Pulmonary tuberculosis
Conditions
Interventions
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Mycobacterium tuberculosis in sputum (rifampicin resistant) was diagnosd positive by Xpert PCR; 2. BD960 Mycobacterium tuberculosis in sputum was positive for Mycobacterium tuberculosis; 3. The drug sensitivity test of BD960 showed that isoniazid and rifampicin were resistant simultaneously; 4. Conform to the established TCM syndrome standard; 5. Aged 18 to 65 years; 6. Accept the drug treatment voluntarily and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. ten items of BD drug sensitivity exclude XDR-TB; 2. the continuous course of disease was more than 5 years and the number of retreatment times was more than 2 times in the past; 3. chest CT showed that the diameter of pulmonary cavity was more than 5cm or the number of cavities was more than 5; 4. with the history of massive hemoptysis; 5. body mass index (BMI) was less than 19; 6. tuberculosis but not Pulmonary tuberculosis, such as lymphoid tuberculosis, bone tuberculosis and brain tuberculosis; 7. family history of mental disease; respiratory failure; severe peptic ulcer; malignant tumor; AIDS; autoimmune disease; 8. legally disabled patients; 9. do not take oral medication; 10. pregnant, preparing pregnant or lactating women; 11. those who are allergic to the test drug and its components; 12. QT interval in ECG is greater than 500 ms after correction; 13. patients with abnormal liver function (ALT more than 1.2 times of the upper limit of normal), or positive for HBsAg, HBeAg and HBcAg at the same time; 14. poor control of blood glucose in diabetic patients (fasting blood glucose > 7mmol/L, postprandial blood glucose > 11mmol/L); 15. the researchers determined that the patients could not complete the treatment in the trial period because of the existence risk of other diseases; 16. those who cannot judge the efficacy or incomplete data, which affect the efficacy or safety judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reaction rate;Cure rate;improvement ratio;Adverse reaction rate;Sputum smear positive rate;the detection rate of Mycobacterium tuberculosis culture in sputum; | — |
Secondary
| Measure | Time frame |
|---|---|
| the rate cavity closing up;rates of focus absorption; | — |
Countries
China
Contacts
Public ContactLU Zhenhui
Outcome results
None listed