丹参多酚酸治疗前循环急性脑梗死的疗效与安全性分析

Observation on efficacy and safety of Salvianolic Acids for injection in treatment of anterior circulation acute cerebral infarction

目的分析对前循环急性脑梗死患者中使用注射用丹参多酚酸治疗的有效性和安全性。方法纳入112例前循环急性脑梗死患者,按照1∶1的比例随机分配到对照组和治疗组。对照组给予缺血性脑血管病基础治疗,治疗组在对照组治疗的基础上加用注射用丹参多酚酸治疗,比较2组治疗前及治疗14 d后美国国立卫生研究院卒中量表(NIHSS)评分、治疗90 d后改良Rankin量表(mRS)评分作为有效性评价指标;比较2组治疗期间药物相关严重不良反应及治疗后90 d症状性脑卒中、心肌梗死、死亡的发生情况做安全性分析。结果2组基线NIHSS评分及基线mRS评分差异无统计学意义(P>0.05);治疗14 d后,与治疗前比较,2组NIHSS评分均显著减低,且治疗组NIHSS评分低于对照组,差异有统计学意义(P<0.05);90 d随访,治疗组基本实现功能独立(mRS≤2分)患者与对照组比较显著增加(P<0.05);治疗过程中无严重不良反应事件发生;90 d随访,2组间症状性脑卒中、心肌梗死、死亡发生情况差异无统计学意义(P>0.05)。结论注射用丹参多酚酸可以改善急性脑梗死患者的早期临床症状,并能够促进患者远期神经功能恢复,改善远期预后,有效性较高。

Objective To observe the efficacy and safety of Salvianolic Acids for injection in treatment of anterior circulation acute cerebral infarction.Methods A total of 112 acute cerebral infarction patients were randomly divided into treatment group and control group at ratio of 11.Patients of the control group received basic treatment,and patients of the treatment group received basic treatment plus Salvianolic Acids for injection.The National Institutes of Health stroke scale(NIHSS)score before and after treatment of 14 days and the modified Rankin scale(mRS)scores of 90 days after treatment were measured in both groups for efficacy estimate;Patients who had gone through severe adverse effects during the treatment or symptomatic cerebral infarct,symptomatic cerebral hemorrhage,myocardial infarction or died during 90 days follow-up were recorded for safety estimate.Results There was no statistically difference of NIHSS score or other baseline informations between the two groups before treatment(P>0.05).After 14 days of treatment,patients of both groups had lower NIHSS score than before treatment,and the treatment group had significantly lower NIHSS score than the control group(P<0.05).A total of 109 patients,including 54 patients in the treatment group while 55 patients in the control group,were followed up during a 90 days span after treatment.90 days after treatment,patients of the treatment group had statistically lower mRS score than the control group(P<0.05).There was no significant difference of severe adverse effects,symptomatic cerebral infarct,symptomatic cerebral hemorrhage,myocardial infarction or mortality between the two groups(P>0.05).Conclusion Salvianolic Acids for injection can not only improve the clinical symptoms of anterior circulation acute cerebral infarction at the early stage,but also promote long-term neurological function recovery and improve long-term prognosis.Salvianolic Acids for injection is effective and safe in the treatment of anterior circulation acute cerebral infarction.