三七总苷治疗进展性脑梗死的疗效和安全性

Efficacy and safety of saponins from Panax notoginseng in adults with progressive cerebral infarction

目的:观察三七总苷对进展性脑梗死的疗效及安全性.方法:640例起病24h内的急性脑梗死患者随机分为两组.对照组320例采用常规治疗,根据病情应用20%甘露醇、706代血浆、舒血宁、川芎嗪、维脑路通、胞磷胆碱、尼莫地平、阿司匹林等,试验组320例在常规治疗基础上给以三七总苷0.4～0.8 g加入氯化钠注射液500 mL,静滴,qd,14 d为1个疗程.观察两组治疗后进展性脑梗死的发病率,检测治疗前后进展性脑梗死全血高切还原黏度、全血低切还原黏度、血浆黏度、红细胞聚集指数、红细胞压积、红细胞变形指数、纤维蛋白原及神经功能缺损评分.结果:试验组进展性脑梗死发生率为10.63%(34/320),对照组进展性脑梗死发生率为28.75%(92/300)(P＜0.05).试验组进展性脑梗死神经功能缺损评分明显低于对照组[进展高峰值:(22±4)vs.(26±6);治疗d20时:(13±8)vs.(18±3),均为P＜0.01].试验组全血高切还原黏度、全血低切还原黏度、血浆黏度、红细胞压积明显低于治疗前(P＜0.05),不良反应轻.结论:三七总苷治疗进展性脑梗死安全有效.

Objective：To evaluate the efficacy and safety of Panax notoginseng saponins （PNS） for the treatment of progressive cerebral infarction （CI）. Methods：640 patients who onset acute CI within 24 hours were randomized 1 ： 1 to one of two groups; one group was treated with conventional regimens, and another group received the adjunctive therapy of conventional regimens with intravenous infusion of PNS 0.4 -0.8 g once daily for 14 days. The efficacy was assessed based on the progressive status of the progressive CI and neurological functional deficit scores in terms of China Stroke Score （CSS） post the therapy. The evaluations of hemorrheologieal indexes included whole blood reduced-viscosity of high shear stress and low shear stress, plasmatic viscosity, red cell aggregation index, packed cell volume, red cell deformability index and fibrinogen. Results：The PNS regimen resulted in a significant less incidence of progressive CI than the conventional regimen alone （ 10.63% vs. 28.75%, P 〈 0.05 ） . The PNS-treated patients experienced a significant reduction in the CSS compared with the patients in the conventional therapy alone [ （22±4） vs. （26± 6） in peak time and （ 13 ±8） vs. （ 18±3） in 20 days, P 〈 0.01 ]. The PNS significantly reduced the whole blood reduced-viscosity of high shear stress and low shear stress, plasmatic viscosity and packed cell volume post the therapy. No serious adverse events were reported in both groups. Conclusion： PNS provided a safe and effective therapy in adults with progressive CI.