In this study, the dose of methimazole was adjusted according to the different states of thyroid function, and the effects of conventional therapy and intensive therapy on the cumulative recurrence of Graves' hyperthyroidism after two years of drug withdrawal were evaluated. At the same time, the changes of immune indexes and inflammatory factors in the regulation process were evaluated. This study is a phase IV clinical study designed and carried out by the First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), which is a randomized, open and routine treatment group with parallel control.
Graves hyperthyroidism (responsible for doctors' clinical diagnosis)
Age 18-65, for both men and women
Thyroid receptor antibody (TRAb) was positive
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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
Parallel
Methimazole
DrugMethimazole used in this study was produced by Merck, Germany, and its trade name is Thyrozol. The specification of this drug is 10mg/ tablet, and its validity period is 36 months. It was approved by FDA in 2009 and listed in China in 2011.
Cumulative recurrence rate between conventional treatment group and intensive treatment group after two years of withdrawal.
Patients took medicine according to the course of treatment. Relapse occurs when the thyroid function returns to hyperthyroidism within 2 years after the drug is stopped.
Number of patients with no adverse reactions during the treatment of Graves' disease
The patient completed the methimazole treatment, and there were no adverse reactions that needed to be stopped. Adverse reactions refer to any symptoms, syndromes or diseases that affect patients' health during clinical research and observation, and also include clinically relevant situations found in the laboratory or other diagnostic processes, such as unplanned diagnosis and treatment measures, withdrawal from research, or clinically significant laboratory examination items. Blood routine, liver function, kidney function and adverse reactions will be recorded during the follow-up.
Cumulative recurrence rate of hyperthyroidism in conventional treatment group and intensive treatment group after stopping treatment for one year.
Patients took medicine according to the course of treatment. Relapse occurs when the thyroid function returns to hyperthyroidism within 1 years after the drug is stopped.
Effects of routine treatment and intensive treatment on titer and positive rate of thyroid autoantibodies
Thyroid function and related antibodies were detected every 4 \~ 8 weeks, and the positive rate and titers of thyroid autoantibodies (including TPOAb, TGAb and TRAb) were compared.
Effect of conventional therapy and intensive therapy on thyroid volume
The changes of thyroid volume during treatment and withdrawal were compared.
Effects of conventional therapy and intensive therapy on cytokines
The changes of cytokines before and after different treatments were compared.
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