Comparison of annual versus twice-yearly mass azithromycin treatment for hyperendemic trachoma in Ethiopia: a cluster-randomised trial
Comparison of annual versus twice-yearly mass azithromycin treatment for hyperendemic trachoma in Ethiopia: a cluster-randomised trial
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DOI：
10.1016/s0140-6736(11)61515-8
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发表时间：
2012-01-14
期刊：
影响因子：
168.9
通讯作者：
Gaynor, Bruce D.
中科院分区：
文献类型：
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作者：
Gebre, Teshome;Ayele, Berhan;Gaynor, Bruce D.
在沙眼控制项目中，阿奇霉素用于治疗引起眼部疾病的衣原体菌株。我们的目的是比较每年与每年两次的阿奇霉素的分布对感染这些strains.Methods的效果，我们做了一个集群随机试验，在24个分区在北方埃塞俄比亚，我们随机分配到接受每年或每年两次的治疗，为所有居民的所有年龄。使用Microsoft Excel的RANDOM和SORT函数进行随机分配。所有患者均接受指定的单次直接观察口服阿奇霉素治疗。在年龄小于12个月的患者中，以及在自我报告妊娠、过敏或拒绝阿奇霉素的患者中，提供6周疗程的局部1%四环素软膏，每日两次涂于双眼，但不直接观察，作为阿奇霉素的替代品。我们的主要的、预先设定的结果是在哨点村庄中随机抽取0-9岁儿童样本，在基线和每6个月共42个月的时间内，调查眼部衣原体感染的患病率。我们的分析是通过意向treat. This研究是注册与ClinicalTrials.gov，编号NCT00322972.Findings抗生素覆盖率的儿童1-9岁是大于80%（范围80.9至93.0）在所有的研究访问。在每年治疗的组中，0-9岁儿童的感染患病率从基线时的平均41.9%（95% CI 31.5 - 52.2）降至42个月时的1.9%（0.3 - 3.5）。在每年治疗两次的组中，感染患病率从基线时的平均38.3%（29.0 - 47.6）降至42个月时的3.2%（0.0 - 6.5）。每年治疗一次的组中0-9岁儿童眼部衣原体感染的患病率与每年治疗两次的组在18、30和42个月时的患病率没有差异（合并回归p>0.99，95%CI-0.06至0.06）。每年两次治疗组的平均消除时间比每年一次治疗组早7.5个月（2.3 ~ 17.3）（p=0.10，考克斯比例风险模型）。然而，在每年接受两次治疗的村庄中，消除感染的速度可能更快。
Background In trachoma control programmes, azithromycin is distributed to treat the strains of chlamydia that cause ocular disease. We aimed to compare the effect of annual versus twice-yearly distribution of azithromycin on infection with these strains.Methods We did a cluster-randomised trial in 24 subdistricts in northern Ethiopia, which we randomly assigned to receive annual or twice-yearly treatment for all residents of all ages. Random assignment was done with the RANDOM and SORT functions of Microsoft Excel. All individuals were offered their assigned treatment of a single, directly observed, oral dose of azithromycin. A 6 week course of topical 1% tetracycline ointment, applied twice daily to both eyes but not directly observed, was offered as an alternative to azithromycin in patients younger than 12 months, and in patients with self-reported pregnancy, with allergy, or who refused azithromycin. Our primary, prespecified outcome was the prevalence of ocular chlamydial infection in a random sample of children aged 0-9 years at baseline and every 6 months for a total of 42 months within sentinel villages. Our analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00322972.Findings Antibiotic coverage of children aged 1-9 years was greater than 80% (range 80.9 to 93.0) at all study visits. In the groups treated annually, the prevalence of infection in children aged 0-9 years was reduced from a mean 41.9% (95% CI 31.5 to 52.2) at baseline to 1.9% (0.3 to 3.5) at 42 months. In the groups treated twice yearly, the prevalence of infection was reduced from a mean 38.3% (29.0 to 47.6) at baseline to 3.2 % (0.0 to 6.5) at 42 months. The prevalence of ocular chlamydial infection in children aged 0-9 years in groups treated annually was not different from that of the groups treated twice yearly at 18, 30, and 42 months (pooled regression p>0.99, 95 % CI -0.06 to 0.06). The mean elimination time in the twice-yearly treatment group was 7.5 months earlier (2.3 to 17.3) than that of the annual group (p=0.10, Cox proportional hazards model).Interpretation After 42 months of treatment, the prevalence of ocular infection with chlamydia was similar in the groups treated annually and twice yearly. However, elimination of infection might have been more rapid in the groups of villages that received treatment twice yearly.