| Research objective:This research bases mainly on Tutor, Professor Xu Xhi Yin’s clinical experience. Through examining the influences of the decoction prescribed by the Tutor, in addition to Methimazole tablets on clinical symptoms,physical changes and related biochemical test of heart-liver heat syndrome of hyperthyroidism, the research objectively evaluates the treatment effect of clearing heart-liver heat decoction (Qing Gan Xie Xin Tang) in reducing the side effects of Methimazole tablets, strengthening its curative effect and shortening its course of treatment. At the same time, animal experiment was conducted. Through establishment of experimental rat model with hyperthyroidism, the influences of clearing heart-liver heat decoction combined with the Methimazole tablets on the throid hormone, liver function, white blood cells counts, throid cell and liver cell were observed, to verify the result of clinical research. During the research, the clinical experience of Professor Xu was studied and the know-how was passed on.Research method:Part1is literature research. By searching the related traditional Chinese medicine literature, hyperthyroidism shall be under the "Ying Disease" category of traditional Chinese medicine. Through systematical history review and analysis, the experience by past ages doctors on disease causes, pathogenesis and dialectical treatment of "Ying Disease", the research and knowledge of modern medicine on hyperthyroidism are concluded. Professor Xu Zhi Yin’s years of clinical experience are summarised as well, so as to establish the theoretical basis for the clinical research.Part2is clinical research. Research subjects were30patients each from surgical out-patient department in Jiangsu province hospital of TCM attched to Nanjing University of Traditional Chinese Medicine, and from Endocrine out-patient department in Nanjing Drum Tower hospital. These patients were diagnosed as hyperthyroidism with heart-liver heat syndrome.30cases in Treatment group,30cases in Comparison group. Comparison group used only basis treatment-Methimazole tablets with preliminary dosage of15～30mg/day, twice or thrice a day. If heart rate was more than100beats/min,then Propranolol should be added with10mg, thrice a day. In addition to basis treatment, Treatment group took also clearing heart-liver heat decoction with one dose per day and decoct twice for each dose, with approximately200ml decoction each time. Combined decoction should be taken orally twice a day. Two-week was a cycle,and four cycles of observation totalled to42days. Before and after treatment of each cycle,main symptom and physical changes,tongue coating and pulse changes, related biocheimical test and safety examination indices were observed and recorded accordingly. Upon completion of four cycles, comparison was carried out on the overall curative effect evaluation of both groups. Results show:①Two groups comparison on overall curative effect after treatment:Overall effectiveness is100%for Treatment group and96.7%for Comparison group. Chi-square test x2=1.017, P=1.000, so two groups had no statistical difference in overall effective cases and ineffective cases after treatment(P>0.05); Through rank sum test, u=2.133, P=0.033, overall curative effect of Treatment group was better than that of Comparison group with statistical difference(P<0.05).②Two groups comparison on syndrome curative effect after treatment:Among30cases in treatment group,0case(0.0%) was clinically recovered,12cases (40.0%) with obvious effectiveness,11cases (36.7%) effective,7cases(23.3%) ineffective, Obvious improvement rate was40.0%. Whereas among30cases in Comparison group,2cases(6.7%) were clinically recovered,3cases (10.0%) with obvious effectiveness,12cases (40.0%) effective,13cases (43.3%) ineffective, Obvious improvement rate was16.7%. Rank sum test u=1.918, P=0.055, the two groups had no statistical difference (P>0.05) in syndrome curative effect; Chi-square test x2=4.022, P=0.084, the two groups have no statistical difference (P>0.05) on obvious improvement rate. However through t test, t=2.412, P=0.019, the Treatment group’s average syndrome curative effect is better than that of Comparison group with with statistical difference (P<0.05).③Two groups comparison on the symptom score improvement after treatment:Both two groups had no statistical difference (P>0.05) in symptom score, through t test after treatment. Both groups had improvement in symptom score after treatment comparing to that before treatment, with statistical difference through t test (P<0.05). The extent of improvement in Treatment group was more than that in Comparison group with statistical difference (P<0.05).④Two groups comparison on the extent of main symptom improvement after treatment:Both two groups had no statistical difference in main symptom grading and main symptom average score (P>0.05), through rank sum test and t test respectively after treatment. However Treatment group had better improvement comparing to Comparion group in palpitation and much eating symptom after treatment, with statistical difference (P<0.05). Five main symptoms in Treatment group had statistical improvement comparing to that before treatment. Whereas Comparison group had statistical improvement in trembling symptom only.⑤Two groups comparison on the extent of secondary symptom improvement after treatment:Both two groups had no statistical difference in secondary symptom grading and secondary symptom average score (P>0.05), through rank sum test and t test respectively after treatment. The extent of improvement in secondary symptom had no statistical difference (P>0.05) between two groups. All four secondary symptoms in Treatment group had statistical improvement (P<0.05) comparing to that before treatment. Whereas Comparison group had statistical improvement (P<0.05) in emaciation and sick of heat symptoms only.⑥Two groups comparison on the improvement of thyroid enlargement and Graves eye disease after treatment:Both two groups had no statistical difference in thyroid enlargement and Graves eye disease gradings and average scores (P>0.05), through rank sum test and t test respectively after treatment.⑦Improvement situation on hyperthyroidism function after treatment:TSH, FT3and FT4values distribuation in both groups had no statistical difference (P>0.05) through Fisher exact test or chi-square test after treatment. However statistical improvement (P<0.05) existed after treatment comparing with that before treatment in both groups respectively, through Fisher exact test or chi-square test.⑧Comparison on safety indices after treatment:Comparing Treatment group and Comparison group after treatment, two groups had no statistical difference (P>0.05) in WBC counts distribution through Fisher exact test. After treatment, Treatment group had better liver function improvement in comparison with that of Comparison group. Statistical difference existed (P<0.05) through Fisher exact test. After treatment, two groups had no statistical difference (P<0.05) through Fisher exact test regarding rash symptom situation.Part3is animal experiment.50experimental hyperthyroidism male rats model were established with L-Thyroxine. They were divided into5groups:Normal (comparison) group, Model group, Methimazole group, clearing heart-liver heat decoction group and joint treatment (clearing heart-liver heat decoction+Methimazole) group. Influence of Clearing heart-liver heat decoction, Methimazole and Joint treatment on the basic metabolism, the thyroid function and shape, the liver and immune system of the rats model built for three weeks were observed. Results showed:①All treatment groups could significantly improve symptom of rat model with hyperthyroidism(P<0.05).②Hyperthyroidism rats model turned up with decreased immune function, endocrine disorder. All treatment groups could significantly reduce the unusually increased coefficients of liver, spleen and thyroid (P<0.05), and could improve the decreased immune functionm and endocrine disorder of rat model. Wherein Methimazole and Joint treatment groups had equal improvement effect.③Methimazole group rat’s white blood cells counts in peripheral blood dropped dramatically, whereas Clearing heart-liver heat decoction group and the joint treatment group, i.e. Methimazole+Clearing heart-liver heat decoction had no significant influence on white blood cell count in peripheral blood of rats. Moreover Methimazole+Clearing heart-liver heat decoction could improve dropping of WBC counts caused by Methimazole with statistical significance (P<0.05)。④Serum TRAb levels in all treatment groups rats have no significant difference in comparison with model group (P>0.05). The joint treatment group and the Methimazole had no statistical difference (P>0.05) in this aspect.⑤High dose of L-Thyroxine could cause damage to liver cells. All treatment groups could improve liver functions of rat with liver injured by hyperthyroidism. The joint treatment group and the Methimazole group had no statistical difference (P>0.05) in this aspect.⑥All treatment groups have good improvements on thyroid function in hyperthyroidism rat model. The joint treatment group and the Methimazole group had equal improvement effect statistically.⑦All Clearing heart-liver heat decoction group, Methimazole group and Joint treatment group could reduce thyroid damage, where joint treatment effect was slightly better.⑧In the case of morphological changes in the liver, most of the livers in Model group, Clearing heart-liver heat decoction group, Methimazole group and Joint treatment group have no significant histopathological changes. Except a few livers have slight damage.⑨After the relavant drug treatment, all Clearing heart-liver heat decoction group, Methimazole group and Joint treatment group could reduce fairly in thyroid follicular hyperplasia and abnormal increase in gliomas. Clearing heart-liver heat decoction group and Methimazole group could still mitigate thyroid follicular epithelial from becoming flat, and gliomas from reduction or missing.Conclusion:This research objectively evaluates the curative effect of Clearing heart-liver heat decoction on primary hyperthyroidism patients with heart-liver heat syndrome, through the clinical observation on60patients. The research shows that:Treatment group is better than Comparison group regarding improving clinical symptom, and reducing the side effect caused by the use of Methimazole. With more potential advantages and more safe in application, treatment group can serve as directing tool for clinical hyperthyroidism treatment exploration, and it is worth promotion. This demonstrates the advantages of using Chinese medicine in the treatment of hyperthyroidism. It provides a practical and duiding significance for the exploration of the clinical treatment of hyperthyroidism. Also, through experimental study on50L-Thyroxine-induced hyperthyroidism rats, the joint treatment by using Clearing heart-liver heat decoction and Methimazole shows better curative effect. This verifies the clinical observations. |
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