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丙酸倍氯米松气雾剂治疗重度慢性哮喘疗效的分级剂量评估

A graded dose assessment of the efficacy of beclomethasone dipropionate aerosol for severe chronic asthma.

作者信息

Toogood J H, Lefcoe N M, Haines D S, Jennings B, Errington N, Baksh L, Chuang L

出版信息

J Allergy Clin Immunol. 1977 Apr;59(4):298-308. doi: 10.1016/0091-6749(77)90051-3.

Abstract

In a 26-wk double-blind controlled study of 34 patients whose asthma had been poorly controlled despite oral steroids, valuable clinical and pulmonary function improvement was derived by adding beclomethasone aerosol to the prednisone regimen. The amount of improvement correlated linearly with beclomethasone dosage over the range 200 to 1,600 microng/day. These patients required relatively high dosage. Success in achieving asymptomatic status was only 26% with the conventional 400 microng/day and 60% at 1,600 microng/day. Oropharyngeal candidiasis was also dose-related but did not prohibit the use of high-dosage beclomethasone. Respiratory infections, physical signs, blood glucose, and electrolytes were unaffected by the drug. A dose-related suppression of cortisol secretion was demonstrated, but about 1/4 of the group had normal plasma cortisol even at 1,600 microng/day plus the oral prednisone. An individualized risk-benefit assessment seems a better basis for choosing an optimal beclomethasone regimen for each patient than adherence to a conventionalized fixed dosage of 400 microng/day. This requires definition of: (1) a specific goal of treatment in the individual patient and the beclomethasone dosage required to achieve it; (2) the adrenocortical functional response of that particular patient to the desired dose of beclomethasone; and (3) the presence and degree of any dose-limiting constraints such as preexisting complications of steroid use.

摘要

在一项针对34例尽管使用口服类固醇但哮喘仍控制不佳的患者进行的为期26周的双盲对照研究中,在泼尼松治疗方案中添加倍氯米松气雾剂可带来有价值的临床和肺功能改善。改善程度在200至1600微克/天的范围内与倍氯米松剂量呈线性相关。这些患者需要相对高的剂量。采用常规的400微克/天,达到无症状状态的成功率仅为26%,而在1600微克/天的剂量下为60%。口咽念珠菌病也与剂量相关,但并不妨碍使用高剂量倍氯米松。呼吸道感染、体征、血糖和电解质均不受该药物影响。已证实存在剂量相关的皮质醇分泌抑制,但即使在1600微克/天加口服泼尼松的情况下,该组中约四分之一的患者血浆皮质醇仍正常。对于为每位患者选择最佳倍氯米松治疗方案而言,个体化的风险效益评估似乎比坚持400微克/天的常规固定剂量是更好的依据。这需要明确:(1)个体患者的具体治疗目标以及实现该目标所需的倍氯米松剂量;(2)该特定患者对所需剂量倍氯米松的肾上腺皮质功能反应;以及(3)是否存在任何剂量限制因素及其程度,例如类固醇使用的既往并发症。

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