疏肝益阳胶囊治疗抑郁症伴勃起功能障碍的随机对照试验

目的:观察疏肝益阳胶囊对抑郁症伴勃起功能障碍的患者情绪、勃起功能及中医证候及症状的疗效和安全性。方法:选取2017年11月至2019年11月首都医科大学附属北京中医医院等全国7家医院的精神心理科或心身医学科门诊收治的抑郁症伴勃起功能障碍的患者154例作为研究对象,按3:1的比例随机分为观察组(n=115)和对照组(n=39)。观察组采用疏肝益阳胶囊进行治疗,对照组采用安慰剂治疗,疗程均为8周。观察情绪、勃起功能、中医证候及安全性情况。结果:治疗后,观察组抑郁疗效总有效率优于对照组(P<0.05),焦虑疗效总有效率优于对照组(P<0.05);观察组中医证候疗效总有效率优于对照组(P<0.05),单项症状疗效等级的改善在心情抑郁、胸闷善太息、腰膝酸软、头晕耳鸣优于对照组(P<0.05),单项症状消失率在腰膝酸软、头晕耳鸣优于对照组(P<0.05);试验过程中发生的不良事件,2组比较差异无统计学意义。结论:疏肝益阳胶囊可显著改善抑郁症伴勃起功能障碍患者的抑郁情绪、焦虑情绪,并显著改善肝郁肾虚的中医证候,心情抑郁、胸闷善太息、腰膝酸软、头晕耳鸣的症状,显示出良好的改善情绪和肝郁肾虚状态的疗效,且显示出良好的临床安全性。

A Randomize Controlled Trial of Shugan Yiyang Capsule in the Treatment of Depression with Erectile Dysfunction

To observe the efficacy and safety of Shugan Yiyang capsule on emotion,erectile function,TCM syndromes and symptoms of depression patients with erectile dysfunction.Methods:A total of 154 outpatients in the department of psychiatry or psychosomatic medicine in 7 hospitals including Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University from November 2017 to November 2019 were randomly divided into an study group of 115 and a control group of 39 according to the ratio of 3:1.The study group was treated with Shugan Yiyang capsule,and the control group was treated with placebo,both for 8 weeks.Patients'' mood,erectile function,TCM syndrome and safety were observed.Results:After treatment,the total effective rate of depression in study group was higher than that in the control group(P<0.05),and the total effective rate of anxiety was higher than that in the control group(P<0.05).The total effective rate of TCM syndrome curative effect in the study group was higher than that in the control group(P<0.05).The improvement of single symptom curative effect grades in depression,chest distress,soreness of waist and knee,and dizziness and tinnitus were higher than those in the control group(P<0.05).The disappearance rate of single symptom in soreness of waist and knee,dizziness and tinnitus was higher than that in the control group(P<0.05).There were no statistically significant adverse events between the two groups.Conclusion:Shugan Yiyang capsule can significantly improve depression and anxiety in patients with depression and erectile dysfunction,and significantly alleviate the TCM syndromes of liver depression and kidney deficiency,depression,chest tightness and excessive breath,soreness of waist and knee,dizziness and tinnitus with good clinical safety.