Multi-drug resistant pulmonary tuberculosis (MDR-PTB)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sputum cultures positive for Mycobacterium tuberculosis that is resistant at least to isoniazid (INH) and rifampicin (RMP); 2. Syndrome differentiation belongs to syndrome of yin deficiency and lung heat, syndrome of qi and yin deficiency; 3. Aged 18 to 65 years; 4. course of tuberculosis>=2 months, <=8 years; 5. patients have fully understand the study, voluntary take the test and informed agreement signed.
Exclusion criteria
Exclusion criteria: 1. Extensively drug-resistant pulmonary tuberculosis; 2. Complicated with HIV infection; 3. Abnormal liver function(serum level of ASK and ALT was 1.2 times higher than normal level ) and/or HBsAg positive,HbeAg positive, HbcAg positive; 4. Chronic kidney disease and abnormal renal function; 5. Plasma glucose poorly controlled undertaking(FBG>7.0mmol/L or 2h PBS>11.1mmol/L); 6. Complicated with severe primary disease such as cardio-cerebrovascular disease, kidney disease, hematopoietic system disease, gastrointestinal ulcer, caners; 7. Allergic to the therapeutic medicine; 8. Pregnant, ready to be pregnant or breast-feeding women; 9. Patients with mental or legal disabilities.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change of the TCM syndrome scores;Treatment failure rate;Treatment completion rate;immunologic function(CD3, CD4, CD8);Change of body mass index;Quality of life score (SF36 score);Erythrocyte Sedimentation Rate (ESR); | — |
Primary
| Measure | Time frame |
|---|---|
| sputum negative conversion rate;Changes in pulmonary lesions;Time to sputum culture conversion; | — |
Countries
China