注射用丹参多酚酸对急性脑梗死患者有效性和安全性及炎性因子水平的影响

目的观察注射用丹参多酚酸对急性脑梗死患者的疗效、用药安全性及炎性因子水平的影响，探究药物干预的新靶点及新方向。 方法前瞻性分析2017年2月至2018年3月山西医科大学第二医院神经内科收治的急性脑梗死患者153例，对照组83例患者给予常规用药治疗，观察组70例患者在常规用药基础上加用注射用丹参多酚酸。2组患者疗程均为14 d。比较治疗前和治疗后14 d 2组神经功能缺损程度（NIHSS评分）和炎性因子［sCD40L和C-反应蛋白（CRP）］水平的变化，同时观察用药时期的不良反应。记录院外随访90 d的mRS评分。利用逐步多元Logistic回归分析急性脑梗死患者出院随访90 d预后良好的独立影响因素。 结果（1）治疗14 d后，观察组NIHSS评分低于对照组［（2.33±1.45）分vs（3.19±3.11）分］，且神经功能好转率高于对照组［（0.56±0.32）vs（0.33±0.36）］，差异均具有统计学意义［F=2.436，P=0.032；t=3.536，P=0.001］。（2）院外随访90 d，观察组mRS水平较对照组低［（0.78±1.17）分vs（1.31±1.42）分］，且预后良好所占比例观察组较对照组高［55.7%（39/70）vs 54.2%（45/83）］，差异均具有统计学意义［t=-2.522，P=0.013；χ²=7.021，P=0.008］。把预后良好作为因变量，纳入对其可能的影响因素并作为自变量，进行逐步多元Logistic回归分析，结果表明，注射用丹参多酚酸的使用和神经功能好转率是急性脑梗死患者90 d后预后良好的独立预测因素。（3）2组患者治疗14 d后对肝功能、肾功能及心肌酶相关实验室指标进行比较，差异均无统计学意义（P>0.05）。（4）2组患者治疗14 d后sCD40L均低于治疗前［观察组：（352.06±150.69）pg/ml vs（522.63±226）pg/ml；对照组：（372.24±135.77）pg/ml vs（554.78±179.86）pg/ml］，差异均有统计学意义（F=2.258，P=0.001；F=2.228，P=0.001）；治疗后14 d，观察组sCD40L水平低于对照组，但差异无统计学意义（F=0.974，P=0.385）。治疗14 d后，观察组CRP水平低于对照组［（2.96±1.83）mg/L vs （3.90±3.29）mg/L］，且观察组CRP下降程度更明显［（2.57±2.41）mg/L vs （1.68±1.15）mg/L］，差异均具有统计学意义（F=2.045，P=0.003；t=3.453，P=0.028）。 结论注射用丹参多酚酸可促进急性脑梗死患者神经功能恢复和临床预后，有效降低炎性因子水平，并且安全性好。

Salvianolic Acid for Injection for treatment of acute cerebral infarction: efficacy,safety, and impact on serum levels of inflammatory factors

ObjectiveTo observe the efficacy and safety of Salvianolic Acid for Injection in patients with acute cerebral infarction as well as its impact on serum levels of inflammatory factors, in order to explore new targets and new directions for drug intervention. MethodsA prospective study was conducted to analyze 153 patients with acute cerebral infarction admitted to the Department of Neurology of the Second Hospital of Shanxi Medical University from February 2017 to March 2018. The patients were divided into either a control group (n=83) or an observation group (n=70). Both groups were treated with conventional drugs, and the observation group was additionally given Salvianolic Acid for Injection. Both groups were treated for 14 days. The neurological deficit (NIHSS scores) and inflammatory factor (sCD40L and C-reactive protein CRP]) levels were compared between the two groups. The occurrence of adverse reactions during medications was recorded. The modified Rankin scale (mRS) scores at the 90-day follow-up were also recorded. Stepwise multivariate logistic regression was used to analyze the independent factors for good prognosis of patients with acute cerebral infarction at 90 days of discharge. ResultsAfter 14 days of treatment, the NIHSS score of the observation group was significantly lower than that of the control group, and the improvement rate of NIHSS score was significantly more obvious in the observation group (2.33±1.45) vs (3.19±3.11), F=2.436, P=0.032; (0.56±0.32) vs (0.33±0.36), t=3.536, P=0.001]. At the 90-day follow-up, the mRS score of the observation group was significantly lower and the proportion of patients with a good prognosis was significantly higher than those of the control group (0.78±1.17) vs (1.31±1.42), t=-2.522, P=0.013; 55.7%(39/70) vs 54.2%(45/83), χ²=7.021, P=0.008]. Using good prognosis as a dependent variable and including its possible influencing factors as independent variables, stepwise multivariate logistic regression analysis showed that the use of Salvianolic Acid for Injection and the improvement of neurological function were independent predictors of good prognosis in acute ischemic stroke patients at 90 days. There were no significant differences in liver function, renal function, or myocardial enzyme related test indexes between the two groups after 14 days of treatment (P>0.05). After 14 days of treatment, the levels of sCD40L were significantly lower than those before treatment in both groups (352.06±150.69) pg/ml vs (522.63±226) pg/ml, F=2.258, P=0.001; (372.24±135.77) pg/ml vs (554.78±179.86) pg/ml, F=2.228, P=0.001]. Although the sCD40L level was lower in the observation group than in the control group after 14 days of treatment, the difference was not statistically significant (F=0.974, P=0.385). After 14 days of treatment, the CRP level of the observation group was significantly lower than that of the control group, and the degree of CRP decrease was significantly more obvious in the observation group (2.96±1.83) mg/L vs (3.90±3.29) mg/L, F=2.045, P=0.003; (2.57±2.41) mg/L vs (1.68±1.15) mg/L, t=3.453, P=0.028]. ConclusionSalvianolic Acid for Injection can promote the recovery of neurological function, improve clinical prognosis in patients with acute cerebral infarction, and effectively reduce the level of inflammatory factors.