近日，芬兰坦佩雷大学医院Per Ashorn团队研究了马里婴儿大量使用阿奇霉素是否可降低死亡率。该研究于2025年10月16日发表在《新英格兰医学杂志》上。

在撒哈拉以南非洲的一些地区，对1至59个月大的儿童大量给予阿奇霉素已被证明可降低这一年龄组婴儿和儿童的死亡率。最大的影响出现在治疗后3个月内的12个月以下的婴儿；这一观察结果激发了当前试验的设计。

在这项试验中，研究组随机分配了西非马里的村庄，按3:4:2的比例分配安慰剂、每年两次阿奇霉素或每年四次阿奇霉素。1至11个月大的婴儿每3个月接受每公斤体重20毫克剂量的安慰剂（对照组）；1月至6月每季度两次服用阿奇霉素，7月至12月每季度两次服用安慰剂（每年两次服用阿奇霉素组）；或每3个月服用一次阿奇霉素（每季度服用一次阿奇霉素组）。在意向治疗人群中分析，主要结局是确认合格后3个月内的死亡。

从2020年12月到2022年12月，共有1151个村庄参与了试点；将386个村庄随机分为对照组，511个村庄分为一年两次的阿奇霉素组，254个村庄分为每季度一次的阿奇霉素组。在所有村庄中，149090名婴儿接受了至少一剂安慰剂或阿奇霉素，总共随访82600人年；共有968人死亡。对照组死亡率为每1000人年11.9例死亡，一年两次阿奇霉素组为每1000人年11.8例死亡（发病率比为1.00；95%可信区间为0.83至1.19），每季度一次阿奇霉素组为每1000人年11.3例死亡（发病率比为0.93；95%可信区间为0.75至1.15）。不良事件很少发生，三组婴儿发生不良事件的百分比相似。未经治疗的12至59个月儿童的死亡率在各组之间相似。

研究结果表明，在马里，大规模给药阿奇霉素（仅限于1至11个月大的婴儿）并未导致婴儿或儿童死亡率低于安慰剂，无论阿奇霉素是每年两次还是每季度两次。

附：英文原文

Title: Mass Administration of Azithromycin to Infants in Mali to Reduce Mortality

Author: Fadima Cheick Haidara, Laura Adubra, Mahamadou Abdou, Dagmar Alber, Ulla Ashorn, Yin Bun Cheung, Elaine Cloutman-Green, Mamadou Diallo, Camilla Ducker, Yue-Mei Fan, Gwydion Gruffudd, Lotta Hallamaa, Tiia Haapaniemi, Rikhard Ihamuotila, Jane Juma, Nigel Klein, Juho Luoma, Owen Martell, Akshaya Murugesan, Collins Okello, Oumar Samaké, Cheick Amadou Tidiane Traore, Taru Vehmasto, Kaisa Ylikruuvi, Samba Sow, Per Ashorn

Issue&Volume: 2025-10-16

Abstract:

BACKGROUND

Mass administration of azithromycin to children 1 to 59 months of age has been shown to reduce mortality among infants and children in this age group in some areas of sub-Saharan Africa. The largest effects have appeared to be among infants younger than 12 months of age, within 3 months after treatment; this observation motivated the design of the current trial.

METHODS

In this trial, we randomly assigned villages in Mali, West Africa, in a 3:4:2 ratio to receive distributions of placebo, azithromycin two times a year, or azithromycin four times a year. Infants 1 to 11 months of age received, in doses of 20 mg per kilogram of body weight, placebo every 3 months (control group); azithromycin at two quarterly visits from January through June and placebo at two quarterly visits from July through December (twice-yearly azithromycin group); or azithromycin every 3 months (quarterly azithromycin group). The primary outcome was death within 3 months after eligibility had been confirmed, analyzed in the intention-to-treat population.

RESULTS

From December 2020 through December 2022, a total of 1151 villages were enrolled in the trial; 386 villages were randomly assigned to the control group, 511 to the twice-yearly azithromycin group, and 254 to the quarterly azithromycin group. Among all the villages, 149,090 infants received at least one dose of placebo or azithromycin, with a total of 82,600 person-years of follow-up; 968 deaths were recorded. Mortality was 11.9 deaths per 1000 person-years at risk in the control group, 11.8 deaths per 1000 person-years in the twice-yearly azithromycin group (incidence rate ratio, 1.00; 95% confidence interval [CI], 0.83 to 1.19), and 11.3 deaths per 1000 person-years in the quarterly azithromycin group (incidence rate ratio, 0.93; 95% CI, 0.75 to 1.15). Adverse events were rare, and the percentages of infants with adverse events were similar in the three groups. Mortality among untreated children 12 to 59 months of age was similar across groups.

CONCLUSIONS

Mass administration of azithromycin in Mali, limited to infants 1 to 11 months of age, did not result in lower infant or child mortality than placebo, regardless of whether azithromycin was delivered twice yearly or quarterly.

DOI: NJ202510163931510

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2504644