“三位一体疗法”对难治性瘿气病的随机、单盲对照临床研究  

Randomized Single-blind Controlled Clinical Study of “Trinity Therapy” for Refractory Goiter Qi Disease

作　　者：夏佳毅[1] 黄艳[1] 孔德明[1] Xia Jiayi;Huang Yan;Kong Deming(Guizhou Hospital of Traditional Chinese Medicine,Guiyang 550001,China)

机构地区：[1]贵州省中医医院

出　　处：《世界中医药》2019年第9期2320-2324,2328,共6页World Chinese Medicine

基　　金：贵州省科学技术基金项目(黔科合LH字[2014]7351号)

摘　　要：目的:观察“三位一体疗法”治疗难治性瘿气病的临床疗效,为难治性瘿气病治疗方案选择提供参考。方法:选取2015年1月至2016年1月贵州省中医医院收治的难治性瘿气病患者90例作为研究对象,按照就诊顺序编号,随机分为观察组、对照1组和对照2组,每组30例。3组患者分别由3位内分泌主治医师治疗,仅告知该组治疗方案。按照《中国甲状腺诊治指南》的常规方法予以基础治疗,对照1组加用中医常规治疗治疗,对照2组加用西医常规治疗治疗,观察组患者加用“三位一体疗法”治疗。3组患者均连续治疗2年。比较3组患者治疗前后主要中医症状积分、甲状腺功能指标,统计3组患者基础治疗减时间、减药频次。评价中医证候疗效。收集治疗期间2组患者药物不良反应并比较。患者治疗有效后8个月随访,判断是否复发,比较3组复发率。结果:治疗2年后,3组患者恶热、食欲亢进、心悸、多汗、女性患者月经不调、甲状腺形态积分均较治疗前降低,且观察组患者恶热、食欲亢进、心悸、甲状腺形态、月经不调积分低于对照1组和对照2组,差异有统计学意义(P<0.05),对照1组和对照2组症状评分比较,差异无统计学意义(P>0.05)。观察组患者恶热、食欲亢进、心悸、甲状腺形态、月经不调症状疗效率高于对照1组和对照2组,差异有统计学意义(P<0.05)。治疗2年后对照1组和对照2组的血清FT4均较治疗前上升,观察组较治疗前下降,治疗后观察组FT4明显低于对照1组和对照2组,差异有统计学意义(P<0.05);3组患者FT3、TRAB阳性率均较治疗前下降,且观察组患者上述指标均低于对照1组和对照2组,差异有统计学意义(P<0.05),对照1组和对照2组间比较,差异无统计学意义(P>0.05)。观察组患者基础治疗减时间、减药频次、复发率均低于对照1组、对照2组,差异有统计学意义(P<0.05)。3组患者治疗过程中均未收集Objective: To observe randomly and single-blindly the clinical efficacy of “Trinity Therapy” in the treatment of refractory goiter qi disease,and to provide reference for the treatment of refractory goiter qi disease. Methods: A total of 90 patients with refractory goiter qi disease admitted in Guizhou Hospital of Traditional Chinese Medicine from January 2015 to January 2016 and eligible for inclusion were selected as research subjects,and according to the order of treatment,they were randomly divided into observation group,control group 1 and control group 2,with 30 cases in each group.The 3 groups of patients were treated by 3 attending doctors of endocrinology respectively,and were only told the treatment plan of the group.According to the conventional methods of the Chinese Guidelines for Thyroid Diagnosis and Treatment,they were given basic treatment,with the control group 1 adding conventional treatment of traditional Chinese medicine(TCM),the control group 2 adding conventional western medicine treatment,and the treatment group adding “Trinity Therapy” treatment.The 3 groups of patients were treated for 2 years.The scores of main TCM symptoms and thyroid function indexes were compared before and after the treatment in the 3 groups.Reduction time and frequency of basic treatment in the 3 groups were counted.The efficacy on TCM syndromes was evaluated.Adverse drug reactions/toxic and side effects of the 2 groups were collected and compared during the treatment period.After 8 months of the treatment,follow-up visits were conducted to diagnose whether there was recurrence or not,and recurrence rates in the 3 groups were compared. Results: 1)After 2 years of the treatment,the scores of adversion to heat,hyper appetite,palpitation,hyperhidrosis,irregular menstruation and thyroid morphology in the 3 groups were lower than those before the treatment,and the scores of adversion to heat,hyper appetite,palpitation,thyroid morphology and irregular menstruation in the observation group were lower than those in

关 键 词：难治性瘿气病 基础治疗 “三位一体疗法” 甲状腺功能 症状改善 临床疗效 不良反应 

分 类 号：R242[医药卫生—中医临床基础]