Effect of ozagrel sodium in ameliorating the motor function of patients with acute lacunar infarct of dyskinesias:a randomized,double-blind,placebo-controlled trial
Li Guo-yi,Lin Ya-xin, Zhou Yin,Song Lei-feng,Li Bao-chun,Department of Neurology,Heilongjiang Provincial Hospital,Harbin 150036,Heilongjiang Province,China
AIM:To observe the influence of ozagrel sodium,which is the thromboxane synthase inhibitor,on motor function, platelet activity,plasma inflammatory cytokines and fibrinolytic activity in patients with acute lacunar infarct of dyskinesias by using a randomized,doubleblind,placebocontrolled method.METHODS:Totally 212 patients with acute lacunar infarct of dyskinesias, who were treated in Heilongjiang Provincial Hospital between October 2003 and October 2004,were involved in this study. All the patients were hospitalized with 24 hours after attack, had no hemorrhagic tendency,and had not taken any drugs of anticoagulation or against platelet aggregation within 2 weeks. According to the serial number of the drugs, the 212 patients were randomly divided into ozagrel sodium group(n=115) and control group(n=97); They all received basic treatment (venous drip of 20 mL ginkgo leaf injection plus 0.5 g corenalin);Besides,placebo(80 mg) in the control group and venous drip of 80 mg ozagrel sodium in the ozagrel sodium were given respectively,twice a day for 14 continuous days.①Before and after treatment,the motor function was assessed with FuglMeyer motor function score (a total of 50 items including 33 for upper limb and 17 for lower limb,2 points for each item,the total score was 100 points, 50 points was taken as severe motor disorder);②Adverse events and side effects were observed;③Blood samples were taken to determine the platelet aggregative rate, thromboxane synthase B2,von Willebrand factor related antigen,interleukin6, tissuetype plasminogen activator and inhibitor activities.Blind method was used for the intervention and evaluation in this study. RESULTS:According to the analysis of actual treatment,201 cases (109 in the ozagrel sodium group and 92 in the control group) were involved in the analysis of results.①Results of FuglMeyer motor function score: It was obviously improved in the ozagrel sodium group after treatment as compared with that before treatment and that in the control group(53.27±7.44, 18.93±7.60,29.88±7.94,P 0.01);The function of lower limb in the ozagrel sodium group after treatment was markedly improved as compared with that before treatment and that in the control group(28.14±4.97, 11.94±4.76,17.83±3.08,P 0.01).②The platelet aggregative rate, thromboxane synthase B2,von Willebrand factor related antigen,interleukin6,tissuetype plasminogen activator inhibitor activities in the ozagrel sodium group after treatment were obviously lower than those before treatment and those in the control group after treatment(P 0.01),and the activity of tissuetype plasminogen activator was remarkably higher than that before treatment and that in the control group after treatment(P 0.05).③No cerebral hemorrhage and hemorrhagic tendency of digestive tract were observed during treatment in both groups;Six cases in the ozagrel sodium group had mild side effects.CONCLUSION:Ozagrel sodium can obviously inhibit the platelet aggregation and the release of thromboxane synthase, decrease the activity of coagulation,ameliorate fibrinolyses,and slow down the development of acute cerebral infarction in patients with acute lacunar infarct of dyskinesias;It has significant therapeutic effect on the recovery of motor function with reliability in the patients within 24 hours after the attack.