ARI Research Cell, Children's Hospital, Pakistan Institute of Medical Sciences, Pakistan.
Clin Infect Dis. 2011 Feb 1;52(3):293-300. doi: 10.1093/cid/ciq142. Epub 2010 Dec 28.
world Health Organization (WHO) acute respiratory illness case management guidelines classify children with fast breathing as having pneumonia and recommend treatment with an antibiotic. There is concern that many of these children may not have pneumonia and are receiving antibiotics unnecessarily. This could increase antibiotic resistance in the community. The aim was to compare the clinical outcome at 72 h in children with WHO-defined nonsevere pneumonia when treated with amoxicillin, compared with placebo.
we performed a double-blind, randomized, equivalence trial in 4 tertiary hospitals in Pakistan. Nine hundred children aged 2-59 months with WHO defined nonsevere pneumonia were randomized to receive either 3 days of oral amoxicillin (45mg/kg/day) or placebo; 873 children completed the study. All children were followed up on days 3, 5, and 14. The primary outcome was therapy failure defined a priori at 72 h.
in per-protocol analysis at day 3, 31 (7.2%) of the 431 children in the amoxicillin arm and 37 (8.3%) of the 442 in placebo group had therapy failure. This difference was not statistically significant (odds ratio [OR], .85; 95%CI, .50-1.43; P = .60). The multivariate analysis identified history of difficult breathing (OR, 2.86; 95% CI, 1.29-7.23; P = .027) and temperature >37.5°C 100°F at presentation (OR, 1.99; 95% CI, 1.37-2.90; P = .0001) as risk factors for treatment failure by day 5.
clinical outcome in children aged 2-59 months with WHO-defined nonsevere pneumonia is not different when treated with an antibiotic or placebo. Similar trials are needed in countries with a high burden of pneumonia to rationalize the use of antibiotics in these communities.
世界卫生组织（WHO）急性呼吸道疾病病例管理指南将呼吸急促的儿童归类为患有肺炎，并建议使用抗生素进行治疗。人们担心，其中许多儿童可能没有肺炎，而不必要地接受了抗生素治疗。这可能会导致社区中的抗生素耐药性增加。本研究旨在比较患有 WHO 定义的非重症肺炎的儿童在接受阿莫西林治疗与安慰剂治疗时，72 小时的临床结局。
我们在巴基斯坦的 4 家三级医院进行了一项双盲、随机、等效性试验。900 名年龄在 2-59 个月的符合 WHO 定义的非重症肺炎患儿被随机分为接受 3 天口服阿莫西林（45mg/kg/天）或安慰剂治疗；873 名儿童完成了研究。所有儿童在第 3、5 和 14 天进行随访。主要结局是预先定义的 72 小时治疗失败。
在方案分析中，31 名（7.2%）接受阿莫西林治疗的 431 名儿童和 37 名（8.3%）接受安慰剂治疗的 442 名儿童在第 3 天发生治疗失败，差异无统计学意义（比值比[OR]，0.85；95%CI，0.50-1.43；P=0.60）。多变量分析发现呼吸困难史（OR，2.86；95%CI，1.29-7.23；P=0.02）和就诊时体温>37.5°C（100°F）（OR，1.99；95%CI，1.37-2.90；P=0.0001）是第 5 天治疗失败的危险因素。
对于年龄在 2-59 个月的 WHO 定义的非重症肺炎患儿，使用抗生素或安慰剂治疗的临床结局无差异。需要在肺炎负担较高的国家进行类似的试验，以合理优化这些社区的抗生素使用。
