随机试验阿奇霉素根除早产儿。
Randomised trial of azithromycin to eradicate in preterm infants.
机构信息
Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland, USA
Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.
出版信息
Arch Dis Child Fetal Neonatal Ed. 2020 Nov;105(6):615-622. doi: 10.1136/archdischild-2019-318122. Epub 2020 Mar 13.
OBJECTIVE
To test whether azithromycin eradicates from the respiratory tract in preterm infants.
DESIGN
Prospective, phase IIb randomised, double-blind, placebo-controlled trial.
SETTING
Seven level III-IV US, academic, neonatal intensive care units (NICUs).
PATIENTS
Infants 24-28 weeks' gestation (stratified 24-26; 27-28 weeks) randomly assigned within 4 days following birth from July 2013 to August 2016.
INTERVENTIONS
Intravenous azithromycin 20 mg/kg or an equal volume of D5W (placebo) every 24 hours for 3 days.
MAIN OUTCOME MEASURES
The primary efficacy outcome was -free survival. Secondary outcomes were all-cause mortality, clearance, physiological bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age, comorbidities of prematurity and duration of respiratory support.
RESULTS
One hundred and twenty-one randomised participants (azithromycin: n=60; placebo: n=61) were included in the intent-to-treat analysis (mean gestational age 26.2±1.4 weeks). Forty-four of 121 participants (36%) were positive (azithromycin: n=19; placebo: n=25). -free survival was 55/60 (92% (95% CI 82% to 97%)) for azithromycin compared with 37/61 (61% (95% CI 48% to 73%)) for placebo. Mortality was similar comparing the two treatment groups (5/60 (8%) vs 6/61 (10%)). Azithromycin effectively eradicated in all azithromycin-assigned colonised infants, but 21/25 (84%) -colonised participants receiving placebo were culture positive at one or more follow-up timepoints. Most of the neonatal mortality and morbidity was concentrated in 21 infants with lower respiratory tract colonisation. In a subgroup analysis, physiological BPD-free survival was 5/10 (50%) (95% CI 19% to 81%) among azithromycin-assigned infants with lower respiratory tract colonisation versus 2/11 (18%) (95% CI 2% to 52%) in placebo-treated infants.
CONCLUSION
A 3-day azithromycin regimen effectively eradicated respiratory tract colonisation in this study.
TRIAL REGISTRATION NUMBER
NCT01778634.
目的
检测阿奇霉素是否能从早产儿的呼吸道中清除。
设计
前瞻性、二期随机双盲安慰剂对照试验。
地点
美国 7 家三级和四级新生儿重症监护病房（NICU）。
对象
2013 年 7 月至 2016 年 8 月出生后 4 天内的 24-28 周龄（24-26 周；27-28 周）的婴儿。
干预
阿奇霉素 20mg/kg 或等容量的 D5W（安慰剂），每 24 小时静脉注射一次，共 3 天。
主要结局指标
主要疗效终点为无 生存。次要结局指标包括全因死亡率、清除率、36 周校正胎龄时的生理支气管肺发育不良（BPD）、早产儿合并症和呼吸支持时间。
结果
121 名随机参与者（阿奇霉素组：n=60；安慰剂组：n=61）纳入意向治疗分析（平均胎龄 26.2±1.4 周）。121 名参与者中有 44 名（36%）为 阳性（阿奇霉素组：n=19；安慰剂组：n=25）。与安慰剂组相比，阿奇霉素组无 生存者为 55/60（92%（95%CI82%至 97%）），而安慰剂组为 37/61（61%（95%CI48%至 73%））。两组死亡率相似（阿奇霉素组 5/60（8%）比安慰剂组 6/61（10%））。阿奇霉素有效清除了所有接受阿奇霉素治疗的定植婴儿的 ，但接受安慰剂治疗的 25 名定植婴儿中有 21 名在一个或多个随访时间点培养为阳性。大多数新生儿死亡率和发病率集中在 21 名有下呼吸道 定植的婴儿中。在亚组分析中，阿奇霉素组下呼吸道 定植的婴儿中，生理 BPD 无生存者为 5/10（50%）（95%CI19%至 81%），而安慰剂组为 2/11（18%）（95%CI2%至 52%）。
结论
3 天阿奇霉素方案能有效清除本研究中呼吸道的 定植。
临床试验注册号
NCT01778634。
Zotero 插件