Rheumatoid Arthritis-related Pulmonary Interstitial Disease
Conditions
Interventions
Control group:Placebo
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria of the disease; 2. TCM syndrome differentiation belongs to lung heat and blood stasis syndrome; 3. Patients aged 18 to 65 years old; 4. Patients who have received the best western medicine for rheumatoid arthritis (according to ACR / EULAR According to 2009 guidelines for diagnosis and treatment of rheumatoid arthritis and draft guidelines for diagnosis and treatment of rheumatoid arthritis issued by rheumatology branch of Chinese Medical Association, it is recommended that anti rheumatic drugs (DMARDs) should be started as soon as RA is diagnosed, and methotrexate (MTX) should be one of the first choice of DMARDs in the treatment plan. If MTX is contraindicated or intolerable, others can be used as DMARDs The preferred drugs include leflunomide, hydroxychloroquine and sulfasalazine. Depending on the condition, it can be used alone or combined with two or more kinds of DMARDs. At present, the commonly used combination schemes for rheumatoid arthritis are as follows: (1) Methotrexate + leflunomide; (2) Methotrexate + hydroxychloroquine; (3) Leflunomide + hydroxychloroquine; (4) Methotrexate + sulfasalazine + hydroxychloroquine; (5) Leflunomide + sulfasalazine + hydroxychloroquine, etc. If DMARDs regimen fails to meet the standard, biological agents should be added.) The joint symptoms were stable for at least 2 weeks. 5. Patients who voluntarily participate in clinical research and sign informed consent form; 6. Combined medication: those who have taken methotrexate, leflunomide and sulfasalazine before enrollment should be included only after taking methotrexate, leflunomide and sulfasalazine for more than 3 months or stopping for more than 1 month; those who have used hormones or biological agents need to stop taking drugs for more than 3 months before they can be included; those who have used non steroidal anti-inflammatory drugs must take more than 2 weeks or stop taking drugs for more than 2 weeks.
Exclusion criteria
Exclusion criteria: 1. Patients with idiopathic pulmonary fibrosis or other causes (such as radiation-induced pulmonary fibrosis, drug-induced pulmonary fibrosis, virus infection) confirmed by examination, or those with definite pulmonary infection confirmed by examination; 2. Patients with lung cancer, tuberculosis or other malignant tumors confirmed by examination; 3. ECG changes with clinical significance, such as arrhythmia, atrioventricular block, QRS complex prolongation more than 120 msec, QTCF interval more than 430 msec, etc; 4. Select the patients who underwent large and medium-sized operation within 3 months before the examination; 5. Patients with abnormal liver and kidney function (laboratory examination results show that serum alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) >= twice the upper limit of normal value stipulated by the center, or serum creatinine (SCR) >= twice the upper limit of normal value stipulated by the center); 6. Patients with previous or current severe cardiovascular and cerebrovascular diseases or severe hematopoietic diseases; 7. Patients who are known to be allergic to the drug ingredients used in the test; 8. Patients with suspected or confirmed history of alcohol and drug abuse; 9. Pregnant or lactating women; or patients with family planning during the trial period; Patients with mental disorders or can not be prescribed; 11. Patients with poor compliance, unable to determine the efficacy or incomplete data, which affect the efficacy and safety judgment; 12. Select patients who have participated in clinical trials of other drugs within 3 months before examination; 13. Patients who were considered unsuitable for the trial due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High Resolution CT;Pulmonary function test; | — |
Secondary
| Measure | Time frame |
|---|---|
| DAS28;Quantitative Points of TCM Symptoms;Serum markers;Blood routine;Liver and kidney function; | — |
Countries
China
Contacts
Public ContactJinghui Yao
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed