Agarwal Girdhar, Awasthi Shally, Kabra S K, Kaul Annapurna, Singhi Sunit, Walter Stephen D
BMJ. 2004 Apr 3;328(7443):791. doi: 10.1136/bmj.38049.490255.DE. Epub 2004 Mar 16.
To assess the efficacy of three days versus five days of treatment with oral amoxicillin for curing non-severe pneumonia in children.
Randomised, double blind, placebo controlled multicentre trial.
Outpatient departments of seven referral hospitals in India.
2188 children aged 2-59 months, 1095 given three days of treatment and 1093 given five days.
Oral amoxicillin 31-54 mg/kg/day in three divided doses.
Treatment failure: defined as development of chest indrawing, convulsions, drowsiness, or inability to drink at any time; respiratory rate above age specific cut points on day 3 or later; or oxygen saturation by pulse oximetry < 90% on day 3.
The clinical cure rates with three days and five days of treatment were 89.5% and 89.9%, respectively (absolute difference 0.4 (95% confidence interval--2.1 to 3.0)). Adherence to treatment regimen was 94% and 85% for three day and five day treatments, respectively. Loss to follow up was 5.4% by day 5. There were no deaths, 41 hospitalisations, and 36 minor adverse reactions. There were 225 (10.3%) clinical failures and 106 (5.3%) relapses, and rates were similar in both treatments. At enrollment, 513 (23.4%) children tested positive for respiratory syncytial virus, and Streptococcus pneumoniae and Haemophilus influenzae were isolated from the nasopharynx in 878 (40.4%) and 496 (22.8%) children, respectively. Clinical failure was associated with isolation of respiratory syncytial virus (adjusted odds ratio 1.95 (95% confidence interval 1.0 to 3.8)), excess respiratory rate of > 10 breaths/minute (2.89 (1.83 to 4.55)), and non-adherence with treatment at day 5 (11.57 (7.4 to 18.0)).
Treatment with oral amoxicillin for three days was as effective as for five days in children with non-severe pneumonia.
评估口服阿莫西林治疗3天与5天对治愈儿童非重症肺炎的疗效。
随机、双盲、安慰剂对照的多中心试验。
印度7家转诊医院的门诊部。
2188名年龄在2至59个月的儿童，其中1095名接受3天治疗，1093名接受5天治疗。
口服阿莫西林31 - 54毫克/千克/天，分3次服用。
治疗失败：定义为在任何时间出现胸廓凹陷、惊厥、嗜睡或无法饮水；第3天或之后呼吸频率高于特定年龄切点；或第3天经脉搏血氧饱和度测定氧饱和度<90%。
3天和5天治疗的临床治愈率分别为89.5%和89.9%（绝对差异0.4（95%置信区间 - 2.1至3.0））。3天和5天治疗的治疗方案依从率分别为94%和85%。到第5天失访率为5.4%。无死亡病例，41例住院，36例轻微不良反应。有225例（10.3%）临床治疗失败和106例（5.3%）复发，两种治疗的发生率相似。入组时，513例（23.4%）儿童呼吸道合胞病毒检测呈阳性，分别从878例（40.4%）和496例（22.8%）儿童的鼻咽部分离出肺炎链球菌和流感嗜血杆菌。临床治疗失败与呼吸道合胞病毒分离（校正比值比1.95（95%置信区间1.0至3.8））、呼吸频率超过10次/分钟（2.89（1.83至4.55））以及第5天不依从治疗（11.57（7.4至18.0））有关。
口服阿莫西林治疗3天对儿童非重症肺炎的疗效与治疗5天相同。
