目的 探究补脾安神合剂联合右佐匹克隆治疗顽固性失眠的临床效果。方法 回顾性选取2022年1月—2024年12月武汉市第一医院收治的80例顽固性失眠患者，按照随机数字表法分为对照组和治疗组，各40例。对照组于睡前30 min温水吞服右佐匹克隆片治疗，1次/d，3 mg/次。治疗组给予补脾安神合剂联合右佐匹克隆治疗，补脾安神合剂3次/d，10 mL/次，右佐匹克隆片用法用量与对照组一致。两组患者均治疗1个月。观察两组的临床疗效，比较两组治疗前后中医证候评分、失眠严重程度指数（ISI）、蒙特利尔认知评估量表（MoCA）、抑郁自评量表（SDS）及焦虑自评量表（SAS）、血清神经递质、神经营养因子和炎症因子的水平变化情况。结果 治疗后，治疗组总有效率95.00%，显著高于对照组77.50%（P＜0.05）。治疗后，两组患者头晕心悸评分、燥乱难寐评分、多梦易醒评分与治疗前比较均显著降低（P＜0.05），且治疗组头晕心悸、燥乱难寐、多梦易醒评分显著低于对照组，具有统计学差异（P＜0.05）。治疗后，两组患者ISI评分、SDS评分、SAS评分与治疗前比较均明显降低，而MoCA评分升高，且治疗组ISI评分、SDS评分、SAS评分低于对照组，MoCA评分高于对照组，具有统计学差异（P＜0.05）。治疗后，两组去甲肾上腺素（NE）、兴奋性氨基酸（EAA）水平下降，乙酰胆碱（Ach）水平上升，且治疗组NE、EAA水平低于对照组，Ach水平高于对照组，具有统计学差异（P＜0.05）。治疗后，两组血清神经生长因子（NGF）、脑衍生神经营养因子（BDNF）水平上升（P＜0.05），且治疗组血清NGF、BDNF水平高于对照组，具有统计学差异（P＜0.05）。治疗后，两组肿瘤坏死因子-α（TNF-α）、白细胞介素-1β（IL-1β）水平显著降低（P＜0.05）；治疗组TNF-α、IL-1β水平低于对照组，具有统计学差异（P＜0.05）。结论 补脾安神合剂联合右佐匹克隆治疗顽固性失眠效果显著，能够有效减轻患者中医证候，改善患者睡眠质量、认知功能及心理情绪，同时可以改善血清神经递质、神经营养因子、炎症指标水平。

Objective To explore the therapeutic effect of Bupi Anshen Mixture combined with dexzopiclone in treatment of intractable insomnia. Methods A retrospective selection was made of 80 patients with intractable insomnia admitted to Wuhan First Hospital from January 2022 to December 2024. They were divided into control group and treatment group according to Random number table method, with 40 cases in each group. Patients in control group were treated with Dexzopiclone Tablets, swallowed with warm water 30 min before bedtime, once daily, 3 mg/time. Patients in treatment group were treated with Bupi Anshen Mixture combined with dexzopiclone. Bupi Anshen Mixture was administered 3 times daily, 10 mL/time. The dosage and administration of Dexzopiclone Tablets were the same as those of control group. Both groups of patients were treated for one month. The clinical efficacy of two groups were observed, and the changes in the levels of TCM syndrome scores, ISI, MoCA, SDS, SAS, serum neurotransmitters, neurotrophic factors and inflammatory factors before and after treatment in two groups were compared. Results After treatment, The total effective rate of the treatment group was 95.00%, significantly higher than that of the control group (77.50%) (P < 0.05). After treatment, the scores of dizziness and palpitations, restlessness and insomnia, and frequent dreams and easy awakening in both groups were significantly lower than those before treatment (P < 0.05), and the scores of dizziness and palpitations, restlessness and insomnia, and frequent dreams and easy awakening in treatment group were significantly lower than those in control group, with statistical differences (P < 0.05). After treatment, the ISI score, SDS score, and SAS score of both groups were significantly lower than those before treatment, but the MoCA score increased. Moreover, the ISI score, SDS score, and SAS score of treatment group were lower than those of control group, and the MoCA score was higher than that of control group, with statistically significant differences (P < 0.05). After treatment, the levels of NE and EAA in both groups decreased, but the level of Ach increased. Moreover, the levels of NE and EAA in treatment group were lower than those in control group, and the level of Ach was higher than that in control group, with statistically significant differences (P < 0.05). After treatment, the levels of serum NGF and BDNF in both groups increased (P < 0.05), and the levels of serum NGF and BDNF in treatment group were higher than those in control group, with a statistically significant difference (P < 0.05). After treatment, the levels of TNF-α and IL-1β in both groups decreased significantly (P < 0.05). The levels of TNF-α and IL-1β in treatment group were lower than those in control group, with a statistically significant difference (P < 0.05). Conclusion The combination of Bupi Anshen Mixture and dexzopiclone has a remarkable effect in treatment of intractable insomnia, and can effectively alleviate the TCM symptoms of patients, improve their sleep quality, cognitive function and psychological mood, and at the same time can improve the levels of serum neurotransmitters, neurotrophic factors and inflammatory indicators.

R971

湖北省卫健委科研项目（2025AFD512）