immunotherapy related hypothyroidism
Conditions
Interventions
Experimental group:Erxianpeiyuan Decoction +Levothyroxine Sodium Tablets
Control group:Erxianpeiyuan Decoction +Levothyroxine Sodium Tablets
Sponsors
Jilin Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-75 years old, gender unlimited; 2) Patients with malignant tumors confirmed by pathology or cytology; 3) Patients who received standard treatment according to the latest published CSCO or NCCN guidelines and had received at least 1 cycle of immunotherapy in the past; 4) Thyroid function TSH and free T4 were normal within one month before immunotherapy, and thyroid function appeared after immunotherapy: ? patients with abnormal TSH and / or free T4; ? Patients with elevated TSH, normal free T4, or elevated TSH (>10 µ Iu/ml) in patients with low free T4; 5) Patients with one of the following symptoms: fatigue, lethargy, chills, constipation; 6) Patients with limited daily use of tools or personal self-care ability so that they need hospitalization; 7) The subjects voluntarily joined the study, and could sign the informed consent form by their own or authorized guardians. The compliance was good, and the medication and follow-up were coordinated.
Exclusion criteria
Exclusion criteria: 1) Patients with subacute thyroiditis, Graves' disease, nodular goiter, thyroid cancer, adrenal insufficiency (monitoring early morning cortisol level); 2) Patients with mental illness, infectious diseases or pregnant and lactating women; 3) Patients taking selenium preparations within 1 month before the study were included; 4) Patients with severe lesions of other endocrine system, autoimmune system or other serious adverse reactions related to immunotherapy; 5) Patients allergic to the intervention drugs of this study; 6) Patients who are treated with external treatment of traditional Chinese medicine (including but not limited to acupuncture, moxibustion, collapse stains, etc.) or oral treatment of other traditional Chinese medicine / Chinese patent medicine; 7) The investigator evaluated patients who were not suitable for inclusion in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correction time for serum thyroid hormone levels (TSH, free T4); | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM symptom rating scale;Quality of life scale;Routine blood test;Routine urine test;Routine stool test;Routine blood biochemical examination;Electrocardiogram;Adverse reactions; | — |
Countries
China
Contacts
Public ContactLu Yi
Jilin Cancer Hospital
Outcome results
None listed