| Objective:To investigate the antithrombotic effect of oral administration of different doses of aspirin enteric extended-release tablets on patients with diabetic lower limb ischemia after endovenous therapy and the effect on patients’ clinical prognosis,as well as to evaluate the safety of patients during administration and to conduct a comparative analysis with aspirin enteric tablets,in order to provide a safer and more effective antithrombotic drug use regimen and more data support for patients after diabetic lower limb ischemic intervention.Methods:One hundred and five patients with diabetic lower limb ischemia who successfully received lower limb endovascular treatment from May 2021 to July 2022 in the Second Central Hospital of Baoding were included.Patients were randomly assigned by lottery to aspirin enteric tablets 100 mg/d group(group A),aspirin enteric extended-release tablets 100 mg/d group(group B)and aspirin enteric extended-release tablets 50 mg/d group(group C),with35 cases in each group.All patients were routinely tested for blood glucose,lipids,electrolytes,routine blood count,coagulation,and liver and kidney function upon admission,and the ischemic condition of the lower extremities was evaluated in detail before surgery based on the patients’ clinical symptoms and CT angiography results.On the day after the intervention,the patient’s target vessel patency was assessed and the intraoperative treatment modality was recorded.Fasting venous blood was collected on the morning of the first postoperative day to measure thrombosis-related indicators,including maximum amplitude of thrombus(MA),clotting reaction time(R),blood clotting time(K),fibrinogen(FIB)content,plasma viscosity(PV),whole blood high shear viscosity(WBHSV),whole blood low shear viscosity(WBLSV),erythrocyte sedimentation rate(ESR)and hypersenstive C-reactive protein(hs-CRP)levels.Patients in group A received 100 mg of aspirin enteric-coated tablets at bedtime,group B received 100 mg of aspirin enteric-coated extended-release tablets at bedtime,and group C received 50 mg of aspirin enteric-coated extended-release tablets at bedtime for 24 weeks.Patients were followed up and thrombosis-related indexes were recorded at 4weeks of dosing,as well as ankle-brachial index(ABI),vascular patency and thrombosis at 4,12 and 24 weeks of dosing.Patients were also evaluated for drug safety while taking the drug,monitored quantitatively for gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale(GSRS),and evaluated in detail for the severity of bleeding adverse events using the Bleeding Academic Research Consortium(BARC)bleeding criteria.SPSS 25.0 statistical software was used for data analysis in this study.Normally distributed measures were expressed as mean ± standard deviation((?)±s),t-test was used for comparison between two groups,chi-square test was performed first for comparison between multiple groups,and one-way ANOVA was used if the variance was chi-square,and LSD was used for two-way comparison between groups.The statistical data were expressed as the number of cases(percentage),and the χ2 test was used for comparison between groups,and the rank sum test was used for rank data.Differences were considered statistically significant at P < 0.05.Results:1.Follow-up results: A total of 105 subjects were included in this study.During the follow-up period,one case in group A was lost,two cases withdrew from the trial after changing the dosing regimen by themselves,and one case was forced to terminate the trial due to a serious bleeding event;two cases in group B were lost,one case did not take the required medication and terminated the trial,and one case withdrew by itself;one case in group C was lost,and two cases did not take the required medication and terminated the trial.A total of 94 subjects completed the trial and follow-up,including31 cases in group A,31 cases in group B,and 32 cases in group C.The differences were not statistically significant when comparing the incidence of dislodgement in the three groups(P>0.05).2.Changes of thrombosis-related indexes: after 4 weeks of drug administration,the three groups of patients had MA,FIB,PV,WBHSV,WBLSV,ESR,and hs-CRP levels were significantly lower in the three groups after 4 weeks of drug administration compared with those before drug administration(P<0.05),and no significant differences were found in R and K values compared with those before drug administration(P>0.05).There was no statistically significant difference in MA,R-value,K-value and FIB levels between the three groups(P>0.05);ESR and hs-CRP levels were significantly higher in group C compared with groups A and B,and PV,WBHSV and WBLSV levels were significantly lower in group B compared with groups A and C(P<0.05);ESR and hs-CRP levels were compared between groups A and B,and PV,WBHSV,WBLSV levels between groups A and B,and PV,WBHSV,WBLSV levels between groups A and C.The differences were not statistically significant(P>0.05).3.Comparison of clinical prognosis: During the follow-up period,the target vessel patency rate of patients in the three groups showed a decreasing trend;there were no statistically significant differences in the incidence of lower limb arterial thrombosis,ABI and target vessel patency rate at the 4th,12 th and 24 th weeks of drug administration in the three groups(P>0.05).4.Safety assessment: During the follow-up period,one patient in group A had BARC type 3b bleeding to terminate the trial,and the remaining patients did not have serious bleeding adverse events or fatal cardiovascular accidents,and the bleeding adverse events were mainly minor bleeding of BARC type 1.There were no statistically significant differences in the incidence of gastrointestinal adverse events,cardiovascular and cerebrovascular disease,and bleeding events among the three groups(P>0.05);GSRS scores were significantly higher in group A compared with groups B and C,and GSRS scores were significantly higher in group B compared with group C(P<0.05).Conclusions:1.Oral administration of 50 mg/d or 100 mg/d aspirin enteral extended-release tablets can effectively exert antithrombotic effects in diabetic lower limb ischemic patients after intervention,and can effectively prevent the occurrence of short-term reischemic events in the target vessel after surgery.2.At the same dose,aspirin enteral extended-release tablets showed better hemodynamic improvement and less gastrointestinal adverse effects than aspirin enteral tablets in patients with diabetic lower limb ischemia;oral50 mg/d aspirin enteral extended-release tablets showed less gastrointestinal adverse effects than oral 100 mg/d aspirin enteral extended-release tablets.3.Aspirin enteric extended-release tablets are both effective and safe,and can be used as a post-interventional antithrombotic drug of choice for diabetic patients with lower limb ischemia in clinical practice.It is recommended that patients take 100mg/d aspirin enteric extended-release tablets orally for thrombosis prevention after surgery.For patients with underlying gastrointestinal diseases or skin mucosa bleeding easily after taking 100mg/d aspirin,it is recommended to take 50mg/d aspirin enteric extended-release tablets orally,which has less gastrointestinal adverse effects and better safety. |
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