目的 观察注射用丹参多酚酸对急性期缺血性脑卒中患者的临床疗效及安全性。方法 选取2018年6月—2019年6月保定市第一中心医院收治的100例急性期缺血性脑卒中住院患者，随机分为常规药物治疗组（对照组）和注射用丹参多酚酸治疗组（试验组），各50例。对照组给予常规治疗，试验组在对照组基础上加用注射用丹参多酚酸0.13 g溶于250 mL0.9%氯化钠注射液中，静脉滴注、每天1次，两组均连续治疗2周。观察两组临床疗效，分别检测治疗前和治疗2周后两组患者血清细胞间黏附分子-1（ICAM-1）及肿瘤坏死因子-α（TNF-α）水平，并对患者进行美国国立卫生研究院卒中量表（NIHSS）评分及日常生活能力评定量表（BI）评分。结果 两组治疗前NIHSS评分、BI评分及血清ICAM-1、TNF-α水平无明显差异；治疗后两组NIHSS评分及血清ICAM-1、TNF-α水平均较同组治疗前降低，且试验组显著低于对照组（P＜0.05），两组BI评分均较治疗前升高，且试验组BI评分较对照组显著升高（P＜0.05）；治疗后，对照组总有效率66.0%，试验组总有效率88.0%，两组比较差异显著（P＜0.05）。两组均未出现不良反应。结论 注射用丹参多酚酸可改善急性期缺血性脑卒中患者神经功能，可有效降低患者血清ICAM-1及TNF-α水平。

Objective To observe the clinical efficacy and safety of Salvianolic Acids for Injection (SAFI) in patients with acute cerebral infarction. Methods A total of 100 patients with acute cerebral ischemic stroke admitted to the Baoding NO. 1 Central Hospital from June 2018 to June 2019 were selected and randomly divided into conventional drug treatment group (control group) and SAFI treatment group (experimental group) with 50 cases each by using random number table. The control group was given conventional drugs for cerebral ischemic stroke, and the experimental group was additionally given 0.13 g SAFI dissolved in 250 mL 0.9% Sodium Chloride Injection, intravenously once a day, and both groups were given consecutive two weeks. Observe the clinical efficacy of two groups, serum levels of intercellular adhesion molecule-1 (ICAM-1) and tumor necrosis factor-α (TNF-α) were detected before and two weeks after treatment, and the patients were evaluated by the National Institutes of Health Stroke Scale (NIHSS) score and the Ability to Daily Living Scale (BI) score. Results There were no significant differences in NIHSS scores, BI scores and serum levels of ICAM-1 and TNF-α expression between control group and experimental group before treatment. After treatment, NIHSS scores and serum levels of ICAM-1 and TNF-α were decreased in both groups, and the experimental group was significantly lower than the control group (P＜0.05). BI scores in both groups were increased, and BI scores in the experimental group were significantly higher than those in the control group (P＜0.05). The total effective rate of the control group was 66.0%, while the total effective rate of the experimental group was 88.0%, there was a significant difference between two groups (P＜0.05). There were no adverse reactions in two groups. Conclusion SAFI can improve the neurological function of patients with acute cerebral ischemic stroke, and can effectively reduce the levels of serum ICAM-1 and TNF-α.

R286.1，R971

河北省卫生厅重点研究项目（20181487）