College of Pharmacy, Chung-Ang University, Seoul, Korea.
Department of Global Innovative Drugs, Graduate School of Chung-Ang University, Seoul, Korea.
Korean J Intern Med. 2024 Nov;39(6):979-988. doi: 10.3904/kjim.2023.557. Epub 2024 Oct 22.
BACKGROUND/AIMS: Few real-world studies explored factors associated with latent tuberculosis infection (LTBI) treatment-related adverse drug reactions (ADRs). This study evaluate ADRs that lead to the discontinuation of LTBI treatment and identify the associated factors, including age groups and drug regimens.
Using the Korean national tuberculosis registry and HHC investigation database linked to the National Health Insurance Service claims database, we examined treatment discontinuation due to ADRs among HHCs on LTBI treatment from January 2015 to December 2018. Multivariable logistic regression analysis was conducted to examine factors associated with ADRs, including demographics, LTBI treatment, comorbidities, and steroid use.
Among 11,913 participants initiated LTBI treatment, 633 participants (5.3%) discontinued treatment due to ADRs. The primary contributors to discontinuation were adverse skin reactions (2.0%) and abnormal liver function (1.9%). Risk associated with ADRs and abnormal liver function showed age-related increase, except for the age group 66-75 (adjusted odds ratio [AOR] 3.82, 95% confidence interval [CI] 2.31-6.31) which reported lower OR to that of age group 36-65 (AOR 4.38, 95% CI 3.09-6.21). Three months isoniazid/rifampin and 4 months rifampin exhibited a lower odds of ADRs and abnormal liver function when compared to 6-9 months isoniazid.
We discovered the real-world prevalence of LTBI treatment discontinuation due to ADRs among HHCs. Our findings suggest a notably increased odds of ADRs resulting in discontinuation with age of 76 years or above, emphasizing careful attention when prescribing LTBI treatment in this population. Further studies are warranted to validate these results.
背景/目的:很少有真实世界的研究探讨与潜伏性结核感染(LTBI)治疗相关不良反应(ADR)相关的因素。本研究评估了导致 LTBI 治疗中断的 ADR,并确定了相关因素,包括年龄组和药物方案。
使用韩国国家结核病登记处和 HHC 调查数据库与国家健康保险服务索赔数据库相链接,我们检查了 2015 年 1 月至 2018 年 12 月期间接受 LTBI 治疗的 HHC 因 ADR 而导致治疗中断的情况。采用多变量逻辑回归分析来检查与 ADR 相关的因素,包括人口统计学、LTBI 治疗、合并症和类固醇使用。
在接受 LTBI 治疗的 11913 名参与者中,有 633 名(5.3%)因 ADR 而中断治疗。导致停药的主要原因是皮肤不良反应(2.0%)和肝功能异常(1.9%)。除了 66-75 岁年龄组(调整后比值比 [AOR] 3.82,95%置信区间 [CI] 2.31-6.31)外,与 ADR 和肝功能异常相关的风险与年龄呈正相关,该年龄组的 OR 低于 36-65 岁年龄组(AOR 4.38,95%CI 3.09-6.21)。与 6-9 个月异烟肼相比,3 个月异烟肼/利福平和 4 个月利福平治疗方案发生 ADR 和肝功能异常的可能性较低。
我们发现了真实世界中 HHC 因 ADR 而导致 LTBI 治疗中断的流行率。我们的研究结果表明,年龄在 76 岁或以上的患者因 ADR 导致停药的可能性明显增加,在为该人群开具 LTBI 治疗处方时需要格外小心。需要进一步的研究来验证这些结果。