丹参多酚酸对急性大动脉粥样硬化型脑卒中的临床治疗效果

Clinical effect of salvianolic acid on acute large artery atherosclerotic stroke

目的观察丹参多酚酸对急性大动脉粥样硬化(LAA)型脑卒中患者的临床治疗效果及其作用机制。方法选择2018年11月至2019年11月新乡医学院第一附属医院收治的200例急性LAA型脑卒中患者为观察对象,使用随机数字表法将患者分为对照组和干预组,并根据入院时美国国立卫生研究院卒中量表(NIHSS)评分将各组患者分为轻、中、重度卒中组。所有患者给予常规治疗,干预组在常规治疗基础上给予注射用丹参多酚酸静脉滴注,连用14 d;对照组患者在常规治疗基础上给予等量生理盐水静脉滴注。分别于治疗前及治疗14 d后采用NIHSS、改良Barthel指数量表(MBI)评估患者的神经功能缺损和日常生活能力,并根据NIHSS评分变化程度比较对照组与干预组患者的治疗效果;采用酶联免疫吸附试验检测2组患者治疗前后血清细胞间黏附分子-1(ICAM-1)水平;观察2组患者不良事件发生情况。结果干预组患者中途自动退出8例,对照组患者中途自动退出7例,干预组和对照组最终纳入患者分别为92例、93例。2组患者治疗前NIHSS、MBI评分比较差异无统计学意义(P>0.05)。治疗14 d后,2组患者的NIHSS评分与治疗前比较均显著降低(P<0.05),MBI评分与治疗前比较均显著增高(P<0.05);治疗14 d后,干预组患者的NIHSS评分显著低于对照组(P<0.05),MBI评分显著高于对照组(P<0.05)。治疗后,干预组患者基本痊愈5例,显著进步44例,进步31例,无效10例,恶化2例,有效率为87.0%(80/92);对照组患者基本痊愈2例,显著进步16例,进步36例,无效33例,恶化6例,有效率为58.1%(54/93);干预组患者的有效率显著高于对照组(χ^2=19.334,P<0.05)。2组轻度卒中患者的有效率比较差异无统计学意义(χ^2=0.366,P>0.05),干预组中、重度卒中患者的有效率显著高于对照组(χ^2=12.752、8.713,P<0.05)。治疗前2组患者血清ICAM-1水平比较差异无统计学意义(Z=-1.213,P>0.05);治疗后2组患者血清ICAM-1水平与治疗前比较均显著降低(Z=-5.238、-7.969,P<0.05),且干预组患者血清ICAM-1水平显著低于对照组(Z=-6.644,P<0.05)。治疗期间,干预组2例(2.2%)患者出现头晕、血压下降,对照组患者未发生类似不良反应;2组患者均未发生过敏反应。结论丹参多酚酸可有效改善急性LAA型脑卒中患者的神经功能,提高日常生活能力,其机制可能是通过降低血清中ICAM-1水平、阻断缺血脑组织炎症级联反应而发挥治疗作用。

Objective To observe the clinical effect of salvianolic acid on acute large artery atherosclerosis(LAA)stroke and explore its mechanism.Methods Two hundred patients with acute LAA stroke admitted to the First Affiliated Hospital of Xinxiang Medical University from November 2018 to November 2019 were selected as observation subjects,and they were randomly divided into control group and intervention group according to the random number table.According to the score of National Institutes of Health stroke scale(NIHSS)at admission,the patients in each group were divided into mild,moderate and severe stroke groups.All patients were given routine treatment,while the patients in the intervention group was given salvianolic acid for injection by intravenous drip for 14 days,the patients in the control group was given same amount of normal saline by intravenous drip.The NIHSS and Modified Barthel Index scale(MBI)were used to evaluate the neurological deficit and activities of daily living before and at 14 days after treatment,and the efficacy of the two groups were compared according to the changes of NIHSS score.The serum intercellular adhesion molecule-1(ICAM-1)level was detected by enzyme-linked immunosorbent assay.The adverse events of the patients in the two groups were observed.Results Eight patients in the intervention group and seven patients in the control group were automatically dropped out.Ninety-two cases and Ninety-three cases were included in the intervention group and the control group,respectively.There was no significant difference in the NIHSS and MBI scores between the two groups before treatment(P<0.05).After 14 days of treatment,the NIHSS score of patients in the the two groups was significantly lower than that before treatment(P<0.05),and the MBI score of patients in the two groups was significantly higher than that before treatment(P<0.05).After 14 days of treatment,the NIHSS score in the interve ntion group was significantly lower than that in the control group,and the MBI score in the intervention group was significantly higher than that in the control group(P<0.05).After treatment,5 cases in the intervention group were basically cured,44 cases were significantly improved,31 cases improved,10 cases were ineffective,2 cases were deteriorated,and the effective rate was 87.0%(80/92).In the control group,2 case were basically cured,16 cases were significantly improved,36 cases were improved,33 cases were ineffective,6 cases were deteriorated,and the effective rate was 58.1%(54/93).The effective rate in the intervention group was significantly higher than that in the control group(χ^2=19.334,P<0.05).There was no significant difference in the effective rate of the mild stroke patients between the intervention group and control group(χ^2=0.366,P>0.05),but the effective rate of the moderate and severe stroke patients in the intervention group was significantly higher than that in the control group(χ^2=12.752,8.713;P<0.05).There was no significant difference in the serum ICAM-1 level between the two groups before treatment(Z=-1.213,P>0.05).The serum ICAM-1 level after treatment was lower than that before treatment in the two groups(Z=-5.238,-7.969;P<0.05).The serum ICAM-1 level in the intervention group was lower than that in the control group after treatment(Z=-6.644,P<0.05).During treatment,dizziness and blood pressure drop occurred in 2 patients(2.2%)in the intervention group,and no similar adverse reactions occurred in the control group.No allergic reaction occurred in the two groups.Conclusion Salvianolic acid can effectively improve the neural function and the ability of daily living in patients with acute LAA stroke.Its mechanism may be through reducing the serum ICAM-1 level and blocking the inflammatory cascade reaction of ischemic brain tissues,so as to play a therapeutic role.