Chylack Leo T, Gross Gary N, Pedinoff Andrew
Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts, USA.
J Asthma. 2008 Dec;45(10):893-902. doi: 10.1080/02770900802353636.
Inhaled corticosteroids (ICS) are recommended first-line therapy for the treatment of persistent asthma. However, reports from observational studies have suggested that the use of ICS may be associated with systemic adverse events, such as glaucoma and cataract (opacity of the lens) formation.
To compare two ICS over 1 year regarding the formation/progression of lenticular opacities in patients with asthma.
Adults (>or=18 years of age) with moderate-to-severe asthma were randomized to ciclesonide 640 micro g/day (n = 785) or beclomethasone dipropionate 640 micro g/day (n = 783) in a multinational, double-blind, active-controlled, parallel-group study. The primary endpoint was the occurrence of a positive Class I grading shift (increase [worsening] in Lens Opacities Classification System [LOCS] III score of >or= 0.5 for nuclear opalescence, >or= 0.8 for cortical opacification, or >or= 0.5 for posterior subcapsular opacification, or cataract surgery) in either eye at any visit over the 12-month, double-blind treatment period.
Mean changes (+/- standard error) in nuclear opalescence and cortical and posterior subcapsular opacification were small and similar between groups (ciclesonide 640 micro g/day: 0.10 +/- 0.02, 0.07 +/- 0.02 and 0.04 +/- 0.01, respectively; beclomethasone dipropionate 640 micro g/day: 0.11 +/- 0.02, 0.09 +/- 0.02 and 0.03 +/- 0.01, respectively). Class I shifts were observed in 34.3% versus 36.8% of ciclesonide-treated and beclomethasone dipropionate-treated patients, respectively. Ciclesonide 640 micro g/day was non-inferior to beclomethasone dipropionate 640 micro g/day regarding Class I shifts (risk ratio of ciclesonide to beclomethasone dipropionate, 0.940 [95% confidence interval, 0.820-1.077]); the 95% confidence interval upper bound was lower than the pre-specified non-inferiority bound of 1.333 (p < 0.0001), thereby excluding the possibility of higher risk ratio values.
Mean changes in LOCS III scores were very small in both groups. Treatment with ciclesonide 640 micro g/day or beclomethasone dipropionate 640 micro g/day for 1 year has a minimal impact on lenticular opacities development and/or progression.
吸入性糖皮质激素（ICS）被推荐为持续性哮喘的一线治疗药物。然而，观察性研究报告提示，使用ICS可能与全身性不良事件相关，如青光眼和白内障（晶状体混浊）形成。
比较两种ICS在1年时间里对哮喘患者晶状体混浊形成/进展的影响。
在一项多国、双盲、活性药物对照、平行组研究中，将年龄≥18岁的中重度哮喘成年患者随机分为两组，分别接受每日640μg环索奈德治疗（n = 785）或每日640μg二丙酸倍氯米松治疗（n = 783）。主要终点是在为期12个月的双盲治疗期内，任何一次随访时，任意一只眼中出现I级分级正向改变（晶状体混浊分类系统[LOCS]III评分中核混浊增加[恶化]≥0.5、皮质混浊增加≥0.8、后囊下混浊增加≥0.5，或进行白内障手术）。
两组的核混浊、皮质混浊和后囊下混浊的平均变化（±标准误）均较小且相似（每日640μg环索奈德组分别为0.10±0.02、0.07±0.02和0.04±0.01；每日640μg二丙酸倍氯米松组分别为0.11±0.02、0.09±0.02和0.03±0.01）。环索奈德治疗组和二丙酸倍氯米松治疗组分别有34.3%和36.8%的患者出现I级改变。在I级改变方面，每日640μg环索奈德不劣于每日640μg二丙酸倍氯米松（环索奈德与二丙酸倍氯米松的风险比为0.940[95%置信区间，0.820 - 1.077]）；95%置信区间上限低于预先设定的非劣效界值1.333（p < 0.0001），从而排除了风险比更高的可能性。
两组的LOCS III评分平均变化都非常小。每日640μg环索奈德或每日640μg二丙酸倍氯米松治疗1年对晶状体混浊的发生和/或进展影响极小。
