乌灵胶囊联合米氮平治疗更年期抑郁症的临床评价

目的 探讨乌灵胶囊联合米氮平治疗更年期抑郁症的疗效与安全性。方法 采用数字随机法将新乡医学院第二附属医院196例更年期抑郁症患者随机分为对照组和治疗组（n=98），对照组给予米氮平治疗，治疗组在对照组基础上给予乌灵胶囊治疗，均治疗8周。于基线、2、4、6、8周末进行汉密尔顿抑郁量表（HAMD）和改良Kupperman指数（KMI）评分，评估两组的疗效；采用不良反应量表（TESS）评价药物的不良反应。结果 治疗8周后，对照组和治疗组的有效率分别为80.61%和92.86%，两组比较差异有显著性（P<0.01）。对照组第2、4、6、8周末的HADM总分分别为21.52±4.19、14.94±2.72、11.36±2.27、8.89±3.11，KMI评分分别为29.52±7.16、25.49±6.45、21.07±6.81、15.89±5.74；治疗组同期的HADM总分分别为16.17±3.28、11.93±2.52、8.13±2.18、5.08±2.16，KMI评分分别为25.17±3.28、19.23±6.27、12.13±5.95、9.54±3.28。从治疗第2周末起，治疗组的HADM总分、KMI评分均较对照组明显下降（P<0.05、0.01）。对照组的不良反应率18.37%，TESS值为5.89±0.41；治疗组的不良反应率8.16%，TESS评分（3.14±0.28）分。治疗组的不良反应率及TESS明显低于对照组（P<0.05、0.01）。结论 乌灵胶囊联合米氮平治疗更年期抑郁症临床疗效显著，不良反应少，依从性好，值得临床推广。

Clinical evaluation on Wuling Capsules combined with mirtazapine in treatment of perimenopausal depression

Objective To explore the curative effects and safety of Wuling Capsules combined with mirtazapine in treatment of perimenopausal depression. Methods Totally 196 patients with erimenopausal depression were randomly divided into observation and control groups. Mirtazapine was taken orally in control group (n=98) for 8 weeks. Patients of observation group (98 cases) took Wuling Capsules combined with mirtazapine for 8 weeks. The Hamilton depression scale (HAMD) and Kuppernlan scale (KMI) were used to assess the therapeutic efficacies. And Treatment Emergent Symptom Scale (TESS) was examined to assess the side effects. Results The effective rate of control group was 80.61% after treatment for 8 weeks, and that of treatment group was 92.86%, with significant difference between two groups. The HAMD and Kuppernlan scale of 2, 4, 6, and 8 weeks in control group were 21.52±4.19, 15.94±2.72, 12.36±2.27, 9.19±3.11 and 29.52±7.16, 25.49±6.45, 21.07±6.81, 15.89±5.74; The HAMD and KMI of 2, 4, 6, and 8 weeks in control group were 16.17±3.28, 11.93±2.52, 8.13±2.18, 5.08±2.16 and 25.17±3.28, 19.23±6.27, 12.13±5.95, 9.54±3.28. Compare with the control group, HADM score and KMI score of the treatment group were significantly decreased from the 2 weeks (P<0.05, 0.01). The TESS score and adverse rate of the control group were 5.89±0.41 and 21.43%, and the TESS score and adverse rate of the treatment group were 3.14 ±0.28 and 8.16%. There were significant changes existing in TESS and the adverse rate after treatment (P<0.05, 0.01). Conclusion The results suggest that Wuling Capsules combined with mirtazapine has good efficacy, less side effects, and better compliance in the treatment of perimenopausal depression. This method deserves extensive application in clinic.