复方脑肽节苷脂注射液治疗急性缺血性脑卒中388例回顾性研究

Efficacy and Safety of Compound Cerebrosideand Ganglioside(CCG)Injections on the Ischemic Stroke:A Retrospective Study

目的:评价复方脑肽节苷脂注射液治疗急性缺血性脑卒中(ischemic stroke,IS)的安全性和有效性。方法:选择2017年11月~2018年11月河北医科大学附属第二医院等6家医院收治的急性IS患者388例为研究对象,在常规治疗的基础上,根据合并用药不同分为试验组(复方脑肽节苷脂注射液+常规治疗)191例、对照组(其他神经节苷脂类药物+常规治疗)100例、空白组(常规治疗)97例。观察治疗前后各组美国国立卫生研究院脑卒中量表(NIHSS)评分及改良Rankin量表(mRS)评估结果,根据NIHSS评分改变情况评估疗效。将试验涉及的其他药物作为疗效判定的混杂因素,采用倾向性评分法对其进行控制,并对试验结果进一步分析。结果:治疗后,试验组、对照组和空白组显效率依次为72.77%、40.00%和12.37%,总有效率依次为78.53%、63.00%和24.74%,具有统计学差异(P均<0.05);各组治疗后NIHSS评分相较基线降低的程度从高到低排序依次为试验组、对照组和空白组,具有统计学差异(P<0.05);治疗后各组间Rankin量表结果分布情况无统计学差异(P>0.05)。经倾向指数评分后,试验组和对照组最终各获得100例匹配病例,试验组和空白组最终各获得97例匹配病例,试验组和对照组总有效率和显效率分别为80%vs 63%(P<0.05),72%vs 40%(P<0.05);NIHSS评分相对于基线的变化,试验组降低-3(-12,-1),对照组降低-1(-3,0),具有统计学差异(P<0.05);倾向指数评分后,试验组和空白组总有效率和显效率分别为81.44%vs 24.74%(P<0.05),76.29%vs 12.37%(P<0.05);NIHSS评分相对于基线的变化,试验组降低-3(-7,-1),空白组降低0(-1,0),具有统计学差异(P<0.05)。三组不良事件发生率无统计学差异(P>0.05),未观察到严重不良事件。结论:复方脑肽节苷脂注射液治疗急性IS安全有效。

Objective:To assess the efficacy and safety of Compound Cerebroside and Ganglioside injections(CCG)on the acute ischemic stroke(IS).Methods:A total of 388 patients with acute ischemic stroke from November 2017 to November 2018 from six comprehensive hospitals were selected as research subjects.On the basis of conventional treatment,according to the different drug combinations,the patients were divided into the experimental group(CCG+conventional treatment,191 cases),the control group(other ganglioside agents+conventional treatment,100 cases)and the blank group(conventional treatment,97 cases).The scores of National Institutes of Health Stroke Scale(NIHSS)and modified Rankin Scale(mRS)were observed before and after treatment,the efficacy was assessed according to changes in NIHSS score.The other drugs involved in the trial were taken as confounding factors in the evaluation of efficacy,and the propensity scoring method was used to control them,and the experimental results were further analyzed.Results:After treatment,the significant efficiency of the experimental group,control group and the blank group were 72.77%,40.00%and 12.37%respectively,and the total effective rate were 78.53%,63.00%and 24.74%respectively,with statistical difference(P<0.05).NIHSS score of each group decreased from high to low in order as the experimental group,the control group and the blank group,with statistical difference(P<0.05).After treatment,there was no significant difference in the distribution of Rankin scale results among all groups(P>0.05).After the propensity index score,the experimental group and control group finally obtained 100 matched cases,and the experimental group and blank group finally obtained 97 matched cases,the total effective rate and significant effective rate of the experimental group and the control group were respectively 80%vs 63%(P<0.05),72%vs 40%(P<0.05).The changes of NIHSS score relative to baseline,the experimental group decreased by-3(-12,-1),and the control group decreased by-1(-3,0),with statistical difference(P<0.05).After propensity index score,the total effective rate and significant effective rate of the experimental group and the blank group were respectively 81.44%vs 24.74%(P<0.05),76.29%vs 12.37%(P<0.05).The changes of NIHSS score relative to baseline,the experimental group decreased by-3(-7,-1),and the blank group decreased by 0(-1,0),with statistical difference(P<0.05).There was no significant difference in the incidence of adverse events among the three groups(P>0.05),and no serious adverse events were observed.Conclusion:CCG is safe and effective in treating acute IS.