Pharmacokinetics of Anti-tuberculosis Drugs in Gastrectomized Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2020-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Tuberculosis Tuberculosis, Pulmonary Early Gastric Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastrectomy

Twenty gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally

standard first line anti-TB drugs

Intervention Type 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

Non-gastrectomy

Twenty non-gastrectomized patients with pulmonary TB, treated with standard first line anti-TB drugs(isoniazid/rifampicin/ethambutol/pyrazinamide), administered daily, orally

standard first line anti-TB drugs

Intervention Type 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

Interventions

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standard first line anti-TB drugs

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

Intervention Type DRUG

Other Intervention Names

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Pharmacokinetics of Anti-tuberculosis Drugs

Eligibility Criteria

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Inclusion Criteria

1. Age greater than 18 years and less than 80 years
2. pulmonary TB confirmed by microbiologic test such as AFB culture or TB PCR
3. usage of 4 first-line anti-TB drugs (Isoniazid(INH) Rifampin(RFP) Ethambutol(EMB), Pyrazinamide(PZA) = HREZ)

Exclusion Criteria

1. 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
2. patients with AIDS or hypoalbuminemia(albumin \< 3.0g/dl)that will influence pharmacokinetics of first line anti-TB drugs
3. patients using other drugs that will influence pharmacokinetics of first line anti-TB drugs during anti-TB treatment (e.g warfarin)
4. patients using anti-cancer or immunosuppressive agents that will influence the response of pulmonary TB to anti-TB drugs
5. discontinuation of first-line anti-TB drugs(HREZ)due to side effect or resistance
6. follow-up loss before completion of anti-TB treatment
7. any condition making the patients undergo gastrectomy during anti-TB treatment in case of Non-gastrectomy group

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No