World Health Organization, Geneva, Switzerland.
Monitoring and Evaluation Consultant, Islamabad, Pakistan.
Clin Infect Dis. 2019 Jul 18;69(3):397-404. doi: 10.1093/cid/ciy918.
Globally, most deaths due to childhood pneumonia occur at the community level. Some countries are still using oral co-trimoxazole, despite a World Health Organization recommendation of oral amoxicillin for the treatment of fast-breathing pneumonia in children at the community level.
We conducted an unblinded, cluster-randomized, controlled-equivalency trial in Haripur District, Pakistan. Children 2-59 months of age with fast-breathing pneumonia were treated with oral amoxicillin suspension (50 mg/kg/day) for 3 days in 14 intervention clusters and oral co-trimoxazole suspension (8 mg trimethoprim/kg and 40 mg sulfamethoxazole/kg/day) for 5 days in 14 control clusters by lady health workers (LHW). The primary outcome was treatment failure by day 4 for intervention clusters and by day 6 for control clusters. The analysis was per protocol.
Out of the 15 749 cases enrolled in the study, 9153 cases in intervention and 6509 cases in control clusters were included in the analysis. Treatment failure rates were 3.6% (326) in intervention clusters and 9.1% (592) in control clusters. After adjusting for clustering, the risk of treatment failure was lower in intervention clusters (risk difference [RD] -5.5%, 95% confidence interval [CI] -7.4--3.7%) than in control clusters. Children with incomplete adherence had a small increase in treatment failure versus those with complete adherence (RD 2.9%, 95% CI 1.6-4.1%). No deaths or serious adverse events occurred.
A 3-day course of oral amoxicillin, administered by LHWs, is an effective and safe treatment for fast-breathing pneumonia in children 2-59 months of age. A shorter course of amoxicillin improves adherence to therapy, is low in cost, and puts less pressure on antimicrobial resistance.
ISRCTN10618300.
在全球范围内，大多数儿童肺炎死亡发生在社区层面。尽管世界卫生组织建议在社区层面使用阿莫西林口服治疗儿童呼吸急促型肺炎，但一些国家仍在使用复方磺胺甲噁唑口服制剂。
我们在巴基斯坦哈布尔区进行了一项非盲、集群随机、对照等效性试验。年龄在 2-59 个月的呼吸急促型肺炎患儿由女卫生工作者（LHW）分别在 14 个干预集群中使用阿莫西林口服混悬剂（50mg/kg/天）治疗 3 天，在 14 个对照集群中使用复方磺胺甲噁唑口服混悬剂（8mg 甲氧苄啶/kg 和 40mg 磺胺甲噁唑/kg/天）治疗 5 天。主要结局是干预集群在第 4 天和对照集群在第 6 天出现治疗失败。分析是按照方案进行的。
在纳入研究的 15749 例病例中，干预集群有 9153 例，对照集群有 6509 例纳入分析。干预集群的治疗失败率为 3.6%（326 例），对照集群为 9.1%（592 例）。调整集群效应后，干预集群的治疗失败风险低于对照集群（风险差异-5.5%，95%置信区间-7.4%3.7%）。不完全依从治疗的儿童与完全依从治疗的儿童相比，治疗失败的风险略有增加（风险差异 2.9%，95%置信区间 1.6%4.1%）。未发生死亡或严重不良事件。
LHW 给予的 3 天疗程阿莫西林口服制剂是治疗 2-59 个月儿童呼吸急促型肺炎的有效且安全的治疗方法。较短疗程的阿莫西林提高了治疗依从性，成本较低，对抗微生物药物耐药性的压力较小。
ISRCTN84256105。
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