抗逆转录病毒治疗开始时机对因严重急性营养不良住院的人类免疫缺陷病毒感染儿童结局的影响。
Effect of the Timing of Antiretroviral Treatment Initiation on Outcomes in Children Living With Human Immunodeficiency Virus Admitted With Severe Acute Malnutrition.
机构信息
Paediatric Unit, King Edward VIII Hospital, Durban, South Africa.
Department of Paediatrics and Child Health, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
出版信息
J Pediatric Infect Dis Soc. 2021 Apr 3;10(3):259-266. doi: 10.1093/jpids/piaa054.
BACKGROUND
Delays in early infant diagnosis and antiretroviral treatment (ART) initiation in developing countries frequently result in malnutrition at initial presentation with associated higher mortality and delayed immune recovery. The optimal timing of ART initiation is yet to be established.
METHODS
Eighty-two children admitted with HIV and severe acute malnutrition (SAM) between July 2012 and December 2015 were enrolled. Patients were randomized to initiate ART within 14 days from admission (early arm) or delay ART initiation until nutritional recovery and >14 days after admission (delayed arm). All patients received a standardized treatment and feeding protocol and were followed to 48 weeks.
RESULTS
The mean age of the patients at baseline was 23.3 months (standard deviation [SD], 27.9; range, 1.6-129 months). The mean time from admission to ART initiation was 5.6 days (SD, 4.4) in the early arm and 23 days (SD, 5.8) in the delayed arm (P < .001). There was no significant difference in mortality (P = .62), virologic response (P = .53), and anthropometric response (P = .57) between the 2 groups at 48 weeks. However, the rates of change in CD4, viral load, weight for age z score, and height for age z score occurred earlier and favored the delayed arm at early time points but were not significant at 24 and 48 months.
CONCLUSIONS
Despite initial improved responses in the delayed arm, lack of difference in outcome at 48 weeks supports a pragmatic approach with earlier ART initiation in children living with HIV admitted with SAM.In this randomised controlled study of ART initiation in children admitted with HIV and severe acute malnutrition (SAM), despite initial improved responses in the delayed arm, lack of difference in outcome at 48 weeks supports a pragmatic approach with earlier ART initiation in children living with HIV admitted with SAM.
CLINICAL TRIALS REGISTRATION
PACTR 21609001751384.
背景
在发展中国家，婴儿早期诊断和抗逆转录病毒治疗（ART）启动的延迟常常导致初始表现时出现营养不良，随之而来的是更高的死亡率和延迟的免疫恢复。ART 启动的最佳时机尚未确定。
方法
2012 年 7 月至 2015 年 12 月期间，共纳入 82 例因 HIV 和严重急性营养不良（SAM）住院的患儿。患者被随机分为在入院后 14 天内开始 ART（早期组）或延迟 ART 启动，直到营养恢复和入院后超过 14 天（延迟组）。所有患者均接受标准化治疗和喂养方案，并随访至 48 周。
结果
患者基线时的平均年龄为 23.3 个月（标准差[SD]，27.9；范围，1.6-129 个月）。早期组从入院到开始 ART 的平均时间为 5.6 天（SD，4.4），延迟组为 23 天（SD，5.8）（P<.001）。两组在 48 周时死亡率（P=.62）、病毒学应答（P=.53）和人体测量学应答（P=.57）均无显著差异。然而，在早期时间点，CD4、病毒载量、体重年龄 z 评分和身高年龄 z 评分的变化率更早且有利于延迟组，但在 24 个月和 48 个月时没有统计学意义。
结论
尽管延迟组的初始反应有所改善，但在 48 周时结果无差异支持对 SAM 住院的 HIV 患儿采用更实用的早期 ART 启动方法。在这项关于 SAM 住院的 HIV 患儿接受 ART 启动的随机对照研究中，尽管延迟组的初始反应有所改善，但在 48 周时结果无差异支持对 SAM 住院的 HIV 患儿采用更实用的早期 ART 启动方法。
临床试验注册
PACTR 21609001751384。
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