Community case management of severe pneumonia with oral amoxicillin in children aged 2-59 months in Haripur district, Pakistan: a cluster randomised trial
Community case management of severe pneumonia with oral amoxicillin in children aged 2-59 months in Haripur district, Pakistan: a cluster randomised trial
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DOI：
10.1016/s0140-6736(11)61140-9
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发表时间：
2011-11-19
期刊：
影响因子：
168.9
通讯作者：
Qazi, Shamim A.
中科院分区：
文献类型：
--
作者：
Bari, Abdul;Sadruddin, Salim;Qazi, Shamim A.
WHO定义的重症肺炎推荐首剂口服复方新诺明和转诊。据报告，在许多资源匮乏的环境中，难以遵守转诊规定，导致难以获得适当治疗。在这项研究的目的是评估是否社区的情况下，由夫人的卫生工作者（LHWs）与口服阿莫西林在儿童重症pneumonia.Methods护理标准相当于目前的标准，在哈里布尔区，巴基斯坦，28个集群进行了随机分配，分层在1：1的比例，干预和控制集群使用计算机生成的随机序列。如果儿童年龄在2-59个月之间，患有WHO定义的重度肺炎，并居住在研究区域，则将其纳入研究。在干预组群中，社区卫生工作者为母亲提供口服阿莫西林（2-11个月婴儿每天80-90毫克/公斤或375毫克，每天两次，12-59个月婴儿每天625毫克，每天两次），并提供具体的使用指导。在对照组中，LHWs给予口服复方新诺明的第一剂（2-11个月，磺胺甲恶唑200 mg+甲氧苄啶40 mg; 12个月至5岁，磺胺甲恶唑300 mg+甲氧苄啶60 mg），并将儿童转介到卫生设施接受标准护理。参与者、护理者和评估者不对治疗分配设盲。主要结局为第6天治疗失败。分析符合方案，并通过使用广义估计方程调整组内聚类。这项研究是注册的，编号ISRCTN10618300.Findings我们分配1995名儿童在14个干预组和1477在14个对照组的治疗，我们分析了1857和1354名儿童，分别。在干预组中，第6天经药物调整的治疗失败率显著降低（165 [9%] vs 241 [18%]，风险差异-8.9%，95%CI-12.4至-5.4）。基线协变量的进一步调整几乎没有差异（-7.3%，-10.1至-4.5）。对照组中报告了2例死亡，干预组中报告了1例死亡。大部分风险降低发生在第3天发热和下胸部内吸（-6.7%，-10.0至-3.3）。不良事件是腹泻（n=4）和皮疹（n=1）在干预集群和腹泻（n=3）在控制cluster.Interpretation社区的情况下管理可能会导致一个标准化的治疗儿童严重肺炎，减少延误治疗开始，并降低家庭和医疗保健系统的成本。
Background First dose oral co-trimoxazole and referral are recommended for WHO-defined severe pneumonia. Difficulties with referral compliance are reported in many low-resource settings, resulting in low access to appropriate treatment. The objective in this study was to assess whether community case management by lady health workers (LHWs) with oral amoxicillin in children with severe pneumonia was equivalent to current standard of care.Methods In Haripur district, Pakistan, 28 clusters were randomly assigned with stratification in a 1:1 ratio to intervention and control clusters by use of a computer-generated randomisation sequence. Children were included in the study if they were aged 2-59 months with WHO-defined severe pneumonia and living in the study area. In the intervention clusters, community-based LHWs provided mothers with oral amoxicillin (80-90 mg/kg per day or 375 mg twice a day for infants aged 2-11 months and 625 mg twice a day for those aged 12-59 months) with specific guidance on its use. In control clusters, LHWs gave the first dose of oral co-trimoxazole (age 2-11 months, sulfamethoxazole 200 mg plus trimethoprim 40 mg; age 12 months to 5 years, sulfamethoxazole 300 mg plus trimethoprim 60 mg) and referred the children to a health facility for standard of care. Participants, carers, and assessors were not masked to treatment assignment. The primary outcome was treatment failure by day 6. Analysis was per protocol with adjustment for clustering within groups by use of generalised estimating equations. This study is registered, number ISRCTN10618300.Findings We assigned 1995 children to treatment in 14 intervention clusters and 1477 in 14 control clusters, and we analysed 1857 and 1354 children, respectively. Cluster-adjusted treatment failure rates by day 6 were significantly reduced in the intervention clusters (165 [9%] vs 241 [18%], risk difference -8.9%, 95% CI -12.4 to -5.4). Further adjustment for baseline covariates made little difference (-7.3%, -10.1 to -4.5). Two deaths were reported in the control clusters and one in the intervention cluster. Most of the risk reduction was in the occurrence of fever and lower chest indrawing on day 3 (-6.7%, -10.0 to -3.3). Adverse events were diarrhoea (n=4) and skin rash (n=1) in the intervention clusters and diarrhoea (n=3) in the control clusters.Interpretation Community case management could result in a standardised treatment for children with severe pneumonia, reduce delay in treatment initiation, and reduce the costs for families and health-care systems.