目的 评价顺气补心十一味丸联合氟哌噻吨美利曲辛治疗脑小血管病（CSVD）伴轻中度抑郁的临床疗效及作用机制。方法 选取2025年4月—12月在内蒙古自治区国际蒙医医院诊治的CSVD伴抑郁患者60例，采用区组随机化方法，将60例患者按1∶1比例分为对照组和治疗组，每组各30例。对照组口服氟哌噻吨美利曲辛片治疗，1片/d，治疗组在对照组基础上口服蒙药顺气补心十一味丸，睡前0.5 h 15粒。两组患者治疗时间均为1个月。比较两组治疗前后及随访期（停药后1个月）汉密尔顿抑郁量表17项（HAMD-17）评分、SDS评分及蒙医症候积分，比较两组治疗前后血清5-羟色胺（5-HT）、多巴胺（DA）、去甲肾上腺素（NE）、同型半胱氨酸（Hcy）、超敏C反应蛋白（hs-CRP）水平及安全性指标。结果 治疗后，对照组总有效率为73.33%，治疗组总有效率为86.67%，治疗组疗效优于对照组（P＜0.05）；治疗后，两组患者的HAMD-17评分、SDS评分、蒙医症候积分均较治疗前显著下降（均P＜0.05），治疗组蒙医症候积分与对照组相比显著下降（P＜0.05）；在随访期，治疗组HAMD-17评分、SDS评分、蒙医症候积分均显著低于对照组（均P＜0.05）；治疗后，血清5-HT、DA、NE、Hcy和hs-CRP水平均较治疗前出现显著变化（P＜0.05）。组间比较显示，治疗后，治疗组血清5-HT、NE水平与对照组相比显著升高（P＜0.05）。结论 顺气补心十一味丸联合氟哌噻吨美利曲辛治疗CSVD伴轻中度抑郁具有确切的临床疗效，且疗效更为持久，其机制可能与上调血清5-HT、NE水平有关。

Objective To evaluate the clinical efficacy and potential mechanism of Shunqi Buxin Shiyiwei Pills combined with flupentixol-melitracen in the treatment of cerebral small vessel disease (CSVD) complicated with mild-to-moderate depression. Methods A total of 60 patients diagnosed with CSVD accompanied by depression who were treated at the Inner Mongolia International Mongolian Medicine Hospital from April to December 2025 were divided into control group and treatment group in a 1:1 ratio using block randomization method, with 30 patients in each group. The control group received oral flupentixol-melitracen tablets at a dose of one tablet daily. On the basis of the conventional treatment, the treatment group was additionally administered 15 Shunqi Buxin Shiyiwei Pills orally half an hour before bedtime, with a one-month treatment course for both groups. The 17-item Hamilton Depression Rating Scale (HAMD-17) score, Self-Rating Depression Scale (SDS) score, and Mongolian medicine symptom score were compared before treatment, after one-month treatment, and during the one-month follow-up after drug withdrawal. Serum levels of 5-hydroxytryptamine (5-HT), dopamine (DA), norepinephrine (NE), homocysteine (Hcy), and high-sensitivity C-reactive protein (hs-CRP), as well as safety indicators, were assessed before and after intervention. Results After treatment, the total effective rate was 73.33% in the control group and 86.67% in the treatment group, with significant difference (P < 0.05). After treatment, the HAMD-17 scores, SDS scores, and Mongolian medicine syndrome scores in both groups were significantly decreased (P < 0.05), and the Mongolian medicine syndrome scores were lower than those in the control group (P < 0.05). During the follow-up period, the HAMD-17 scores, SDS scores, and Mongolian medicine syndrome scores in the treatment group were significantly lower than those in the control group (P < 0.05). After treatment, serum levels of 5-HT, DA, NE, Hcy, and hs-CRP all showed significant changes compared with before treatment (P < 0.05). Intergroup comparison showed that after treatment, serum 5-HT and NE levels in the treatment group were significantly higher than those in the control group (P < 0.05). Conclusion The combination of Shunqi Buxin Shiyiwei Pills and flupentixol-melitracen achieves reliable and more sustained clinical efficacy in the treatment of CSVD complicated with mild-to-moderate depression. The underlying mechanism may be associated with the upregulation of serum 5-HT and NE levels.

R971

内蒙古科技计划项目（2023YFSH0059，2025YFSH0131）