A new scheme of traditional Chinese medicine treatment for drug-resistant tuberculosis

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