高频重复经颅磁刺激联合舒肝解郁胶囊治疗抑郁症的随机双盲对照研究

Effects of High Frequency Repetitive Transcranial Magnetic Stimulation with Suganjieyu Capsules on Depression: A Double-blind,Randomized Controlled Trial

目的：探讨高频重复经颅磁刺激（rTMS）联合舒肝解郁胶囊对抑郁症治疗的临床疗效,并观察不良反应。方法：本研究为双盲随机对照治疗。根据《疾病和有关健康问题的国际统计分类第10版》（ICD-10）中抑郁症的诊断标准,选取77例抑郁症患者按随机数字表法1：1分为治疗组（n=38）与对照组（n=39）。在给予中药舒肝解郁胶囊治疗的基础上,治疗组给予高频10Hz rT MS治疗,对照组给予伪线圈刺激。共治疗2周,每周5次。采用汉密尔顿抑郁量表（HAMD）17项评估治疗前以及治疗后两组患者抑郁症状的变化和减分率。减分率≥75%为治愈;减分率50%～74%为显效;减分率25%～49%为有效;减分率〈25%为无效,采用治疗中需处理的副反应量表（TESS）评估不良反应。结果：共有77例（98.7%）患者完成治疗。治疗组总体有效率高于对照组（P=0.025）。2周后治疗组HAMD的减分率明显优于对照组（t=-7.071,P〈0.001）。另外,对4个重要的单一项目指标（抑郁情绪、睡眠障碍、焦虑、性症状）的评定中,治疗组在抑郁情绪症状（t=-2.999,P〈0.01）、睡眠障碍症状（t=-2.147,P〈0.05）和性症状（t=-2.175,P〈0.05）的改善程度上也都显著优于对照组。治疗组和对照组的病例都无严重不良反应发生,发生率无统计学差异。结论：10Hz左背外侧前额叶rTMS联合舒肝解郁胶囊治疗抑郁症安全、有效。

Objective： To explore the effectiveness and safety of high frequency repetitive transcranial magnetic stimulation（ rTMS） with Suganjieyu capsules on depression.Methods： A double blind and randomized controlled study was conducted.A total of 77 depression patients who met the International Statistical Classification of Diseases and Related Health Problems 10 th Revision（ ICD-10） criteria for depression were recruited. Subjects were grouped into active treatment group（ n =38） and sham group（ n = 39） randomly and took routine Shuaganjieyu capsule for treatment.10 Hz rTMS were applied to the patients in active treatment group,while patients in sham group received only sham rT MS.The Hamilton depression scale-17 items（ HAMD） was used to assess the severity of clinical and reduction rates. Side effects were valuated with Treatment Emergent Symptom Scale（ TESS）.Results： A total of 77（ 98.7%） patients completed the trial. Treatment efficiency in the active treatment group was significantly better than that in the sham group（ P〈0.05）.Additionally,score-reducing rate in the active treatment group was significantly higher than that in the sham group（ t =-7.071,P〈0.001）.Furthermore,the improvement of depression symptoms（ t =-2.999,P〈0.01）,insomnia（ t =-2. 147,P〈0. 05）,and sexual symptoms（ t =-2. 175,P〈0.05） in the active treatment group were significantly better than those in the sham group.No adverse reactions were recorded in both groups.There was no obvious difference about the incidence of side effects. Conclusion： rT MS together with Suganjieyu capsules can provide an effective and well-tolerant treatment for depression.