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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastrectomy | Twenty gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally |
| |
| Non-gastrectomy | Twenty non-gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard first line anti-TB drugs | Drug | We will perform pharmacokinetic study in gastrectomy and non-gastrectomy group, to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-TB drugs in patients with TB |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the maximum concentration (Cmax) of first-line TB drugs | Before and 1, 2, 4, 6 and 8 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| The effects of pharmacokinetics on responses of pulmonary TB to anti-TB drug | Treatment duration can be varied according to several factors such as a first TB episode or not, cavitary TB, and AFB culture(+) after 2month-treatment etc. We will plan 6 or 9 months treatment for each patient according to these factors. During treatment period, we will check chest radiographs and sputum AFB smear/culture with every 2-3month intervals. At 9month after treatment, we will evaluate the effects of pharmacokinetics on responses of pulmonary TB to anti-TB drug by taking account of improvement on chest radiograph and negative conversion and its continuation on sputum smear/culture. |
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Inclusion Criteria:
Exclusion Criteria:
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Among patients with pulmonary TB diagnosed in our hospital and treated with 4 first line anti-TB drug(isoniazid/rifampicin/ethambutol/pyrazinamide= HREZ), we recruit patients who underwent gastrectomy to Gastrectomy group. And then, we recruit age-sex matched patients who did not underwent gastrectomy to Non-gastrectomy group.(age ±3 years)
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| Name | Affiliation | Role |
|---|---|---|
| Hee Seok Lee, M.D. | National Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Clinic, National Cancer Center | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D014397 | Tuberculosis, Pulmonary |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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|
| 9month after anti-TB treatment |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |