Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease
Graves Disease, Relapse, Treatment
About this trial
This is an interventional treatment trial for Graves Disease
Eligibility Criteria
Inclusion Criteria:
- Graves hyperthyroidism (responsible for doctors' clinical diagnosis)
- Age 18-65, for both men and women
- Thyroid receptor antibody (TRAb) was positive
- Take part in this research voluntarily and sign the informed consent form
Exclusion Criteria:
- Those who have used glucocorticoid or other immunosuppressants for a long time within 3 months before being selected
- Those who have participated in any other drug trials within 3 months before being selected
- Subjects who are participating in clinical research of other drugs
- Patients with a history of malignant tumors
- Ill-controlled hypertension: diastolic blood pressure≥100mmHg, systolic blood pressure ≥160 mmHg
- Blood routine: the total number of white blood cells < 3.0×109 or neutrophils < 1.5× 109
- Other thyroid diseases: such as subacute thyroiditis, thyroid nodules, high-function adenoma
- Alanine aminotransferase(ALT) or aspartate amino transferase(AST) is greater than 2 times of the normal upper limit; When ALT or AST is less than 2 times of the normal upper limit, and the test of hepatitis B two half-and-half positive
- Renal insufficiency: serum creatinine is higher than the upper limit of normal value
- Patients with heart failure
- Patients with coronary heart disease
- Patients with other autoimmune diseases
- Patients who are known to be allergic to any component of this medicine are allergic to the active ingredients or any auxiliary materials in the prescription
- Patients with multiple drug allergies, allergic diseases, people with high sensitivity and drug addicts
- Alcoholism, mental disorder or other observers who are not suitable for drug testing
- Pregnant and lactating women cannot rule out the possibility of pregnancy
- Taking any medicine with unknown ingredients or using traditional Chinese medicine, the researcher judges the medicine that may affect the curative effect of hyperthyroidism
- According to the researcher's judgment, other medical history that reduces the possibility of joining the group or complicates the joining of the group, such as frequent changes in the working environment, may easily lead to lost follow-up.
Rejection Criteria:
- The compliance of this clinical trial protocol is < 80% or > 120%;
- Those who did not meet the inclusion criteria or the exclusion criteria were found during the experiment;
- Those who can't cooperate, including those who can't complete the whole course of treatment, don't complete the follow-up as planned, and increase or decrease adjuvant drugs at will;
- During the trial, use other drugs that may affect the curative effect of this trial.
Termination of Research Criteria:
- Those who are allergic or intolerant to this drug;
- Adverse reactions or serious adverse events that patients can't tolerate occur;
- Pregnant women of childbearing age in the experiment;
- Other diseases appear during the treatment, and the treatment of accompanying diseases will interfere with the clinical observers of this medicine;
- The researcher thinks it is inappropriate to continue the experiment.
Sites / Locations
- the First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Conventional treatment group
Intensive treatment group
According to the thyroid function, if the initial free thyroxine(FT4) ≥ 3 times the normal value, the initial dose of methimazole is 30mg/ day, the thyroid function will be tested every four weeks, and the dose will be reduced when thyroid stimulating hormone(TSH) > normal lower limit or free triiodothyronine(FT3) < normal lower limit or FT4 < normal lower limit. The dose will be reduced according to the clinical routine, specifically, every day (30 mg→20 mg→10 mg→5mg→2.5 mg) If the initial FT4 is less than 3 times the normal value, the initial dose of methimazole is 15mg/ day, and the thyroid function is tested every four weeks. When TSH is greater than the normal lower limit or FT3 is less than the normal lower limit or FT4 is less than the normal lower limit, the dose will be reduced according to the clinical routine, specifically every day for 24 months. If TSH > 100 mIU/L occurs during the treatment, the reduction speed will be accelerated, and 1-2 dose levels can be skipped.
If the initial FT4≥ 3 times of normal value, the initial dose of methimazole was 30mg/ day, and the thyroid function and antibodies were detected every four weeks. When TSH≥4.2 mIU/L, the amount of methimazole began to decrease, specifically in a daily manner (30 mg→20 mg→15mg). The dose was maintained after the decrease to 15 mg. In the case of hypothyroidism, levothyroxine was added until the three antibodies (TPOAb, TGAb and TRAb) were negative. The dose was maintained for six months, and then the doses of methimazole and levothyroxine were gradually reduced until drug discontinuation (each month). If the initial FT4 was less than 3 times of normal level, the initial dose of methimazole was 15 mg/ day, and levothyroxine was added when hypothyroidism occurred. After all three antibodies were negative, the doses were gradually reduced to the point of drug discontinuation.