Research Unit, Baylor College of Medicine Bristol Myers Squibb Children's Clinical Center of Excellence at Mulago Hospital, Kampala, Uganda.
J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):274-80. doi: 10.1097/QAI.0b013e3182423668.
Antiretroviral therapy (ART) is known to cause a number of adverse effects. The objective of this study was to determine the frequency and outcome of ART-related adverse events among patients aged 6 weeks to 18 years.
We followed up a cohort of 378 HIV-infected children and adolescents who started ART at the Baylor-Uganda Clinic during the period July 2004 to July 2009. Patients were started on zidovudine or stavudine, plus lamivudine, and efavirenz or nevirapine. Adverse events were recorded as they occurred. Descriptive analyses and Kaplan-Meier survival analysis were carried out.
Of 126 adverse events reported among 107 (28.3%) patients, dizziness (17.5%), diarrhea (13.5%), and nausea and vomiting (14.3%) were the most frequent. Anxiety/night mares, skin rashes, nail discoloration, and lipodystrophy each contributed between 5% and 10%; whereas anorexia, abdominal pain, hepatitis, and somnolence contributed 1%-5%. Amnesia, lactic acidosis, gynaecomastia, cardiomyopathy, and peripheral neuropathy were rare, each contributing less than 1% of the total events. The overall probability of remaining free of adverse events was 77.1% (95% confidence interval: 72.38 to 81.13) at month 6 of ART.Among infants and young children, neurologic events could not be determined. Laboratory abnormalities were present at baseline and during follow-up, and hemoglobin levels increased significantly during the first 6 months of ART. There was no association between adverse events and baseline patient characteristics.
Close to one-third of children on ART experience adverse events. Most events occur within the first 3 months of ART and are not associated with baseline patient characteristics.
抗逆转录病毒疗法（ART）已知会引起许多不良反应。本研究的目的是确定在 6 周至 18 岁的患者中接受 ART 治疗的不良反应的频率和结局。
我们对 2004 年 7 月至 2009 年 7 月在贝勒乌干达诊所接受 ART 的 378 名 HIV 感染儿童和青少年进行了随访。患者开始接受齐多夫定或司他夫定加拉米夫定，以及依非韦伦或奈韦拉平治疗。当出现不良反应时，会对其进行记录。进行描述性分析和 Kaplan-Meier 生存分析。
在 107 名（28.3%）患者中报告了 126 起不良反应事件，头晕（17.5%）、腹泻（13.5%）和恶心呕吐（14.3%）最常见。焦虑/梦魇、皮疹、指甲变色和脂肪营养不良各占 5%至 10%；而厌食、腹痛、肝炎和嗜睡占 1%至 5%。遗忘症、乳酸性酸中毒、男性乳房发育症、心肌病和周围神经病罕见，每种疾病均占总事件的不到 1%。ART 治疗 6 个月时，无不良反应事件的总体概率为 77.1%（95%置信区间：72.38%至 81.13%）。在婴儿和幼儿中，无法确定神经事件。基线和随访期间存在实验室异常，血红蛋白水平在 ART 治疗的前 6 个月内显著增加。不良反应与基线患者特征之间无关联。
接近三分之一接受 ART 治疗的儿童会出现不良反应。大多数事件发生在 ART 的前 3 个月内，且与基线患者特征无关。
