首都医科大学学报 ›› 2026, Vol. 47 ›› Issue (3): 549-557.doi: 10.3969/j.issn.1006-7795.2026.03.018

• 精神科中西医结合临床及认知神经基础 • 上一篇    下一篇

温阳解郁方治疗抑郁症患者残留疲劳症状的随机双盲对照研究

徐欢舒1,2,尹冬青1,2*,贾竑晓1,2   

  1. 1.首都医科大学附属北京安定医院三病区，国家精神疾病医学中心，精神心理疾病国家临床医学研究中心，精神疾病创新药智能研发北京市重点实验室，北京  100088；2.人脑保护高精尖创新中心，首都医科大学，北京  100069
  • 收稿日期:2026-02-02 修回日期:2026-03-27 出版日期:2026-06-21 发布日期:2026-06-26
  • 通讯作者: 尹冬青 E-mail:yindq1123@mail.ccmu.edu.cn
  • 基金资助:
    首都卫生发展科研专项项目（首发2020-2-2123）,研究型病房卓越临床研究计划（BRWEP2024072120118）,北京市属医院科研“培育计划”（ PZ2025030）。

Efficacy of Wenyang jieyu recipe on residual fatigue in major depressive disorder: a randomized double-blind controlled trial

Xu Huanshu1,2 , Yin Dongqing1,2* , Jia Hongxiao1,2   

  1. 1.3rd ward, Beijing Anding Hospital, Capital Medical University；National Center for Mental Disorders; National Clinical Research Center for Mental Disorders; Beijing Key Laboratory of Intelligent Drug Research and Development for Mental Disorders， Beijing 100088, China;  2. Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing 100069, China
  • Received:2026-02-02 Revised:2026-03-27 Online:2026-06-21 Published:2026-06-26
  • Supported by:
    This study was supported by Capital Health Development Scientific Research Special Project（首发2020-2-2123）, the Parallel Projects of Excellence of China （BRWEP2024072120118）, Cultivation Program of Beijing Municipal Hospital Management Center（PZ2025030）.

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摘要： 目的  探讨温阳解郁方对抑郁症患者残留疲劳症状的临床疗效及安全性。方法  采用随机、双盲、安慰剂对照试验设计，纳入符合标准的单相抑郁发作且伴有肾虚肝郁证残留疲劳症状的受试者，最终完成研究111例，采用数字表法按1∶1随机分为试验组（温阳解郁方+草酸艾司西酞普兰，55例）与对照组（中药安慰剂+草酸艾司西酞普兰，56例）。分别于基线及治疗后第2、4、8周评估疲劳症状量表-14（Fatigue Scale-14, FS-14）、中医证候量表、汉密尔顿抑郁量表-17项（Hamilton Depression Scale-17, HAMD-17）、汉密尔顿焦虑量表（Hamilton Anxiety Scale,HAMA）、临床总体印象量表（Clinical Global Impression, CGI）、Young氏躁狂量表（Young Manic Rating Scale, YMRS）、中文版个人与社会功能量表（Personal and Social Performance Scale-Chinese Version, PSP-CHN）及治疗不良反应量表（Treatment Emergent Symptom Scale, TESS）评分，并于第8周进行血常规、血生化、尿常规和心电图检查；中途退出受试者的检查项目同第8周。主要疗效指标为第8周FS-14评分较基线的变化。结果  试验组在改善疲劳症状方面显著优于对照组。重复测量方差分析显示，FS-14评分随时间显著下降（时间主效应P<0.01），组间差异显著（分组主效应P<0.01），试验组在第4周与第8周评分均显著低于对照组（均P<0.01）。次要指标方面，试验组HAMD-17、HAMA及中医证候积分下降幅度亦显著大于对照组（均P<0.01），两组YMRS基线评分差异无统计学意义（P>0.05），但治疗第8周时试验组评分显著低于对照组（P<0.01），2、4周组间比较差异无统计学意义。PSP评分组间比较差异亦无统计学意义。安全性良好，未增加不良反应风险。结论  温阳解郁方能有效改善抑郁症受试者残留疲劳症状，对抑郁与焦虑情绪有改善作用，安全性良好，不良反应较少。

关键词: 抑郁症, 残留疲劳症状, 温阳解郁方, 随机对照试验, 双盲法, 中医治疗

Abstract: Objective  To investigate the clinical efficacy and safety of Wenyang Jieyu recipe in treating residual fatigue symptoms in patients with depressive disorder. Methods  A randomized, double-blind, placebo-controlled trial was conducted. Patients with unipolar depressive episodes and residual fatigue symptoms (kidney deficiency and liver depression syndrome) who met the inclusion criteria were enrolled, with 111 patients completing the study. They were randomly assigned in a 1∶1 ratio to the experimental group (Wenyang Jieyu formula granules + maintenance dose of escitalopram oxalate, n=55) and the control group (Chinese herbal placebo + maintenance dose of escitalopram oxalate, n=56). Assessments were performed at baseline and at weeks 2, 4 and 8, including the Fatigue Scale-14 (FS-14), traditional Chinese medicine (TCM) symptom score, Hamilton Depression Scale-17 Item (HAMD-17) , Hamilton Anxiety Scale (HAMA), Clinical Global Impression (CGI) , Young Mania Rating Scale (YMRS) , Personal and Social Performance Scale-Chinese Version (PSP-CHN) , and Treatment Emergent Symptom Scale (TESS) . Inflammatory markers and brain-derived neurotrophic factor (BDNF) levels were measured at week 8. The primary outcome was the change in FS-14 score from baseline to week 8. Results  Compared with the control group, the experimental group showed more obvious improvement in fatigue symptoms. Repeated-measures ANOVA revealed significant time (P<0.01) and group effects (P<0.01) for FS-14 scores. At weeks 4 and 8, the experimental group had lower FS-14 score than the control group (P<0.01 for both time points). For secondary outcomes, the experimental group also showed greater reductions in HAMD-17, HAMA, and TCM symptom scores (all P<0.01). There was no significant difference between the two groups in baseline YMRS score (P>0.05). At week 8, the experiment group had significantly lower YMRS score than the control group (P0.01), with no significant difference between the two groups at weeks 2 and 4.  PSP scores also showed no statistical difference between groups. Patients tolerated the treatment well, and no increased risk of adverse events was observed. Conclusion  Wenyang Jieyu recipe can improve residual fatigue symptoms in patients with depression, and it also provides additional benefits for depressive and anxiety symptoms as well as TCM patterned kidney deficiency and liver depression syndrome. This therapy does not increase the risk of mania with a favorable safety profile, and show potential for clinical application.

Key words: depression, residual fatigue symptoms, Wenyang Jieyu therapy, randomized controlled trial, double-blind method, traditional Chinese medicine therapy

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