美国华盛顿大学临床试验中心Amy-Sarah Ginsburg团队比较了阿莫西林治疗胸凹陷肺炎儿童3天或5天的疗效。2020年7月2日，该研究发表在《新英格兰医学杂志》上。

在非洲资源匮乏地区，对肺炎患儿使用抗生素治疗的合适时间尚不明确。

研究组在马拉维的利隆圭进行了一项双盲、随机、对照、非劣效性试验，2016年3月29日至2019年4月1日，研究组招募了3000名胸凹陷肺炎的儿童，即持续咳嗽<14天或呼吸困难，伴或不伴快速呼吸时胸壁均有明显凹陷。这些患儿的年龄为2-59个月，均未感染HIV。将其随机分组，其中1497名接受阿莫西林治疗3天，1503名接受阿莫西林治疗5天。所有患儿均随访14天。

在有第6天数据的儿童中，三天组的治疗失败率为5.9%，五天组为5.2%，校正后的差异为0.7个百分点，符合非劣效性标准。在可获得第14天数据的儿童中，三天组中6天内治疗失败和14天内复发的发生率为12.5%，五天组为10.8%，差异为1.7个百分点。三天组中有9.8%的患儿发生严重不良事件，五天组中有8.8%，差异不显著。

总之，对于未感染HIV的胸凹陷肺炎的马拉维儿童，阿莫西林治疗3天的疗效不逊于治疗5天。

附：英文原文

Title: Amoxicillin for 3 or 5 Days for Chest-Indrawing Pneumonia in Malawian Children

Author: Amy-Sarah Ginsburg, M.D., M.P.H.,, Tisungane Mvalo, M.M.E.D.,, Evangelyn Nkwopara, M.S.,, Eric D. McCollum, M.D.,, Melda Phiri, M.B., B.S.,, Robert Schmicker, M.S.,, Jun Hwang, M.S.,, Chifundo B. Ndamala, Dip.,, Ajib Phiri, M.D.,, Norman Lufesi, M.Phil.,, and Susanne May, Ph.D.

Issue&Volume: 2020-07-01

Abstract: BACKGROUND

Evidence regarding the appropriate duration of treatment with antibiotic agents in children with pneumonia in low-resource settings in Africa is lacking.

METHODS

We conducted a double-blind, randomized, controlled, noninferiority trial in Lilongwe, Malawi, to determine whether treatment with amoxicillin for 3 days is less effective than treatment for 5 days in children with chest-indrawing pneumonia (cough lasting <14 days or difficulty breathing, along with visible indrawing of the chest wall with or without fast breathing for age). Children not infected with human immunodeficiency virus (HIV) who were 2 to 59 months of age and had chest-indrawing pneumonia were randomly assigned to receive amoxicillin twice daily for either 3 days or 5 days. Children were followed for 14 days. The primary outcome was treatment failure by day 6; noninferiority of the 3-day regimen to the 5-day regimen would be shown if the percentage of children with treatment failure in the 3-day group was no more than 1.5 times that in the 5-day group. Prespecified secondary analyses included assessment of treatment failure or relapse by day 14.

RESULTS

From March 29, 2016, to April 1, 2019, a total of 3000 children underwent randomization: 1497 children were assigned to the 3-day group, and 1503 to the 5-day group. Among children with day 6 data available, treatment failure had occurred in 5.9% in the 3-day group (85 of 1442 children) and in 5.2% (75 of 1456) in the 5-day group (adjusted difference, 0.7 percentage points; 95% confidence interval [CI], 0.9 to 2.4) — a result that satisfied the criterion for noninferiority of the 3-day regimen to the 5-day regimen. Among children with day 14 data available, 176 of 1411 children (12.5%) in the 3-day group and 154 of 1429 (10.8%) in the 5-day group had had treatment failure by day 6 or relapse by day 14 (between-group difference, 1.7 percentage points; 95% CI, 0.7 to 4.1). The percentage of children with serious adverse events was similar in the two groups (9.8% in the 3-day group and 8.8% in the 5-day group).

CONCLUSIONS

In HIV-uninfected Malawian children, treatment with amoxicillin for chest-indrawing pneumonia for 3 days was noninferior to treatment for 5 days.

DOI: NJ202007023830107

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1912400