【目的】 探讨运用化瘀安神法治疗瘀血内阻型不寐（失眠）的临床疗效。【方法】 基于随机、平行、对照原则，将2024年 1 月至 2024 年 6 月就诊于广州中医药大学附属宝安中医院的 88 例瘀血内阻型不寐患者随机分为观察组和对照组，每组各 44 例。观察组依据化瘀安神法给予自拟的中药化瘀安神方（血府逐瘀汤加减）治疗，对照组给予右佐匹克隆片口服治疗，疗 程均为4周。观察2组患者治疗前后中医证候积分、匹兹堡睡眠质量指数（PSQI）评分、抑郁自评量表（SDS）评分、焦虑自评 量表（SAS）评分的变化情况，并评价2组患者的临床疗效及用药安全性。【结果】（1）疗效方面，治疗4周后，观察组的总有效 率为 86.36%（38/44），对照组为 70.45%（31/44），组间比较，观察组的临床疗效明显优于对照组，差异有统计学意义 （χ2 = 8.080，P < 0.05）。（2）量表评分方面，治疗后，2组患者的中医证候积分、PSQI评分、SDS评分、SAS评分均较治疗前 明显降低（P < 0.01），且观察组对中医证候积分、PSQI评分、SDS评分、SAS评分的降低作用均明显优于对照组，差异均有 统计学意义（P < 0.05）。（3）安全性方面，治疗过程中，2组患者均无明显不良反应，均有较高的安全性。【结论】 化瘀安神法 治疗瘀血内阻型不寐可以有效缓解患者临床症状，提高患者睡眠质量，改善患者抑郁、焦虑状态，具有较好的临床疗效和 较高的安全性。

Objective To observe the clinical efficacy of therapy of resolving blood stasis and tranquilizing mind in the treatment of insomnia with internal blockage of blood stasis type. Methods A parallel randomized controlled trial was conducted on 88 cases of insomnia patients with internal blockage of blood stasis type who admitted to Bao􀆳 an Traditional Chinese Medicine Hospital Affiliated to Guangzhou University of Chinese Medicine from January 2024 to June 2024. The patients were randomly divided into an observation group and a control group ， with 44 cases in each group. The observation group was treated with the self-made Huayu Anshen Prescription（modified Xuefu Zhuyu Decoction）orally following the therapy of resolving blood stasis and tranquilizing mind，while the control group was treated with Dexzopiclone Tablets orally. The course of treatment for the two groups covered four weeks. The changes in the scores of traditional Chinese medicine（TCM）syndrome， Pittsburgh Sleep Quality Index（PSQI），Self-Rating Depression Scale（SDS），and Self-Rating Anxiety Scale（SAS）in the two groups before and after treatment were observed，and then the clinical efficacy and medication safety of the patients in the two groups were evaluated. Results （1） After four weeks of treatment， the total effective rate of the observation group was 86.36%（38 / 44）and that of the control group was 70.45%（31 / 44），and the intergroup comparison showed that the clinical efficacy of the observation group was significantly superior to that of the control group，the difference being statistically significant（χ2 = 8.080，P < 0.05）.（2）After treatment，the scores of TCM syndrome，PSQI，SDS，and SAS of patients in the two groups were all significantly decreased compared with those before treatment（P < 0.01），and the decrease in the observation group was significantly superior to that in the control group，the differences all being statistically significant（P < 0.05）.（3）During the treatment，there were no obvious adverse reactions occurred in the two groups，with higher safety. Conclusion Therapy of resolving blood stasis and tranquilizing mind for treating insomnia with internal blockage of blood stasis type can effectively alleviate patients􀆳 clinical symptoms，improve their sleep quality and relieve depression and anxiety，with stronger clinical efficacy and higher safety.

R256.13

国家自然科学基金青年科学基金项目（编号：82204998）；广东省中医药局科研项目（编号：20201303）；深圳市“医疗卫生三名 工程”资助项目（编号：SZZYSM202311014）；深圳市科技创新委员会博士基础启动项目（编号：20210795132528002）