目的 探討烏靈膠囊聯(lián)合米氮平治療更年期抑郁癥的療效與安全性。方法 采用數(shù)字隨機法將新鄉(xiāng)醫(yī)學(xué)院第二附屬醫(yī)院196例更年期抑郁癥患者隨機分為對照組和治療組（n=98），對照組給予米氮平治療，治療組在對照組基礎(chǔ)上給予烏靈膠囊治療，均治療8周。于基線、2、4、6、8周末進行漢密爾頓抑郁量表（HAMD）和改良Kupperman指數(shù)（KMI）評分，評估兩組的療效；采用不良反應(yīng)量表（TESS）評價藥物的不良反應(yīng)。結(jié)果 治療8周后，對照組和治療組的有效率分別為80.61%和92.86%，兩組比較差異有顯著性（P<0.01）。對照組第2、4、6、8周末的HADM總分分別為21.52±4.19、14.94±2.72、11.36±2.27、8.89±3.11，KMI評分分別為29.52±7.16、25.49±6.45、21.07±6.81、15.89±5.74；治療組同期的HADM總分分別為16.17±3.28、11.93±2.52、8.13±2.18、5.08±2.16，KMI評分分別為25.17±3.28、19.23±6.27、12.13±5.95、9.54±3.28。從治療第2周末起，治療組的HADM總分、KMI評分均較對照組明顯下降（P<0.05、0.01）。對照組的不良反應(yīng)率18.37%，TESS值為5.89±0.41；治療組的不良反應(yīng)率8.16%，TESS評分（3.14±0.28）分。治療組的不良反應(yīng)率及TESS明顯低于對照組（P<0.05、0.01）。結(jié)論 烏靈膠囊聯(lián)合米氮平治療更年期抑郁癥臨床療效顯著，不良反應(yīng)少，依從性好，值得臨床推廣。

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.

河南省教育廳科學(xué)技術(shù)研究重點資助項目（13A190867）