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目的观察降纤酶治疗急性脑梗塞的疗效及血浆纤维蛋白原的改变 ,为进一步的临床研究提供一些参考依据。方法采用随机双盲、安慰剂对照的多中心临床试验的方法 ,将 85例急性脑梗塞患随机分为两组即研究组 (降纤酶组 )和对照组 (安慰剂组 ) ,于用药前后作神经功能缺损评分 ,并且检测血浆纤维蛋白原 (FIB) ,凝血酶原时间 (PT) ,血小板计数 (PLT) ,出血时间 (BT) ,凝血时间 (CT)。结果研究组的神经功能缺损程度明显改善 ,治愈率和有效率均高于对照组 (P <0 0 5或P <0 0 1 ) ;研究组血浆纤维蛋白原降低 ,在治疗后第 4、6、8、1 0天与对照组比较有显著差异 (P <0 0 1 ) ,用药前后PT、PLT、BT、CT均无明显变化。结论降纤酶治疗急性脑梗塞能明显改善神经功能 ,且有良好的安全性 ;控制血浆纤维蛋白原水平是治疗的关键。
Objective To observe the therapeutic effect of defibrase on acute cerebral infarction and the changes of fibrinogen in plasma, and provide some references for further clinical research. Methods A randomized, double-blind, placebo-controlled, multicentre clinical trial was conducted in which 85 patients with acute cerebral infarction were randomized into two groups, the study group (defibrase group) and the control group (placebo group) The neurological deficit scores were evaluated. Fibrinogen (FIB), prothrombin time (PT), platelet count (PLT), bleeding time (BT) and clotting time (CT) were measured. Results The degree of neurological deficit in the study group was significantly improved, and the cure rate and effective rate were both higher than those in the control group (P <0.05 or P <0.01). In the study group, plasma fibrinogen decreased. After treatment, , There was a significant difference between the control group and the control group (P <0.01) on 8 and 10 days. No significant changes were found in PT, PLT, BT and CT before and after treatment. Conclusion Defibrase treatment of acute cerebral infarction can significantly improve neurological function, and have good safety; control of fibrinogen level is the key to treatment.