Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis

Korábbi kezelés

• 1. Patients who received similar traditional Chinese medicine treatment 4 weeks prior to enrollment;
• 3. Known or suspected to have a history of allergies or serious adverse reactions to the investigational drug and its excipients, or allergic constitution.
• 4. Patients with drug sensitivity indicating the growth of non tuberculosis mycobacteria (more than twice) or clinically diagnosed with non tuberculosis mycobacterial disease or concomitant non tuberculosis mycobacterial disease;
• 5. For patients with recurrent pulmonary tuberculosis, those with bacterial negative pulmonary tuberculosis or those with initial bacterial positive pulmonary tuberculosis who have received anti tuberculosis treatment for more than one week;
• 7. Concomitant severe organic cardiovascular and cerebrovascular diseases (such as congestive heart failure, myocardial infarction, and acute stroke with NYHA heart function grading of III-IV);
• 12. Concomitant with other lung diseases, such as lung tumors, cysts, abscesses, interstitial lung disease, silicosis, pneumoconiosis, etc

Más betegség

• 2. Patients with drug-resistant and extensively drug-resistant pulmonary tuberculosis;
• 6. Patients with combined autoimmune diseases, malignant tumors, severe hematological and hematopoietic system diseases, epilepsy, and psychiatric disorders;
• 8. Merge uncontrolled hypertension (blood pressure ≥ 160/100mmHg at enrollment);
• 9. diabetes with poor glycemic control;
• 11. Patients with extrapulmonary tuberculosis such as lymph node tuberculosis, intestinal tuberculosis, bone tuberculosis, renal tuberculosis, epididymal tuberculosis, urogenital tuberculosis, nervous system tuberculosis, and tuberculous meningitis;
• 14. HIV patients; Syphilis antibody positive patients;
• 16. Those who suspect or have a history of alcohol or drug abuse or a tendency towards drug dependence;

Laborértékek

• 10. Concomitant severe liver and kidney diseases, or abnormal liver and kidney function tests (ALT, AST ≥ 2.5 times the upper limit of normal, Scr>the upper limit of normal);

Egyéb

• 13. Pregnant and lactating women;
• 15. Individuals who have participated in other clinical trials within 15.1 months;
• 17. The researchers believe that patients are not suitable for inclusion in this trial.

• 1. Age: 18 to 65 years old, regardless of gender;
• 2. Meets the diagnostic criteria for Western medicine pulmonary tuberculosis (formulated in accordance with the health industry standard WS 288-2017 "Diagnosis of Pulmonary Tuberculosis" of the People's Republic of China [9])
• 3. Have not received anti tuberculosis treatment in the past, or have received HRZE anti tuberculosis treatment for less than 1 week as a first-line option
• 4. The subjects themselves have informed consent, voluntarily participate in this study, have good medication compliance, and have signed the subject's informed consent form.
  • Conforming to the diagnostic criteria for Qi and Yin deficiency syndrome in traditional Chinese medicine (in accordance with the industry standards of traditional Chinese medicine in the People's Republic of China - Traditional Chinese Medicine Internal Medicine - Diagnosis and Efficacy Criteria for Disease Symptoms ZY/T0011.1-94) Main symptoms: shortness of breath, fatigue, mental fatigue, weak pulse Secondary symptoms: hemoptysis, spontaneous sweating, night sweating, insufficient appetite, bloating, red and tender tongue, thin coating Diagnosis can be made by having two main symptoms and one secondary symptom.