Effectiveness of 3-Day Amoxycillin vs. 5-Day Co-trimoxazole in the Treatment of Non-severe Pneumonia in Children Aged 259 Months of Age: A Multi-centric Open Labeled Trial

Effectiveness of 3-Day Amoxycillin vs. 5-Day Co-trimoxazole in the Treatment of Non-severe Pneumonia in Children Aged 259 Months of Age: A Multi-centric Open Labeled Trial
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DOI:
10.1093/tropej/fmn050
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发表时间:
2008-12-01
影响因子:
2
通讯作者:
Dhasmana, Puneet
Dhasmana, Puneet
中科院分区:
医学4区
文献类型:
--
作者:
Awasthi, Shally;Agarwal, Girdhar;Dhasmana, Puneet

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本项随机、开放标签试验旨在比较口服阿莫西林3天和复方新诺明5天治疗印度农村初级卫生中心世界卫生组织(WHO)定义的非重度肺炎儿童临床失败的有效性。参与者是259个月的儿童,患有WHO定义的非严重肺炎,有或没有喘息,他们可以接受随访。每组7个初级卫生中心,2009例病例被随机分配,993例和1016例分别接受阿莫西林和复方新诺明治疗。发热1247例(62.1),喘息443例(22.1)。依从性良好,随访丢失率低。意向治疗分析中阿莫西林和复方新诺明的临床失败分别为137例和97例(绝对差异0.04,95置信区间:0.0350.12)。我们得出结论,口服复方新诺明或阿莫西林治疗非重症肺炎的有效性没有差异。
This cluster randomized, open labeled trial was conducted to compare the effectiveness of 3 days of oral amoxycillin and 5 days of co-trimoxazole treatment in terms of clinical failure in children with World Health Organization (WHO) defined non-severe pneumonia in primary health centers in rural India. Participants were children aged 259 months with WHO defined non-severe pneumonia, with or without wheeze, who were accessible to follow up. From seven primary health centers in each arm, 2009 cases were randomized, 993 and 1016 in treatment with amoxycillin and co-trimoxazole, respectively. Fever was present in 1247 (62.1) and wheeze in 443 (22.1). There was good adherence and low loss to follow-up. Clinical failure on amoxycillin and co-trimoxazole on intention to treat analysis was 137 and 97, respectively (absolute difference 0.04, 95 confidence interval: 0.0350.12). We conclude that there was no difference in effectiveness of oral co-trimoxazole or amoxycillin in treating non-severe pneumonia.