目的 探究補脾安神合劑聯(lián)合右佐匹克隆治療頑固性失眠的臨床效果。方法 回顧性選取2022年1月—2024年12月武漢市第一醫(yī)院收治的80例頑固性失眠患者，按照隨機數(shù)字表法分為對照組和治療組，各40例。對照組于睡前30 min溫水吞服右佐匹克隆片治療，1次/d，3 mg/次。治療組給予補脾安神合劑聯(lián)合右佐匹克隆治療，補脾安神合劑3次/d，10 mL/次，右佐匹克隆片用法用量與對照組一致。兩組患者均治療1個月。觀察兩組的臨床療效，比較兩組治療前后中醫(yī)證候評分、失眠嚴(yán)重程度指數(shù)（ISI）、蒙特利爾認知評估量表（MoCA）、抑郁自評量表（SDS）及焦慮自評量表（SAS）、血清神經(jīng)遞質(zhì)、神經(jīng)營養(yǎng)因子和炎癥因子的水平變化情況。結(jié)果 治療后，治療組總有效率95.00%，顯著高于對照組77.50%（P＜0.05）。治療后，兩組患者頭暈心悸評分、燥亂難寐評分、多夢易醒評分與治療前比較均顯著降低（P＜0.05），且治療組頭暈心悸、燥亂難寐、多夢易醒評分顯著低于對照組，具有統(tǒng)計學(xué)差異（P＜0.05）。治療后，兩組患者ISI評分、SDS評分、SAS評分與治療前比較均明顯降低，而MoCA評分升高，且治療組ISI評分、SDS評分、SAS評分低于對照組，MoCA評分高于對照組，具有統(tǒng)計學(xué)差異（P＜0.05）。治療后，兩組去甲腎上腺素（NE）、興奮性氨基酸（EAA）水平下降，乙酰膽堿（Ach）水平上升，且治療組NE、EAA水平低于對照組，Ach水平高于對照組，具有統(tǒng)計學(xué)差異（P＜0.05）。治療后，兩組血清神經(jīng)生長因子（NGF）、腦衍生神經(jīng)營養(yǎng)因子（BDNF）水平上升（P＜0.05），且治療組血清NGF、BDNF水平高于對照組，具有統(tǒng)計學(xué)差異（P＜0.05）。治療后，兩組腫瘤壞死因子-α（TNF-α）、白細胞介素-1β（IL-1β）水平顯著降低（P＜0.05）；治療組TNF-α、IL-1β水平低于對照組，具有統(tǒng)計學(xué)差異（P＜0.05）。結(jié)論 補脾安神合劑聯(lián)合右佐匹克隆治療頑固性失眠效果顯著，能夠有效減輕患者中醫(yī)證候，改善患者睡眠質(zhì)量、認知功能及心理情緒，同時可以改善血清神經(jīng)遞質(zhì)、神經(jīng)營養(yǎng)因子、炎癥指標(biāo)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

湖北省衛(wèi)健委科研項目（2025AFD512）