Department of General Practice, University Medical Center Groningen, University of Groningen, Hanzeplein 1, Groningen, The Netherlands.
Respir Med. 2010 Dec;104(12):1825-33. doi: 10.1016/j.rmed.2010.05.021. Epub 2010 Jul 2.
Patient-reported outcomes provide new insights into the dynamics of asthma management. Further to asthma control and quality of life, self-reported side effects of treatment can be assessed with the validated Inhaled Corticosteroid Questionnaire (ICQ).
To compare patient-reported side effects between the inhaled corticosteroids ciclesonide and fluticasone propionate.
Patients with moderate or moderate-to-severe asthma, pre-treated with a constant dose and type of medication, were randomized in three separate studies: 1) once daily ciclesonide 320 μg (n = 234) or twice daily fluticasone propionate 200 μg (n = 240); 2) twice daily ciclesonide 320 μg (n = 255) or twice daily fluticasone propionate 375 μg (n = 273); and 3) twice daily ciclesonide 320 μg (n = 259) or twice daily fluticasone propionate 500 μg (n = 244). Patients rated the side effect questions of the 15 domain ICQ on a 7-point Likert scale (0 = not at all, 6 = a very great deal) during scheduled visits.
The majority of side effect scores remained similar with ciclesonide but worsened statistically significantly with fluticasone propionate from baseline to the end of the study in within-treatment analyses. In between-treatment analyses of studies 1 and 3 ciclesonide significantly improved total side effect scores (p < 0.025) and 14 out of 30 individual local and systemic domain scores (p < 0.025) compared with fluticasone propionate. In Study 2, although ciclesonide improved the majority of scores compared with fluticasone propionate only 'oropharyngeal itching' reached statistical significance (p < 0.025, one-sided).
Patient-perceived side effects differ depending on the type of inhaled corticosteroids used. Patients with moderate-to-severe asthma report less intense side effects assessed with ICQ with ciclesonide than with fluticasone propionate.
The reported trials were completed before July 1 2005 and, therefore, are not registered.
患者报告的结局为哮喘管理动态提供了新的视角。除了哮喘控制和生活质量之外，还可以使用经过验证的吸入皮质激素问卷（ICQ）评估治疗的自我报告副作用。
比较吸入皮质激素昔萘酸沙美特罗和丙酸氟替卡松的患者报告副作用。
预先用固定剂量和药物类型治疗的中重度或中重度哮喘患者随机分为三项独立研究：1）每日一次昔萘酸沙美特罗 320μg（n=234）或每日两次丙酸氟替卡松 200μg（n=240）；2）每日两次昔萘酸沙美特罗 320μg（n=255）或每日两次丙酸氟替卡松 375μg（n=273）；3）每日两次昔萘酸沙美特罗 320μg（n=259）或每日两次丙酸氟替卡松 500μg（n=244）。患者在预定就诊时使用 7 分李克特量表（0=一点也不，6=非常多）对 ICQ 的 15 个域的副作用问题进行评分。
在治疗内分析中，与昔萘酸沙美特罗相比，大多数副作用评分在研究期间从基线到结束时保持相似，但与丙酸氟替卡松相比，统计学上显著恶化。在研究 1 和 3 的治疗间分析中，昔萘酸沙美特罗与丙酸氟替卡松相比，显著改善了总副作用评分（p<0.025）和 30 个局部和全身域评分中的 14 个（p<0.025）。在研究 2 中，尽管与丙酸氟替卡松相比，昔萘酸沙美特罗改善了大多数评分，但只有“咽喉瘙痒”达到统计学意义（p<0.025，单侧）。
患者感知的副作用因使用的吸入皮质激素类型而异。中重度哮喘患者使用昔萘酸沙美特罗报告的副作用强度低于丙酸氟替卡松。
报告的试验均在 2005 年 7 月 1 日前完成，因此未注册。
