【目的】 观察复元胶囊联合醒脑开窍针刺治疗血管性痴呆（VD）的临床疗效，并探讨其可能的作用机制。【方法】 选取 2019年10月至2022年10月衡水市中医医院病房及门诊收治的204例明确诊断为VD的患者为研究对象。按随机数字表将患 者随机分为观察组和对照组，每组各102例。2组患者均给予控制血压、降糖、调脂等对症治疗，以及认知功能训练，对照 组给予醒脑开窍针刺治疗，观察组在对照组治疗的基础上，给予口服复元胶囊治疗。治疗1周为1个疗程，连续治疗8个疗 程。治疗 2 个月后，评价 2 组临床疗效，观察 2 组患者治疗前后简易精神状态量表（MMSE）评分和蒙特利尔认知评估量表 （MoCA）评分的变化情况，以及改良长谷川痴呆量表（HDS-R）、临床痴呆评定量表（CDR）评分的情况。比较2组患者治疗前 后日常生活活动能力量表（ADL）评分、Hachinski缺血量表（HIS）评分以及中医证候积分的变化情况。并检测2组患者治疗前 后神经调节蛋白1（NRG1）表达水平的变化情况。【结果】（1）研究过程中，观察组退出2例，对照组退出2例，最终观察组100例、 对照组 100 例纳入疗效统计。（2）治疗后，2 组患者的 MMSE 和 MoCA 评分均明显改善（P < 0.05），且观察组在改善 MMSE 和 MoCA评分方面明显优于对照组，差异有统计学意义（P < 0.05）。（3）治疗后，2组患者的HDS-R和CDR评分均明显改善（P < 0.05），且观察组在改善HDS-R和CDR评分方面明显优于对照组，差异有统计学意义（P < 0.05）。（4）治疗后，2组患者的ADL 和 HIS 评分均明显改善（P < 0.05），且观察组在改善 ADL 和 HIS 评分方面明显优于对照组，差异有统计学意义（P < 0.05）。 （5）治疗后，2组患者的中医证候积分均明显改善（P < 0.05），且观察组在改善中医证候积分方面明显优于对照组，差异有统 计学意义（P < 0.05）。（6）观察组总有效率为84.00%（84/100），对照组为67.00%（67/100）。观察组疗效优于对照组，差异有统 计学意义（P < 0.05）。（7）治疗后，2组患者的 NRG1水平明显改善（P < 0.05），且观察组在改善 NRG1水平方面明显优于对照 组，差异有统计学意义（P < 0.05）。【结论】 复元胶囊联合醒脑开窍针刺治疗VD，能明显改善患者的临床症状，提高患者大脑 的认知水平，有效提升患者血清NRG1水平，从而提高患者生活质量，疗效显著。

Objective To observe the clinical efficacy of Fuyuan Capsules combined with Xingnao Kaiqiao acupuncture in the treatment of vascular dementia （VD）， and to explore its possible mechanism of action. Methods A total of 204 cases of patients with a definitive diagnosis of VD admitted to the wards and outpatient clinics of Hengshui Hospital of Traditional Chinese Medicine from October 2019 to October 2022 were selected for the study. The patients were randomly divided into observation group and control group according to the random number table method，with 102 cases in each group. The patients in both groups were treated with symptomatic treatments such as blood pressure-controlling，glucose-lowering，blood lipids-regulating，along with cognitive function training. The control group was treated with Xingnao Kaiqiao acupuncture，and the observation group was given oral administration of Fuxing Capsules on the basis of the treatment in the control group. One week constituted a course of treatmen，and eight consecutive courses of treatment were carried out. After two months of treatment，the clinical efficacy of the two groups was evaluated. The changes in the scores of the Mini-Mental State Examination（MMSE），Montreal Cognitive Assessment（MoCA），Revised Hasegama􀆳s Dementia Scale（HDS-R）， and Clinical Dementia Rating Scale（CDR）were observed in the patients of the two groups before and after treatment. The changes in the scores of the Activity of Daily Living Scale（ADL）， Hachinski Ischemic Scale （HIS），and the traditional Chinese medicine（TCM）syndrome scores before and after treatment were compared in patients of the two groups. The changes in the expression level of neuregulin 1（NRG1）before and after treatment in patients of the two groups were detected. Results（1）During the study，two cases fell off from both groups， respectively. Finally，100 cases in the observation group and 100 cases in the control group were included in the efficacy statistics.（2）After treatment， the MMSE and MoCA scores of the patients in the two groups were significantly improved（P < 0.05），and the improvement in the observation group was significantly superior to that in the control group，the difference being statistically significant（P < 0.05）.（3）After treatment，the HDS-R and CDR scores of patients in the two groups were significantly improved（P < 0.05），and the improvement in the observation group was significantly superior to that in the control group， the difference being statistically significant （P < 0.05）. （4） After treatment， the ADL and HIS scores of patients in the two groups were significantly improved（P < 0.05），and the improvement in the observation group was significantly superior to that in the control group， the difference being statistically significant（P < 0.05）.（5）After treatment， the TCM syndrome scores of patients in the two groups were significantly improved（P < 0.05），and the improvement in the observation group was significantly superior to that in the control group， the difference being statistically significant（P < 0.05）.（6）The total effective rate was 84.00%（84/100）in the observation group and 67.00% （67/100）in the control group. The efficacy of the observation group was superior to that of the control group，the difference being statistically significant（P < 0.05）.（7）After treatment，the NRG1 levels of patients in the two groups were improved significantly（P < 0.05），and the improvement in the observation group was significantly superior to that in the control group，the difference being statistically significant（P < 0.05）. Conclusion Fuyuan Capsules combined with Xingnao Kaiqiao acupuncture in the treatment of VD can significantly improve the clinical symptoms of patients，enhance the cognitive function，and effectively increase the serum NRG1 level，so as to improve their quality of life.

R246.9

河北省中医药管理局科研计划资助项目（编号：2020530）