Li Jing, He Jinge, Li Ting, Li Yunkui, Gao Wenfeng, Zhong Yin, Yang Ni, Chen Chuang, Xia Lan, Yang Wen
Sichuan Provincial Centre for Disease Prevention and Control, Chengdu, Sichuan, China.
Sichuan Provincial Centre for Disease Prevention and Control, Chengdu, Sichuan, China
BMJ Open Respir Res. 2024 Dec 25;11(1):e002801. doi: 10.1136/bmjresp-2024-002801.
As China is scaling up tuberculosis preventive therapy (TPT) for people living with HIV (PLHIV) in its national programmes, the objective of this study was to evaluate the feasibility and performance of 6-month regimen of isoniazid monotherapy (6H) in terms of preventive therapy acceptance, adherence, effectiveness and outcomes in minority areas with a high burden of tuberculosis (TB) and HIV/AIDS.
A prospective observational cohort study was initiated among 461 PLHIV in Butuo County after ruling out active TB (ATB) and followed up for up to 3 years to collect incidence events in real-world settings. TB incidence and protective rates were calculated. The risk factors related to acceptance and adherence were identified using a logistic regression model.
Of the 688 PLHIV screened for TB, 115 (16.72 %) had ATB. Among the 461 participants eligible for 6H, 392 (85.03%) initiated 6H, and 277 (70.67%) completed the therapy. In total, 15 were identified as having ATB during follow-up. The incidence of ATB in the complete group was 0.62/100 person years (95% CI 0.20 to 1.45) as compared with the incomplete group 2.96/100 person years (95% CI 1.36 to 5.63) (p=0.005), and the protective rate of 6H was 79.05%. The protection rate between the complete and incomplete and refusal groups was 69.31%. In total, 142 (36.22%) patients experienced adverse drug reactions during isoniazid preventive therapy. The logistic regression model revealed several factors associated with 6H acceptance: first CD4 T lymphocyte count was between 200 and 350 cells/mm (adjusted OR (aOR)=0.30, 95% CI 0.10 to 0.92) or>500 cells/mm (aOR=0.25, 95% CI 0.08 to 0.77). Factors associated with 6H adherence: 36-45 years old (aOR=2.76, 95% CI 1.49 to 5.10), middle school education (aOR=0.26, 95% CI 0.08 to 0.79) and history of prior TB (aOR=0.09, 95% CI 0.05 to 0.20).
6H can reduce the incidence of ATB in minority areas with high burdens of TB and HIV/AIDS. Periodic counselling of patients on adherence and retraining of the TPT staff are essential. Health monitoring and education for specific populations improve TPT acceptance and adherence.
随着中国在其国家项目中扩大对艾滋病毒感染者（PLHIV）的结核病预防性治疗（TPT），本研究的目的是评估在结核病（TB）和艾滋病毒/艾滋病负担较高的少数民族地区，异烟肼单药6个月治疗方案（6H）在预防性治疗接受度、依从性、有效性和结局方面的可行性和效果。
在排除活动性结核病（ATB）后，对布拖县的461名PLHIV启动了一项前瞻性观察队列研究，并随访长达3年，以收集实际环境中的发病事件。计算结核病发病率和保护率。使用逻辑回归模型确定与接受度和依从性相关的危险因素。
在筛查结核病的688名PLHIV中，115名（16.72%）患有ATB。在符合6H治疗条件的461名参与者中，392名（85.03%）开始了6H治疗，277名（70.67%）完成了治疗。在随访期间，共确定15名患有ATB。完成治疗组的ATB发病率为0.62/100人年（95%CI 0.20至1.45），而未完成治疗组为2.96/100人年（95%CI 1.36至5.63）（p=0.005），6H的保护率为79.05%。完成治疗组与未完成治疗组及拒绝治疗组之间的保护率为69.31%。在异烟肼预防性治疗期间，共有142名（36.22%）患者出现药物不良反应。逻辑回归模型揭示了与6H接受度相关的几个因素：首先，CD4 T淋巴细胞计数在200至350个细胞/mm之间（调整后比值比（aOR）=0.30，95%CI 0.10至0.92）或>500个细胞/mm（aOR=0.25，95%CI 0.08至0.77）。与6H依从性相关的因素：36至45岁（aOR=2.76，95%CI 1.49至5.10）、中学教育程度（aOR=0.26，95%CI 0.08至0.79）和既往结核病病史（aOR=0.09，95%CI 0.05至0.20）。
6H可降低结核病和艾滋病毒/艾滋病负担较高的少数民族地区的ATB发病率。定期对患者进行依从性咨询和对TPT工作人员进行再培训至关重要。对特定人群的健康监测和教育可提高TPT的接受度和依从性。
