drug-susceptible pulmonary tuberculosis with diabetes mellitus
Conditions
Interventions
Standard treatment group :2HRZE/4HR
Extended treatment group:2HRZE/7HR
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily signed the informed consent as the subject; 2. Aged 18 years or above; 3. With rifampicin-susceptible tuberculosis confirmed by GeneXpert; 4. Sputum culture positive within 3 months before enrollment [excluding non-mycobacterium tuberculosis]; 5. With diabetes mellitus; 6. not started anti-TB treatment before enrollment.
Exclusion criteria
Exclusion criteria: 1. PTB with Extrapulmonary tuberculosis; 2. Before treatment was initiated, resistance to isoniazid, rifampicin, pyrazinamide or ethambutol was determined by rapid molecular biological methods, or in vitro drug susceptibility tests, or whole genome sequencing; 3. Impaired renal function (serum creatinine exceeds 1.5 times the upper limit of normal), or impaired liver function (ALT and / or AST levels are three times the upper limit of laboratory reference values); 4. According to the judgment of the researchers, the subject has any disease that is not suitable for participating in this topic or may prevent the patient from participating in the whole process of this topic (such as having a history of cardiovascular disease or are suffering from such diseases, such as heart failure, high blood pressure (poor blood pressure control), arrhythmia or post-myocardial infarction; severe mental illness, alcoholism, drug addiction or other related serious diseases that affect treatment Including immunodeficiency); 5. HIV positive or AIDS patients; 6. Using drugs that affect the observation of the curative effect of this study (glucocorticoids, interferon); drugs that are contraindicated with the drugs in this study, including non-steroidal anti-inflammatory drugs, monoamine oxidase inhibitors (phenelzine, isocarb Hydrazine, etc.); direct or indirect sympathomimetic drugs (such as pseudoephedrine); vasopressor drugs (such as epinephrine, norepinephrine); dopamine drugs (such as dopamine, dobutamine); serotonin Reuptake inhibitors; tricyclic antidepressants; serotonin 5-HTI receptor antagonists (amitriptyline); pethidine or buspirone, etc.; 7. According to the judgment of the research physician, Severely ill patients who is impossible to survive more than 4 months; 8. Karnofsky score < 50%; 9. Pregnant; 10. Those who participated in any other clinical trials within three months before the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The recurrence rate within 2 years after successful treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| treatment success rate;The incidence, frequency, duration, severity and prognosis of serious adverse events and pre-defined adverse events of special concern that can lead to changes in the treatment of tuberculosis (QT prolongation, peripheral neuropathy, optic neuritis, bone marrow suppression, lactic acid Poisoning and serotonin syndrome, etc.); | — |
Countries
China
Contacts
Public ContactFu Liang
Shenzhen Third People's Hospital
Outcome results
None listed