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每日两次服用的沙丁胺醇控释片与每日四次服用的标准片剂在慢性阻塞性肺疾病管理中的比较。

Comparison of a controlled-release tablet of salbutamol given twice daily with a standard tablet given four times daily in the management of chronic obstructive lung disease.

作者信息

Maesen F P, Smeets J J

出版信息

Eur J Clin Pharmacol. 1986;31(4):431-6. doi: 10.1007/BF00613520.

Abstract

In a double-blind cross-over study 20 patients with reversible airways obstruction were treated either with conventional 4 mg tablets of salbutamol a.i.d., or 8 mg controlled release (CR) tablets of salbutamol b.d. Each treatment was given for 2 weeks. The morning PEFR was significantly higher with the CR tablets (p less than 0.05) but although the evening PEFR was also better the difference was not significant. Wheeze was significantly lower (p less than 0.05) and extra "rescue" inhalation of bronchodilators was required less often and on fewer occasions during treatment with the CR tablets. Comparison of the 12-h mean plasma salbutamol profile showed a peak and trough every 6 h with the standard tablets, and a flatter profile with a single, lower and delayed peak during the 12 h between CR tablets. Although the minimum and average plasma salbutamol levels were similar in the groups on the two preparations, the maximum plasma level was significantly lower and there was significantly less fluctuation on CR tablets (p less than 0.02). The CR and standard tablets had equivalent bio-availability.

摘要

在一项双盲交叉研究中,20例可逆性气道阻塞患者分别接受常规的沙丁胺醇有效成分4毫克片剂治疗,或沙丁胺醇8毫克控释(CR)片剂每日两次治疗。每种治疗持续2周。使用CR片剂时早晨的呼气峰流速(PEFR)显著更高(p<0.05),尽管晚上的PEFR也更好,但差异不显著。喘息显著减轻(p<0.05),并且在使用CR片剂治疗期间,额外“急救”吸入支气管扩张剂的频率和次数更少。12小时平均血浆沙丁胺醇曲线比较显示,标准片剂每6小时有一个峰谷,而CR片剂在12小时内有一个更平缓的曲线,有一个单一、较低且延迟的峰。尽管两组接受两种制剂治疗时血浆沙丁胺醇的最低水平和平均水平相似,但CR片剂的血浆最高水平显著更低,波动也显著更小(p<0.02)。CR片剂和标准片剂具有等效的生物利用度。

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