目的 探讨坤泰胶囊联合唑吡坦治疗肾虚肝郁型更年期综合征睡眠障碍的临床效果。方法 选取2022年1月—2022年12月济宁医学院附属医院收治的120例肾虚肝郁型更年期综合征睡眠障碍患者，随机分为对照组与治疗组，每组各60例。对照组患者睡前口服酒石酸唑吡坦片，起始剂量5 mg/次，1次/d，最大剂量10 mg。治疗组在对照组基础上口服坤泰胶囊，4粒/次，3次/d。两组患者治疗12周。观察两组患者临床疗效，比较治疗前后两组患者中医证候积分和匹兹堡睡眠质量指数量表（PSQI）评分，及雌二醇（E₂）、卵泡刺激素（FSH）和促黄体生成素（LH）水平。结果 治疗后，治疗组患者总有效率较对照组显著升高（98.33% vs 88.33%，P＜0.05）。治疗后，两组患者中医证候积分及PSQI评分均显著低于治疗前（P＜0.05），且治疗组评分显著低于对照组（P＜0.05）。治疗后，两组患者FSH和LH水平显著低于治疗前，而E₂水平显著高于治疗前（P＜0.05），且治疗组患者性激素水平显著好于对照组（P＜0.05）。结论 坤泰胶囊联合唑吡坦治疗肾虚肝郁型更年期综合征睡眠障碍能有效调控患者性激素水平，改善中医证候及提高睡眠质量。

Objective To explore the clinical effect of Kuntai Capsules combined with zolpidem in treatment of sleep disorder of climacteric syndrome with kidney deficiency and liver depression syndrome. Methods Patients (120 cases) with sleep disorder of climacteric syndrome with kidney deficiency and liver depression syndrome in Affiliated Hospital of Jining Medical University from January 2022 to December 2022 were randomly divided into control and treatment group, and each group had 60 cases. Patients in the control group were po administered with Zolpidem Tartrate Tablets before bed, the initial dose was 5 mg/time, once daily, and the maximum dose was 10 mg. Patients in the treatment group were po administered with Kuntai Capsules on the basis of the control group, 4 grains/time, three times daily. Patients in two groups were treated for 12 weeks. After treatment, the clinical evaluations was evaluated, the TCM syndrome score and PSQI score, and the FSH, LH, and E₂ levels in two groups before and after treatment were compared. Results After treatment, the clinical effective rate of the treatment group was significantly higher than that of the control group (98.33% vs 88.33%, P＜0.05). After treatment, the TCM syndrome score and PSQI score in two groups were significantly lower than those before treatment (P＜0.05), and these scores in the treatment group were significantly lower than those of the control group (P＜0.05). After treatment, the levels of FSH and LH in two groups were significantly lower than those before treatment, while the level of E₂ was significantly higher (P＜0.05), and the level of sex hormones in the treatment group was significantly better than that in the control group (P＜0.05). Conclusion Kuntai Capsules combined with zolpidem in the treatment of sleep disorder of climacteric syndrome with kidney deficiency and liver depression syndrome can effectively regulate the level of sex hormones, improve TCM syndrome and improve sleep quality.

R971

山东省医药卫生科技发展计划项目（2017WS336）