Wilson A M, Duong M, Pratt B, Dolovich M, O'Byrne P M
Biomedicine Group, School of Medicine, Health Policy and Practice, University of East Anglia, Norwich, UK.
Allergy. 2006 May;61(5):537-42. doi: 10.1111/j.1398-9995.2006.01061.x.
Ciclesonide exhibits clinical efficacy at 160 microg (ex-actuator) once daily but the anti-inflammatory effects at this dose are not known. We wished to know whether 4 weeks therapy with ciclesonide pMDI 160 microg once daily in the morning exhibited significant anti-inflammatory effects.
Seventeen patients with mild persistent asthma (FEV(1) 3.35 l) were recruited into a double-blind placebo-controlled randomized crossover study. Measurements were made after ciclesonide and placebo treatment as well as after run-in and washout periods, for adenosine monophosphate (AMP) bronchial challenge (primary variable), exhaled nitric oxide (NO) and induced sputum (in a subgroup).
The mean (SEM) AMP bronchial challenge PC(20) following ciclesonide (140 (63) mg/ml) was significantly (P < 0.001) increased compared with placebo (17 (8) mg/ml), run-in (13 (5) mg/ml) and washout (9 (3) mg/ml) periods. This amounted to an eightfold (CI: 5.3-12.0) for ciclesonide vs placebo. Likewise, there were significant improvements in exhaled NO levels and a significant reduction in induced sputum eosinophil cell counts.
We have shown that inhaled ciclesonide given at 160 microg once daily in the morning exhibits significant anti-inflammatory effects that are in keeping with the previously described clinical effects.
环索奈德每天一次160微克(从吸入装置喷出量)具有临床疗效,但此剂量的抗炎作用尚不清楚。我们想了解每天早晨使用160微克环索奈德压力定量吸入器治疗4周是否具有显著的抗炎作用。
17例轻度持续性哮喘患者(第一秒用力呼气容积[FEV(1)]为3.35升)被纳入一项双盲安慰剂对照随机交叉研究。在环索奈德和安慰剂治疗后以及导入期和洗脱期后进行测量,包括单磷酸腺苷(AMP)支气管激发试验(主要变量)、呼出一氧化氮(NO)和诱导痰(在一个亚组中)。
与安慰剂(17(8)毫克/毫升)、导入期(13(5)毫克/毫升)和洗脱期(9(3)毫克/毫升)相比,环索奈德治疗后(140(63)毫克/毫升)的平均(标准误)AMP支气管激发试验PC(20)显著升高(P<0.001)。环索奈德与安慰剂相比升高了8倍(可信区间:5.3-12.0)。同样,呼出NO水平有显著改善,诱导痰嗜酸性粒细胞计数显著降低。
我们已表明,每天早晨吸入160微克环索奈德具有显著的抗炎作用,这与先前描述的临床效果一致。