中国上海一款移动健康应用程序对结核病患者治疗效果的影响：一项多中心随机对照试验

Effectiveness of a mobile health application on treatment outcomes among patients with tuberculosis in Shanghai, China: a multicentre randomised controlled trial.

作者信息

Qin Nan, Chen Jing, Chen Lili, Hu Weihong, Feng Yan, Xu Chunhua, Zhang Huaiqing, Hou Yun, Tang Lihong, Shen Xin, Wu Zheyuan

机构信息

Shanghai Municipal Center for Disease Control and Prevention, Shanghai, China.

Shanghai Academy of Preventive Medicine, Shanghai, China.

出版信息

BMJ Glob Health. 2025 Jun 6;10(6):e018022. doi: 10.1136/bmjgh-2024-018022.

DOI:10.1136/bmjgh-2024-018022

PMID:40480646

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12161389/

Abstract

INTRODUCTION

Treatment compliance is considered significant for curing tuberculosis (TB). Digital adherence technologies (DATs) have been recommended for improving treatment compliance and outcomes of patients with TB. Whereas the effectiveness of DATs on TB treatment remains indefinite, we estimated whether a mobile application has an effect on treatment adherence and outcomes among patients with TB in an urban area in China.

METHODS

We conducted a multicentre, two-arm, open-label, equivalent, stratified block randomisation trial from 7 districts involving 4670 eligible new patients with TB in Shanghai, China. Patients in the intervention group were instructed to get access to the app through WeChat. In the control group, patients were treated with standard of care. The primary outcome of this study was a composite outcome, which included death, treatment failure, loss to follow-up and relapse. The secondary outcomes were mainly described as overall poor treatment adherence and monthly poor treatment adherence. A generalised estimating equation is used to estimate the correlation between the two groups' outcomes after adjusting for concomitant variables.

RESULTS

Between 1 March 2021 and 31 December 2022, 741 patients (371 in the intervention group and 370 in the control group) were included in the intention-to-treat population, 430 (58%) were male and the median age was 33 years (IQR 27-49). 80 (22%) patients in the intervention group and 104 (28%) patients in the control group had a primary composite outcome event. The adjusted risk difference for the intervention versus control was -7.04 percentage points (95% CI -13.25 to -1.14, p=0.025); secondary outcome included overall poor treatment adherence with an adjusted risk difference -16.39 percentage points (95% CI -22.13 to -9.62, p<0.001).

CONCLUSIONS

The mobile health application improved TB treatment adherence and outcomes significantly, especially for loss to follow-up. Future research should be focused on implementation problems in various settings and the improvement of patient-centred management strategies.

TRIAL REGISTRATION NUMBER

ChiCTR2000037575.

摘要

引言

治疗依从性被认为对治愈结核病（TB）至关重要。数字依从技术（DATs）已被推荐用于提高结核病患者的治疗依从性和治疗效果。尽管DATs对结核病治疗的有效性仍不明确，但我们评估了一款移动应用程序对中国某城市地区结核病患者的治疗依从性和治疗效果是否有影响。

方法

我们在中国上海的7个区开展了一项多中心、双臂、开放标签、等效、分层区组随机试验，纳入4670名符合条件的新结核病患者。干预组患者被指导通过微信访问该应用程序。对照组患者接受标准治疗。本研究的主要结局是一个复合结局，包括死亡、治疗失败、失访和复发。次要结局主要描述为总体治疗依从性差和每月治疗依从性差。使用广义估计方程在调整伴随变量后估计两组结局之间的相关性。

结果

在2021年3月1日至2022年12月31日期间，意向性分析人群纳入了741名患者（干预组371名，对照组370名），其中430名（58%）为男性，年龄中位数为33岁（四分位间距27 - 49岁）。干预组80名（22%）患者和对照组104名（28%）患者发生了主要复合结局事件。干预组与对照组调整后的风险差异为 -7.04个百分点（95%置信区间 -13.25至 -1.14，p = 0.025）；次要结局包括总体治疗依从性差，调整后的风险差异为 -16.39个百分点（95%置信区间 -22.13至 -9.62，p < 0.001）。