Holliday S M, Faulds D, Sorkin E M
Adis International Limited, Auckland, New Zealand.
Drugs. 1994 Feb;47(2):318-31. doi: 10.2165/00003495-199447020-00007.
Fluticasone propionate is an androstane carbothioate glucocorticosteroid with almost twice the topical anti-inflammatory potency of beclomethasone dipropionate. Importantly, it is not appreciably absorbed from the gastrointestinal tract. However, the fraction of active drug absorbed from the lungs after inhalation, and therefore total systemic availability, has yet to be determined. Inhaled fluticasone propionate administered at dosages of 1500 micrograms/day for 1 year or 2000 micrograms/day for 6 weeks did not cause clinically significant pituitary-adrenal suppression. Preliminary data from 2 published trials also indicate no significant effect on growth in children. However, wider clinical experience is needed to clarify the effects of long term administration on pituitary-adrenal function, bone metabolism and attainment of adult height in children. In clinical studies, inhaled fluticasone propionate was at least as effective as beclomethasone dipropionate or budesonide when administered at half the dosage of the comparators in patients with mild to moderate or severe asthma. Limited data suggest that fluticasone propionate also has considerable potential in the management of childhood asthma. In trials of up to 1 year in duration, fluticasone propionate appeared to be well tolerated by both adults and children. Whether an improved tolerability profile compared with other corticosteroids is a major clinical benefit of the extremely low oral bioavailability of inhaled fluticasone propionate requires confirmation. Nevertheless, on the basis of available data from initial clinical trials of mostly limited duration, inhaled fluticasone propionate offers an effective treatment option for the management of asthma, with the potential of an enhanced safety profile.
丙酸氟替卡松是一种雄甾烷硫代羧酸酯糖皮质激素,其局部抗炎效力几乎是二丙酸倍氯米松的两倍。重要的是,它几乎不会从胃肠道吸收。然而,吸入后从肺部吸收的活性药物比例以及因此的全身总可用性尚未确定。以1500微克/天的剂量吸入丙酸氟替卡松1年或2000微克/天的剂量吸入6周,均未引起临床上显著的垂体-肾上腺抑制。两项已发表试验的初步数据也表明对儿童生长没有显著影响。然而,需要更广泛的临床经验来阐明长期给药对儿童垂体-肾上腺功能、骨代谢和成人身高的影响。在临床研究中,对于轻至中度或重度哮喘患者,吸入丙酸氟替卡松的剂量为对照药物的一半时,其疗效至少与二丙酸倍氯米松或布地奈德相当。有限的数据表明,丙酸氟替卡松在儿童哮喘管理中也有相当大的潜力。在长达1年的试验中,丙酸氟替卡松似乎在成人和儿童中都具有良好的耐受性。与其他皮质类固醇相比,吸入丙酸氟替卡松极低的口服生物利用度是否能带来更好的耐受性这一主要临床益处尚需证实。尽管如此,根据大多为有限疗程的初始临床试验的现有数据,吸入丙酸氟替卡松为哮喘管理提供了一种有效的治疗选择,且有可能具有更高的安全性。