【目的】 探讨补肾活血开窍方对急性缺血性脑卒中（AIS）患者疗效及脑内神经递质和血管内皮功能的影响。【方法】 选取 2023年1月至2025年1月在河北省衡水市第七人民医院接受治疗的87例肾虚血瘀型AIS患者进行前瞻性研究，按随机数字表 法将患者随机分为观察组44例和对照组43例。2组患者均给予维持水电解质平衡、保护脑神经、减轻脑水肿、低流量吸氧 等基础治疗。在此基础上，对照组患者给予阿替普酶静脉溶栓治疗，观察组在对照组的基础上给予补肾活血开窍方治疗， 疗程为4周并随访8周（共12周）。观察2组患者治疗前后中医证候评分、美国国立卫生研究院卒中量表（NIHSS）评分、改良 Barthel 指数（MBI）评分、脑内神经递质指标、血管内皮功能指标的变化情况，评估 2 组患者的临床疗效和用药安全 性。【结果】（1）疗效方面，治疗4周后，观察组的总有效率为93.18%（41/44），对照组为76.74%（33/43）；组间比较，观察组 的总体疗效（Ridit检验）和总有效率（χ2检验）均明显优于对照组（P＜0.05）。（2）中医证候方面，治疗4、8、12周后，2组患者 的半身不遂、言语謇涩、舌质紫暗、腰膝酸软评分均较前 1 个观察时间点降低（P＜0.05），且观察组在治疗 4、8、12周后 的半身不遂、言语謇涩、舌质紫暗、腰膝酸软评分均明显低于对照组（P＜0.05）。（3）神经功能缺损程度和生活能力方面，治 疗 4、8、12周后，2组患者的 NIHSS 评分均较前 1个观察时间点降低（P＜0.05），MBI评分均较前 1个观察时间点升高（P＜ 0.05），且观察组在治疗 4、8、12周后的 NIHSS评分均明显低于对照组，MBI评分均明显高于对照组（P＜0.05）。（4）脑内神 经递质方面，治疗 4、8、12 周后，2 组患者的血清多巴胺（DA）、5-羟色胺（5-HT）水平均较前 1 个观察时间点降低（P＜ 0.05），且观察组在治疗 4、8、12周后的血清 DA、5-HT 水平均明显低于对照组（P＜0.05）。（5）血管内皮功能方面，治疗4、 8、12周后，2组患者的血清内皮素1（ET-1）水平均较前1个观察时间点降低（P＜0.05），血清一氧化氮（NO）水平均较前1个 观察时间点升高（P＜0.05），且观察组在治疗4、8、12周后的血清ET-1水平均明显低于对照组，血清NO水平均明显高于对 照组（P＜0.05）。（6）安全性方面，观察组的不良反应总发生率为6.82%（3/44），对照组为9.30%（4/43），组间比较，差异无统 计学意义（P＞0.05）。【结论】 补肾活血开窍方可有效减轻肾虚血瘀型AIS患者神经功能受损程度，提高生活自理能力，调节 5-HT等脑内神经递质释放，改善血管内皮功能，且患者未出现明显不良反应，安全有效。

Objective To investigate the efficacy of Bushen Huoxue Kaiqiao Formula in patients with acute ischemic stroke （AIS） and to observe its effects on cerebral neurotransmitters and vascular endothelial function. Methods A prospective study was conducted on 87 AIS patients with kidney deficiency and blood stasis syndrome treated at the Hengshui Seventh People’s Hospital from January 2023 to January 2025. Patients were randomly divided into an observation group （44 cases） and a control group （43 cases） using a random number table. Both groups received basic treatments of maintaining water and electrolyte balance， protecting cerebral neuron， reducing cerebral edema， and low-flow oxygen therapy. Based on this， the control group received intravenous thrombolysis with alteplase，while the observation group received Bushen Huoxue Kaiqiao Formula in addition to the control group’s treatment. The treatment course was 4 weeks，followed by an 8-week follow-up （total 12 weeks）. Changes in traditional Chinese medicine （TCM） syndrome scores， National Institutes of Health Stroke Scale （NIHSS） scores， Modified Barthel Index （MBI） scores， cerebral neurotransmitter indicators， and vascular endothelial function indicators were observed before and after treatment. The clinical efficacy and medication safety of the two groups were evaluated. Results （1） Regarding efficacy，after 4 weeks of treatment，the total effective rate was 93.18% （41/44） in the observation group and 76.74% （33/43） in the control group. Intergroup comparisons showed that the overall efficacy （by Ridit test） and the total effective rate （by chi-square test） of the observation group were significantly superior to those of the control group （P＜0.05）. （2） Regarding TCM syndromes，after 4，8，and 12 weeks of treatment，scores for hemiplegia，slurred speech，purple-dark tongue， and soreness and weakness of the waist and knees decreased in both groups compared to the previous observation time point （P＜0.05）. The scores for these symptoms in the observation group were significantly lower than those in the control group at weeks 4，8，and 12（P＜0.05）.（3） Regarding the degree of neurological deficit and life ability，after 4，8，and 12 weeks，NIHSS scores decreased in both groups compared to the previous time point （P＜0.05），while MBI scores increased （P＜0.05）. The NIHSS scores in the observation group were significantly lower，and the MBI scores were significantly higher than those in the control group at weeks 4，8，and 12（P＜ 0.05）.（4） Regarding cerebral neurotransmitters，after 4，8，and 12 weeks，serum levels of dopamine （DA） and 5-hydroxytryptamine （5-HT） decreased in both groups compared to the previous time point （P＜0.05），and the levels in the observation group were significantly lower than those in the control group （P＜0.05）.（5） Regarding vascular endothelial function，after 4，8，and 12 weeks，serum endothelin-1（ET-1） levels decreased in both groups compared to the previous time point （P＜0.05），while nitric oxide （NO） levels increased （P＜0.05）. The ET-1 levels in the observation group were significantly lower，and the NO levels were significantly higher than those in the control group at all time points （P＜0.05）.（6） Regarding safety， the total incidence of adverse reactions was 6.82% （3/44） in the observation group and 9.30% （4/43） in the control group，with no statistically significant difference between the groups （P＞0.05）. Conclusion Bushen Huoxue Kaiqiao Formula can effectively reduce the degree of neurological impairment，improve the ability of daily living，regulate the release of cerebral neurotransmitters such as 5-HT，and enhance vascular endothelial function in AIS patients with kidney deficiency and blood stasis syndrome，with no significant adverse reactions observed，demonstrating safety and efficacy.

R277.7

国家自然科学基金青年科学基金项目（编号：82302879）