Observation Of The Efficiency And Safety Of Acute Cerebral Infarction Cured With Union Application Of Rt-PA And Batroxobin

Objectives: To observe the curative effect and security about union application of rt-PA and batroxobin to treat acute cerebral infarction onset within 6 hours, seeks the new method to be an auxiliary of the intravenous thrombolysis. Increases the treatment effect and improves the prognosis of patients.Methods: we divided the patients with the stroke symptoms (the internal carotid artery system) onset within 6 hours into 3 groups at randoms: 1. rt-PA+batroxobin group: Gives the rt-PA0.7mg/Kg for intravenous thrombolysis, 24 hours later reexamines the head CT, if it does not have the hemorrhage, check the blood fibrinogen(FIB) urgently, if the FIB>1.0g/L, take the batroxobin 5BU for intravenous use. Reexamines FIB every other day, regards the result to be possible once more use the batroxobin. In 10 day of treatment course, batroxobin integral dose is 20BU; 2. rt-PA group: Gives the rt-PA0.7mg/Kg for intravenous thrombolysis; 3. batroxobin group: gives the batroxobin 10BU for the first time, and 5BU,everyother day, the integral dose is 20BU. It must be reexamine FIB before each time. Each group simultaneously carries on the conventional treatment. We used the modified Rankin scale (mRS) and the Activity of Daily Living Scale (ADL or Barthel Index, BI) at 3 months to be the main curative effect target: mRS (0-1) divides as well as the Barthel index≥95 divides into effectively; And use the National Institutes of Health Stroke Scale (NIHSS) as the secondary target. The incidence of intracranial hemorrhage within the treatment period and mortality at 3 months were used as the target of the validity and the security. Statistical analysis was performed using a medical software package(SPSS) to carry out the single factor variance analysis and Chi-square examination, p values<0.05 were considered significant.Results:1. Among the 113 patients enrolled, excluded 6 patients as follow-up losers and 2 patients that information were not completed, there were 105 patients participated in the final statistical analysis.2. Union application of rt-PA and batroxobin or the two applies alone can improve patients'nerve function, it was not obvious in the latter 24 hours between 3groups, but at the 3 months. At 3months, the favourable outcome (mRS score 0 or 1) between the 3groups respectively was: 75.86%, 52.27% and 28.13%; the proportion of Barthel index≥95 respectively was: 79.31%, 59.10%, 34.38%, this differentce has the significance; The proportion of intracranial hemorrhage respectively was: 6.88%, 6.82%, 3.13%; The mortality rate was: 7%th, 11.3%, 9.38%, the differences of the two target were insignificant. We need to further expand the sample size to discuss the mechanism of union application of rt-PA and batroxobin for treat the stroke onset within 6hours, enable the result to be more objective and have the clinical guiding sense.Conclusions:1. We have confirmed the clinical curative effect and security of intravenous thrombolysis with rt-PA within 6 hours of stroke onset.2. It is safety and efficacy to treat the stroke onset within 6 hours with baroxobin, but it is less favourable outcome than veno-thrombolysis.3. Union application of rt-PA and batroxobin will take more favourable outcome than they were applied alone.4. We need to further expand the sample size to discuss the mechanism, safety and efficacy of union application of rt-PA and batroxobin for treat the stroke onset within 6hours.