Bronchiectasis
Conditions
Interventions
Control Group:Polycolistin E 30 mg + 4 ml normal saline atomized inhalation, bid*5 days
Treatment Group :Tobe Inhalation Solution 300 mg atomized inhalation, bid*5 days
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 40 and 75 years old; 2. Patients with chronic cough and sputum symptoms and clinically diagnosed bronchiectasis (confirmed by chest HRCT scan within the past 12 months); 3. The diagnosis of this admission includes acute exacerbation of bronchodilation (defined as: cough, change in sputum volume, purulent sputum, dyspnea or exercise tolerance, fatigue or malaise, hemoptysis, worsening of 3 or more of the above 6 symptoms for more than 48 hours, and clinicians estimate that urgent changes to treatment strategies are required); 4. The sputum culture results of this admission showed positive for Pseudomonas aeruginosa; 5. The drug susceptibility test during the screening period showed that the patient was not resistant to tobramycin and colistimethate sodium; 6. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Abnormal liver and kidney function [alanine aminotransferase (ALT), glutamate aminotransferase (AST)> 2 times upper limit of normal value; Serum creatinine (SCr) 1.5 times higher than the upper limit of normal; 2. Combined with severe cardiovascular diseases (such as: congestive heart failure, clinically significant coronary heart disease, known history of stroke, clinically significant arrhythmia, known aortic aneurysm etc.); 3. Other pulmonary infections requiring standardized treatment (e.g., active tuberculosis, pulmonary aspergillosis) at the time of admission; 4. Patients with immunodeficiency diseases and blood diseases (such as AIDS and leukemia); 5. Patients with known allergies to study drugs; 6. Cases judged by the investigator to not meet the criteria for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount of change in clinical lung infection score (CPIS score) from baseline after 5 days of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Interleukin 6 (IL-6) and procalcitonin (PCT) levels changed from baseline after 5 days of treatment;Proportion of patients discharged after 5 days of treatment;Proportion of patients who failed treatment;Change in sputum culture PA from baseline load after 5 days of treatment;The patient's PA conversion rate after 5 days of treatment;Total length of stay from randomization to discharge;The mean change in the effectiveness index score of the Health Index Scale (EQ-5D-5L) after 5 days of treatment from baseline.; | — |
Countries
China
Contacts
Public ContactYang Shuanying
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed