目的 探討坤泰膠囊聯(lián)合唑吡坦治療腎虛肝郁型更年期綜合征睡眠障礙的臨床效果。方法 選取2022年1月—2022年12月濟(jì)寧醫(yī)學(xué)院附屬醫(yī)院收治的120例腎虛肝郁型更年期綜合征睡眠障礙患者，隨機(jī)分為對(duì)照組與治療組，每組各60例。對(duì)照組患者睡前口服酒石酸唑吡坦片，起始劑量5 mg/次，1次/d，最大劑量10 mg。治療組在對(duì)照組基礎(chǔ)上口服坤泰膠囊，4粒/次，3次/d。兩組患者治療12周。觀察兩組患者臨床療效，比較治療前后兩組患者中醫(yī)證候積分和匹茲堡睡眠質(zhì)量指數(shù)量表（PSQI）評(píng)分，及雌二醇（E₂）、卵泡刺激素（FSH）和促黃體生成素（LH）水平。結(jié)果 治療后，治療組患者總有效率較對(duì)照組顯著升高（98.33% vs 88.33%，P＜0.05）。治療后，兩組患者中醫(yī)證候積分及PSQI評(píng)分均顯著低于治療前（P＜0.05），且治療組評(píng)分顯著低于對(duì)照組（P＜0.05）。治療后，兩組患者FSH和LH水平顯著低于治療前，而E₂水平顯著高于治療前（P＜0.05），且治療組患者性激素水平顯著好于對(duì)照組（P＜0.05）。結(jié)論 坤泰膠囊聯(lián)合唑吡坦治療腎虛肝郁型更年期綜合征睡眠障礙能有效調(diào)控患者性激素水平，改善中醫(yī)證候及提高睡眠質(zhì)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

山東省醫(yī)藥衛(wèi)生科技發(fā)展計(jì)劃項(xiàng)目（2017WS336）