Jing Li, Jinge He, Ting Li, Yunkui Li, Wenfeng Gao, Yin Zhong, Ni Yang, Chuang Chen, Lan Xia, Wen Yang
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The risk factors related to acceptance and adherence were identified using a logistic regression model.</p><p><strong>Results: </strong>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<sup>+</sup> T lymphocyte count was between 200 and 350 cells/mm<sup>3</sup> (adjusted OR (aOR)=0.30, 95% CI 0.10 to 0.92) or>500 cells/mm<sup>3</sup> (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).</p><p><strong>Conclusion: </strong>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. 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引用次数: 0
摘要
随着中国在其国家规划中扩大对艾滋病毒感染者（PLHIV）的结核病预防治疗（TPT），本研究的目的是评估6个月异烟肼单药治疗（6H）方案在结核病（TB）和艾滋病毒/艾滋病高负担少数民族地区的预防性治疗接受度、依从性、有效性和结果的可行性和性能。方法：在排除活动性结核（ATB）后，对布拖县461名PLHIV患者进行前瞻性观察队列研究，随访3年，收集真实世界的发病情况。计算结核发病率和保护率。使用逻辑回归模型确定与接受和依从性相关的危险因素。结果：在688例结核筛查的PLHIV患者中，115例（16.72%）有ATB。在461名符合6H治疗条件的参与者中，392名（85.03%）开始了6H治疗，277名（70.67%）完成了治疗。在随访期间，总共有15人被确定为ATB。完整组ATB发生率为0.62/100人年（95% CI 0.20 ~ 1.45），不完整组为2.96/100人年（95% CI 1.36 ~ 5.63） （p=0.005）， 6H保护率为79.05%。完整组、不完整组和拒绝组之间的保护率为69.31%。共有142例（36.22%）患者在异烟肼预防治疗过程中出现药物不良反应。逻辑回归模型揭示了与6H接受度相关的几个因素：CD4+ T淋巴细胞计数在200到350个细胞/mm3之间（调整OR (aOR)=0.30, 95% CI 0.10至0.92）或bbb500个细胞/mm3 （aOR=0.25, 95% CI 0.08至0.77）。与6H依从性相关的因素：36-45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）和既往结核病史（aOR=0.09, 95% CI 0.05至0.20）。结论：6H可降低少数民族地区结核病和艾滋病高负担地区ATB的发病率。定期对患者进行依从性咨询和对TPT工作人员进行再培训是必不可少的。针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。
6-month regimen of isoniazid prevention therapy for tuberculosis among people living with human immunodeficiency virus in minority areas of China: a 3-year prospective cohort study.
Introduction: 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.
Method: 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.
Results: 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/mm3 (adjusted OR (aOR)=0.30, 95% CI 0.10 to 0.92) or>500 cells/mm3 (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).
Conclusion: 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.
期刊介绍：
BMJ Open Respiratory Research is a peer-reviewed, open access journal publishing respiratory and critical care medicine. It is the sister journal to Thorax and co-owned by the British Thoracic Society and BMJ. The journal focuses on robustness of methodology and scientific rigour with less emphasis on novelty or perceived impact. BMJ Open Respiratory Research operates a rapid review process, with continuous publication online, ensuring timely, up-to-date research is available worldwide. The journal publishes review articles and all research study types: Basic science including laboratory based experiments and animal models, Pilot studies or proof of concept, Observational studies, Study protocols, Registries, Clinical trials from phase I to multicentre randomised clinical trials, Systematic reviews and meta-analyses.
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