immune-related cutaneous adverse events
Conditions
Interventions
Experimental group:Zhiyangpingfu Liquid
Control group:Placebo for Zhiyangpingfu Liquid
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Received immune checkpoint inhibitor therapy and developed immune dermatitis, clinically diagnosed as immune-related skin toxicity, graded at grade 1 or above; 2. Patients with malignant solid tumors with clear pathological diagnosis; 3. Age 18-80 years old, gender is not limited; 4. Those who meet the diagnostic criteria of traditional Chinese medicine syndrome of damp-heat syndrome; 5. Willing to receive treatment, observation and various inspections, with good compliance, and must sign an informed consent form before enrollment; 6. The subject agrees not to participate in other intervention studies during the treatment period.
Exclusion criteria
Exclusion criteria: 1. Vitiligo, reactive capillary hemangioma, bullous pemphigoid, Stevens-johnson syndrome after treatment with immune checkpoint inhibitors; 2. Those with severe bleeding or systemic infection that have not been controlled, or those with purulent and chronic infection wounds that do not heal; 3. Those who have a history of allergies to external Chinese medicines or allergic constitution; 4. Patients with severe cardiovascular system complications, cerebrovascular system complications, active hepatitis, and severe liver and kidney dysfunction; 5. Patients who have participated in other drug trials in the past 4 weeks, or are currently participating in clinical trials; 6. Intestinal obstruction cannot be treated with oral medication, and intravenous high-energy nutrition is required; 7. Suffering from severe malabsorption or other diseases affecting gastrointestinal absorption; 8. Any unstable situation or situation that may endanger the safety of patients and their compliance with the research, such as mental retardation, schizophrenia and other serious mental illnesses, cannot understand, read and fill in the patient self-evaluation scale, and cannot cooperate with treatment and examination By; 9. The researcher judges that he is not suitable to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IrCAE rating;Scoring Atopic Dermatitis Index ;Hormone dosage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life score of patients with dermatosis;Function status score;Edmonton Symptom Scale;TCM Syndrome Information Collection Form; | — |
Countries
China
Contacts
Public ContactCui Huijuan
China-Japan Friendship Hospital
Outcome results
None listed