【目的】探讨补肾通脉方治疗2型糖尿病 （T2DM） 合并动脉粥样硬化性心血管疾病 （ASCVD） 肾虚血瘀型患者的临床疗效 及对血清微小RNA-126 （miR-126） 的影响。【方法】将2023年3月至2023年10月在深圳市中医院老年医学科门诊及住院部就 诊的60例T2DM合并ASCVD肾虚血瘀型患者按随机数字表法随机分为研究组和对照组，每组各30例。2组患者均实施低盐 低脂糖尿病饮食和运动干预，并给予降糖、调脂、降血压、抗血小板聚集等常规西药治疗，研究组在对照组的基础上给予 补肾通脉方治疗，疗程为8周。观察2组患者治疗前后C反应蛋白 （CRP） 、白细胞介素1β （IL-1β） 、白细胞介素6 （IL-6） 、血 管细胞黏附分子1 （VCAM1） 、miR-126、颈动脉内膜中层厚度 （CIMT） 、颈动脉斑块Crouse积分以及血脂指标[总胆固醇 （TC） 、 甘油三酯 （TG） 、低密度脂蛋白胆固醇 （LDL-C） 、高密度脂蛋白胆固醇 （HDL-C） ]的变化情况，并评估2组患者的颈动脉疗效 和用药安全性。【结果】（1） 血清miR-126水平方面：治疗后，研究组患者的血清miR-126水平较治疗前明显升高 （P < 0.01） ， 对照组的血清miR-126水平较治疗前有升高趋势，但差异无统计学意义 （P > 0.05） ；组间比较，研究组对血清miR-126水平 的升高幅度明显优于对照组 （P < 0.05） 。 （2） 血清VCAM1水平方面：治疗后，研究组患者的血清VCAM1水平较治疗前明显下 降 （P < 0.01） ，对照组患者的血清VCAM1水平较治疗前有下降趋势，但差异无统计学意义 （P > 0.05） ；组间比较，研究组对 血清VCAM1水平的下降幅度明显优于对照组 （P < 0.01） 。 （3） 血清炎症因子方面：治疗后，2组患者的血清CRP、IL-1β、IL-6 水平均较治疗前下降 （P < 0.05或P < 0.01） ，且研究组对血清IL-1β、IL-6水平的下降幅度均明显优于对照组 （P < 0.05） 。 （4）血脂指标方面：治疗后，研究组患者的TC、TG、LDL-C水平较治疗前下降 （P < 0.01） ，HDL-C水平较治疗前升高 （P < 0.01） ，而对照组患者的TC、TG、LDL-C、HDL-C水平均无明显变化 （P > 0.05） ；组间比较，研究组对TC、LDL-C水平 的下降幅度均明显优于对照组 （P < 0.05） 。 （5） 颈动脉疗效方面：治疗8周后，研究组的总有效率为90.00% （27/30） ，对照组为 63.33% （19/30） ；组间比较 （χ2 检验） ，研究组的疗效明显优于对照组 （P < 0.05） 。 （6） 安全性方面：治疗过程中，2组患者均未 发生严重的不良反应及毒副作用。【结论】补肾通脉方联合西医常规治疗能够上调miR-126的水平，抑制VCAM1表达，降低 血清CRP、1L-1β、IL-6水平，从而抑制炎症反应，延缓T2DM合并ASCVD病情进展，具有较好的临床疗效和安全性。

Objective To observe the clinical efficacy of Bushen Tongmai Prescription in treating type 2 diabetes mellitus（T2DM）complicated with atherosclerotic cardiovascular disease（ASCVD）of kidney deficiency and blood stasis type，and to investigate its effect on serum microRNA-126（miR-126）. Methods Sixty patients with T2DM complicated with ASCVD of kidney deficiency and blood stasis type who admitted to the outpatient and inpatient departments of the Department of Geriatric Medicine of Shenzhen Traditional Chinese Medicine Hospital from March 2023 to October 2023 were randomly divided into the study group and the control group according to random number table method，with 30 patients in each group. All patients in the two groups were required to take low-salt and low - fat diabetic diet and exercise for intervention， and were also given the conventional western medical treatment with hypoglycemic，lipid-lowering，antihypertensive，anti-platelet aggregation agents. Additionally， the study group was treated with Bushen Tongmai Prescription. The course of treatment for the two groups covered eight weeks. Before and after treatments， the two groups were observed in the changes of C-reactive protein （CRP），interleukin 1β（IL-1β），interleukin 6（IL-6），vascular cell adhesion molecule 1（VCAM1），miR- 126，carotid intima-media thickness（CIMT），carotid plaque Crouse scores，and blood lipid indicators of total cholesterol（TC），triglycerides（TG），low-density lipoprotein cholesterol（LDL-C）and high-density lipoprotein cholesterol（HDL-C）. After treatment，the therapeutic efficacy on carotid artery and drug safety in the two groups were evaluated. Results（1）After treatment， the serum miR-126 level in the study group was significantly increased compared with that before treatment（P < 0.01），but the level in the control group only showed a rising trend and the difference was not statistically significant（P > 0.05）. The comparison between the two groups showed that the increase of serum miR-126 level in the study group was significantly superior to that in the control group （P < 0.05）.（2）After treatment，the serum VCAM1 level in the study group was decreased significantly compared with that before treatment（P < 0.01）， but the level in the control group only showed a rising trend and the difference was not statistically significant（P > 0.05）. The comparison between the two groups showed that the decrease of serum VCAM1 level in the study group was significantly superior to that in the control group（P < 0.01）. （3）After treatment，the serum CRP，IL-1β，and IL-6 levels in the two groups were decreased compared with those before treatment（P < 0.05 or P < 0.01），and the decrease of serum IL-1β and IL-6 levels in the study group was significantly superior to that in the control group（P < 0.05）.（4）After treatment，the TC，TG and LDL-C levels in the study group were decreased（P < 0.01）and the HDL-C level was increased compared with that before treatment（P < 0.01），but in the control group，the changes in the TC，TG，LDL-C，and HDL-C levels were not significant（P > 0.05）. The comparison between the two groups showed that the decrease of TC and LDL-C levels in the study group was significantly superior to that in the control group（P < 0.05）.（5）After eight weeks of treatment，the total effective rate of the study group was 90.00%（27 /30），while that of the control group was 63.33%（19/30）. The intergroup comparison（tested by chi-square test）showed that the therapeutic efficacy of the study group was significantly superior to that of the control group（P < 0.05）.（6）During the treatment，no serious adverse reactions or toxic-side effects occurred in the two groups. Conclusion Bushen Tongmai Prescription combined with conventional western medicine treatment can up-regulate the level of miR-126， inhibit the expression of VCAM1，and decrease the levels of serum CRP，1L-1β，and IL-6，so as to inhibit inflammatory response and retard the progression of T2DM complicated with ASCVD. The combined therapy exerts certain clinical efficacy and higher safety in treating T2DM complicated with ASCVD.

R259.872

广东省中医药局科研项目 （编号：20221354） ；深圳市科技计划项目 （编号：JCYJ20180305163238685） ；深圳市中医院“3030” 计划项目 （编号：G3030202134）