connective tissue disease associated interstitial lung disease
Conditions
Interventions
Test group:Hydrogen oxygen atomization with basic therapy
Control group : Oxygen saturation refers to conventional oxygen supply equipment (wall oxygen or cylinder oxygen) with basic therapy
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants in this experiment must meet all of the following criteria: 1) Age 18 and above, regardless of gender; 2) The diagnosis of interstitial lung disease related to connective tissue disease is clear; 3) At least one of the following conditions must be met within the first 24 months of visit 1 as evaluated by the researcher: a. There is a clinically significant decrease in the percentage of FVC to the expected value, i.e. a relative decrease of = 10% b. The percentage of FVC in the expected value shows a critical decrease, with a relative decrease of = 5-10%, accompanied by worsening respiratory symptoms c. The percentage of FVC in the expected value shows a critical decrease, with a relative decrease of = 5-10%, accompanied by an increase in the range of interstitial lesions or new lesions on chest imaging examination d. Simultaneously exacerbating respiratory symptoms and increasing interstitial lesions or new lesions on chest imaging examination 4) Volunteer to participate in this experiment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria cannot be included in this trial: 1) Other clinically significant lung abnormalities considered by researchers; 2) Subjects who are known to have malignant tumors; 3) Subjects who are known to be intolerant to inhalation therapy; 4) Subjects with known mental disorders or cognitive impairments that prevent informed consent; 5) Subjects with severe heart, liver, and kidney dysfunction or severe primary systemic diseases; Acute exacerbation of chronic obstructive pulmonary disease; Acute attack of bronchial asthma; 6) Those who use non expectorant antioxidant drugs, including high-dose vitamin C and vitamin E; 7) Subjects participating in clinical trials of other drugs or devices; 8) Female subjects during pregnancy or lactation; 9) Other situations evaluated by the researcher as unsuitable for participation in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of blood gas oxygenation index before and after CTD-ILD adjuvant therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| imaging evaluation;Inflammatory indicators;Clinical response rate after 14 days of treatment;The recovery rate and time of main symptoms;Oxygen saturation; | — |
Countries
China
Contacts
Public ContactXue Yu
Huashan Hospital, Fudan University
Outcome results
None listed