Ophthalmology Service, Hospital San Pedro, Logroño, Spain.
PLoS One. 2012;7(12):e52696. doi: 10.1371/journal.pone.0052696. Epub 2012 Dec 19.
To determine whether oral doxycycline treatment reduces pterygium lesions.
Double blind, randomized, placebo controlled clinical trial.
98 adult patients with primary pterygium.
Patients were randomly assigned to receive 100 mg oral doxycycline twice a day (49 subjects), or placebo (49 subjects), for 30 days. Photographs of the lesion were taken at the time of recruitment and at the end of the treatment. Follow-up sessions were performed 6 and 12 months post-treatment. Statistical analyses for both continuous and categorical variables were applied. p values of less than 0.05 were considered to indicate statistical significance.
The primary endpoint was the change in lesion size after 30 days of treatment.
The primary endpoint was not met for the whole population but subgroup analysis showed that doxycycline was effective in patients of Caucasian origin while other ethnicities, mostly Hispanic, did not respond to the treatment. Moreover, there was a correlation between age and better response (p = 0.003). Adverse events were uncommon, mild, and in agreement with previous reports on short doxycycline treatments.
Oral doxycycline was superior to placebo for the treatment of primary pterygia in older Caucasian patients. These findings support the use of doxycycline for pterygium treatment in particular populations.
European Union Clinical Trials Register EudraCT 2008-007178-39.
确定口服多西环素治疗是否能减少翼状胬肉病变。
双盲、随机、安慰剂对照临床试验。
98 名原发性翼状胬肉的成年患者。
患者随机分为两组,每天口服 100 毫克多西环素两次(49 例)或安慰剂(49 例),共 30 天。在招募时和治疗结束时拍摄病变的照片。在治疗后 6 个月和 12 个月进行随访。对连续和分类变量均进行了统计分析。p 值小于 0.05 表示具有统计学意义。
主要终点是治疗 30 天后病变大小的变化。
整个人群的主要终点未达到,但亚组分析显示,多西环素对白人患者有效,而其他种族(主要是西班牙裔)对治疗无反应。此外,年龄与更好的反应之间存在相关性(p=0.003)。不良反应罕见且轻微,与短期多西环素治疗的先前报告一致。
口服多西环素在治疗老年白人原发性翼状胬肉方面优于安慰剂。这些发现支持在特定人群中使用多西环素治疗翼状胬肉。
欧洲联盟临床试验注册 EudraCT 2008-007178-39。