| Objective:To observe the clinical efficacy and safety of Jiawei Yinjia prescription in the treatment of moderate-to-severe and active thyroid associated ophthalmopathy patients with liver fire flaming upward syndrome.Methods:Sixty patients with moderate-to-severe and active thyroid associated ophthalmopathy with liver fire flaming upward syndrome,who met the criteria were randomly divided into control group(n=30)and treatment group(n=30).Among them,treatment group were treated with Jiawei Yinjia prescription and glucocorticoid,while the control group were treated with glucocorticoid.The course includes 12 weeks for each group.The clinical symptoms and laboratory indexes of patients before and after treatment were observed,and the changes of CAS score,NOSPECS,OI value,the degree of exophthalmos,TCM syndrome score,the thyroid function,the level of TRAb and adverse reaction were compared.All data were processed with SPSS 26.0 software package to evaluate the clinical efficacy of Jiawei Yinjia prescription.Results:1.There was a total of 30 cases in the treatment group,25 cases of them were completed,and 5 cases of shedding;there were 30 cases in the control group,and 26 cases were completed,4 cases of shedding.2.There were no significant differences between the treatment group and the control group in terms of age,gender,course of disease,CAS score,NOSPECS,OI value,the degree of exophthalmos TCM syndrome score,the thyroid function,and level of TRAb(P>0.05).3.After treatment,the CAS scores of the two group had significantly decreased(P<0.01).The decrease in CAS score in the treatment group was significantly higher than that in the control group(P<0.05).4.After treatment,the NOSPECS of the two group had significantly decreased(P<0.01).The decrease in NOSPECS in the treatment group was significantly higher than that in the control group(P<0.05).5.After treatment,the OI value of the two group had significantly decreased(P<0.01).The decrease in OI value in the treatment group was significantly higher than that in the control group(P<0.01).6.After treatment,the degree of exophthalmos of the two group had significantly decreased(P<0.01).The reduction of the degree of exophthalmos of the treatment group was similar to the control group(P>0.05).7.The overall TCM syndrome efficacy of treatment group was significantly better than control group(P<0.05).After treatment,the total scores and individual scores of TCM syndromes of the two group had significantly decreased((P<0.01 orP<0.05).The decrease in the total scores of TCM syndromes,red eyes with pain,dry mouth in the treatment group were significantly higher than that in the control group(P<0.01).The scores of diplopia,irritability,sweating,constipation,and hunger in the treatment group were significantly lower than those in the control group after treatment(P<0.05).8.After treatment,the thyroid function and the level of TRAb in both groups had improved(P<0.05).The improvement of thyroid function in the treatment group was similar to that in the control group(P>0.05).The decrease of the level of TRAb in the treatment group was significantly higher than that in the control group(P<0.01).9.After treatment,two cases of liver enzymes increased in the treatment group and 4 cases in the control group.All of them improved after protecting the liver and reducing enzymes,and there were no other adverse reactions.Conclusion:Jiawei Yinjia prescription which was formulated under the guidance of"clearing liver and purging fire,dispersing clear eyesight" can significantly reduce eye discomfort and systemic symptoms in patients with thyroid associated ophthalmopathy with liver fire flaming upward syndrome in moderate-to-severe active stage,regulate immunity,and improve treatment resistance.Jiawei Yinjia prescription is acceptable,safe and reliable. |