Radiation pneumonitis
Conditions
Interventions
Azithromycin group:Azithromycin treatment
Jinshuibao tablets group:Jinshuibao tablets treatment
Azithromycin combined Jinshuibao tablets group:Azithromycin and Jinshuibao tabltes treatment
Control group:N/A
Sponsors
shanghai pulmonary hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Each subject must meet all of the following criteria to be included in this study: 1) The subjects fully understand the requirements and risks of this trial; 2) Agree to participate in this trial and sign the informed consent; 3) 18 years old = age = 75 years old, gender is not limited; 4) Lung cancer confirmed by histopathological examination; 5) Diagnosed with grade 1 asymptomatic radiation pneumonitis, meeting the following conditions: ? There is a history of chest irradiation in the past; ?CT imaging changes are mainly patch shadows, ventilation bronchus signs, streak shadows, lung consolidation shadows or honeycomb-like changes confined to the irradiated area, less than 25% of the lung parenchyma is involved, and a small number of patients have changes in the irradiated area. , accompanied by corresponding imaging changes outside the radiation area; ? There are no obvious symptoms, and it is judged by the investigator that glucocorticoid treatment is not necessary. 6) Expected survival period = 24 weeks; 7) ECOG physical activity status (PS) score of 0 to 1; 8) Have the following requirements to determine good organ function: ?Hematology: a. The absolute value of neutrophils is =1.0×10^9/L; b. Platelet count =50×10^9/L; c. Hemoglobin =80 g/L. ? Liver: a. ALT and AST=3×Upper limit of normal b. Total bilirubin=1.5×the upper limit of normal value; ? Kidney a. Serum creatinine = 1.5 × upper limit of normal
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria should be excluded from this study: 1) Patients with grade 2 or above radiation pneumonitis with obvious clinical symptoms requiring hormone therapy after tumor radiation therapy; 2) Severe liver disease, kidney disease, blood and hematopoietic system disease, psychiatric or central nervous system disease; 3) Patients who are known to be allergic to azithromycin, erythromycin, other macrolides or ketolides, and Jinshuibao tablets; 4) Patients with a history of cholestatic jaundice/hepatic insufficiency after previous use of azithromycin; 5) Drugs that may have preventive and/or therapeutic effects on radiation pneumonitis, such as pentoxifylline, angiotensin converting enzyme inhibitor (ACEI), berberine, statin, nicorandil, stem cells, etc.; 6) Other patients who are judged by the investigator to be unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of symptomatic radiation pneumonitis of grade 2 and above; | — |
Secondary
| Measure | Time frame |
|---|---|
| hormone usage;Quality of life assessment; | — |
Countries
China
Contacts
Public ContactYaping Xu/Lan Zhao
shanghai pulmonary hospital
Outcome results
None listed