Shanghai Public Health Clinical Center, Fudan University, Shanghai, China.
The Affiliated Infectious Hospital of Soochow University, Soochow University, Suzhou, Jiangsu, China.
PLoS One. 2021 Jun 11;16(6):e0253159. doi: 10.1371/journal.pone.0253159. eCollection 2021.
Three months of weekly rifapentine plus isoniazid (3HP) is a short course regimen for latent tuberculosis infection treatment with satisfied safety and efficacy. However, research on its use in children is limited. In this study, we evaluated the completion rate and safety of the 3HP regimen among children in China. Participants aged 1-14 years receiving 3HP for TB prevention at Shanghai Public Health Clinical Center were followed from December 2019 to November 2020 to evaluate the safety and completion rate of the treatment. Thirty-one children were eligible for inclusion, but five were excluded from the analysis (three were treated with a lower than recommended dose, and two were lost to follow-up). Of the 26 children included in the analysis, the treatment completion rate was 100%. Adverse drug reactions (ADRs) were reported in 38.5% (10/26) of the patients. The most common ADRs were gastrointestinal symptoms (19.2%,5/26), and all ADRs were rated as Grade 1. The 3HP regimen has a high completion rate, and it seems well tolerated in our study population. However, further randomized controlled clinical trial with larger sample size are warranted.
三个月每周利福喷丁加异烟肼（3HP）方案是一种治疗潜伏性结核感染的短程方案，具有满意的安全性和疗效。然而，关于其在儿童中的应用研究有限。本研究评估了该方案在中国儿童中的完成率和安全性。2019 年 12 月至 2020 年 11 月，在上海公共卫生临床中心接受 3HP 预防结核病的 1-14 岁参与者接受随访，以评估治疗的安全性和完成率。31 名儿童符合纳入标准，但有 5 名被排除在分析之外（3 名接受的剂量低于推荐剂量，2 名失访）。在纳入分析的 26 名儿童中，治疗完成率为 100%。38.5%（10/26）的患者报告了药物不良反应（ADR）。最常见的 ADR 是胃肠道症状（19.2%，5/26），所有 ADR 均评为 1 级。3HP 方案的完成率较高，在我们的研究人群中似乎具有良好的耐受性。然而，需要进一步开展更大样本量的随机对照临床试验。
