| Eligibility |
Inclusion Criteria:
- 1. Age 18~70 years old (including 18 years old and 70 years old), gender is not
limited.
2. Diagnosed with silicosis or coal worker's pneumoconiosis, in line with GBZ 70-2015
"Diagnosis of Occupational Pneumoconiosis".
3. Forced vital capacity at screening percentage of predicted value %FVC=40% and <80%
4. The percentage of carbon monoxide dispersion in the predicted value at the time of
screening %DLCO=30% and <80%.
5.HRCT at screening showed diffuse interstitial changes in the lungs. 6. Patients
voluntarily participated in this trial, with good compliance, and had the ability to
understand and sign informed consent before the study.
Exclusion Criteria:
- 1. Those who do not meet any of the inclusion criteria. 2. Those who have received
lung lavage therapy within 3 months and plan to receive lung lavage therapy during the
trial.
3. ALT or AST > 3 times ULN. 4. TBiL > 2 times ULN. 5. Creatinine clearance <30
mL/min. 6. Patients with co-infection or high fever within 4 weeks prior to screening,
including but not limited to acute bronchitis, pneumonia, sinusitis, urinary tract
infection, or cellulitis.
7. Combined with tuberculosis or lung cancer. 8. Significant pulmonary arterial
hypertension requiring parenteral therapy with epoprostenol/treprostinil or severe
right heart failure determined by the investigator to be unsuitable to participate in
the trial.
9. Severe cardiovascular disease with one of the following conditions:
1. Severe hypertension within 6 weeks and uncontrolled with treatment (=160/100
mmHg);
2. Myocardial infarction within 6 months;
3. Unstable angina within 6 months. 10. Coagulation parameters: International
normalized ratio (INR) > 2, prothrombin time (PT) prolongation > 1.5 times ULN.
11. Other conditions or comorbidities that may interfere with testing procedures
(eg, intolerance to interruption of supplemental oxygen during pulmonary function
tests) or, based on the investigator's judgment, that may interfere with trial
participation or that may put patients at risk.
12. Patients with dysphagia or clinical signs of malabsorption or who require
parenteral nutrition.
13. With active peptic ulcer. 14. History of thrombotic events (including stroke
and transient ischemic attack) within 12 months.
15. Use of cytotoxic drugs, immunosuppressive drugs, cytokine-modulating drugs,
or receptor antagonist drugs such as azathioprine, cyclophosphamide,
cyclosporine, etanercept, infliximab, white Triene antagonists, methotrexate,
tacrolimus, TNF-a inhibitors and tyrosine kinase inhibitors TKIs and other drugs.
16. Use of interferon, bisbenzylisoquinoline alkaloids (tetrandrine),
polyethylene pyrimidine nitroxide (gramsilpine), quinape phosphate,
hydroxyquinoline phosphate, aluminum citrate within 1 month before randomization
, nintedanib, or high-dose acetylcysteine.
17. Patients who have previously used drugs that may cause pulmonary fibrosis,
such as amiodarone, or have been exposed to asbestos, beryllium and other
substances, or exposed to radioactive environments.
18. Hypersensitivity to the investigational drug or its components (eg, lactose).
19. Investigator judges that life expectancy due to other medical conditions is <
2.5 years.
20. Major surgery planned during treatment. 21. Women who were pregnant,
breastfeeding, or planning to become pregnant during the trial.
22. Women of childbearing age who are unwilling or unable to use a highly
effective method of contraception during the 28 days before or 3 months after
dosing.
23. According to the researcher, the patient is either alcohol or drug abuser.
24. mentally ill. 25. Those who participated in clinical trials of other drugs
within 3 months. 26. Investigators judged to be unfit to participate in the
trial.
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