| BackgroundSince the concept of "Neuroprotective Cocktails" therapy has beenproposed, in more than ten years, many researchers have carried out a largenumber of study about the combination of neuroprotective agents in acuteischemic stroke. It was found that combinations of neuroprotective agentslead to significantly better neuroprotection than any one alone in animalmodels of ischemic stroke. But so far, there was no definite conclusion that acombinations achieved to safe and effective. Searching the best safe andeffective combination of different neuroprotective agents is promisingresearch of cerebral infraction therapy, it is a long way to go.PurposeThe research aims to observe the clinical efficacy and the occurrence ofserious adverse events about union application of GM1and Edaravone totreat acute cerebral infarction onset within72hours, and to supply atheoretical basis for the Neuroprotective Cocktail Therapy of acute cerebral infarction.MethodsA retrospective case-control study on clinical data of patients derivedform July2008to March2012in Neurology Department, The FirstAffiliated Hospital of Chongqing Medical University, who received GM1plus Edaravone or GM1alone to treat acute cerebral infarction onset within72hours. The matching was conducted based on three aspects: generalphysical condition, the severity of stroke and the main therapy for cerebralischemia.67cases were selected. Among which,33in combination groupwas treated with GM1plus Edaravone, and the single agent group was34patients received GM1alone. The NIHSS changes, the total effective rateand the markedly effective rate of each group were computed andcompared. Serious adverse events were observed and analysed of relation-ships between the occurrence of it with drugs used.Statistical analysis was performed by SPSS, version17.0. The baselinedata of two groups before treatment was compared by Chi-squareexamination. The data of two groups between pretreatment andposttreatment was compared by Wilcoxon signed-rank test. The data ofdifference in each group between pretreatment and posttreatment wascompared by Mann-Whitney U test. The grade data adopt Ridit analysis.P<0.05was considered significant．Results 1．The NIHSS change in two groups before and after treatment: TheNIHSS score after treatment in both groups were statistically different thanbefore. Moreover, compared with GM1used alone, the combination therapysignificantly decreased The NIHSS score (P<0.05).2．Clinical Overall Efficacy assessment: The total effective rate of thecombination therapy was66.6％, and the markedly effective rate was33.3％. The total effective rate of the monotherapy therapy was50.0％, andthe markedly effective rate was23.5％. There was no statisticallysignificant difference between two groups(P>0.05).3．The observation of serious adverse events: There were three cases ofserious adverse events, two cases in the combination group and one case insingle drug group. All of them were sicker to extend the duration ofhospitalization.Conclusion1．The GM1used alone or plus Edaravone also demonstrated improveneurological function, but combination therapy was more effective onneurological deficits improving.2．Both the total effective rate and the markedly effective rate wereslightly high, when GM1plus Edaravone or GM1alone was just used inshort-term to treat acute cerebral infarction onset within72hours. The totaleffective rate of combination therapy was higher than that of monotherapy,so was the markedly effective rate. But there was no statistically significant difference between two therapies(P>0.05).3．During the treatment, there were three cases of serious adverseevents, which were not associated with GM1or GM1plus Edaravone use.We need to further expand the sample size or add some analysis oflaboratory parameters to discuss the safety and efficacy of combination ofGM1and Edaravone to treat the stroke onset within72hours. |
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