| Objective Using Xiaojin Capsule in treating nodular goiter with phlegm-blood stasis syndrome,compared with follow-up group and western medicine group,the final clinical curative effect,TCM symptom,objective clinical index and safety were observed to guide clinical treatment and medication.Methods From June 2017 to December 2017,75 patients with thyroid nodules diagnosed by TCM and Western medicine in the Department of Endocrinology and outpatient department of Wuhan Hospital of traditional Chinese medicine were included.Randomly divided into 3 groups,25 cases in each group,All patients were given psychological counseling,dietary guidance and living adjustment.The blank group was simply followed up.and the control group was treated with levothyroxine sodium tablets(Euthyrox),each 25-50 ug,once daily;The observation group was treated with xiaojin capsules,4 tablets each time,twice daily.All three groups were treated for 12 weeks.Detailed records before and after treatment three sets of TCM syndrome points,the maximum nodule diameter,the number of nodules,nodular malignant risk score and thyroid function and other indicators of efficacy and safety indexes such as change of liver and kidneys,all the collected data were analyzed with SPSS 21.0 statistical analysis software,in which the measurement data are all t test;the count data are used X2 test,to objectively evaluate the clinical efficacy and safety of Xiaojin Capsule in the treatment of nodular goiter.Results(1)Comparison of three groups of patients removed:two of the patients in the blank group were excluded from the referral after the trial ended,one patient in the control group was excluded because of the inability to take medication and regular follow-up,and treatment group without rejection.General information comparison:There was no significant difference in sex,age,course of disease,path of nodule,nodule number,maximum nodule diameter,TCM syndrome score and nodular malignant risk score in the three groups before treatment.(3)The clinical efficacy comparison:The total effective rate of the blank group was 8.70%,the total effective rate of the control group was 41.67%,and the total effective rate of the control group was 60.00%.After X2 test,the control group and the blank group,the observation group and the blank group total effective rate was statistically significant,P <0.05,but the observation group and the control group,the total effective rate was not statistically significant,P> 0.05.(4)Comparison of efficacy of TCM syndromes:The total effective rate of blank group was 4.35%,the total effective rate of control group was 29.17%,the total effective rate of control group was 72.00%.After X2 test,the total effective rate of the control group and the blank group,the observation group and the blank group were statistically significant,P <0.05,the total effective rate of the observation group and the control group were significantly different(P>0.05).(5)Comparison of symptoms and signs of TCM:There was no difference between the three groups in the scores of TCM symptoms and signs before treatment(P >0.05).There were significant differences(P<0.05)between the three groups after treatment and before treatment,but there was no significant difference between the blank group and the control group before and after treatment(P > 0.05).Symptoms after treatment points were compared with each other,the observation group compared with the control group was significantly different(P<0.05).(6)Comparison of the maximum diameter of thyroid nodules:Three groups of patients before treatment,the maximum nodule diameter was no difference(P>0.05).After treatment,there was no significant change in the blank group before and after treatment(P>0.05),and there was significant difference between the observation group and the control group(P<0.05).The diameter of the largest nodules after treatment compared with each other,the observation group compared with the control group was significantly different(P<0.05).(7)Thyroid nodules number comparison:Three groups of patients before treatment no difference in the number of nodules(P>0.05).There was no difference between the number of nodules in the three groups after treatment(P>0.05).(8)Comparison of thyroid nodular malignant risk score:There was no difference between the three groups of patients with malignant risk of nodules before treatment(P>0.05).In the three groups of patients,compared with before treatment,only the patients in the observation group had significantly lower nodular malignant risk score,with significant difference(P < 0.05),there was no significant difference between the blank group and the control group before and after treatment(P>0.05).The scores of malignant risk after treatment were compared,and there were significant differences in the observation group compared with the control group(P < 0.05).(9)Comparison of thyroid function and autoantibody:There were no differences in thyroid function(TSH?FT3?FT4)and autoantibodies(TPOAb?TGAb)before treatment(P>0.05).After treatment,the TSH in the control group decreased significantly compared with that before treatment(P<0.05).There was no significant difference between the blank group and the observation group before and after treatment(P>0.05).(10)Safety indicators and adverse reactions:There was no difference in liver function(ALT,AST)and renal function(Scr,BUN)before and after treatment in the three groups(P > 0.05).In the control group,there were 3 cases of palpitations,2 cases of insomnia,2 cases of skin itching in the observation group,all of which were tolerated and unstopped.Results Through this study,we found that Xiaojin capsule treatment of patients with tuberculous goiter of phlegm-blood stasis syndrome can not only reduce the maximum diameter of nodules,improve clinical curative effect,reduce the score of TCM symptoms and signs,improve clinical symptom of TCM,but also reduce the node.However,there was no obvious advantage in reducing the number of nodules compared with western medicine group.xiao jin capsules for proprietary Chinese medicine,compared to the herbs both easy to carry,simplifying the patient's medication process,and no significant adverse reactions and side effects,high safety,worthy of clinical promotion. |
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