| Objective:To observe the clinical efficacy of Bei Mu E Xiao Pills on the treatment of Hashimoto thyroiditis combined nodules.In addition,try to explore the relationship between Bei Mu E Xiao Pills and the outcome of IL-8,IL-10 affected by Hashimoto thyroiditis combined nodules and discuss its therapeutic mechanism.Methods:A total of 60 subjects who met the including criteria of Hashimoto thyroiditis combined nodules were randomly allocated the treatment group containing 30 cases and control group containing 30 cases.The control group was given Euthyrox(Levothyroxine Sodium Tablets),12.5ug once daily for one week and then changed it to 25ug once daily.The dosage was adjusted by outcome of thyroid function test every four weeks.Besides the therapy the treatment group was treated with Bei Mu E Xiao Pills(composition:Thunberg Fritillary Bulb,Concha Ostreae,Rhizoma Zedoariae,Radix Scrophulariae,Prunella Vulgaris)with the form of water-paste pills 9.0g three times daily.To both groups,24 weeks are a course and 1 course of treatment was need to be observed.The following indicators were detected before the treatment and after treating each 8 weeks:changes of the largest solid nodule diameter under ultrasound scanning,cytokines(IL-8、IL-10),thyroid auto antibodies determination(TPO-Ab.TG-Ab),the TCM score and routine examination of blood,urine and stool,liver and kidney function.Results:After 1 courses of treatment,the changes as follows:(1)The longest diameter of the biggest nodules decreased in both of groups,but the treatment group was significantly shorter than the control group(P<0.05).(2)The level of thyroid auto antibodies(TPO-Ab.TG-Ab)in the treatment was a marked drop in the treatment group(P<0.05)and the case was contrary in the control group(P>0.05).(3)The cytokines-IL-8 was lower significant and IL-10 was obviously risen than before in the treatment group(P<0.05).But the IL-8,IL-10 had no substantial changed in the control group(P>0.05).(4)The item symptom integral calculus of clinical symptom and physical sign in the treatment group was refined notably(P<0.05),whereas the control group was not changed obviously(P>0.05)except the loss of appetite.(5)The total effective rate of TCM syndrome integral in the treatment group was 75%,having statistic significance than total effectiveness 44%in the control group(P<0.05).Conclusion:(1)Bei Mu E Xiao Pills have a good curative effect on the type of blood stasis and phlegm coagulation of Hashimoto thyroiditis combined nodules of TCM syndrome.(2)Bei Mu E Xiao Pills get a reduction on the lagest diameter of thyroid nodule of HT significantly.(3)Bei Mu E Xiao Pills decrease the level of TPO-Ab、TG-Ab(4)Bei Mu E Xiao Pills may partly work by down-regulated the IL-8 I and up-regulated L-10. |