseline on day 92. Tiotropium was significantly more effective than placebo in both trough and average FEV(1) and FVC response (p < 0.001). These spirometric effects were corroborated by significant improvements in daily morning and evening peak expiratory flow rate, as well as a reduction in "as-needed" albuterol use. Symptoms of wheezing and shortness of breath were significantly less in patients receiving tiotropium, and the physician global assessment noted overall improvements with those treated with tiotropium relative to placebo. The most common reported adverse event after tiotropium was dry mouth (9.3% vs 1.6% relative to placebo; p < 0.05).

CONCLUSIONS

These data demonstrate that tiotropium is a safe and effective once-daily anticholinergic bronchodilator and should prove useful as first-line maintenance therapy in COPD.

摘要

研究目的

比较噻托溴铵与安慰剂的支气管扩张疗效及安全性。

设计

一项为期3个月的随机、双盲、安慰剂对照、多中心试验。

地点

门诊。

患者

470例稳定期慢性阻塞性肺疾病患者(预计第一秒用力呼气容积平均为预测值的38.6%)。

干预措施

通过基于乳糖的干粉吸入装置,每日一次给予18微克噻托溴铵(N = 279)或安慰剂(N = 191)。

测量指标与结果

在第1、8、50和92天进行肺量计评估。数据表示为平均谷值(即晨服前;上次给药后23至24小时)以及服药后3小时观察到的平均反应。噻托溴铵使谷值第一秒用力呼气容积和用力肺活量有显著改善,在第8天比基线平均增加12%;这些改善在第50天和第92天得以维持。服药后第一秒用力呼气容积在第1天比基线平均增加16%,在第92天比基线增加20%;用力肺活量在第1天比基线增加17%,在第92天比基线增加19%。在谷值以及平均第一秒用力呼气容积和用力肺活量反应方面,噻托溴铵比安慰剂显著更有效(p < 0.001)。每日早晚呼气峰值流速的显著改善以及“按需”使用沙丁胺醇的减少证实了这些肺量计效应。接受噻托溴铵治疗的患者喘息和气短症状明显减轻,医生整体评估指出,与安慰剂相比,接受噻托溴铵治疗的患者总体状况有所改善。噻托溴铵治疗后报告的最常见不良事件是口干(相对于安慰剂为9.3%对1.6%;p < 0.05)。

结论

这些数据表明,噻托溴铵是一种安全有效的每日一次抗胆碱能支气管扩张剂,应可作为慢性阻塞性肺疾病的一线维持治疗药物。

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