注射丹参多酚酸治疗急性脑梗死的前瞻性临床研究

·论　著·注射丹参多酚酸治疗急性脑梗死的

前瞻性临床研究

苗江永　王力娜　张祥建　张海林　窦荣花　缴秀玲　程丽萍　王文胜

【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。

【关键词】　注射丹参多酚酸；急性脑梗死；神经功能；临床试验

中图分类号：R743.32 文献标识码：A 文章编号：1006-351X（2019）04-0199-04

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

Corresponding auther: Zhang Xiangjian, Email: Zhang6xj@

【Abstract】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.

【Key words】　Salvianolic acids; Acute cerebral infarction; Neurological function; Clinical trial

基金项目：国家十二五重大新药创制专项（2012ZX09101202）

作者单位：050000 石家庄，河北医科大学第二医院（苗江永、王力娜、张祥建）；河北医科大学（张海林）；沧州中西医

结合医院（窦荣花）；泊头市中医院（缴秀玲）；邯郸市第一医院（程丽萍）；邢台市人民医院（王文胜）

通信作者：张祥建，Email:Zhang6xj@