Chloramphenicol treatment for,acute infective conjunctivitis in children in primary care: a randomised double-blind placebo-controlled trial
Chloramphenicol treatment for,acute infective conjunctivitis in children in primary care: a randomised double-blind placebo-controlled trial
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DOI：
10.1016/s0140-6736(05)66709-8
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发表时间：
2005-07-02
期刊：
影响因子：
168.9
通讯作者：
Mant, D
中科院分区：
文献类型：
--
作者：
Rose, PW;Hamden, A;Mant, D
背景 每年有八分之一的学童患有急性感染性结膜炎。标准的临床实践是开局部抗生素，尽管支持这种做法的证据很少。我们进行了一项随机双盲试验，比较氯霉素滴眼液与安慰剂对初级保健感染性结膜炎儿童的有效性。方法我们的研究纳入了 326 名临床诊断为结膜炎的 6 个月至 12 岁儿童，他们是从英国 12 个全科医疗机构招募的。我们让 163 名儿童接受氯霉素滴眼液，163 名儿童接受安慰剂滴眼液。采集眼拭子进行细菌和病毒分析。主要结局是第 7 天的临床治愈，这是根据父母填写的日记进行评估的。所有儿童均接受为期 6 周的随访，以确定复发情况。使用生存统计数据进行比较，并按意向治疗进行分析。结果 9 名儿童失访（氯霉素组 1 名；安慰剂组 8 名）。服用安慰剂的 155 名儿童中有 128 名（83%）在第 7 天出现临床治愈，而服用氯霉素的 162 名儿童中有 140 名（86%）出现临床治愈（风险差异 3.8%，95% CI-4.1% 至 11.8%）。 7 名（4%）服用氯霉素的儿童和 5 名（3%）服用安慰剂的儿童在 6 周内进一步结膜炎发作（1.2%、-2.9% 至 5.3%）。不良事件很少见，并且在各组之间分布均匀。 解释 大多数在初级保健中出现急性感染性结膜炎的儿童会自行好转，不需要抗生素治疗。
Background One in eight schoolchildren have an episode of acute infective conjunctivitis every year. Standard clinical practice is to prescribe a topical antibiotic, although the evidence to support this practice is scarce. We undertook a randomised double-blind trial to compare the effectiveness of chloramphenicol eye drops with placebo in children with infective conjunctivitis in primary care.Methods Our study included 326 children aged 6 months to 12 years with a clinical diagnosis of conjunctivitis who were recruited from 12 general medical practices in the UK. We assigned 163 children to receive chloramphenicol eye drops and 163 to receive placebo eye drops. Eye swabs were taken for bacterial and viral analysis. The primary outcome was clinical cure at day 7, which was assessed from diaries completed by parents. All children were followed up for 6 weeks to identify relapse. Survival statistics were used for comparison, and analysis was by intention to treat.Findings Nine children were lost to follow-up (one in chloramphenicol group; eight in placebo group). Clinical cure by day 7 occurred in 128 (83%) of 155 children with placebo compared with 140 (86%) of 162 with chloramphenicol (risk difference 3.8%, 95% CI-4.1% to 11.8%). Seven (4%) children with chloramphenicol and five (3%) with placebo had further conjunctivitis episodes within 6 weeks (1.2%, -2.9% to 5.3%). Adverse events were rare and evenly distributed between each group.Interpretation Most children presenting with acute infective conjunctivitis in primary care will get better by themselves and do not need treatment with an antibiotic.