背景：由于老年期抑郁症患者往往不能耐受足量的抗抑郁药物，所以药物治疗老年抑郁症的疗效不佳。n 目的：探讨舒肝解郁胶囊（中国药品监督管理部门批准用于治疗抑郁症的首个中草药）单用或联合重复经颅磁刺激（repeititve transcranial magneitc sitmula-iton，rTMS）治疗老年期抑郁症的疗效和安全性。n 方法：将65例60岁以上符合ICD-10诊断标准的抑郁症住院患者随机分为研究组（舒肝解郁胶囊+rTMS）（n=36）和对照组（舒肝解郁胶囊+伪rTMS）（n=29）。所有患者每日服用4粒舒肝解郁胶囊，一共服用6周。rTMS（或伪rTMS）治疗20 min/d，每周5 d，共4周。评估者在不知患者分组情况下，采用汉密尔顿抑郁量表（HAMD-17）和副反应量表评估基线和治疗开始后1、2、4、6周的临床疗效和安全性。在6周的研究过程中，研究组仅有1人脱落，对照组仅有2人脱落。n 结果：没有一例患者出现严重不良反应，但研究组和对照组中分别有40％和50％的患者出现轻微的不良反应，均自行缓解。两组的抑郁症状在6周内均逐步明显改善。重复测量方差分析没有发现两组之间有显著差异。6周后，研究组97％的患者抑郁程度下降幅度大于等于25％，但只有20％者的下降幅度大于等于50％；对照组中相应的患者比例分别为96％和19％。虽然不同的抑郁症状之间治疗起效有着轻微的、非显著性的差异，但是治疗第二周后两组HAMD-17五个分量表的评分均显著改善。n 结论：中草药舒肝解郁胶囊治疗老年抑郁症是有效和安全的，然而只有少数患者的抑郁症状在治疗6周后改善程度大于50％。联合重复经颅磁刺激治疗并没有增加舒肝解郁胶囊的总体疗效，也没有显著加快后者的起效。%Background:Pharmacological treatment of geriatric depression is often ineffective because patients cannot tolerate adequate doses of anitdepressant medicaitons. n Aims:Examine the effcacy and safety of shuganjieyu–the ifrst Chinese herbal medicine approved for the treatment of depression by China’s drug regulatory agency--with and without adjuncitve treatment with repeititve transcranial magneitc sitmulaiton (rTMS) in the treatment of geriatric depression. n Methods: Sixty-five inpatients 60 or older who met ICD-10 criteria for depression were randomly assigned to an experimental group (shuganjieyu+rTMS) (n=36) or a control group (shuganjieyu+sham rTMS)(n=29). All paritcipants received 4 capsules of shuganjieyu daily for 6 weeks. rTMS (or sham rTMS) was administered 20 minutes daily, ifve days a week for 4 weeks. Blinded raters used the Hamilton Raitng Scale for Depression (HAMD-17) and the Treatment Emergent Symptom Scale to assess clinical effcacy and safety at baseline and 1, 2, 4, and 6 weeks atfer staritng treatment. Over the six-week trial, there was only one dropout from the experimental group and two dropouts from the control group. n Results:None of the paitents had serious side effects, but 40%in the experimental group and 50%in the control group experienced minor side effects that all resolved spontaneously. Both groups showed substantial stepwise improvement in depressive symptoms over the 6 weeks. Repeated measures ANOVA found no differences between the two groups. After 6 weeks, 97%of the experimental group had experienced a 25%or greater drop in the level of depression, but only 20%had experience a 50%or greater drop in the level of depression;the corresponding values in the control group were 96%and 19%. There were some minor, non-significant differences in the onset of the treatment effect between the different types of depressive symptoms, but by the second week of treatment all ifve HAMD-17 subscale scores had improved signiifcantly in both groups n Conclusions:The Chinese herbal medicine shuganjieyu is effecitve and safe in the treatment of geriatric depression, but only a minority of patients have greater than 50%improvement in their depressive symptoms atfer 6 weeks of treatment. Adjuncitve use of rTMS with shuganjieyu does not improve the overall outcome and does not signiifcantly speed up the onset of aciton of shuganjieyu.
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