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Received:February 15, 2021 Published Online:April 20, 2021
Received:February 15, 2021 Published Online:April 20, 2021
中文摘要: 目的 观察复方蓉芪通络颗粒对脾肾阳虚血瘀证甲状腺功能减退症(甲减)合并颈动脉粥样硬化(CAS)患者的临床证候疗效。方法 选取2016年8月至 2020年3月就诊的甲减合并CAS患者70例,按随机数字表分为研究组和对照组,各35例。对照组治疗方案为:左甲状腺素钠片+阿托伐他汀钙治疗;研究组治疗方案:对照组基础上加用复方蓉芪通络颗粒。治疗12周后,比较治疗前后患者的中医证候积分及相关指标［甲状腺功能、血脂、同型半胱氨酸(Hcy)、超敏C反应蛋白(hs-CRP)、颈动脉彩超颈动脉内中膜(IMT)］的变化情况。结果 治疗12周后,相较于对照组,研究组各中医症状(面色萎黄、体倦乏力、神疲懒言、大便秘结、面目或双下肢水肿、腰膝酸软、畏寒肢冷、夜尿频多)的改善率均有显著提高(P<0.01,P<0.05);两组甲状腺功能、血脂、Hcy、hs-CRP等指标均较前改善(P<0.01,P<0.05),研究组较对照组改善更显著(P<0.01,P<0.05);两组患者IMT和斑块面积测定值较治疗前有所减小,且研究组IMT和斑块面积测定值稍低于对照组,但差异无统计学意义(P均>0.05)。结论 具有温肾健脾活血通络作用的复方蓉芪通络颗粒安全、无明显毒副作用,与他汀类药物联用,能够有效地调节血脂、改善甲状腺功能低下,对于甲减合并CAS患者,临床疗效确切;对CAS斑块能否获得有统计学意义的改善,有待扩大样本量、延长治疗疗程,进一步探讨。
Abstract:Objective To observe the clinical effect of compound Rongqi Tongluo granule on hypothyroidism complicated with carotid atherosclerosis (CAS) patients with Yang deficiency of spleen and kidney combined with stasis of blood syndrome.
Methods Total 70 patients with hypothyroidism complicated with CAS from August 2016 to March 2020 were randomly divided into study group (n=35) and control group (n=35).The control group was treated with levothyroxine sodium tablets plus atorvastatin calcium,and the study group was treated with compound Rongqi Tongluo granule on the basis of the control group.After 12 weeks of treatment,the changes of Traditional Chinese Medicine (TCM) syndromes and related indexes such as thyroid function,blood lipid,homocysteine (Hcy),hypersensitive C-reactive protein (hs-CRP) and carotid artery intima-media (IMT) were compared before and after treatment.
Results After 12 weeks of treatment,compared with control group,the improvement rates of TCM symptoms(sallow complexion,fatigue,mental fatigue,constipation,edema of face or lower limbs,sore waist and knees,cold sensations in the limbs,frequent nocturnal urination)in study group were significantly increased (P<0.01,P<0.05);the levels of thyroid function,blood lipid,Hcy and hs-CRP were improved in both groups,and the improvements in study group were more significant when compared with control group (P<0.01,P<0.05).After treatment,the measured values of IMT and plaque area were slightly lower than those before treatment in two gruops,and also slightly lower in study group than those in control group,but the differences were not significant (all P>0.05).
Conclusions Compound Rongqi Tongluo granule,which has the effect of warming the kidney,invigorating the spleen,promoting blood circulation and dredging collaterals,is safe and has no obvious side effects.Combined with statins,it can effectively regulate blood lipids and improve hypothyroidism,and has a definite clinical effect in patients with hypothyroidism complicated with CAS.Whether CAS plaque can be improved statistically needs to be further discussed by expanding the sample size and prolonging the course of treatment.
keywords: Hypothyroidism Carotid atherosclerosis Compound Rongqi Tongluo granule Statins Levothyroxine tablet
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基金项目:国家中医药管理局中医药重点学科—中医内分泌学(20091221);国家自然科学基金项目(81774286);国家中医临床研究基地业务建设第二批科研专项(JDZX3015123);方朝晖安徽省名中医工作室(2019-8-5)
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