【摘要】：目的:觀察九味散結(jié)膠囊治療橋本甲狀腺炎合并甲狀腺功能減退(肝郁脾虛,痰氣瘀結(jié)型)的臨床療效,并對(duì)其安全性進(jìn)行初步評(píng)價(jià),為臨床應(yīng)用的進(jìn)一步推廣提供依據(jù)。方法:本臨床研究采用隨機(jī)、對(duì)照臨床試驗(yàn)方法,將符合西醫(yī)診斷橋本甲狀腺炎合并甲狀腺功能減退及中醫(yī)辨證屬肝郁脾虛、痰氣瘀結(jié)型的120例患者隨機(jī)分為兩組,治療組和對(duì)照組各60例,治療組予九味散結(jié)膠囊配合左甲狀腺素鈉片治療,對(duì)照組予夏枯草膠囊配合左甲狀腺素鈉片治療,兩組均連續(xù)治療12周,并以4周為一個(gè)療程。觀察兩組患者治療前后甲狀腺激素水平、甲狀腺自身相關(guān)抗體(TPOAb、TGA)、甲狀腺雙葉體積、甲狀腺峽部厚度及中醫(yī)證候積分的變化,所有數(shù)據(jù)采用SPSS20.0統(tǒng)計(jì)軟件進(jìn)行分析。結(jié)果:兩組患者治療前的性別比、年齡比及病程比經(jīng)數(shù)據(jù)分析均無統(tǒng)計(jì)學(xué)差異(P0.05),具有可比性。經(jīng)過12周的治療后:1.兩組患者的甲狀腺激素水平、甲狀腺自身相關(guān)抗體(TPOAb、TGA)較治療前均有改善,組內(nèi)比較差別均有統(tǒng)計(jì)學(xué)意義(P0.05),且治療組明顯優(yōu)于對(duì)照組,組間比較差別具有統(tǒng)計(jì)學(xué)意義(P0.05);2.兩組患者的甲狀腺雙葉體積與峽部厚度較治療前均有改善,組內(nèi)比較差別均具有統(tǒng)計(jì)學(xué)意義(P0.05),且治療組明顯優(yōu)于對(duì)照組,組間比較差別具有統(tǒng)計(jì)學(xué)意義(P0.05);3.兩組患者的中醫(yī)癥狀及體征較治療前均有改善,且治療組中醫(yī)癥狀及體征改善優(yōu)于對(duì)照組(P0.05);4.治療組顯效17例,有效32例,無效7例,有效率為87.5%;對(duì)照組顯效12例,有效24例,無效21例,有效率為63.16%,兩組對(duì)比,治療組療效明顯優(yōu)于對(duì)照組,差別具有統(tǒng)計(jì)學(xué)意義(P0.05);5.試驗(yàn)期間患者沒有不良反應(yīng)發(fā)生。結(jié)論:九味散結(jié)膠囊治療橋本甲狀腺炎合并甲狀腺功能減退(肝郁脾虛,痰氣瘀結(jié)型)臨床療效確切且安全性較高,可進(jìn)一步研究其作用機(jī)制以更好的推廣應(yīng)用。
[Abstract]:Objective: to observe the clinical efficacy of Jiuwei Sanjie capsule in treating Hashimoto's thyroiditis with hypothyroidism (liver depression and spleen deficiency, phlegm and qi stasis syndrome), and to evaluate its safety so as to provide the basis for further clinical application. Methods: in this clinical study, 120 patients with Hashimoto's thyroiditis combined with hypothyroidism and TCM syndrome differentiation were randomly divided into two groups. There were 60 cases in the treatment group and 60 cases in the control group. The treatment group was treated with Jiuwei Sanjie capsule combined with levothyroxine sodium tablet, and the control group was treated with Xixucao capsule and levothyroxine sodium tablet. The two groups were treated continuously for 12 weeks and 4 weeks as a course of treatment. The changes of thyroid hormone level, thyroid autocorrelation antibody (TPOAb,TGA), thyroid bilobular volume, thyroid isthmus thickness and TCM syndromes were observed before and after treatment. All the data were analyzed by SPSS20.0 software. Results: there was no significant difference in sex ratio, age ratio and course of disease between the two groups before treatment (P0.05). After 12 weeks of treatment: 1. The thyroid hormone level and thyroid autocorrelation antibody (TPOAb,TGA) in the two groups were improved compared with those before treatment, and the difference was statistically significant (P0.05), and the treatment group was significantly better than the control group. The difference between groups was statistically significant (P0.05). 2. The volume of thyroid gland and the thickness of isthmus were improved in both groups (P0.05), and the difference between the two groups was statistically significant (P0.05), and the difference between the treatment group and the control group was statistically significant (P0.05). 3. The TCM symptoms and signs of the two groups were improved compared with those before treatment, and the improvement of TCM symptoms and signs in the treatment group was better than that in the control group (P0.05); 4. In the treatment group, 17 cases were effective, 32 cases were effective, 7 cases were ineffective, and the effective rate was 87.5%. Control group 12 cases, effective 24 cases, ineffective 21 cases, the effective rate is 63.16, the two groups, the treatment group was significantly better than the control group, the difference was statistically significant (P0.05); No adverse reactions occurred during the trial. Conclusion: Jiuwei Sanjie capsule is effective and safe in treating Hashimoto's thyroiditis with hypothyroidism.
【學(xué)位授予單位】：山西省中醫(yī)藥研究院
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R259

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