注射丹参多酚酸治疗急性脑梗死的前瞻性临床研究  

The clinical prospective study of salvianolic acids in treatment of acute cerebral infarction

作　　者：苗江永[1] 王力娜[1] 张祥建[1] 张海林[2] 窦荣花[3] 缴秀玲 程丽萍[5] 王文胜[6] Miao Jiangyong;Wang Lina;Zhang Xiangjian;Zhang Hailin;Dou Ronghua;Jiao Xiuling;Cheng Liping;Wang Wensheng(Department of Neurology,the Second Hospital of Hebei Medical University,Shijiazhuang 050000,China)

机构地区：[1]河北医科大学第二医院,石家庄050000 [2]河北医科大学 [3]沧州中西医结合医院 [4]泊头市中医院 [5]邯郸市第一医院 [6]邢台市人民医院

出　　处：《脑与神经疾病杂志》2019年第4期199-202,共4页Journal of Brain and Nervous Diseases

基　　金：国家十二五重大新药创制专项(2012ZX09101202)

摘　　要：目的评价注射丹参多酚酸对轻中度急性脑梗死(ACI)的有效性和安全性。方法采用前瞻性临床研究的试验方法。注射丹参多酚酸0.13g·d^(-1)×14d,加于0.9%氯化钠注射液250mL中静脉滴注,输液速度2ml·min^(-1)。结果用药14 d后,头颅MRI/CT所示患者的脑梗死体积与用药前比较显著减小,差异有统计学意义(P<0.01)。用药后第7天、14天及90天,NIHSS评分和改良Rankin与用药前比较评分减少,差异有统计学意义(P<0.01);Bartel Index与用药前比较显著升高,差异有统计学意义(P<0.01)。用药后14d,患者血浆总胆固醇及低密度脂蛋白水平与用药前比较明显下降,差异有统计学意义(P<0.01)。半胱氨酸水平与用药前比较明显下降,差异均有统计学意义(P<0.01)。安全性分析显示,用药后14 d,患者丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、及碱性磷酸酶(ALP)与用药前相比水平轻度升高,差异均有统计学意义(P<0.01)。其余安全性检查如血常规、尿常规、凝血功能、肝功能、肾功能、心肌酶、心电图、血流动力学检查在用药前后,均无差异性变化。结论注射丹参多酚酸对轻、中度ACI的治疗安全、有效。同时提示注射丹参多酚酸在改善卒中神经功能缺损总评分、神经功能指标和日常生活能力,以及调节血脂、半胱氨酸水平等方面,具有一定的优势。Objective To explore the safty and effectiveness of salvianolic acids in treatment of acute cerebral infarction(ACI).Method A prospective randomized controlled tial was designed.Salvianolic acids was dissolved in 250ml 0.9%normal saline,and administered intravenously daily for 14 consecutive days.The drip speed was no more than 2ml/minute.Results The results of brain MRI showed that the infarct volume of salvianolic acids group was significantly decreased,when compared with control group(P<0.01).The NIHSS score and modified Rankin score was significantly decreased at 7d,14d,and 90d after salvianolic acids treatment,when compared with control group(P<0.01).The bartel index was significantly increased at 7d,14d,and 90d after salvianolic acids treatment,when compared with control group(P<0.01).The level of plasma total cholestrol and LDL-C was significantly decreased at 14d after salvianolic acids treatment,when compared with control group(P<0.01).The level of homocysteine was significantly decreased in salvianolic acids group,when compared with control group(P<0.01).Compared with control group,the level of ALT,AST and ALP was increased at 14 d after salvianolic acids treatment,while,there was no clinical difference.The function of patient's blood,urine,blood coagulation,liver and renal as well as heart functions before and after therapy in each group was evaluated,and there was no significant difference.Conclusion Salvianolic acids is safe and effective for the treatment of ACI.Salvianolic acids can significantly improve the neurological deficits and activities of daily living of the patients,and played an important role in decreasing the level of plasma cholestrol and homocysteine.

关 键 词：注射丹参多酚酸 急性脑梗死 神经功能 临床试验 

分 类 号：R743.32[医药卫生—神经病学与精神病学]