Zhong Tao, Fan Yuzheng, Dong Xiao-Li, Guo Xujun, Wong Ka Hing, Wong Wing-Tak, He Daihai, Liu Shengyuan
Department of Tuberculosis Control and Prevention, Shenzhen Nanshan Center for Chronic Disease Control, Shenzhen, China.
Research Institute for Future Food, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR, China.
Front Pharmacol. 2021 Nov 8;12:708522. doi: 10.3389/fphar.2021.708522. eCollection 2021.
To identify the risk factors associated with anti-tuberculosis drug-induced liver injury (AT-DILI) or abnormal living functioning from 757 patients with pulmonary tuberculosis (TB) registered at Nanshan Center for Chronic Disease Control (Nanshan CCDC), Shenzhen, Guangdong Province, China. We identified 757 TB patients who met our inclusion criteria by screening the Hospital Information System (HIS) at Nanshan CCDC. Next, we identified positive cases of AT-DILI or abnormal liver functioning based on results of the first-time liver function tests (LFTs) after taking anti-TB drugs. The χ2 test was used to relate the positive rate with a variety of factors. A logistic regression model was also used to identify statistically significant risk factors. Of the 757 patients, the positive rate of AT-DILI or abnormal liver functioning was 37.9% (287/757). Univariate analysis revealed that the positive rate was 42.91% (212/494) for males and 28.52% (75/263) for females. The positive rate was significantly higher in males ( <0.001). Patients with an annual income of 9,231-13,845 USD had a significantly higher positive rate (67.35%; 33/49) than those with an income of 1,540-4616 USD (37.97%; 30/79) ( = 0.022). The most frequent prescription regime among positive cases was a 2 months supply of fixed dose combination Ethambutol Hydrochloride, Pyrazinamide, Rifampicin and Isoniazid Tablets (Ⅱ) 450 mg) followed by a 4 months supply of fixed dose combination Rifampin and Isoniazid Capsules (2FDC-HRZE half/4FDC-HR) at 56.03% (144/257). The least frequent prescription regime was a 2 months supply of fixed dose combination Rifampin, Isoniazid and Pyrazinamide Capsules with Ethambutol independently followed by a 4 months supply of fixed dose combination Rifampin and Isoniazid Capsules (2FDC-HRZ + EMB/4FDC-HR) at 24.27% (25/103). The difference between these two different regimes was significant ( = 0.022). With an increase in the duration of medication, patients under various prescription regimes all showed a gradual increase in the positive rate of AT-DILI or abnormal liver functioning. We identified several risk factors for the occurrence of AT-DILI or abnormal liver functioning, including gender, annual income, prescription regime, dosage, and treatment time.
为了确定在中国广东省深圳市南山慢性病防治中心（南山疾控中心）登记的757例肺结核患者中，与抗结核药物性肝损伤（AT-DILI）或肝功能异常相关的危险因素。我们通过筛查南山疾控中心的医院信息系统（HIS），确定了757例符合纳入标准的肺结核患者。接下来，我们根据服用抗结核药物后首次肝功能检查（LFTs）的结果，确定AT-DILI或肝功能异常的阳性病例。采用χ2检验将阳性率与各种因素相关联。还使用逻辑回归模型来确定具有统计学意义的危险因素。在这757例患者中，AT-DILI或肝功能异常的阳性率为37.9%（287/757）。单因素分析显示，男性阳性率为42.91%（212/494），女性为28.52%（75/263）。男性的阳性率显著更高（<0.001）。年收入在9231 - 13845美元的患者阳性率（67.35%；33/49）显著高于年收入在1540 - 4616美元的患者（37.97%；30/79）（P = 0.022）。阳性病例中最常见的处方方案是2个月供应固定剂量复方盐酸乙胺丁醇、吡嗪酰胺、利福平及异烟肼片（Ⅱ）450mg，随后4个月供应固定剂量复方利福平和异烟肼胶囊（2FDC-HRZE半/4FDC-HR），占56.03%（144/257）。最不常见的处方方案是2个月供应固定剂量复方利福平、异烟肼和吡嗪酰胺胶囊加独立的乙胺丁醇，随后4个月供应固定剂量复方利福平和异烟肼胶囊（2FDC-HRZ + EMB/4FDC-HR），占24.27%（25/103）。这两种不同方案之间的差异具有统计学意义（P = 0.022）。随着用药时间的增加，各种处方方案下的患者AT-DILI或肝功能异常的阳性率均呈逐渐上升趋势。我们确定了AT-DILI或肝功能异常发生的几个危险因素，包括性别、年收入、处方方案、剂量和治疗时间。
