Oral amoxicillin versus injectable penicillin for severe pneumonia in children aged 3 to 59 months: a randomised multicentre equivalency study
Oral amoxicillin versus injectable penicillin for severe pneumonia in children aged 3 to 59 months: a randomised multicentre equivalency study
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DOI：
10.1016/s0140-6736(04)17100-6
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发表时间：
2004-09-25
期刊：
影响因子：
168.9
通讯作者：
Nguyen, NTV
中科院分区：
文献类型：
--
作者：
Addo-Yobo, E;Chisaka, N;Nguyen, NTV
注射青霉素是WHO定义的重症肺炎（下胸部内陷）的推荐治疗方法。如果口服阿莫西林证明同样有效，它可以减少转诊，住院和治疗费用。我们的目的是确定口服阿莫西林和肠外青霉素是否相当于在3-59 months.Methods的儿童重症肺炎的治疗，这多中心，随机，开放标签的等效性研究进行了三级保健中心在非洲，亚洲和南美洲的8个发展中国家。患有严重肺炎的3-59个月的儿童入院48小时，如果症状改善，则出院，口服阿莫西林5天。1702名儿童被随机分配接受口服阿莫西林（n = 857）或肠外青霉素（n = 845）治疗48 h。在入组后第5天和第14天进行随访评估。主要结局为48 h时治疗失败（持续下胸部内吸或新的危险体征）。结果治疗失败率为19%，在48小时（161例患者，阿莫西林; 167阿莫西林;风险差-0.4%，95%CI-4.2至3.3）。多变量分析显示，婴儿期（年龄3-11个月;比值比2.72，95%CI 1.95 - 3.79）、非常快的呼吸（1.94，1.42 - 2.65）和缺氧（1.95，1.34 - 2.82）在基线时预测治疗失败。口服治疗的潜在益处包括降低（1）针媒感染的风险;（2）转诊或住院的需要;（3）管理费用;以及（4）家庭成本。
Background Injectable penicillin is the recommended treatment for WHO-defined severe pneumonia (lower chest indrawing). If oral amoxicillin proves equally effective, it could reduce referral, admission, and treatment costs. We aimed to determine whether oral amoxicillin and parenteral penicillin were equivalent in the treatment of severe pneumonia in children aged 3-59 months.Methods This multicentre, randomised, open-label equivalency study was undertaken at tertiary-care centres in eight developing countries in Africa, Asia, and South America. Children aged 3-59 months with severe pneumonia were admitted for 48 h and, if symptoms improved, were discharged with a 5-day course of oral amoxicillin. 1702 children were randomly allocated to receive either oral amoxicillin (n = 857) or parenteral penicillin (n = 845) for 48 h. Follow-up assessments were done at 5 and 14 days after enrolment. Primary outcome was treatment failure (persistence of lower chest indrawing or new danger signs) at 48 h. Analyses were by intention-to-treat and per protocol.Findings Treatment failure was 19% in each group (161 patients, pencillin; 167 amoxillin; risk difference -0.4%; 95% CI-4.2 to 3.3) at 48 h. Infancy (age 3-11 months; odds ratio 2.72, 95% CI 1.95 to 3.79), very fast breathing (1.94, 1.42 to 2.65), and hypoxia (1.95, 1.34 to 2.82) at baseline predicted treatment failure by multivariate analysis.Interpretation Injectable penicillin and oral amoxicillin are equivalent for severe pneumonia treatment in controlled settings. Potential benefits of oral treatment include decreases in (1) risk of needle-borne infections; (2) need for referral or admission; (3) administration costs; and (4) costs to the family.