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密切接触肺结核患者的潜伏性结核感染预防治疗的依从性:中国的一项集群随机对照试验。

Adherence to preventive treatment for latent tuberculosis infection in close contacts of pulmonary tuberculosis patients: A cluster-randomized controlled trial in China.

机构信息

National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.

Henan Provincial Center for Disease Control and Prevention, Zhengzhou, China.

出版信息

Int J Infect Dis. 2024 Oct;147:107196. doi: 10.1016/j.ijid.2024.107196. Epub 2024 Jul 27.

Abstract

OBJECTIVES

This study examined adherence rates to tuberculosis preventive treatment (TPT) among close contacts of individuals with pulmonary tuberculosis (PTB) and identified factors associated with TPT adherence in China.

METHODS

A multicenter, cluster-randomized, open-label control trial was carried out across three sites involving 34 counties in China. Close contacts of bacteriologically confirmed rifampin and isoniazid-susceptible PTB cases were identified and screened for latent tuberculosis infection (LTBI). Eligible participants were randomly assigned to either the 3HP group, which consisted of a 3-month, twice-weekly regimen of rifapentine and isoniazid, or the 6H group, which entailed a 6-month daily regimen of isoniazid. To assess the factors influencing adherence, a two-level logistic regression model was utilized.

RESULTS

Out of the 2434 close contacts who initiated TPT, 2121 (87.1%) completed the regimen. Of the 313 individuals who did not complete TPT, 60.1% refused to continue, and 27.8% discontinued due to adverse effects. The two-level logistic regression model revealed several factors associated with enhanced TPT adherence: enrollment in the 3HP group (odds ratio [OR] = 2.09), management by a TB dispensary responsible for TPT (OR = 2.55), supervision by healthcare workers (OR = 6.40), and clinician incentives (OR = 2.49). Conversely, the occurrence of any adverse effects (OR = 0.08) was identified as a risk factor for nonadherence.

CONCLUSION

Administering TPT to individuals with LTBI is feasible among close contacts. Adherence to TPT can be enhanced through shorter, safer treatment regimens and supportive interventions, such as directly supervised therapy for TPT recipients and incentives for healthcare providers managing TPT.

摘要

目的

本研究旨在调查中国肺结核(PTB)密切接触者接受结核预防性治疗(TPT)的依从率,并确定与 TPT 依从性相关的因素。

方法

在三个地点进行了一项多中心、集群随机、开放性对照试验,涉及中国的 34 个县。对经细菌学证实的利福平及异烟肼敏感型 PTB 病例的密切接触者进行识别和潜伏性结核感染(LTBI)筛查。符合条件的参与者被随机分配至 3HP 组或 6H 组。3HP 组采用利福喷丁和异烟肼双周疗法,共 3 个月;6H 组采用异烟肼每日疗法,共 6 个月。为评估影响依从性的因素,采用了两水平逻辑回归模型。

结果

在 2434 名开始接受 TPT 的密切接触者中,有 2121 名(87.1%)完成了疗程。在 313 名未完成 TPT 的个体中,60.1%拒绝继续治疗,27.8%因不良反应而停药。两水平逻辑回归模型显示,以下因素与 TPT 依从性提高相关:纳入 3HP 组(比值比 [OR] = 2.09)、由负责 TPT 的结核病防治所管理(OR = 2.55)、由医护人员监督(OR = 6.40)和医师激励(OR = 2.49)。相反,出现任何不良反应(OR = 0.08)被认为是不依从的风险因素。

结论

在 LTBI 个体中实施 TPT 是可行的。通过更短、更安全的治疗方案和支持性干预措施,如对 TPT 接受者进行直接监督治疗和对管理 TPT 的医护人员进行激励,可以提高 TPT 的依从性。

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