重组组织型纤溶酶原激活剂静脉溶栓联合安宫牛黄丸治疗急性缺血性脑卒中的临床疗效及安全性研究

Study on clinical efficacy and safety of recombinant tissue-type plasminogen activator intravenous thrombolysis combined with Angong Niuhuang pill in treatment of patients with acute ischemic stroke

目的观察安宫牛黄丸联合重组组织型纤溶酶原激活剂(rt-PA)对急性缺血性脑卒中(AIS)患者临床疗效的影响。方法选择2019年9月至2021年6月在温州医科大学附属衢州医院治疗的112例AIS患者作为研究对象。按随机原则将患者分为观察组和对照,每组56例。两组均给予基础治疗,对照组在基础治疗的同时加用rt-PA;观察组在对照组基础上给予安宫牛黄丸每次1丸、每日1次,两组均治疗14 d。比较两组治疗前后美国国立卫生研究院卒中量表(NIHSS)评分、临床疗效和不良反应发生率的差异。结果随着治疗时间延长,两组NHISS评分均较溶栓后即刻降低,以观察组的降低程度更显著,且出院时观察组NHISS评分明显低于对照组(分:3.94±2.81比6.33±4.17,P<0.05)。观察组总有效率和预后良好率均明显高于对照组〔总有效率:94.64%(53/56)比76.79%(43/56),预后良好率:66.07%(37/56)比41.07%(23/56),均P<0.05〕。观察组与对照组不良反应发生率比较差异无统计学意义〔23.2%(13/56)比19.6%(11/56),P>0.05〕。结论对于AIS患者采用安宫牛黄丸联合rt-PA治疗有利于恢复神经功能,且安全有效。

Objective To observe the effect of Angong Niuhuang pill combined with recombinant tissue-type plasminogen activator(rt-PA)on clinical afficacy for treatment of patients with acute ischemic stroke(AIS).Methods A total of 112 AIS patients who were treated in Quzhou Hospital Affiliated to Wenzhou Medical University from September 2019 to June 2021 were selected as the study subjects.The patients were randomly divided into an observation group and a control group,with 56 cases in each group.Both groups were given basic treatment,while the control group was given rt-PA at the same time of applying basic treatment;on the basis of the control group,the observation group was given Angong Niuhuang pill one pill each time,once a day,and both groups were treated for 14 days.The differences in National Institutes of Health Stroke scale(NIHSS)score,clinical effect and adverse reaction rate between the two groups before and after treatment were compared.Results With the prolongation of treatment time,the NHISS scores of both groups decreased immediately after thrombolysis,especially in the observation group,and the NHISS scores of the observation group were significantly lower than those of the control group at discharge(3.94±2.81 vs.6.33±4.17,P<0.05).The total effective rate and the good prognosis rate of the observation group were significantly higher than those of the control group[total effective rate:94.64%(53/56)vs.76.79%(43/56),good prognosis rate:66.07%(37/56)vs.41.07%(23/56),both P<0.05].There was no significant difference in the incidence of adverse reactions between the observation group and the control group[23.2%(13/56)vs.19.6%(11/56),P>0.05].Conclusion For AIS patients,Angong Niuhuang pill combined with rt-PA is safe and effective,which is beneficial to the recovery of neurological function.