| Research objective:Through examining influence of Clearing Liver and Purging the Heart Decoction and Thiamazole tables treatment on clinical symptom, physical signs and related physicochemical examination of hyperactivity of heart-liver fire patient(a dialectical classification of hyperthyroidism), the research subjectively evaluate its curing effect and clinical value, and provides reference materials for clinical practices.Research method:In the first part, with referring to related traditional Chinese medicine literature, retrospection and systematical analysis, we assume hyperthyroidism belong to the traditional Chinese medicine of "Ying Disease" category; we recall the experience concluded by doctors throughout history on disease cause, pathological mechanism of "Ying Disease" and dialectical treatment, and recall modern medicine's interpretation on hyperthyroidism, and we combine these together with Xu Zhiyin professor's years of clinical experience, so as to establish theory foundation for this clinical research. The second part is about clinical research, and research subjects are 30 cases patients from surgical out-patient department in Jiangsu province hospital of TCM affiliated by Nanjing University of Traditional Chinese Medicine, and another 30 cases from Endocrine out-patient branch in Nanjing Drun Tower hospital,60 cases in total which are diagnosed hyperthyroidism (hyperactivity of heart-liver fire). We divide these patients into 2 groups with 30 cases in treatment group and 30 cases in control group. Methimazole is served in preliminary treatment with its amount 15-30mg/day, two or three times per day. If heart rate is higher than 90, then propanalol should be added with three times per day. Treatment group adopts clearing liver and purging the Heart decoction on the basis of preliminary treatment, with 1 dose per day and slightly fried 2 times in water for each dose, approximately 200ml decoction. Decoction after combination should be taken by mouth,2 times per day. Control group only uses preliminary treatment.2 weeks is called a cycle, and 3 cycles of observation which is totally 42 days. Before and after treatment of each phase, we examine main symptom changes, related clinical signs, tongue coating and signs changes, safety examination index and related physical examination and keep record accordingly. Curative effect is evaluated after 3 cycles of treatment and we compare the integral effect between two groups. And we probe into the principle and prescription foundation of clearing liver and purging the heart decoction, and analyze the clinical statistical material as well as treatment effect evaluation.Result:①After treatment integral curative effect comparison between treatment group and control group:effective rate in treatment group is 96.6% while 93.4% in control group,χ2=1.879, P=0.391, so there is no statistical meaning on comparison of after treatment integral effect between two groups(P>0.05).②comparison on symptom effect after treatment in two groups:there are 30 cases in treatment group, of which 1 case is clinically recovered (3.3%), and positive effect appears in 9 cases (63.3%),9 cases effective (30.0%) and 1 case invalid (3.3%), and improvement rate is 66.6%. Among 30 cases in control group,0 case is clinically recovered, positive effect appears in 16 cases (53.3%),13 cases effective (43.3%),1 cases ineffective(3.3%), and improvement rate is 53.3%. P=0.498, so there is no statistical meaning in the comparison (P>0.05). average symptom treatment effect tells us that treatment group is better than comparison group in terms of average treatment effect, P=0.09, so there is no statistical meaning on comparison of after between two groups.③Improvement comparison on main symptoms after treatment:There is obvious improvement in two groups after treatment, particularly comparison on heart throb has statistical meaning (P<0.05).④improving condition on hyperthyroidism:FT3, FT4 are obviously reduced in both groups, and there is big difference with before (P<0.01).⑤comparison on safety parameter after treatment:of two groups prior to treatment, WBC has slightly reduced (>3.0×109) in 17 cases in total, with 8 cases in treatment group and another 9 case in control group.χ2=0.08, P=0.77, so there is no statistical meaning for the comparison (P>0.05), so it has comparability. After treatment, there are totally 9 cases that leukocyte slightly reduces in two groups (>3.0×109), with 1 case in treatment group and 8 cases in comparison group,χ2=4.71, P=0.03. Comparison of two groups has statistical meaning (P<0.05). In addition, slight abnormal liver function of 15 cases were found prior to treatment, and 9 cases in treatment group and the other 6 cases in comparison group,χ2=0.80, P=0.37, and there is no statistical meaning between two groups (P>0.05).13 cases slight abnormal liver function occur after treatment, among which 2 cases are of treatment group and 11 cases in comparison groups,χ2=1.95,.P=0.01. Comparison between two groups in this case has statistical meaning (P<0.05). No obvious abnormal signs are found in terms of other related parameters. Adverse reactions are examined in both groups during therapy. In treatment group, there is one case skin rash, and negative effect incidence is 3.3%. No abnormal liver and kidney functions and other adverse reaction are found. In comparison group, there are 3 cases skin rash, and 5 cases that leucopenia reduces after medication,7 cases that abnormal liver function occurs after medication, and adverse reaction incidence rate is 23.3%. In sum, incidence of adverse reaction of treatment group is lower than that of comparison group.Conclusion:This research objectively evaluates the effect of Clearing Liver and Purging the Heart Decoction on constitutional hyperthyroidism patient through the observation on 60 patients, and the research turns out that treatment group is better than control group on improving clinical symptom, physical signs or reducing the occurring possibility of the negative influence brought by Thiamazole tablets. 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. |
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