环索奈德和氟替卡松对持续性哮喘患者皮质醇分泌的影响
2010/01/07
关键词：吸入治疗；抗哮喘药；哮喘；支气管高反应性；皮质醇；吸入激素
为了比较环索奈德（ciclesonide, CIC)）和氟替卡松(fluticasone propionate, FP)的全身作用和临床疗效，Derom等对32个持续性哮喘患者进行了一项随机、双盲、双模拟、安慰剂对照、5段式的交叉研究。
研究对象为中度持续哮喘患者，乙酰甲胆碱激发阳性的浓度PC20<8 mg·mL–1 ，腺苷激发阳性的浓度PC20<60 mg·mL–1。所有患者均以CIC 160 µg·day–1 和沙美特罗50 µg b.i.d为基础治疗，并在此基础上按方案给予以下治疗：CIC 160 µg b.i.d、CIC 320 µg b.i.d.、FP 250 µg b.i.d.、FP 500 µg b.i.d或安慰剂。研究主要结果为7天后24小时血清皮质醇抑制程度，次要结果为9天后乙酰甲胆碱和腺苷激发阳性浓度PC20的变化。
FP （500 µg·day–1 或 1,000 µg·day–1 ）治疗能明显抑制考的松的分泌，与安慰剂相比分别下降 -46.2 (95%CI -83.8– -8.5) nmol·L–1 和 -76.1 (95% CI -112.9– -39.3) nmol·L–1。CIC (320 或 640 µg·day–1)对考的松分泌的抑制与安慰剂相比分别下降-28.2 (95% CI -65.5–9.2) nmol·L–1 和 -37.3 (95% CI -74.7–0.0) nmol·L–1，但均不具有统计学意义，且均低于FP（1,000 µg·day–1 ）的作用 (CIC 320 µg·day–1: -48.0 (95% CI -84.8– -11.1) nmol·L–1; CIC 640 µg·day–1: -38.8 (95% CI -75.7– -1.9) nmol·L–1)。
与安慰剂相比，4种治疗后腺苷PC20 均有小幅增加且具有统计学意义。FP（500 µg·day–1）治疗后腺苷PC20 改善(1.8 (95% CI 1.0–2.6)优于CIC （320 µg·day–1）的作用(0.9 (95% CI 0.1–1.7)，而FP（1,000 µg·day–1）和CIC（640 µg·day–1）治疗后腺苷PC20 的变化没有统计学差异。
研究表明，虽然同样降低气道高反应性，但环索奈德治疗并不出现大剂量氟替卡松所引起的皮质激素分泌抑制，因而更适合用于持续性哮喘的长期治疗。
为了比较环索奈德（ciclesonide, CIC)）和氟替卡松(fluticasone propionate, FP)的全身作用和临床疗效，Derom等对32个持续性哮喘患者进行了一项随机、双盲、双模拟、安慰剂对照、5段式的交叉研究。
研究对象为中度持续哮喘患者，乙酰甲胆碱激发阳性的浓度PC20<8 mg·mL–1 ，腺苷激发阳性的浓度PC20<60 mg·mL–1。所有患者均以CIC 160 µg·day–1 和沙美特罗50 µg b.i.d为基础治疗，并在此基础上按方案给予以下治疗：CIC 160 µg b.i.d、CIC 320 µg b.i.d.、FP 250 µg b.i.d.、FP 500 µg b.i.d或安慰剂。研究主要结果为7天后24小时血清皮质醇抑制程度，次要结果为9天后乙酰甲胆碱和腺苷激发阳性浓度PC20的变化。
FP （500 µg·day–1 或 1,000 µg·day–1 ）治疗能明显抑制考的松的分泌，与安慰剂相比分别下降 -46.2 (95%CI -83.8– -8.5) nmol·L–1 和 -76.1 (95% CI -112.9– -39.3) nmol·L–1。CIC (320 或 640 µg·day–1)对考的松分泌的抑制与安慰剂相比分别下降-28.2 (95% CI -65.5–9.2) nmol·L–1 和 -37.3 (95% CI -74.7–0.0) nmol·L–1，但均不具有统计学意义，且均低于FP（1,000 µg·day–1 ）的作用 (CIC 320 µg·day–1: -48.0 (95% CI -84.8– -11.1) nmol·L–1; CIC 640 µg·day–1: -38.8 (95% CI -75.7– -1.9) nmol·L–1)。
与安慰剂相比，4种治疗后腺苷PC20 均有小幅增加且具有统计学意义。FP（500 µg·day–1）治疗后腺苷PC20 改善(1.8 (95% CI 1.0–2.6)优于CIC （320 µg·day–1）的作用(0.9 (95% CI 0.1–1.7)，而FP（1,000 µg·day–1）和CIC（640 µg·day–1）治疗后腺苷PC20 的变化没有统计学差异。
研究表明，虽然同样降低气道高反应性，但环索奈德治疗并不出现大剂量氟替卡松所引起的皮质激素分泌抑制，因而更适合用于持续性哮喘的长期治疗。
（韩伟 青岛市市立医院东院呼吸科 266071 摘译）
（Eur Respir J 2009; 33:1277-1286）
（Eur Respir J 2009; 33:1277-1286）
Effects of ciclesonide and fluticasone on cortisol secretion in patients with persistent asthma
E. Derom1, R. Louis2, C. Tiesler3, R. Engelstätter3, J-M. Kaufman4 and G. F. Joos1
Keywords: Aerosol therapy, anti-asthmatic agent, asthma, bronchial hyperreactivity, cortisol, inhaled corticosteroids
We compared the systemic and clinical effects of ciclesonide (CIC) and fluticasone propionate (FP) administered, in addition to CIC 160 µg·day–1 and salmeterol 50 µg twice daily, in 32 patients with persistent asthma using a randomised double-blind, placebo-controlled, double-dummy, five-period crossover design.
All patients exhibited a provocative concentration leading to a 20% decrease in forced expiratory volume in 1 s (PC20) methacholine <8 mg·mL–1 and a PC20 adenosine <60 mg·mL–1. Primary outcome was 24-h serum cortisol suppression after 7 days. Secondary outcomes were changes in PC20 methacholine and adenosine after 9 days.
FP 500 µg·day–1 and 1,000 µg·day–1 significantly suppressed cortisol secretion versus placebo by -46.2 (95% confidence interval (CI) -83.8– -8.5) nmol·L–1 and by -76.1 (95% CI -112.9– -39.3) nmol·L–1, respectively. Neither dose of CIC (320 nor 640 µg·day–1) had a significant suppressive effect (-28.2 (95% CI -65.5–9.2) nmol·L–1 and -37.3 (95% CI -74.7–0.0) nmol·L–1, respectively). Differences between FP 1,000 µg·day–1 and both CIC treatments were statistically significant (CIC 320 µg·day–1: -48.0 (95% CI -84.8– -11.1) nmol·L–1; CIC 640 µg·day–1: -38.8 (95% CI -75.7– -1.9) nmol·L–1). Compared with placebo, the increase in PC20 adenosine after the four treatments was small, but significant. Greater improvements in PC20 adenosine were seen with FP 500 µg·day–1 (1.8 (95% CI 1.0–2.6) doubling concentrations) compared with CIC 320 µg·day–1 (0.9 (95% CI 0.1–1.7) doubling concentrations). No significant difference was seen between CIC 640 µg·day–1 and FP 1,000 µg·day–1.
Compared with placebo, the increase in PC20 adenosine after the four treatments was small, but significant. Greater improvements in PC20 adenosine were seen with FP 500 µg·day–1 (1.8 (95% CI 1.0–2.6) doubling concentrations) compared with CIC 320 µg·day–1 (0.9 (95% CI 0.1–1.7) doubling concentrations). No significant difference was seen between CIC 640 µg·day–1 and FP 1,000 µg·day–1.
For a similar decrease in hyperresponsiveness, cortisol secretion was suppressed significantly with moderate-to-high doses of fluticasone propionate, but not with ciclesonide.
Eur Respir J 2009; 33:1277-1286
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