| Objective: To observe clinical efficacy of the Jiuweisanjie capsules with Hashimoto’s Thyroiditis associated with hypothyroidism,whose syndrome in TCM is stagnation of liver qi and spleen deficiency,and intermingled phlegm,qi and blood stasis.And an assessmnt on its safety so as to provide evidence for its further applicaction.Methods: The study was designed in randomized and parallel controlled principle with prospective methods.Study subject selected 120 patients who are diagnosed with Hashimoto’s Thyroiditis associated with hypothyroidism under western medicine criteria and syndrome of stagnation of liver qi and spleen deficiency,and intermingled phlegm,qi and blood stasis under Traditional Chinese Medicine(TCM)criteria,these patients were randomly divided into treatment group(60 cases)and control group(60 cases).The treatment group were given the Jiuweisanjie capsules and Euthyrox,The control group were given the Xiakucao capsules and Euthyrox.Four weeks was a course of treatment,and observed continuously three courses of treatment to two groups.To observe mutation of thyroid hormone level,thyroid autoantibodies(TPOAb and TGA),Thyroid glangd volume and isthmus thickness as well as TCM syndromone score before and after the treatment of two group.All data were analyzed by the SPSS20.0 statistics software.Results: After the treatment,the gender,age and course of disease of the patients in two group had no statistically significant differences and thus were comparable between the groups(P>0.05).After 12 weeks of treatment:1.Two groups with thyroid hormone level and thyroid autoantibodies(TPOAb and TGA)were improved,data of inter group had statistically significant differences(P<0.05),the treatment group than the control group,data of two groups had statistically significant differences(P<0.05);2.Two groups with thyroid glangd volume and isthmus thickness were improved,data of inter group had statistically significant differences(P < 0.05),the treatment group than the control group,data of two groups had statistically significant differences(P < 0.05);3.Two groups with disease symptoms and signs were improved,data of inter group had statistically significantdifferences(P < 0.05),the treatment group than the control group,data of two groups had statistically significant differences(P<0.05);4.The effect of the treatment group,17 cases marked effectiveness,32 cases effectiveness and 7 cases failure,the total effective rate was87.50%;The effect of the control group,12 cases marked effectiveness,24 cases efectiveness effectiveness and 21 cases failure,the total effective rate was 63.16%,the treatment group than the control group,The two groups had statistically significant(P <0.05);5.During the tests adversere actions did not appear.Conclusion: The Jiuweisanjie capsules has curative effecton and higher safety to treat Hashimoto’s Thyroiditis associated with hypothyroidism,It is worth to further study to clear mechanism of action,to use and popularize widely. |