| ObjectiveAcute cerebral infarction(ACI) is one of the main diseases that is harm to people’s health, which has high incidence, mortality and morbidity. The main pathogenesis of ACI is that atherosclerosis disease and thrombosis disease on the artery of brain blood supply cause more cerebral blood deficiency, which occupy 40-60 percent of patients with ACI. Thus Thrombosis caused by atherosclerosis disease is the main pathologic basis of the disease. It is currently recommended that ultra early thrombolysis is an effective method for ACI clinical treatment. But there are strict indications and contraindications, therefore the off-label patients still cannot receive the very good treatment. Domestic researchers found fibrinogenase can lower the level of plasma fibrinogen and fibrous protein in patients with ACI, and make small effects on other clotting factors. In recent years Thrombus precursor protein(Tp P) that is the intermediate product of the process where fibrinogen turns into insoluble fibrin. It receives serious attention because of its specificity to the diagnosis of acute thrombosis. It is suggested that we could further observe fibrinogenase block thrombosis in patients with ACI based on the detection of Tp P level. Therefore this study is aimed to explore whether fibrinogenase could make effect on Tp P in order to provide new experimental evidence that further elucidate the mechanism of action for the treatment of ACI. MethodsThis trial was undertaken as a multicenter, single blind, randomized study.Acute stroke patients within 72 h of onset were studied prospectively. According to the different duration of the disease, venous blood was collected within 6 hours, 6-24 hours, 24-48 hours, 48-72 hours. Tp P was determined by enzyme-Linked inmunosorbent assay(ELISA). Patients with ACI were randomly divided into two groups, one group received conventional treatment(group A)and the other group received conventional treatment plus Fibrinogenase(group B). The level of Tp P was measured before and after treatment in 24 h, 48 h and 72 h extraction of venous blood by using enzyme-linked immunosorbent assay(ELISA). Healthy subjects were allocated to the health control group.Compare the national institutes of health stroke scale(NIHSS) scores and the activities of daily life(ADL) scores after discharge for 3 months between the two groups so as to evaluate the clinical efficacy. Results92 patients were enrolled(group A included 47 patients and group B included 45 patients). The health control group included 43 patients. The Tp P concentration of ACI begin to increase within 6 hours[(10.85±2.44)mg/l],and reach a peak in 24-48 hours[(20.69±3.09)mg/l],but start to decline in 48-72 hours[(17.96±2.44)mg/l]. The Tp P level in 24-48 hours and 48-72 hours was superior to that control group(P<0.01 for each). Compared with the control group, the plasma Tp P levels of A and B groups before treatment were significantly increased(all P<0.01).Compared with the A group, the plasma Tp P levels and the NIHSS scores of B group at each time point after treatment were significantly decreased(all P<0.05).Compared with before treatment, the plasma Tp P levels of A and B groups at each time point after treatment were significantly decreased, and the NIHSS scores of B group at each time point after treatment were significantly decreased(all P<0.05).The ADL score of A group(89.87±10.13)compared with B group(82.16±16.09)had no significantly difference. The rate of high rehabilitation efficiency in B group was significantly higher than that in A group(χ2=5.842,P<0.05).A,B two groups were no serious adverse reactions. ConclusionThe Tp P proved to be a reliable indicator of early monitoring ACI, and can detect disease development, and analysis treatment effect. Fibrinogenase can depress the plasma Tp P level of ACI patients, reduce the neurological impairment and improve the clinical outcomes.It has no obvious adverse reactions, which is worth promoting. |
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