Refractory Mycobacterium avium pulmonary disease (MAC)
Conditions
Interventions
Experimental group:Azithromycin 250mg, ethambutol 15mg/kg once a day, rifampicin 10mg/kg (450mg-600mg) once a day, amikacin liposome inhalation suspension 590mg once a day, once a day, Bufeijiedu gran
Placebo group:Azithromycin 250mg, ethambutol 15mg/kg once a day, rifampicin 10mg/kg (450mg-600mg) once a day, amikacin liposome inhalation suspension 590mg once a day, Bufei Jiedu granule placebo 1 ba
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of NTM lung disease, and sputum or alveolar lavage culture identified as MAC; 2. Meet refractory MAC lung disease: follow the GBT regimen for >= 6 months, and the GBT regimen is still being continued or the regimen is discontinued The protocol is less than 12 months, but the culture of Mycobacterium avium complex in sputum or bronchial aspiration is still positive; 3. Those who are sensitive to amikacin; 4. Meet the dialectical diagnostic criteria of traditional Chinese medicine; 5. Aged 18 -75 years, no gender limit; 6. Those who signed the informed consent and agreed to participate in this experiment.
Exclusion criteria
Exclusion criteria: 1. Patients with cystic fibrosis bronchiectasis, severe pneumonia and lung cancer; 2. Inhaled or systemic aminoglycosides with anti-MAC activity (such as amikacin, kanamycin or streptomycin) were used within 28 days prior to enrollment; 3. Use lung tonifying and detoxifying Chinese medicine within 2 weeks before enrollment; 4. Patients with serious diseases of cardiovascular and cerebrovascular system, digestive system, nervous system, urinary system, blood system, rheumatism and immunity, and HIV-positive patients; 5. Patients with abnormal liver function (ASK, ALT more than 2 times of the normal limit), or HbsAg, HbeAg and HbcAg positive simultaneously; 6. Serum creatinine >2 ULN at screening; 7. Current abuse of alcohol, drugs or illicit drugs; 8. Pregnant and lactating patients; 9. Unable to cooperate due to mental, intellectual and thinking abnormalities; 10. Patients with legal disabilities; 11. Patients who have participated in or are participating in other clinical trials within the last three months; 12. Patients who are allergic to the drug used in this study and its components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sputum negative conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lesion absorption rate;Cavity closure rate ;6-minute walk test;St George's Respiratory Questionnaire;TCM symptom score; | — |
Countries
China
Contacts
Public ContactWu Dingzhong
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed