荷芪散治疗痰瘀互结证2型糖尿病合并冠心病的临床疗效及对血清TMAO水平的影响

【目的】观察荷芪散治疗痰瘀互结证2型糖尿病(T2DM)合并冠心病(CHD)的临床疗效及其对血清氧化三甲胺(TMAO)水平的影响。【方法】将40例痰瘀互结证T2DM合并CHD患者随机分为观察组和对照组,每组各20例。2组患者均给予降压、调脂及抗血小板聚集等西医基础治疗,在此基础上,对照组给予利拉鲁肽治疗,观察组在对照组的基础上加用荷芪散治疗,疗程为1个月。观察2组患者治疗前后中医证候积分、糖代谢指标、脂代谢指标、左心室功能相关指标、炎症因子、内皮素1(ET-1)以及肠道菌群代谢产物TMAO水平的变化情况,并评价2组患者的临床疗效和安全性。【结果】(1)疗效方面:治疗1个月后,观察组的总有效率为95.0%(19/20),对照组为70.0%(14/20),组间比较,观察组的临床疗效明显优于对照组(P<0.05)。(2)中医证候积分方面:治疗后,2组患者的中医证候积分均较治疗前明显下降(P<0.01),且观察组对中医证候积分的下降作用明显优于对照组(P<0.01)。(3)糖代谢相关指标方面:治疗后,2组患者的空腹血糖(FPG)、餐后2 h血糖(2hPG)、糖化血红蛋白(HbA1c)、空腹胰岛素(FINS)、胰岛素抵抗指数(HOMA-IR)均较治疗前明显下降(P<0.01),且观察组对FPG、2hPG、HbAlc、FINS、HOMA-IR的下降作用均明显优于对照组(P<0.05或P<0.01)。(4)脂代谢相关指标方面:治疗后,2组患者总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)均较治疗前明显下降(P<0.01),且观察组对TC、TG和LDL-C的下降作用均明显优于对照组(P<0.05)。(5)炎性因子、血管内皮因子以及肠道菌群代谢产物方面:治疗后,2组患者血清白细胞介素6(IL-6)、超敏C反应蛋白(hs-CRP)、ET-1和TMAO水平均较治疗前明显下降(P<0.01),且观察组对血清IL-6、hs-CRP、ET-1和TMAO水平的下降作用均明显优于对照组(P<0.05)。(6)超声心动图方面:治疗后,2组患者的左室射血分数(LVEF)、二尖瓣口血流频谱E峰与A峰流速比值(E/A)均较治疗前升高(P<0.01),且观察组对LVEF、E/A的升高作用均明显优于对照组(P<0.05)。(7)治疗过程中,2组患者均未出现相关并发症及药物不良反应。【结论】荷芪散联合利拉鲁肽治疗痰瘀互结证T2DM合并CHD患者,可以提高临床疗效,降低中医证候积分,改善糖脂代谢和胰岛素抵抗,提高左心室功能,降低炎症因子以及ET-1的表达,并降低血清TMAO水平,其疗效优于单用利拉鲁肽治疗。

Clinical Efficacy of Heqi Powder on Type 2 Diabetes Mellitus Complicated with Coronary Heart Disease and Differentiated as Phlegm Blended with Blood Stasis Syndrome and Its Influence on Serum Level of Trimethylamine N-Oxide

Objective To investigate the clinical efficacy of Heqi Powder on type 2 diabetes mellitus(T2 DM)complicated with coronary heart disease(CHD)differentiated as phlegm blended with blood stasis syndrome,and to observe its effect on serum trimethylamine N-oxide(TMAO). Methods Forty T2 DM patients complicated with CHD and differentiated as phlegm blended with blood stasis syndrome were randomly divided into the observation group and the control group,with 20 patients in each group. The patients of both groups were given basic western medicine treatment for lowering blood pressure, regulating blood lipids and counteracting platelet aggregation,and additionally,the control group was given subcutaneous injection of Liraglutide Injection,and the observation group was given Heqi Powder orally together with subcutaneous injection of Liraglutide Injection. The course of treatment for the two groups lasted for one month. The changes of traditional Chinese medicine(TCM)syndrome scores, glucose metabolism indexes, lipid metabolism indexes, left ventricular function related indexes,inflammatory factors,endothelin 1(ET-1)and intestinal microflora metabolite TMAO level in the two groups were observed before and after treatment. After treatment, the clinical efficacy and safety of the two groups were evaluated. Results(1)Clinical efficacy:after one month of treatment,the total effective rate of the observation group was 95.0%(19/20),and that of the control group was 70.0%(14/20). The intergroup comparison showed that the clinical efficacy of the observation group was significantly superior to that of the control group(P<0.05).(2)TCM syndrome scores:after treatment,the TCM syndrome scores of both groups were significantly decreased compared with those before treatment(P<0.01),and the effect of the observation group on the decline of TCM syndrome scores was significantly superior to that of the control group(P<0.01).(3)Glucose metabolism related indicators: after treatment, the levels of fasting plasma glucose(FPG), 2-hour postprandial blood glucose(2 hPG),glycosylated hemoglobin(HbA1 c),fasting insulin(FINS)and insulin resistance index(HOMA-IR)in the two groups were significantly decreased compared with those before treatment(P<0.01). And the effects on decreasing FPG,2 hPG,HbAlc,FINS and HOMA-IR in the observation group were significantly superior to those in the control group(P<0.05 or P<0.01).(4)Lipid metabolism related indexes:after treatment,the levels of total cholesterol(TC),triglyceride(TG)and low-density lipoprotein cholesterol(LDL-C)in the two groups were significantly decreased compared with those before treatment(P<0.01),and the lowering effect on TC,TG and LDL-C in the observation group was significantly superior to that in the control group(P<0.05).(5)Inflammatory factors,vascular endothelial factors and intestinal microflora metabolites:after treatment,the levels of serum interleukin 6(IL-6),hypersensitive C-reactive protein(hs-CRP),ET-1 and TMAO in the two groups were significantly decreased compared with those before treatment(P<0.01),and the effects on decreasing the levels of serum IL-6, hs-CRP, ET-1 and TMAO in the observation group were significantly superior to those in the control group(P<0.05).(6)Echocardiography:after treatment,the left ventricular ejection fraction(LVEF)and the ratio of early diastolic E-peak velocity to late diastolic A-peak velocity(E/A)in the two groups were increased compared with those before treatment(P<0.01),and the effect on increasing LVEF and E/A in the observation group was significantly superior to that in the control group(P<0.05).(7)During the treatment,there were no related complications or adverse drug reactions occurred in the two groups. Conclusion For the treatment of T2 DM patients complicated with CHD and differentiated as phlegm blended with blood stasis syndrome, Heqi Powder combined with Lilaclutide is effective on enhancing clinical efficacy,reducing TCM syndrome scores,improving glucolipid metabolism and insulin resistance, improving left ventricular function, reducing the expression of inflammatory factors and ET-1 as well as the serum TMAO level. And its efficacy is superior to using Lilaclutide alone.