Sheffer A L, LaForce C, Chervinsky P, Pearlman D, Schaberg A
Brigham and Women's Hospital, Boston, Massachusetts, 02115, USA.
J Fam Pract. 1996 Apr;42(4):369-75.
This double-blind, randomized, parallel-group, placebo-controlled study investigated the efficacy and tolerability of fluticasone propionate aerosol (25, 50, or 100 mg bid for 12 weeks) administered as primary maintenance therapy to patients whose mild to moderate asthma was inadequately controlled by as-needed use of an inhaled beta-agonist.
At all clinic visits, fluticasone propionate compared with placebo was associated with significant (P<.05) improvement in pulmonary function indexed by forced expiratory volume in 1 second (FEV1) as well as fewer night awakenings and less use of rescue albuterol. Values for patient-measured morning peak expiratory flow rates (PEFR) were significantly (P<.05) higher and the use of rescue albuterol was significantly (P<.05) lower beginning 3 to 5 days after initiation of therapy in the groups treated with fluticasone propionate, compared with the placebo group. Maximal improvement in FEV1 was achieved during the second week of treatment and maintained throughout the course of therapy. Differences among the three fluticasone propionate dosing groups for these efficacy measures were not statistically significant. The incidence of adverse events was similar across groups.
These data indicate that fluticasone propionate aerosol is an effective and well-tolerated treatment for asthma and significantly improves pulmonary function within days of initiation of treatment in patients whose asthma is inadequately controlled with as-needed beta-agonists.
本双盲、随机、平行组、安慰剂对照研究调查了丙酸氟替卡松气雾剂（每日两次，每次25、50或100毫克，共12周）作为初始维持治疗药物，用于按需使用吸入型β受体激动剂但中轻度哮喘控制不佳患者的疗效和耐受性。
在所有门诊就诊时，与安慰剂相比，丙酸氟替卡松可使以一秒用力呼气量（FEV1）为指标的肺功能显著改善（P<0.05），夜间觉醒次数减少，沙丁胺醇急救药物使用量降低。与安慰剂组相比，丙酸氟替卡松治疗组在治疗开始3至5天后，患者自测的早晨呼气峰值流速（PEFR）值显著更高（P<0.05），沙丁胺醇急救药物的使用量显著更低（P<0.05）。FEV1在治疗的第二周达到最大改善，并在整个治疗过程中维持。这三种丙酸氟替卡松给药组在这些疗效指标上的差异无统计学意义。各组不良事件的发生率相似。
这些数据表明，丙酸氟替卡松气雾剂是一种有效且耐受性良好的哮喘治疗药物，对于按需使用β受体激动剂但哮喘控制不佳的患者，在治疗开始数天内即可显著改善肺功能。
