二术二陈汤加减对2型糖尿病痰浊血瘀证主要心血管高危因素的观察

Effect of Modified Erzhu Erchentang on Major Cardiovascular Risk Factors Caused by Type 2 Diabetes Mellitus with Phlegm Turbidity and Blood Stasis Syndrome

目的:探讨二术二陈汤加减对2型糖尿病(T2DM)痰浊血瘀证主要心血管高危因素的影响及抗炎效果。方法:将142例患者随机按数字表法分为对照组和观察组各72例。对照组采用注射胰岛素或口服降糖药控制血糖;口服拜阿司匹林肠溶片,100 mg/次,1次/d;口服替米沙坦片,40 mg/次,1次/d;口服阿托伐他汀钙片,10 mg/次,1次/d,并进行非药物干预措施。观察组西医处理措施同对照组,并内服二术二陈汤加减治疗,1剂/d,每周服用5 d。两组患者连续治疗24周,再进行24周随访。监测空腹血糖(FPG),餐后2 h血糖(2 hPG),糖化血红蛋白(Hb A1c),收缩压(SBP),舒张压(DBP),三酰甘油(TG),总胆固醇(TC),高密度脂蛋白胆固醇(HLD-C),低密度脂蛋白胆固醇(LDL-C);记录48周内的主要心血管事件、脑血管事件和周围血管事件的发生情况;进行治疗前后体质量(BMI),颈动脉内膜-中层厚度(IMT),弗明汉高危风险评分(FRS)和腰臀比评价;检测治疗前后降钙素原(PCT),同型半胱氨酸(Hcy),超敏C反应蛋白(hs-CRP),胱抑素C (CysC)和基质金属蛋白酶-9(MMP-9)。结果:治疗后观察组患者2 hPG,Hb A1c,SBP和DBP均低于对照组(P <0. 05);观察组TC,TG,LDL-C均低于对照组(P <0. 05),HDL-C高于对照组(P <0. 05);在48周的观察期间,观察组患者主要心血管事件的发生率为9. 23%,低于对照组的23. 44%(χ2=4. 775,P <0. 05);观察组患者主要终点事件的累积发生率为20%,低于对照组的39. 06%(χ~2=5. 639,P <0. 05);观察组IMT,BMI均低于对照组(P <0. 05);经秩和检验分析,观察组患者FRS心血管危险情况轻于对照组(Z=2. 165,P <0. 05);治疗后观察组患者hs-CRP,PCT,Hcy,CysC和MMP-9均低于对照组(P <0. 01)。结论:在常规西医综合治疗的基础上,采用内服二术二陈汤加减治疗T2DM痰浊血瘀证患者,可减轻血清炎症因子,能有效控制T2DM患者的心血管疾病高危因素,从而起到了降低主要心血管事件发生的效果。

Objective:To discuss the efficacy of Erzhu Erchentang on major cardiovascular risk factors caused by type 2 diabetes mellitus(T2DM)with phlegm turbidity and blood stasis syndrome,and its antiinflammatory effect.Method:One hundred and forty-two patients were randomly divided into control group and observation group by random number table.Patients in control group got insulin or oral hypoglycemic drugs for controlling blood sugar,aspirin enteric-coated tablets,100 mg/time,1 time/day,telmisartan tablets,40 mg/time,1 time/day,atorvastatin,10 mg/time,1 time/day,and non-drug interventions.In addition to the therapy of control group,patients in observation group were also given modified Erzhu Erchentang,1 dose/day,5 times/week.The course of treatment was 24 weeks.And a 24-week follow-up was recorded.And levels of fasting blood glucose(FPG),2 h postprandial blood glucose(2 hPG),glycosylated hemoglobin(HbA1 c),systolic blood pressure(SBP),diastolic blood pressure(DBP),triglyceride(TG),total cholesterol(TC),high-density lipoprotein cholesterol(HLD-C)and low-density lipoprotein(LDL-C)were detected.And the occurrence of major cardiovascular events,cerebrovascular events and peripheral vascular events were recorded.Before and after treatment,levels of body mass index(BMI),carotid intima-media thickness(IMT),framingham risk(FRS)and waist-hip ratio(WHR)were assessed.And procalcitonin(PCT),homocysteine(Hcy),hypersensitive C-reactive protein(hs-CRP),cystatin C(CysC)and matrix metalloproteinase-9(MMP-9)were measured.Result:After treatment,levels of 2 hPG,HbA1 c,SBP,DBP,TC,TG,LDL-C,IMT and BMI in observation group were lower than those in control group(P<0.05),while level of HDL-C was higher than that in control group(P<0.05).During 48 hours of observation,the incidence of major cardiovascular events in observation group was 9.23%,which was lower than 23.44%in control group(χ2=4.775,P<0.05).The cumulative incidence of major endpoint events in observation group was 20%,which was lower than 39.06%in control group(χ~2=5.639,P<0.05).According to rank sum test,cardiovascular risk in observation group was lighter than that in control group(Z=2.165,P<0.05).And levels of hs-CRP,PCT,Hcy,CysC and MMP-9 were all lower than those in control group(P<0.01).Conclusion:In addition to the comprehensive therapy of conventional western medicine,modified Erzhu Erchentang can increase the reduce serum inflammatory factors and control the high risk factors of cardiovascular disease of patients with T2DM,so as to reduce the major cardiovascular events.