软坚清脉颗粒预防糖尿病性闭塞性动脉硬化动脉支架置入术后血管再狭窄的临床研究

Clinical study on Ruanjian Qingmai granule in preventing vascular restenosis after arterial stent placement in patients with diabetic arteriosclerosis obliterans

目的探讨中药软坚清脉颗粒预防糖尿病性闭塞性动脉硬化患者动脉支架置入术后血管再狭窄的临床疗效。方法收集2019年1月至2020年1月上海中医药大学附属上海市中西医结合医院收治的95例患有糖尿病性闭塞性动脉硬化患者的临床资料。按照随机数字表法将患者随机分为软坚清脉组(n=48)和对照组(n=47)。对照组行基础治疗,软坚清脉组在对照组的基础上同时口服软坚清脉颗粒。比较治疗前后两组患者的动脉通畅率、足溃疡愈合率、足溃疡复发率、踝肱指数(ABI)、白细胞介素-6(IL-6)、血管细胞黏附分子-1(VCAM-1)、国际标准化比值(INR)、纤维蛋白原(Fib)、血小板计数(PLT)及不良反应发生情况。结果治疗后12个月,软坚清脉组患者的动脉通畅率、ABI、足溃疡愈合率均高于对照组患者,足溃疡复发率低于对照组患者,差异有统计学意义(P<0.05)。治疗后6个月,软坚清脉组患者的IL-6水平、VCAM-1水平、Fib水平、PLT均低于对照组患者PLT(P<0.05)。治疗期间,两组患者均未出现胃肠道不良反应。结论软坚清脉颗粒能够有效预防糖尿病性闭塞性动脉硬化患者支架置入术后血管再狭窄的发生,提高足溃疡愈合率,促进创面愈合,提高血管通畅率,降低足溃疡复发率。

Objective To investigate the clinical efficacy of the traditional Chinese medicine"Ruanjian Qingmai granule"in preventing vascular restenosis after arterial stent placement in patients with diabetic arteriosclerosis obliterans.Method The clinical data of 95 patients with diabetic arteriosclerosis obliterans from Shanghai University of TCM,Shanghai TCM-INTEGRATED Hospital from January 2019 to January 2020 were collected.They were randomly divided into Ruanjian Qingmai group(n=48)and control group(n=47).The control group was given basic treatment,while the Ruanjian Qingmai group was given Ruanjian Qingmai granule orally on the basis of the control group.The arterial patency rate,foot ulcer healing rate,foot ulcer recurrence rate,ankle brachial index(ABI),interleukin-6(IL-6),vascular cell adhesion molecule-1(VCAM-1),international standardized ratio(INR),fibrinogen(Fib),platelet count(PLT)and adverse reactions were compared before and after treatment.Result Twelve months after treatment,the patency rate of artery,ABI and the healing rate of foot ulcer in the Ruanjian Qingmai group was higher than that in the control group,and the difference was statistically significant(P<0.05).Twelve months after treatment,the recurrence rate of foot ulcer in the Ruanjian Qingmai group was lower than that in the control group(P<0.05).Six months after treatment,the levels of IL-6,VCAM-1,Fib and PLT in the Ruanjian Qingmai group were lower than those in the control group(P<0.05).During the treatment,there were no gastrointestinal adverse reactions in both groups,and the difference was statistically significant(P<0.05).Conclusion Ranjian Qingmai granule can effectively prevent vascular restenosis in patients with diabetic arteriosclerosis occlusion after stent placement,and can improve the healing rate of foot ulcers after surgery and promote wound healing.It can increase the patency rate of blood vessels and reduce the recurrence rate of foot ulcers.