Absorption of Anti-tuberculosis Drugs and Its Effect to Treatment Response in Gastrectomized Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The change in the maximum concentration (Cmax) of first-line TB drugs
研究概览
简要总结
The purpose of this study is to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-tuberculosis drugs in patients with pulmonary tuberculosis (TB).
详细描述
Gastrectomy is a well-known risk factor for TB. Also, there were some reports about malabsorption of anti-TB drugs in the gastrectomized patients. However, pharmacokinetics of recently used first line anti-TB drugs in the gastrectomized patients have not been well evaluated simultaneously. Therefore, the investigators aim to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-TB drugs in patients with pulmonary TB through this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years and less than 80 years
- •pulmonary TB confirmed by microbiologic test such as AFB culture or TB PCR
- •usage of 4 first-line anti-TB drugs (Isoniazid(INH) Rifampin(RFP) Ethambutol(EMB), Pyrazinamide(PZA) = HREZ)
排除标准
- •patients with liver disease (bilirubin ≥ 1.5 mg/d or AST ≥ 2 x normal upper limit) or chronic renal failure (Cr ≥ 2.0 mg/d) who cannot use first-line anti-TB drugs
- •patients with AIDS or hypoalbuminemia(albumin < 3.0g/dl)that will influence pharmacokinetics of first line anti-TB drugs
- •patients using other drugs that will influence pharmacokinetics of first line anti-TB drugs during anti-TB treatment (e.g warfarin)
- •patients using anti-cancer or immunosuppressive agents that will influence the response of pulmonary TB to anti-TB drugs
- •discontinuation of first-line anti-TB drugs(HREZ)due to side effect or resistance
- •follow-up loss before completion of anti-TB treatment
- •any condition making the patients undergo gastrectomy during anti-TB treatment in case of Non-gastrectomy group
研究组 & 干预措施
Gastrectomy
Twenty gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally
干预措施: standard first line anti-TB drugs (Drug)
Non-gastrectomy
Twenty non-gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally
干预措施: standard first line anti-TB drugs (Drug)
结局指标
主要结局
The change in the maximum concentration (Cmax) of first-line TB drugs
时间窗: Before and 1, 2, 4, 6 and 8 hours after dosing
次要结局
- The effects of pharmacokinetics on responses of pulmonary TB to anti-TB drug(9month after anti-TB treatment)
研究者
Hee Seok Lee
Pulmonologist
National Cancer Center, Korea