Evaluation of the therapeutic effect of " YunKe" and prednisone on moderate and severe thyroid associated ophthalmopathy

Objective To evaluate the therapeutic efficacy of and prednisone on moderate and severe thyroid associated ophthalmopathy(TAO). Methods 108 hyperthyroidism patients with moderately severe TAO were randomly divided into group, hormone group and the control group.All of the patients were given anti-thyroid medication(ATD) treatment.By thyroid hormone level upper limit every times higher than normal for a sulfhydryl imidazole 5mg/day to calculate daily dosage, based on thyroid hormone level adjusted a sulfhydryl imidazole dose every two weeks, make thyroid hormone levels in the normal range.YunKe set: intravenous push note per day A + B agent four groups (including cloud 20mg), each treatment medicine for five days in A row, interval of 25 days to the next period of treatment, medication six procedures.Hormone group: oral prednisone for 6 months, monthly dose in the order 1mg·kg-1·d-1, 0.75mg·kg-1·d-1, 0.5mg·kg-1·d-1, 0.25mg·kg-1·d-1, 0.125mg·kg-1·d-1, 0.062 5mg·kg-1·d-1, 1 time a day, took at 8 o'clock in the morning.The control group treated ATD.Before and 6 months after treatment, all of the patients were checked the TNF-αand TRab, CT scan to measure degree of exophthalmus.Six months after treatment, respectively, on the basis of TAO classification (NOSPECS) and TNF-α, TRab level changes to determine the efficacy of treatment.Data entry Excel 2003 statistical software, used SPSS 19.0 statistical software to analyze data.Non parametric tests of three groups of data with Kruskal Wallis test.Not matching the two independent samples nonparametric test with the Mann-Whitney test, with P<0.05 for the difference was statistically significant. Results The markedly effective rate, effective rate and ineffective rate of group were 36.1%, 47.2% and 16.7% respectively, which of the hormone group were 20.0%, 37.1% and 42.9%, which of the control group were 13.9%, 22.2% and 63.9%.The efficacy among the three groups had statistically significant differences (Kruskal-Wallis χ2=10.736, P=0.005). The lighter exophthalmos, tge curative effect was better(Mann-Whitney Z=-4.599, P<0.001). The changes of TNF alpha, TRab levels among the three groups had significant differences(YunKe group, the TNF alpha, TRab levels markedly reduced 75.0% and 80.6%, respectively, which of the hormone group were 37.1% and 34.3%, which of the control group were 19.4% and 27.8%, TNF χ2=23.527, P<0.001; TRab χ2=23.831, P<0.001). Conclusion The therapeutic efficacy of YunKe on TAO is better than prednisone, but the long-term effect deserves more investigation. Key words: Technetium Tc 99m pyrophosphate; Prednisone; Hyperthyroidism; Graves ophthalmopathy