采用综合护理策略的儿童结核感染治疗依从性：一项设有历史对照组的前瞻性队列研究

Adherence to treatment for tuberculosis infection in children using a comprehensive care strategy: a prospective cohort study with a historical control group.

作者信息

Rodríguez-Márquez Iader, Benjumea-Bedoya Dione, Restrepo-Gouzy Andrea Victoria, Beltrán-Arroyave Claudia Patricia, Marín Diana, Montes-Zuluaga Fernando Nicolás, Alzate-Ángel Juan Carlos, Cadavid-Álvarez Lina Marcela, Paniagua-Saldarriaga Lizeth Andrea, Realpe Teresa, Perea-Torres Yesenia, Arango-García Lisandra María, Pérez-Doncel Natalia, Arbeláez-Montoya María Patricia, Robledo Jaime

机构信息

Grupo de Investigación en Epidemiología, Facultad Nacional de Salud Pública, Universidad de Antioquia, Antioquia, Medellín, Colombia.

Unidad de Bacteriología y Micobacterias, Corporación para Investigaciones Biológicas (CIB), Antioquia, Medellín, Colombia.

出版信息

Lancet Reg Health Am. 2025 Apr 22;46:101094. doi: 10.1016/j.lana.2025.101094. eCollection 2025 Jun.

DOI:10.1016/j.lana.2025.101094

PMID:40329939

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12052824/

Abstract

BACKGROUND

Low adherence to treatment for tuberculosis infection (TBI) in children threatens tuberculosis (TB) control goals. This research focuses on children with close contact to TB and TBI. This study evaluated adherence to treatment of TBI using a comprehensive care strategy (CCS) for close-contact children with pulmonary TB compared with standard of care (SOC).

METHODS

A prospective cohort study with a historical control group was conducted on children under five, who were close contacts of patients with bacteriologically confirmed pulmonary TB in three Colombian cities (study registration number: NCT04331262). The CCS comprised clinical evaluations, rifampicin for four months, multidisciplinary care, and logistical support, while the SOC followed program regulations with isoniazid for nine months. The primary outcome was the proportion of children completing 100% treatment during follow-up, and the secondary outcome was treatment-related adverse events (AEs).

FINDINGS

213 children in the SOC group and 86 children in the CCS group were analyzed. The treatment adherence in the SOC group was 40·8% (95% CI 34%; 48%), while in the CCS group it was 76·7% (95% CI 66%; 85%). Children exposed to CCS had 87% higher probability of adherence to TBI treatment compared to SOC (RR 1·87; 95% CI 1·52; 2·31). The incidence of AEs was lower in the CCS group (n = 3) than in those receiving SOC (n = 24).

INTERPRETATION

The CCS increases adherence to treatment for TBI in children safely compared to SOC. Future cost-effectiveness studies will help implement this strategy in programmatic settings.

FUNDING

Colombian Ministry of Science, Technology and Innovation.

摘要

背景

儿童对结核感染（TBI）治疗的低依从性威胁着结核病（TB）控制目标。本研究聚焦于与结核病和结核感染密切接触的儿童。本研究评估了采用综合护理策略（CCS）对肺结核密切接触儿童进行TBI治疗的依从性，并与标准护理（SOC）进行比较。

方法

对哥伦比亚三个城市中五岁以下、与细菌学确诊的肺结核患者密切接触的儿童进行了一项有历史对照组的前瞻性队列研究（研究注册号：NCT04331262）。CCS包括临床评估、四个月的利福平治疗、多学科护理和后勤支持，而SOC遵循项目规定，使用异烟肼治疗九个月。主要结局是随访期间完成100%治疗的儿童比例，次要结局是与治疗相关的不良事件（AE）。

结果

分析了SOC组的213名儿童和CCS组的86名儿童。SOC组的治疗依从率为40.8%（95%CI 34%；48%），而CCS组为76.7%（95%CI 66%；85%）。与SOC相比，接受CCS的儿童坚持TBI治疗的可能性高87%（RR 1.87；95%CI 1.52；2.31）。CCS组的AE发生率（n = 3）低于接受SOC的组（n = 24）。