目的 观察养血清脑丸联合奥沙西泮片治疗血虚肝旺型失眠症的临床疗效。方法 选取开滦精神卫生中心2024年1月—2025年6月收治的106例血虚肝旺型失眠症患者，采用随机数字表法将患者分为对照组和治疗组，每组各53例。对照组睡前口服奥沙西泮片，1片/次，1次/d；治疗组在对照组的治疗方案基础上口服养血清脑丸，1袋/次，3次/d。两组治疗3周。比较两组的临床疗效、睡眠结构参数、临床症状、血清神经递质指标。结果 治疗组的总有效率94.34%高于对照组的总有效率81.13%，组间比较差异显著（P＜0.05）。两组治疗后睡眠潜伏期（SOL）、入睡后的觉醒（WASO）下降，睡眠效率（SE）、总睡眠时间（TST）升高（P＜0.05）；且治疗组的SOL、WASO低于对照组，SE、TST高于对照组（P＜0.05）。两组治疗后匹兹堡睡眠质量指数（PSQI）、阿森斯失眠量表（AIS）、汉密尔顿焦虑量表（HAMA）、疲劳量表（FS-14）评分均下降（P＜0.05），且治疗组PSQI、AIS、HAMA、FS-14评分低于对照组（P＜0.05）。两组治疗后血清去甲肾上腺素（NE）水平下降，血清5-羟色胺（5-HT）、5-羟吲哚乙酸（5-HIAA）、神经肽Y（NPY）、褪黑素（MT）水平升高（P＜0.05）；且治疗组血清NE水平低于对照组，血清5-HT、5-HIAA、NPY、MT水平高于对照组（P＜0.05）。结论 养血清脑丸联合奥沙西泮片治疗血虚肝旺型失眠症可有效改善睡眠质量，调节相关神经递质水平。

Objective To observe the clinical efficacy of Yangxue Qingnao Pills combined with Oxazepam Tablets in treatment of insomnia caused by blood deficiency and liver hyperactivity. Methods A total of 106 patients with insomnia caused by blood deficiency and liver hyperactivity admitted to Kailuan Mental Health Center from January 2024 to June 2025 were selected. Using a random number table, the patients were divided into control group and treatment group, with 53 cases in each group. The control group was orally administered Oxazepam Tablets before bedtime at a dose of 1 tablets per time, once daily. The treatment group was additionally given Yangxue Qingnao Pills on the basis of the control group's regimen at a dose of 1 bag per time, three times daily. Two groups were treated for 3 weeks. The clinical efficacy, sleep structure parameters, clinical symptoms, and serum neurotransmitter indicators were compared between two groups. Results The total effective rate (94.34%) of the treatment group was higher than 81.13% of the control group, and the difference between two groups was significant (P < 0.05). After treatment, the sleep latency (SOL) and wakefulness after falling asleep (WASO) of two groups decreased, while sleep efficiency (SE) and total sleep time (TST) increased (P < 0.05). The SOL and WASO of the treatment group were lower than those of the control group, while SE and TST were higher than those of the control group (P < 0.05). After treatment, the Pittsburgh Sleep Quality Index (PSQI), Ashens Insomnia Scale (AIS), Hamilton Anxiety Scale (HAMA), and Fatigue Scale (FS-14) scores in two groups decreased (P < 0.05), and the PSQI, AIS, HAMA, and FS-14 scores in the treatment group were lower than those in the control group (P < 0.05). After treatment, the serum levels of norepinephrine (NE) decreased in two groups, while the serum levels of 5-hydroxytryptamine (5-HT), 5-hydroxyindoleacetic acid (5-HIAA), neuropeptide Y (NPY), and melatonin (MT) increased (P < 0.05). The serum level of NE in the treatment group was lower than that in the control group, while the serum levels of 5-HT, 5-HIAA, NPY, and MT were higher than those in the control group (P < 0.05). Conclusion The combination of Yangxue Qingnao Pills and Oxazepam Tablets in treatment of patients with insomnia caused by blood deficiency and liver hyperactivity can effectively improve sleep quality and regulate the levels of related neurotransmitters.

R971

河北省中医药类科学研究课题计划项目（2023170）