脑蛋白水解物注射液治疗卒中后认知功能障碍的随机对照研究

A randomized controlled study of Cerebroprotein Hydrolysate Injection in the treatment of poststroke cognitive impairment

目的评估脑蛋白水解物注射液治疗卒中后认知功能障碍的临床疗效及安全性。方法通过简易智能状态量表(MMSE)及蒙特利尔认知评估量表(MoCA)选取在48 h内发病的卒中后认知功能障碍患者190例,随机分为脑蛋白水解物组(96例)及对照组(94例),脑蛋白水解物组予脑蛋白水解物30 ml入生理盐水250 ml静脉滴注。在入院1 d、2 d、7 d、14 d、30 d、90 d对两组患者进行MMSE及MoCA量表评分,以评价临床疗效,并对其安全性进行评估。结果在入院2 d,两组患者的MoCA及MMSE评分无统计学差异(P>0.05)。入院7 d、14 d、30 d、90 d,脑蛋白水解物组MoCA及MMSE评分显著增加,与对照组比较,差异有统计学意义(P<0.01),对照组在治疗7 d、14 d时,MoCA及MMSE评分明显增加,但在30 d、90 d时,评分无明显增加。两组在治疗期间的安全性无明显区别。结论脑蛋白水解物治疗卒中后认知功能障碍安全有效,可以显著提高卒中后认知功能障碍患者的生活质量。

Objective To assess safety and efficacy of Cerebroprotein Hydrolysate Injection in the treatment of post- stroke cognitive impairment. Methods 190 patients with poststroke cognitive impairment who got stroke in 48 hours were selected according to Mini Mental State Examination （MMSE）and Montreal Cognitive Assessment （MoCA）, they were ran- domly divided into the Cerebroprotein Hydrolysate group（96 cases ）which treated with intravenous injection of Cerebropro- tein Hydrolysate, and control group （94 cases）which treated with intravenous injection of physiological saline. MoCA scale and MMSE score changes were observed in the two groups at 1,2,7,14,30,90 day during the treatment in order to evaluate the clinical curative effect. The safety of Cerebroprotein Hydrolysate was estimated. Results The difference of the MoCA scale and MMSE scores of the two group at the twist day was not statistically significant（ P 〉 0.05 ）. The MoCA scale and MMSE scores significant increased in the Cerebroprotein Hydrolysate group at 7,14,30,90 days,the difference between the two groups was statistically significant（P 〈0.01 ）. The MoCA scale and MMSE scores increased in control group at 7,14 days, at 30,90 day the MoCA scale and MMSE scores had no significant increase. The safety between the two groups was not significant. Conclusions Cerebroprotein Hydrolysate in the treatment of poststrokc cognitive impairment is safe and effective, it can significantly enhance the quality of life of the patients with poststroke cognitive impairment.