目的 探讨乌灵胶囊联合奥沙西泮治疗慢性失眠的临床疗效。方法 选取2021年1月—2023年2月上海市精神卫生中心收治的118例慢性失眠患者，随机分为对照组（59例）和治疗组（59例）。对照组睡前口服奥沙西泮片，15 mg/次，1次/d。在对照组基础上，治疗组口服乌灵胶囊，3粒/次，3次/d。两组服药21 d。观察两组患者临床疗效，比较治疗前后两组患者症状好转时间，觉醒次数与总睡眠时间，匹兹堡睡眠质量指数（PSQI）和过度觉醒量表（HAS）评分，白细胞介素1β（IL-1β）、5-羟色胺（5-HT）、γ-氨基丁酸（GABA）、肿瘤坏死因子-α（TNF-α）、脑源性神经营养因子（BDNF）、S100钙结合蛋白（S100B）、神经生长因子（NGF）和胶质源性神经营养因子（GDNF）水平。结果 治疗后，治疗组临床有效率为98.31%，明显高于对照组（86.44%，P＜0.05）。治疗后，治疗组症状好转时间均明显早于对照组（P＜0.05）。治疗后，两组每日的觉醒次数明显下降，而总睡眠时间明显延长（P＜0.05），且治疗组每日的觉醒次数、总睡眠时间明显优于对照组（P＜0.05）。治疗后，两组患者PSQI评分和HAS评分明显降低（P＜0.05），且治疗组PSQI评分和HAS评分降低更明显（P＜0.05）。治疗后，两组患者TNF-α、IL-1β和S100B水平均明显低于治疗前，而GABA、5-HT、BDNF、NGF和GDNF水平明显高于治疗前（P＜0.05），且治疗组这些指标均明显好于对照组（P＜0.05）。结论 奥沙西泮联合乌灵胶囊治疗慢性失眠效果确切，能有效改善临床症状，明显缓解过度觉醒状态，增强神经递质的能力，减弱神经炎性反应，充分调节神经细胞因子水平。

Objective To explore the effects of Wuling Capsules combined with oxazepam in treatment of chronic insomnia. Methods Patients (118 cases) with chronic insomnia in Shanghai Mental Health Center from January 2021 to February 2023 were randomly divided into control (59 cases) and treatment (59 cases) group. Patients in the control group were po administered with Oxazepam Tablets, 15 mg/time, once daily. Patients in the treatment group were po administered with Wuling Capsules on the basis of the control group, 3 grains/time, three times daily. Patients in two groups were treated for 21 d. After treatment, the clinical evaluation was evaluated, and the improvement time of symptom, awakening frequency, sleep time, the scores of PSQI and HAS, the levels of TNF-α, IL-1β, GABA, 5-HT, S100B, BDNF, NGF and GDNF in two groups before and after treatment were compared. Results After treatment, the clinical effective rate of the treatment group was 98.31%, which was significantly higher than that of the control group (86.44%, P < 0.05). After treatment, the improvement time of symptom in the treatment group was significantly earlier than that in the control group (P < 0.05). After treatment, the daily awakening times of the two groups were significantly decreased, while the total sleep time was significantly prolonged (P< 0.05), and the daily awakening times and total sleep time in the treatment group were significantly better than those in the control group (P < 0.05). After treatment, the PSQI and HAS scores in two groups were significantly decreased, and which in the treatment group decreased more significantly (P < 0.05). After treatment, the levels of TNF-α, IL-1β and S100B in two groups were significantly lower than those before treatment, while the levels of GABA, 5-HT, BDNF, NGF and GDNF were significantly higher than those before treatment (P < 0.05), and the indexes in the treatment group were significantly better than those in the control group (P < 0.05). Conclusion Oxazepam combined with Wuling Capsules is effective in treatment of chronic insomnia, which can effectively improve clinical symptoms, relieve excessive awakening, enhance the ability of neurotransmitters, weaken neuroinflammatory response and fully regulate the level of neurocytokines.

R971

上海市科学技术委员会项目(12401906200)