Campbell J Peter, Mkocha Harran, Munoz Beatriz, West Sheila K
Dana Center for Preventive Ophthalmology, Wilmer Eye Institute, Johns Hopkins University , Baltimore, Maryland , USA.
Ophthalmic Epidemiol. 2012 Feb;19(1):38-42. doi: 10.3109/09286586.2011.627490.
To determine whether 2-day dosing of azithromycin may improve the efficacy of azithromycin dosing in children with severe trachoma.
Fifty children with severe trachoma (defined as either trachoma intense or follicular trachoma with ten or more follicles) were enrolled from five villages in Kongwa, Tanzania. Enrollment occurred within 1 month and within the same district as the historical control population of 99 children with severe trachoma, all of whom received 1-day dosing. Baseline data on age, sex, and trachoma status were obtained, and swabs for determination of Chlamydia trachomatis were taken. All 50 children received 20 mg/kg azithromycin daily for 2 days, which was directly observed. Children were followed up at 6 weeks for trachoma and infection. The laboratory was masked to treatment assignment.
Baseline characteristics were similar between the treatment group and the control group. A total of 1/46 (2.2%) of children in the treatment group were polymerase chain reaction (PCR)-positive at 6 weeks, a 96.3% reduction from baseline, compared to 13/96 (13.5%) in the historical control group, an 89.4% reduction. This difference was statistically significant. However when modeled using logistic regression and accounting for age, gender, weight, and baseline percent PCR positivity, the difference was not significant. Prevalence of clinical trachoma did not differ between the groups at 6 weeks.
For children with severe trachoma, a randomized controlled trial of 2-day versus 1-day treatment may be warranted.
确定阿奇霉素两日给药方案是否可提高重度沙眼患儿阿奇霉素给药的疗效。
从坦桑尼亚孔瓜的五个村庄招募了50名重度沙眼患儿（定义为严重沙眼或有十个及以上滤泡的滤泡性沙眼）。招募在1个月内进行，且与99名重度沙眼历史对照人群在同一地区，所有历史对照人群均接受一日给药。获取了年龄、性别和沙眼状况的基线数据，并采集了用于检测沙眼衣原体的拭子。所有50名儿童均接受每日20mg/kg阿奇霉素，共2天，给药过程直接观察。在6周时对儿童进行沙眼和感染情况的随访。实验室人员对治疗分配情况不知情。
治疗组和对照组的基线特征相似。治疗组中共有1/46（2.2%）的儿童在6周时聚合酶链反应（PCR）呈阳性，较基线时降低了96.3%，而历史对照组中为13/96（13.5%），降低了89.4%。这一差异具有统计学意义。然而，在使用逻辑回归模型并考虑年龄、性别、体重和基线PCR阳性百分比后，差异不显著。6周时两组间临床沙眼患病率无差异。
对于重度沙眼患儿，可能有必要进行2日与1日治疗的随机对照试验。
