A multicenter randomized, double-blind, parallel controlled, trial for integrated traditional Chinese medicine and western short-course chemotherapy in the treatment of multidrug resistance pulmonary tub

onghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

onghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine