九味散结胶囊治疗桥本甲状腺炎的临床观察

发布时间：2018-11-18 07:25

【摘要】：目的:观察九味散结胶囊治疗桥本甲状腺炎合并甲状腺功能减退(肝郁脾虚,痰气瘀结型)的临床疗效,并对其安全性进行初步评价,为临床应用的进一步推广提供依据。方法:本临床研究采用随机、对照临床试验方法,将符合西医诊断桥本甲状腺炎合并甲状腺功能减退及中医辨证属肝郁脾虚、痰气瘀结型的120例患者随机分为两组,治疗组和对照组各60例,治疗组予九味散结胶囊配合左甲状腺素钠片治疗,对照组予夏枯草胶囊配合左甲状腺素钠片治疗,两组均连续治疗12周,并以4周为一个疗程。观察两组患者治疗前后甲状腺激素水平、甲状腺自身相关抗体(TPOAb、TGA)、甲状腺双叶体积、甲状腺峡部厚度及中医证候积分的变化,所有数据采用SPSS20.0统计软件进行分析。结果:两组患者治疗前的性别比、年龄比及病程比经数据分析均无统计学差异(P0.05),具有可比性。经过12周的治疗后:1.两组患者的甲状腺激素水平、甲状腺自身相关抗体(TPOAb、TGA)较治疗前均有改善,组内比较差别均有统计学意义(P0.05),且治疗组明显优于对照组,组间比较差别具有统计学意义(P0.05);2.两组患者的甲状腺双叶体积与峡部厚度较治疗前均有改善,组内比较差别均具有统计学意义(P0.05),且治疗组明显优于对照组,组间比较差别具有统计学意义(P0.05);3.两组患者的中医症状及体征较治疗前均有改善,且治疗组中医症状及体征改善优于对照组(P0.05);4.治疗组显效17例,有效32例,无效7例,有效率为87.5%;对照组显效12例,有效24例,无效21例,有效率为63.16%,两组对比,治疗组疗效明显优于对照组,差别具有统计学意义(P0.05);5.试验期间患者没有不良反应发生。结论:九味散结胶囊治疗桥本甲状腺炎合并甲状腺功能减退(肝郁脾虚,痰气瘀结型)临床疗效确切且安全性较高,可进一步研究其作用机制以更好的推广应用。
[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.
【学位授予单位】：山西省中医药研究院
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R259

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