Patel Archana B, Bang Akash, Singh Meenu, Dhande Leena, Chelliah Luke Ravi, Malik Ashraf, Khadse Sandhya
Lata Medical Research Foundation and Indira Gandhi Government Medical College, Nagpur, India.
Mahatma Gandhi Institute of Medical Sciences, Sewagram, Maharashtra, India.
BMC Pediatr. 2015 Nov 17;15:186. doi: 10.1186/s12887-015-0510-9.
Pneumonia is the leading cause of child mortality under five years of age worldwide. For pneumonia with chest indrawing in children aged 3-59 months, injectable penicillin and hospitalization was the recommended treatment. This increased the health care cost and exposure to nosocomial infections. We compared the clinical and cost outcomes of a seven day treatment with oral amoxicillin with the first 48 h of treatment given in the hospital (hospital group) or at home (home group).
We conducted an open-label, multi-center, two-arm randomized clinical trial at six tertiary hospitals in India. Children aged 3 to 59 months with chest indrawing pneumonia were randomized to home or hospital group. Clinical outcomes, treatment adherence, and patient safety were monitored through home visits on day 3, 5, 8, and 14 with an additional visit for the home group at 24 h. Clinical outcomes included treatment failure rates up to 7 days (primary outcome) and between 8-14 days (secondary outcome) using the intention to treat and per protocol analyses. Cost outcomes included direct medical, direct non-medical and indirect costs for a random 17% subsample using the micro-costing technique.
1118 children were enrolled and randomized to home (n = 554) or hospital group (n = 564). Both groups had similar baseline characteristics. Overall treatment failure rate was 11.5% (per protocol analysis). The hospital group was significantly more likely to fail treatment than the home group in the intention to treat analysis. Predictors with increased risk of treatment failure at any time were age 3-11 months, receiving antibiotics within 48 h prior to enrolment and use of high polluting fuel. Death rates at 7 or 14 days did not differ significantly. (Difference -0.0%; 95% CI -0.5 to 0.5). The median total treatment cost was Rs. 399 for the home group versus Rs. 602 for the hospital group (p < 0.001), for the same effect of 5% failure rate at the end of 7 days of treatment in the random subsample.
Home based oral amoxicillin treatment was equivalent to hospital treatment for first 48 h in selected children of chest indrawing pneumonia and was cheaper. Consistent with the recent WHO simplified guidelines, management with home based oral amoxicillin for select children with only fast breathing and chest-indrawing can be a cost effective intervention.
ClinicalTrials.gov NCT01386840, registered 25th June 2011 and the Indian Council of Medical Research REFCTRI/2010/000629.
肺炎是全球五岁以下儿童死亡的主要原因。对于3 - 59个月大的有胸凹陷的肺炎患儿，推荐的治疗方法是注射青霉素并住院治疗。这增加了医疗成本以及医院感染的风险。我们比较了口服阿莫西林七天治疗的临床和成本结果，其中治疗的前48小时在医院（医院组）或在家中（家庭组）进行。
我们在印度的六家三级医院进行了一项开放标签、多中心、双臂随机临床试验。3至59个月大的有胸凹陷肺炎的儿童被随机分为家庭组或医院组。通过在第3、5、8和14天进行家访来监测临床结果、治疗依从性和患者安全性，家庭组在24小时时额外增加一次家访。临床结果包括使用意向性分析和符合方案分析的7天内（主要结果）以及8 - 14天内（次要结果）的治疗失败率。成本结果包括使用微观成本核算技术对随机抽取的17%子样本的直接医疗、直接非医疗和间接成本。
1118名儿童被纳入并随机分为家庭组（n = 554）或医院组（n = 564）。两组具有相似的基线特征。总体治疗失败率为11.5%（符合方案分析）。在意向性分析中，医院组治疗失败的可能性显著高于家庭组。在任何时候治疗失败风险增加的预测因素包括年龄3 - 11个月、入组前48小时内接受过抗生素治疗以及使用高污染燃料。7天或14天的死亡率无显著差异。（差异 -0.0%；95%置信区间 -0.5至0.5）。在随机子样本中，家庭组的中位总治疗成本为399卢比，而医院组为602卢比（p < 0.001），在治疗7天结束时失败率为5%的相同效果下。
对于部分有胸凹陷肺炎的儿童，在家口服阿莫西林治疗在开始的48小时内与住院治疗等效且成本更低。与世界卫生组织最近的简化指南一致，对于仅表现为呼吸急促和胸凹陷的部分儿童，采用在家口服阿莫西林治疗可能是一种具有成本效益的干预措施。
ClinicalTrials.gov NCT01386840，于2011年6月25日注册，以及印度医学研究理事会REFCTRI/2010/000629。
