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清肝消瘿方治疗Graves眼病肝火旺盛证的临床研究
The Clinic Research of QingGanXiaoYing Prescription for Treatment of Graves’ Ophthalmopathy with Prosperity of Hepatic Fire
【作者】 鲍玉晓;
【导师】 王旭;
【作者基本信息】 南京中医药大学 , 中医内科学, 2009, 硕士
【摘要】 目的:通过与醋酸泼尼松治疗方案的对比研究,客观评价中药清肝消瘿方治疗GO的疗效和安全性。方法:根据简单随机、非盲、对照的临床观察原则,入选76例符合GO诊断,以及中医辨证符合肝火旺盛标准的病人,皆完成观察。76例病人随机分为两组,其中中西结合治疗组(以下简称治疗组)38例,基础药物加清肝消瘿方治疗;西药对照组(以下简称对照组)38例,基础药物加醋酸泼尼松治疗。疗程均为8周.结果:①对症状体征的改善作用:治疗组各种症状体征改善程度均优于对照组,其中目胀流泪两组改善程度相比有显著统计学意义(P<0.01)、手指震颤改善程度相比有统计学意义(P<0.05),心悸烦躁的改善程度相比接近有统计学意义(P=0.09);②突眼度、视力改善作用:治疗组眼球突出度改善情况明显优于对照组,组间对比有统计学意义(P<0.05),两组治疗后视力均有显著改善(P<0.01或P<0.05),但组间对比无统计学意义(P>0.05);③甲状腺激素及甲状腺相关抗体改善作用:两组TT3、TT4、FT3、FT4,均有显著下降(P<0.01或P<0.05),且TT3、FT3、FT4下降幅度优于对照组,但组间对比无统计学意义(P>0.05),两组治疗后TGAb、TMAb、TRAb均有显著下降(P<0.01或P<0.05),且治疗组TGAb、TMAb下降水平明显优于对照组(P<0.05):④安全性:在本研究中,应用中药清肝消瘿方对照组和西药醋酸泼尼松对照组均有良好的安全性,两组比较差异无明显统计学意义。结论:应用清肝消瘿方的治疗组在改善患者突眼度、眼部自觉症状及临床高代谢症状方面其效果明显优于对照组;治疗组可改善患者异常的甲状腺功能,其甲功(TT3、TT4、FT3、FT4)下降幅度、TSH上升幅度均优于对照组;治疗组具有调节异常甲状腺相关抗体(TRAb、TGAb、TMAb)的作用,具有免疫调节功能,对提高甲亢疗效,缩短病程,降低复发率有一定意义;清肝消瘦方安全,无毒副作用.
【Abstract】 Objective:Treatment with prednisone acetate comparative study of the program,the objective evaluation of traditional Chinese medicine treatment QingGanXiaoYing prescription of the efficacy and safety.Method:Based on simple random,non-blind,controlled clinical trial principles,in line with the 76 cases selected GO diagnosis,as well as the TCM Prosperity of hepatic fire standards in line with the patients,all completed observation.76 cases were randomly divided into two groups,which combines Chinese and Western treatment group(hereinafter referred to as the treatment group)38 cases,the basis of the drug plus side treatment QingGanXiaoYing prescription;Western medicine control group(hereinafter referred to as the control group) 38 cases,the basis of the drug plus acetate prednisone treatment.Courses are for 8 weeks.Result:①The symptoms and signs of improvement:the treatment group improvements in a variety of symptoms and signs are better than the control group,which heads to improve the level of inflation in tears compared to the two groups with significant statistical significance (P<0.01),finger tremor improved statistical significance compared(P<0.05),irritability palpitations improvement was statistically significant compared to close to(P=0.09);②exophthalmos,the visual improvement:the treatment group after treatment to improve the situation exophthalmos obviously gifted in the control group,comparison between groups was statistically significant(P<0.05),the two groups after treatment were significantly improved visual acuity(P<0.01 or P<0.05),but inter-group comparison was not significant(P>0.05);③thyroid hormone and thyroid-associated antibodies to improve the role:the two groups after treatment TT3,TT4,FT3,FT4,were significantly decreased(P<0.01 or P<0.05),and TT3,FT3, FT4 decline was better than the control group,but Comparison between groups was not significant(P>0.05),the two groups after treatment TGAb,TMAb,TRAb were significantly decreased(P<0.01 or P<0.05),after treatment,TGAb,TMAb decline significantly better than the control group(P<0.05);④security:In this study,both of them have good security,no significant difference between the two groups statistically significant.Conclusion:The treatment group in improving the degree of exophthalmos,eye symptoms and clinical symptoms of high metabolic its better than the control group alone;The treatment group may improve in patients with abnormal thyroid function,the thyroid function(TT3,TT4, FT3,FT4) decrease,TSH rise are better than the control group;The treatment group side with abnormal regulation of thyroid-associated antibodies(TRAb,TGAb,TMAb) the role of immune regulatory function,to improve the hyperthyroidism efficacy,shorten the course,reduce the relapse rate in a certain sense;QingGanXiaoYing Prescription security,non-toxic side effects.
【Key words】 Graves’ Ophthalmopathy; QingGanXiaoYingPrescription; Prosperity of hepatic fire; Prednisone acetate; Clinical Research;