阿司匹林肠溶缓释片对糖尿病下肢动脉硬化闭塞症患者的抗栓作用和安全性评估  

Antithrombotic effect and safety evaluation of aspirin enteric-coated sustained release tablets in patients with diabetes lower extremity arteriosclerosis obliterans

作　　者：陈强 韩冰 CHEN Qiang;HAN Bing(Chengde Medical University,Hebei Province,Chengde 067000,China;不详)

机构地区：[1]承德医学院,河北省承德市067000 [2]河北省保定市第二中心医院血管外科,072750

出　　处：《临床合理用药杂志》2024年第5期26-30,共5页Chinese Journal of Clinical Rational Drug Use

摘　　要：目的 观察糖尿病下肢动脉硬化闭塞症(DLASO)患者口服不同剂量阿司匹林肠溶缓释片的抗栓效果及安全性,并与阿司匹林肠溶片进行比较。方法 选取2021年1月—2022年5月保定市第二中心医院收治的DLASO患者102例,采用随机数字表法分为A组和B1、B2组,每组34例。在控制原发疾病的基础上,A组口服阿司匹林肠溶片100 mg/d, B1组口服阿司匹林肠溶缓释片50 mg/d, B2组口服阿司匹林肠溶缓释片100 mg/d, 3组均治疗12周。比较3组治疗前后血栓最大振幅(MA)、凝血反应时间(R)、凝血形成时间(K)与纤维蛋白原(Fib)、超敏C反应蛋白(hs-CRP)水平、血流动力学指标[血浆黏度(PV)、全血高切黏度(WBHSV)、全血低切黏度(WBLSV)、红细胞沉降率(ESR)]、踝肱指数(ABI)、跛行距离及不良事件发生情况。结果 最终92例受试者完成试验,A组30例,B1、B2组各31例。与治疗前比较,治疗后3组R、WBHSV、ABI未见明显改变(P>0.05);MA、PV、WBLSV、ESR与Fib、hs-CRP水平较治疗前降低,K和跛行距离较治疗前增加(P<0.05或P<0.01);治疗后3组间MA、R、K、Fib、跛行距离比较差异无统计学意义(P>0.05),B1组hs-CRP水平、ESR较A组和B2组升高,B2组PV、WBLSV较A组和B1组降低(P<0.05)。3组不良事件发生率比较差异无统计学意义(P>0.05);3组胃肠道症状评分比较,B1、B2组显著低于A组,且B1组较B2组降低(P<0.05)。结论 DLASO患者口服50 mg/d或100 mg/d阿司匹林肠溶缓释片均可有效发挥抗栓作用,二者安全性较高,与口服100 mg/d阿司匹林肠溶片相比,前者胃肠道症状更轻,后者改善血流动力学效果更佳。Objective To observe the antithrombotic effect and safety of oral administration of different doses of aspirin enteric-coated sustained release tablets in patients with diabetes lower extremity arteriosclerosis obliterans(DLASO),and to compare them with aspirin enteric coated tablets.Methods One hundred and two patients with DLASO admitted to the Baoding Second Central Hospital were selected and randomly assigned to the group A,the group B1 and the group B2,with 34 cases in each group.Based on the control of the primary disease,the three groups were treated with oral aspirin enteric coated tablets 100 mg/d in group A,oral aspirin enteric-coated sustained release tablets 50 mg/d in group B1,and oral aspirin enteric-coated sustained release tablets 100 mg/d in group B2.The three groups were treated for 12 weeks.The maximum amplitude of thrombus(MA),coagulation reaction time(R),coagulation formation time(K),fibrinogen content(Fib),hypersensitive C-reactive protein(hs-CRP)level,hemodynamic indexes[plasma viscosity(PV),whole blood high shear viscosity(WBHSV),whole blood low shear viscosity(WBLSV),erythrocyte sedimentation rate(ESR)],ankle-brachial index(ABI),claudication distance before and after treatment,and the occurrence of adverse events were compared among the three groups.Results Finally 92 subjects completed the trial,30 in group A and 31 in each of groups B1 and B2.After treatment,R,WBHSV and ABI did not change significantly in the three groups(P>0.05);MA,PV,WBLSV,ESR,Fib and hs-CRP levels decreased,while K and claudication distance increased(P<0.05 or P<0.01);There was no significant difference in MA,R,K,Fib and claudication distance among the three groups after treatment(P>0.05);hs-CRP level and ESR in group B1 were higher than those in group A and B2,while PV and WBLSV in group B2 were lower than those in group A and B1(P<0.05).There was no significant difference in the incidence of adverse events among the three groups(P>0.05).The scores of gastrointestinal symptoms in groups B1 and B2 were significantly

关 键 词：糖尿病 动脉硬化闭塞症 阿司匹林肠溶缓释片 抗栓作用 安全性 

分 类 号：R587.2[医药卫生—内分泌] R543.5[医药卫生—内科学]