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Objective To observe the effect of defibrase on activated partial thromboplastin time (APTT),prothrombin time (PT)and the blood rheology at the acute stage of cerebral infarction.Methods 46 cases of cerebral infarction were selected in the Nanyang City Center Hospital.They were randomly divided into two groups;23 cases of control group,with regular treatment of 5% low molecular dextran and venoruton injection,intravenous drip,one week for a course,for two courses of treatment;23 cases of experimental group,with 10U defibrase,intravenous drip,every two days,one week for a course,for two courses of treatment.After treatment,APTT,PT and blood rheology were compared before and after treatment.Results APTT were improved in both groups after treatment,and APTT in experimental group was higher than that in control group,and the difference was statistically significant (P<0.05 );PT were improved in both groups after treatment,and the experimental group was higher than that in control group,and the difference was statistically significant (P<0.05);the blood rheology were improved in two groups after treatment (including high shear rate,low shear rate,plasma viscosity,erythrocyte deposited and fibrinogen),and the high shear rate,plasma viscosity,and fibrinogen of experimental group were lower than those of control group,and the differences was statistically significant (P<0.05 ).Conclusion Defibrase could obviously improve the APTT,PT and hemorheology indexes of cerebral infarction at the acute stage,which gives a clinical guidance.
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Objective To investigate the clinical efficacy and safety evaluation of fibrinolytic,anticoagulant and antiplatelet drug combination treatment in patients with progressive ischemic stroke (PIS). Methods Ninety cases with PIS were randomly divided into the treatment group (47 cases) and the control group (43 cases). The patients in the control group were given combination therapy of Diemailing, Nadroparin calcium and Ozagrel,while the combination therapy of Defibrase, Diemailing, Nadroparin Calcium and Ozagrel were given in the treatment group. The plasma fibrinogen (Fib), prothrombin time (PT), part enabled prothrombin time (APTT), liver and kidney function were observed. The clinical efficacy was evaluated after 14 days treatment. Results After treatment,the total effective rate of the treatment group was 89.4% ,which was significantly higher than that of the control group (67.4%) (P ＜ 0.05). After treatment, the PT and APTT levels of the treatment group were respectively (19.76± 5.53)s and (35.43 ± 6.03)s,the control group were respectively(17.26 ± 1.49)s and (35.71±5.64) s, the PT and APTT increased significantly compared with the pre-treatment condition in both groups (P ＜ 0.05), while the difference between the two groups was not statistically significant (P ＞ 0.05). The Fib level was (1.51 ±0.42)g/L in the treatment group,and (3.10 ±0.69)g/L in the control group. In the treatment group the Fib level was significantly lower than the control group and the condition before treatment(P ＜0.05). We found no significant difference between conditions before or after the treatment in the control group (P ＞ 0.05). The incidence of adverse clinical events showed no significantly difference between the treatment group and control (P ＞0.05). Conclusions Applying of fibrinolytic, anticoagulant and antiplatelet drug combination treatment in patients with PIS has a good efficacy and safety,which is good for clinical application.
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Objective To investigate the influence of early rehabilitation and defibrase on the hemodynamic cerebral vascular dynamic index (CVDI) of hemiplegic patients with acute cerebral infarction. Methods Ninety hemiplegic patients with acute infarction were randomly divided into a rehabilitation and a control group. Both groups received defibrase routine treatment. The rehabilitation group received systematic rehabilitation training in addition. The Fugl-Meyer assessment ( FMA) , the Scandinavian Scoring Scale ( SSS) and Barthel's index ( MBI) were employed to evaluate the functioning of the two groups. The CVDIs of all patients were quantified before and after treatment. Results The FMA, MBI and SSS scores as well as the CVDIs of both groups had improved after 4 weeks of treatment, but all were more improved in the rehabilitation group than in the control group. Conclusions Early rehabilitation was effective for relieving neurological impairment and improving ability in the activities of daily living for patients with acute cerebral infarction.
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Objective To observe the clinical efficacy of combined treatment of acute cerebral infarction with Yinxinggye injection and defibrase.Methods 70 cases with acute cerebral infarction were randomly divided into a treatment group and a control group,with 35 cases in each group.The treatment was injected with 10ml Ylnxinggye injection adding into 250 ml 5% glucose (iv.drip,qd.) for 10 days and 10u defibrase (iv.drip,qd.) for 3 days.The control group was injected with 10ml Compositive Salvia Miltiorrhiza Injection adding into 250 ml 5% glucose (iv.drip,qd.) for 10 days and 10u defibrase (iv.drip,qd.) for 3 days.Results The total effective rate of the treatment group and the control group was 97.7% and 80% respectively.The difference between the two groups was obvious (P＜0.01).Conclusion The efficacy of combined treatment of acute cerebral infarction with Yinxinggye injection and defibrase was good.
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Objective:To assess the safety and efficacy of defibrase in the treatment of acute cerebral infarction by a randomized, double-blind, and placebo-controlled clinical trial. Methods:65 cases with acute infarction were randomly allocated to receive either an initial intravenous infusion of defibrase 10IU or placebo 250ml of normal saline within 24 hours of stroke onset. Subsequent infusions of defibrase 5IU or placebo were given on the third and the fifth day respectively. The end points included Clinically Neurological Deficits Scale of Stroke, Barthel Index in 3 months, adverse reaction and the level of plasma fibrinogen(FIB). Results:1.The level of plasma FIB in defibrase group was remarkably declined after treatment whereas the bleeding events and other adverse reactions were not increased as compared with the control group. 2.There were no statistically significant differences at Clinically Neurological Deficits Scale of Stroke at 2 weeks,Barthel Index score between two groups. Conclusion:This study shows that defibrase appears safe and effective in degrading plasma FIB.This study does not show that clinical efficacy of defibrase is superior to those medicines being used at present for acute cerebral infarction.
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Objective To analyse the clinical efficacy of combined defibrase with mannitol in treating acute cerebral in- farction.Methods 64 cases with acute cerebral infarction were randomly divided into treated group (34 cases) and control group (30 cases),The patients in treated group were treated intravenously with defibrase 10 U per diem and 20% mannitol 250 mL twice a day,The 30 patients in control group treated with defibrase alone.The treatment course of both groups was 14 days,the nerve function deficit score was evaluated before and the 15th day,the routine life abili- ty (Barthel Index) was evaluated,Therapeutic efl'ects and adverse effects were observed.Results After treatment, The nerve function deficit score and The Barthel Index improved much more than those of the control group (P
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Aim To investigate the effect of iontophoresis on skin permeation of defibrase. Methods Iontophoresis was carried out in side-by-side chambers, excised rat skin membrane (RSM) or human epidermis membrane (HEM). The effects of electrode polarity, permeation medium pH and ionic strength were evaluated. Results Permeation of defibrase caused by anodal iontophoresis was more effective [the apparent permeability coefficient was (1.2±0.4)×10-4 cm·h-1] than that of cathodal iontophoresis[(4.3±1.4)×10-5 cm·h-1]. The amount of permeated defibrase caused by anodal iontophoresis in pH 7.4 medium was (25±5)×10-14 mol·cm-2, which was higher than that of in pH 6.4 permeation medium [(15±4)×10-14 mol·cm-2]. Conclusion Iontophoresis could enhance skin permeation of defibrase. Electroosmotic flow effect played an important role.
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0.05 ; and (2) in combined test, the combined OR= 3.2353 and its 95% confidence interval was in 2.21 - 4.74 (? 2= 36.2 ,P
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@#ObjectiveTo investigate the therapeutic effectiveness of defibrase in treating penumbra and reperfusion.MethodsIntraluminal suture method was used to develope reversible middle cerebral artery occlusion(MCAO). Rats were subjected to MCAO 3 hours followed by reperfusion for 3, 6, 24, 72 hours, and to MCAO 6 hours followed by reperfusion for 3, 6, 24 hours. The treatment groups rats were injected intravenously defibrase at 0.5 hour before reperfusion. Meanwhile, the control group received normal saline. Clinically Neurological Deficits Scale were evaluated every day. Infarction volume was measured by using 2,3,5-triphenyltetrazolium chloride staining. Pathologic change were examined microscopically in HE stained sections.ResultsThere were significant difference at treatment groups of reperfusion 3 hours after MCAO.Infarction volume and Clinically Neurological Deficits Scale was significant reduced as control group (P<0.05). There were no significant differences at treatment groups of reperfusion 6 hours after MCAO (P>0.05). Cerebral hemorrhage wasn't increased in defibrase treatment group.ConclusionsDefibrase was effective on Clinically Neurological Deficits of rats in reperfusion 3 hours after MCAO.
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@#ObjectiveTo investigate the effect of defibrase on hemorheology on the patients with acute ischemic stroke. Methods40 patients with acute ischemic stroke were treated by defibrase and the change of hemorheology was recorded before and after the treatment respectively. ResultsThe whole blood viscosity, the blood plasma viscosity, RBC aggregate index and RBC hematocrit got reduced on different degrees.Conclusions Defibrase can reduce the blood viscosity,inhibit RBC aggregate,and improve the micro-circulation. It is helpful to recover the nerve function earlier.
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@#ObjectiveTo investigate the intensity of degrading plasma fibrinogen(FIB) and the therapeutic effectiveness of defibrase on treating cerebral ischemia by different administrated ways. MethodsIntraluminal suture method was used to develop reversible middle cerebral artery occlusion (MACO). 154 healthy male Wistar rats were randomized into 2 groups. The rats in intravenous treatment group were injected defibrase intravenously at 0.5,3,6,9,12hours after MACO,while the rats in coeliac treatment group were injected defibrase by abdominocentesis. Meanwhile the control group received normal saline. All rats were killed at 24 hours after MCAO. The thrombus in middle cerebral artery (MCA) and cerebral infarction were examined microscopically in HE stained sections. Infarction volume was measured by using 2,3,5-triphenyltetrazolium chloride staining. 24 rats were selected randomly and injected defibrase by intravenous injection and abdominocentesis. Plasma FIB was measured before and after injection 1,3,6,12,24h by intravenous haemospasia. ResultsPlasma FIB was significantly reduced in intravenous treatment group, and it was lowerest in 3h after intravenous treatment.Clinical Neurological Deficits Scale and infarction volume was significantly reduced in intravenous treatment group than saline control group and coeliac treatment group.There was improvement in Clinical Neurological Deficits Scale in coeliac treatment group compared with that of saline control group, but there was no statistically significant differences at infarction volume.Clinical Neurological Deficits Scale and infarction volume was statistically significant differences in intravenous treatment group at 0.5,3 hours after MCAO. There were no statistically significant differences in intravenous treatment group at 6, 9,12 hours after MCAO.Conclusions Defibrase can reduce the infarction volume in cerebral ischemia early stage.
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Aim To ascertain whether defibrase has the protective effect against reperfusion injury after cerebral ischemia.Methods 70 renovascular hypertensive rats(RHR) were randomly divided into defibrase group, control group and sham-operated group.Reversible middle cerebral artery occlusion(MCAO) models were produced by the modified. Longa's method,and reperfusion was begun 2 hours after occlusion.Rats in the defibrase group were given defibrase 10 U?kg-1 body weight via femonal intraveneous injection, and in the control group with the same amount of saline. The brain pieces were processed by TTC and HE staining and the infarct size,brain microvessels damage and secondary bleeding were compared between the two groups. Results The volume of infarction in the defibrase group was obviously smaller than in the control group, the damage of brain microvessels was less severe, and the bleeding lesions under optical microscope were less than in the control group. Conclusion Defibrase has protective effect against reperfusion injury post cerebral ischemia.
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OBJECTIVE:To discuss the general pattern and features of adverse drug reactions(ADRs) of defibrase.MET-HODS:The cases of ADRs of defibrase reported in the national medical journals during 1999 and 2003 were collected and analyzed.RESULTS:ADRs of defibrase mainly included bleeding,urticaria,high fever,positive cutantest,liver function injury,ecchymoma,purpura haemorrhagica,incision hemorrhea,and arterial embolism.CONCLUSION:Great importance should be attached to ADRs of defribrase in clinic in order to ensure the safety of drug use.
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Objective:To assess the safety and efficacy of defibrase in the treatment of acute cerebral infarction by a randomized,double-blind,and placebo-controlled clinical trial.Methods:65 cases with acute infarction were randomly allocated to receive either an initial intravenous infusion of defibrase 10U or placebo 250ml of normal saline within 24 hours of stroke onset.Subsequent infusions of defibrase 5U or placebo were given on the third and the fifth day respectively.The end points included Clinically Neurological Deficits Scale of Stroke,Barthel Index,fatality rate of stroke in 3 months and 12 months,adverse reaction and the level of plasma fibrinogen(FIB).Results:(1)The level of plasma FIB in defibrase group was remarkably declined after treatment whereas the bleeding event and other adverse reaction were not increased as compared with the control group.(2)There were no statistically significant differences at Clinically Neurological Deficits Scale of Stroke at 2 weeks,Barthel Index score and fatality rate at 3 months between two groups.(3)The recurring rate of stroke in control group was higher than that in defibrase group at 12 months(P
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In the in vitro model of thrombolysis designed by ourselves, urokinase (500 000~ 5 000 000IU ? L-1) reduced the weight of artificial thrombi in a way of dose-dependence. At the level of 2 000 000 IU ? L-1, the action reached the peak. On the contrary, defibrase (6. 25~25 IU ? L-1) dose-relatedly increased the thrombus weight. After defibrinogenation in platelet-poor plasma by addition of porcine thrombin (100 000 IU ? L-1) , defibrase no longer increased the thrombus weight, whereas in comparison with saline, defibrase still showed no apprciable reduction in thrombus weight. The findings hinted that defibrase may have no direct thrombolytic property.