Three-Year Outcomes of the Surgery for Trichiasis, Antibiotics to Prevent Recurrence Trial
Three-Year Outcomes of the Surgery for Trichiasis, Antibiotics to Prevent Recurrence Trial
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DOI：
10.1001/archophthalmol.2011.374
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发表时间：
2012-04-01
影响因子：
--
通讯作者：
West, Sheila K.
中科院分区：
文献类型：
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作者：
Woreta, Fasika;Munoz, Beatriz;West, Sheila K.
目的：确定口服阿奇霉素与外用四环素相比是否能减少倒睫术后长达3年的复发率。方法：倒立手术，抗生素预防复发(STAR)试验是在埃塞俄比亚南部沙眼高发地区进行的一项随机、单盲、临床试验。将1452例接受倒睫手术的患者按2：1的比例随机分为两组，分别口服单剂量阿奇霉素组(1g)和外用四环素组(每天两次，共6周)。主要观察指标：术后3年内倒睫复发。结果：阿奇霉素组和四环素组的复发率分别为10%和13%。与四环素组相比，阿奇霉素组术后3年倒睫复发率降低22%(P=.13)。基线时内翻的严重程度是倒睫3年后复发的最显著的预测因素。结论：STAR试验中的倒睫复发率在术后3年内保持在较低水平。单剂阿奇霉素的保护作用小于1年，虽然在统计学上没有显著意义，但仍提示倒立手术后长达3年。临床应用：手术后单剂阿奇霉素仍然是世界卫生组织2020年前消除沙眼战略的组成部分。
Objective: To determine whether treatment with oral azithromycin compared with topical tetracycline reduces the recurrence of trichiasis for up to 3 years following surgery for trichiasis.Methods: The Surgery for Trichiasis, Antibiotics to Prevent Recurrence (STAR) trial is a randomized, single-masked, clinical trial conducted in southern Ethiopia, a region where trachoma is hyperendemic. A total of 1452 patients who underwent trichiasis surgery were randomly assigned at a 2: 1 ratio to either a single dose of oral azithromycin (1 g) or topical tetracycline (twice per day for 6 weeks) following surgery.Main Outcome Measures: Recurrence of trichiasis within 3 years following surgery.Results: The rate of recurrence was 10% in the azithromycin group and 13% in the tetracycline group. The azithromycin group had a 22% reduction in recurrence of trichiasis 3 years after surgery compared with the tetracycline group (P=.13). Severity of entropion at baseline was the most significant predictor of recurrence of trichiasis at 3 years.Conclusion: Trichiasis recurrence rates in the STAR trial remained low for up to 3 years following surgery. The protective effect of a single dose of azithromycin was less than at 1 year and, although not statistically significant, was still suggestive up to 3 years following trichiasis surgery.Application to Clinical Practice: A single dose of azithromycin after surgery remains an integral component of the World Health Organization's strategy for the elimination of trachoma by the year 2020.