Chronic pulmonary aspergillosis
Conditions
Interventions
Basic treatment group:Voriconazole 200mg po Bid for 6 months.
Amphotericin B liposome atomization treatment group:Voriconazole 200mg po Bid for 6 months
Amphotericin B liposome inh: 25mg Qod for the first 2 months and 25mg Qw for the second 4 months.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients agreed to participate in the study and signed an informed consent form; 2. Patients aged 18 years and above, of both sexes; 3. Patients should have bronchopulmonary inflammatory lesions confirmed by chest CT, and the types can include: cavitary, fibrotic, necrotic and nodular; 4. The diagnostic criteria for aspergillosis in this study cover both confirmed and possible cases: (1) Proven: the presence of Aspergillus filaments/mycelium in lung histopathology, or positive Aspergillus culture in bronchoalveolar lavage fluid obtained through bronchoscopy; (2) Probable: if the patient has obvious symptoms such as fever, cough, expectoration, pulmonary rales and other signs, and lung imaging findings support Aspergillus infection, GM test and/or G test are positive.
Exclusion criteria
Exclusion criteria: 1. Patients with isolated pulmonary aspergiloma; 2. Patients with contraindications to voriconazole and isaconazole; 3. patients with ß2-agonist intolerance; 4. patients with voriconazole-resistant Aspergillus infection; 5. Patients with a history of allergy to voriconazole and liposomal amphotericin B; 6. Patients who had complications during liposomal amphotericin B atomization therapy; 7. Patients with severe liver and/or renal failure (liver failure: transaminase and alkaline phosphatase values more than 5 times the normal value; renal failure: creatinine clearance <30 ml/min); 8. Accompanied by serious underlying diseases, including uncontrolled clinically significant cardiac, hematologic, digestive, neurological, psychiatric, immunological, metabolic diseases or malignant tumors; 9. Concomitant use of one or more drugs contraindicated to the trial drug; 10. Patients who meet the diagnostic criteria for invasive pulmonary aspergillosis or allergic bronchopulmonary aspergillosis; 11. Chronic pulmonary aspergillosis patients with surgical indications within 6 months after onset; Patients with cystic fibrosis; 12. 13. Patients with life-threatening hemoptysis requiring emergency surgery (patients who met the inclusion and exclusion criteria after hemostasis could be enrolled); 14. Patients with worsening of preexisting chronic pulmonary aspergillosis due to respiratory infection with a pathogen other than Aspergillus (patients can be enrolled after eradication of infection); 15. Women of child-bearing age who are not using highly effective contraception, are pregnant or breastfeeding; 16. Patients in the exclusion period after participating in another intervention study evaluating antifungal agents or drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with clinically significant remission in the two groups within the treatment time window; | — |
Secondary
| Measure | Time frame |
|---|---|
| Whether there was clinical deterioration within 12 months after the end of treatment;The number of recurrences within 12 months after the end of treatment;The incidence of drug-related adverse events during treatment in the two groups was compared;Pulmonary function within 12 months after the end of treatment; | — |
Countries
China
Contacts
Public ContactYe Feng
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed