Kelly H W
College of Pharmacy, University of New Mexico Health Sciences Center, Albuquerque 87131, USA.
Ann Pharmacother. 1998 Feb;32(2):220-32. doi: 10.1345/aph.17014.
To review the comparative studies evaluating both efficacy and safety of inhaled corticosteroids in the management of asthma. Specifically, comparative clinical trials are evaluated that allow clinicians to determine relative potencies of the various inhaled corticosteroids.
A critical review was performed of the published clinical trials, either as articles or abstracts, comparing the clinical efficacy or systemic activity of inhaled corticosteroids. No a priori criteria were applied, as this was not a meta-analysis.
In vitro measures of antiinflammatory activity of corticosteroids consistently demonstrate potency differences among the various corticosteroids. Traditionally, these in vitro measures have been used to develop new corticosteroids with greater topical activity. While no accepted direct measure of antiasthmatic antiinflammatory activity exists, clinical trials using surrogate measures (e.g., forced expiratory volume in 1 second, peak expiratory flow, bronchial hyperresponsiveness, symptom control) indicate that in vitro measures provide a relatively accurate assessment of antiasthmatic potency. The relative antiinflammatory potency of the inhaled corticosteroids is in the following rank order. flunisolide = triamcinolone acetonide < beclomethasone dipropionate = budesonide < fluticasone. Studies of systemic activity appear to confirm this relative order of potency. Currently, no evidence exists for greater efficacy for any of the inhaled corticosteroids when administered in their relative equipotent dosages. The preponderance of current data suggests that when administered in equipotent antiinflammatory doses as a metered-dose inhaler plus spacer or as their respective dry-powder inhaler, the existing inhaled corticosteroids have similar risks of producing systemic effects.
Delivery systems can significantly affect both topical and systemic activity of inhaled corticosteroids. More direct comparative studies between agents are required to firmly establish comparative topical to systemic activity ratios. The preponderance of evidence suggests that the agents are not equipotent on a microgram basis.
回顾评估吸入性糖皮质激素治疗哮喘有效性和安全性的比较研究。具体而言,对比较性临床试验进行评估,以便临床医生确定各种吸入性糖皮质激素的相对效力。
对已发表的比较吸入性糖皮质激素临床疗效或全身活性的临床试验(文章或摘要形式)进行批判性综述。由于这不是一项荟萃分析,因此未应用先验标准。
糖皮质激素抗炎活性的体外测量结果始终表明不同糖皮质激素之间存在效力差异。传统上,这些体外测量方法已被用于开发具有更高局部活性的新型糖皮质激素。虽然不存在公认的直接测量抗哮喘抗炎活性的方法,但使用替代指标(如一秒用力呼气量、呼气峰值流速、支气管高反应性、症状控制)的临床试验表明,体外测量可相对准确地评估抗哮喘效力。吸入性糖皮质激素的相对抗炎效力按以下顺序排列。氟尼缩松 = 曲安奈德 < 二丙酸倍氯米松 = 布地奈德 < 氟替卡松。全身活性研究似乎证实了这种相对效力顺序。目前,没有证据表明任何一种吸入性糖皮质激素在相对等效剂量给药时具有更高的疗效。现有数据表明,当以等量抗炎剂量通过定量吸入器加储雾罐或各自的干粉吸入器给药时,现有的吸入性糖皮质激素产生全身作用的风险相似。
给药系统可显著影响吸入性糖皮质激素的局部和全身活性。需要更多药物之间的直接比较研究来牢固确立局部与全身活性的比较比率。大量证据表明,这些药物在微克基础上并非等效。