| Methods |
Parallel design. Due to the randomisation method wasn't mentioned in original article, we telephone interviewed the original author and made clear that the allocation sequence was generated by computer software. Single blindness: the patients didn't know which group they were in. |
| Participants |
123 diagnosed GD patients (M/F=33/90, 32+/‐7 years old on average) were included. The diagnoses was based on typical hypermetabolic symptoms, enlargement of thyroid gland, exophthalmos and high concentration of T3,T4. All the patients had light symptoms and short length of disease. The enlargement of thyroid gland was within ¢ò degree and the increase of T3, T4 was less than 20%. Excluding criterion: hyperthyroidism crisis, recurrence cases after treatment of radioiodine or operation, pregnancy, cases accompanied by heart disease, ¢ó degree or more severe exophthalmos and cases with other chronic and endocrine diseases.
The patients were divided into three groups. 41 cases for each group. Baseline of two groups were similar. |
| Interventions |
Tapazole and Huangqi injection was given in the intervention group. The usage of Tapazole was similar to control 2 group, 60 ml/day Huangqi injection diluted in 500 ml 5% glucose infusion, venous transfusing for 15 days. In diapause, Tapazole was used; Jiakangling was used in control 1 group, p.o., t.i.d., 2 tablets each time; Tapazole was used in control 2 group, p.o., t.i.d., 10 mg each time. |
| Outcomes |
The outcomes were evaluated by function of thyroid gland (FT3,FT4,TSH), TGA, TMA, T lymphocytes, blood routine test and liver function.
1. The changes of WBC amount, liver function and thyroid gland function: The liver function of the patients in control 1 group improved, but little improvement was seen on their WBC amount and thyroid gland function; in control 2 group, liver function and thyroid gland function of the patients improved; in the intervention group, liver function, thyroid gland function, WBC amount and concentration of TGA, TMA improved obviousely. And the result showed that the effects of intervention group were better than other groups;
2. The changes of T lymphocytes: In control 1 group, the T lymphocytes almost stayed the same; in control 2 group, CD4 decreased and CD8 increased a little so that CD4/CD8 decreased; in the intervention group, CD4 and CD8 improved so that CD4/CD8 decrease obviousely. The result showed that there was statistical significance between intervention group and other groups. |
| Notes |
1. 'Positive drug' jiakangling was used to be the control but there was no any record about its effect;
2. Two cases in control 1 group quit the study for aggravation of the disease. |
