乌灵胶囊治疗女性更年期焦虑抑郁状态的随机、阳性药平行对照临床试验

背景：更年期焦虑抑郁的发病率逐年上升。精神类药物对本病虽有不错的干预效果，但患者的依从性较差，因此，有必要寻找一种切实有效而又容易被患者接受的药物。 目的：评价乌灵胶囊对女性更年期综合征伴抑郁、焦虑状态患者的临床疗效。 设计、场所、对象和干预措施：收集就诊于复旦大学华山医院中西医结合妇科、上海中医药大学龙华医院中医妇科以及复旦大学妇产科医院中医科门诊的更年期征合征伴焦虚抑郁的病例共96例。采用随机、阳性药平行对照的方法，64例为治疗组，口服乌灵胶囊；32例为对照组，口服更年安片。 主要结局指标：两组在治疗前及治疗后第3周、第6周分别以Kupperman评分表、抑郁自评量表（Self-rating Depression Scale, SDS）及焦虑自评量表（Self-rating Anxiety Scale, SAS）进行评估。 结果：治疗组和对照组的临床总有效率分别为89.66%（52/58）、76.67%（23/30），Ridit检验显示治疗组总有效率更高，差异有统计学意义（P＜0.05）。两组治疗后Kupperman评分均低于治疗前（P＜0.01）；两组治疗后的SAS和SDS的评分也显著改善（P＜0.01），经协方差分析，治疗组在用药第3周和第6周时SAS评分的改善程度优于对照组（P＜0.05，P＜0.01），治疗组用药第6周时SDS评分改善程度优于对照组（P＜0.05）。 结论：乌灵胶囊和更年安片均适合于女性更年期综合征伴焦虑、抑郁状态的治疗。乌灵胶囊在某些时相对SAS和SDS评分的改善程度优于更年安片，在缓解抑郁和焦虑状态方面，乌灵胶囊疗效更好一些。

Wuling Capsule for climacteric patients with depression and anxiety state: a randomized, positive parallel controlled trial

Background： The incidence of menopausal anxiety and depression is increasing. It can induce and aggravate a variety of somatic symptoms. Despite of the good effects of psychotropic drugs on the disease, patients’ compliance is poor. Therefore, it is necessary to find a drug which is practical, effective, and easy for patients to take.
Objective： To evaluate the efficacy of Wuling Capsule （WC）, a Chinese herbal medicine, in treatment of female climacteric syndrome with depression and anxiety state.
Design, setting, participants and interventions： A total of 96 outpatients of female climacteric syndrome from Department of Gynecology of Integrated Traditional Chinese and Western Medicine, Huashan Hospital, Fudan University, Department of Gynecology of Traditional Chinese Medicine, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, and Department of Traditional Chinese Medicine, Obstetrics and Gynecology Hospital, Fudan University were included. The study was designed as a randomized, positive drug parallel controlled trial. The patients were divided into WC group （64 cases） and control group （32 cases） and were orally administered Wuling Capsule and Gengnianan Tablet, respectively.
Main outcome measures： The efficacy was evaluated with Kupperman menopausal index （KMI）, Self-rating Depression Scale （SDS）, and Self-rating Anxiety Scale （SAS） before treatment, and after 3-week and 6-week treatment.
Results： The total response rate was 89.66% （52/58） in the WC group, which was superior to that in the control group 76.67% （23/30）]. Ridit test showed that there was a significant difference between the two groups （P〈0.05）. Kupperman score of the two groups decreased markedly after the treatment （P〈0.01）, but there was no statistical difference between the two groups. The scales of SAS and SDS in both groups were improved obviously after the treatment （P〈0.01）. Covariance analysis showed that the decrease of SAS score in the WC group was more significant than that in the control group after 3- and 6-week treatment （P〈0.05, P〈0.01）, but the SDS score was improved more significantly in the WC group than in the control group after 6-week treatment （P〈0.05）.
Conclusion： Both Wuling Capsule and Gengnian’an Tablet are effective in treating female climacteric patients with depression and anxiety state. Wuling Capsule is more effective to alleviate depression and anxiety as compared with Gengnianan Tablet.