清热解郁方治疗双相抑郁火热内郁证的随机双盲对照研究

doi:10.3969/j.issn.1006-7795.2025.03.012

首都医科大学学报 ›› 2025, Vol. 46 ›› Issue (3): 479-486.doi: 10.3969/j.issn.1006-7795.2025.03.012

• 精神疾病中西医结合治疗 • 上一篇下一篇

清热解郁方治疗双相抑郁火热内郁证的随机双盲对照研究

尹冬青^1,2,贾竑晓^1,2*,李雪^1,2,郑思思^1,2,宁艳哲^1,2

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国家精神心理疾病临床医学研究中心精神疾病诊断与治疗北京市重点实验室，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:2025-03-04 出版日期:2025-06-21 发布日期:2025-06-25
通讯作者: 贾竑晓 E-mail:jhxlj@ccmu.edu.cn
基金资助:
北京市中医药科技发展资金项目(JJ2018-42)，研究型病房卓越临床研究计划项目（BRWEP2024072120118），北京市属医院科研“培育计划”项目(PZ2025030)。

Qingre Jiedu recipe in the treatment of bipolar depression with the syndrome of internal stagnation of fire-heat: a randomized double-blind controlled trial

Yin Dongqing^1,2, Jia Hongxiao^1,2* , Li Xue^1,2, Zheng Sisi^1,2, Ning Yanzhe^1,2

1.Beijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Medical Center for Mental Disorders, 3rd Ward, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China; 2.Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing 100069, China

Received:2025-03-04 Online:2025-06-21 Published:2025-06-25
Supported by:
This study was supported by Beijing TCM Science and Technology Development Fund Project(JJ2018-42), the Parallel Projects of Excellence of China (BRWEP2024072120118) ， Cultivation Program of Beijing Municipal Hospital Management Center(PZ2025030).

摘要/Abstract

摘要： 目的明确清热解郁方治疗双相抑郁的有效性和安全性。方法本研究采用随机、双盲、中药、西药安慰剂对照设计方法。对符合入组标准的双相抑郁火热内郁证的患者80例，按照1∶1比例，将患者分为试验组（西药模拟片+中药配方颗粒）和对照组（西药+中药安慰剂），入组后脱落7例，试验组36例，对照组37。分别于基线期和治疗后第2周、第4周、第8周进行中医火热内郁证积分（Traditional Chinese Medicine Heat Internal Depression Syndrome,TCMIDS）、汉密尔顿抑郁量表-24项（Hamilton Depression Scale-24 Item, HAMD-24）、汉密尔顿焦虑量表（Hamilton Anxiety Scale,HAMA）、33项轻躁狂清单（Hypomania Checklist-33,HCL-33）、Young氏躁狂量表（Young Manic Rating Scale, YMRS）和治疗不良反应量表（Treatment Emergent Symptom Scale, TESS）评分，记录重要体征、不良事件；分别于筛选期和治疗后的第8周进行血常规、肝功能、肾功能、尿常规和心电图检查；中途退出患者的检查项目同第8周。主要治疗效果评价指标为第8周HAMD评分较基线的变化。次要治疗效果评价指标：第8周TCMIDS、HAMA、HCL-33、YMRS评分较基线的变化。结果试验组和对照组不同时点HAMD-24项量表评分较基线均有明显降低，差异有统计学意义（P<0.01），但与对照组相比，试验组在第4周和第8周时HAMD-24项量表评分下降幅度更为明显，差异有统计学意义（P<0.01）。两组TCMIDS评分和HAMD评分不同时点较基线均有明显下降，差异有统计学意义（P<0.01），与对照组相比，试验组在TCMIDS评分、HAMD评分在第4周和第8周量表评分下降幅度更为明显，差异统计学意义（P<0.01）。两组YMRS和HCL-33评分不同时点较基线均有明显下降，差异有统计学意义（P<0.01），但两组之间对比，差异无统计学意义。结论清热解郁方能有效缓解双相抑郁的抑郁和焦虑情绪，且较西药有更多优势，另外对双相情感障碍轻躁狂或躁狂相关症状有一定疗效，且该疗法无转燥风险，安全性较好，不良反应较少。

关键词: 双相抑郁, 双相情感障碍, 清热解郁方, 随机对照试验, 中医

Abstract: Objective To evaluate the efficacy and safety of Qingre Jiedu recipe in the treatment of bipolar depression. Methods A randomized, double-blind, Chinese medicine and western medicine placebo control design was used in this study. Totally 80 subjects with bipolar depression and fiery internal depression that met the enrollment criteria, were divided into the experimental group (EG, 40 cases of western medicine simulation tablets + Chinese medicine formula granules) and the control group (CG, 40 cases of western medicine + Chinese medicine placebo) according to a 1∶1 ratio at last, 7 cases dropped out after enrollment, EG 36 cases, CG 37 cases. TCM Heat Internal Depression Syndrome (TCMHIDS), Hamilton Depression Scale-24 Item (HAMD-24), Hamilton Anxiety Scale (HAMA), Hypomania Checklist-33 (HCL-33), Young Manic Rating Scale (YMRS) and Treatment Emergent Symptom Scale (TESS) scores were assessed at baseline and at the 2nd, 4th and 8th week after treatment. Important signs and adverse events were recorded. Blood routine, hepatic and renal function, urine routine and electrocardiogram were performed during the screening period and the 8th week after treatment. For the patients who dropped out of the examination program, the examination item are identical to those at week 8. The primary outcome measure was the change in HAMD score from baseline to 8th week. Secondary outcome evaluation indicators included the changes of TCMHIDS, HAMA, HCL-33 and YMRS scores from baseline to 8th week. Results The scores of the HAMD-24 between EG and CG decreased significantly compared with the baseline at different time-point, and the difference was statistically significant（P<0.01）. However, the scores of the EG on the HAMD-24 decreased more significantly compared with the CG at the 4th and 8th week, and this difference was statistically significant（P<0.01）. The TCMHIDS and HAMD scores between two groups decreased compared with the baseline at different time-point, and this difference was statistically significant（P<0.01）. However, the TCMHIDS and HAMD scores of the EG decreased more significantly ot the 4th and 8th week, compared with the CG, and this difference was statistically significant（P<0.01）. Both YMRS and HCL-33 scores decreased more significantly between two groups at different time-point, compared with the baseline, and this differences was statistically significant, but there was no difference between two groups. Conclusion TCM Qingre Jiedu recipe could effectively relieve depression and anxiety mood of bipolar depression, with more advantages than western medicine. In addition, it showed a certain effect on hypomania or manic-related symptoms of bipolar disorder, No risk of turning to hypomania or manic, better safety and less adverse reactions were observed.

Key words: bipolar depression, bipolar disorder, traditional Chinese medicine formula of clearing heat and eliminating depression, randomized controlled trial, traditional Chinese medicine

中图分类号:

R749

尹冬青, 贾竑晓, 李雪, 郑思思, 宁艳哲. 清热解郁方治疗双相抑郁火热内郁证的随机双盲对照研究[J]. 首都医科大学学报, 2025, 46(3): 479-486.

Yin Dongqing, Jia Hongxiao, , Li Xue, Zheng Sisi, Ning Yanzhe. Qingre Jiedu recipe in the treatment of bipolar depression with the syndrome of internal stagnation of fire-heat: a randomized double-blind controlled trial[J]. Journal of Capital Medical University, 2025, 46(3): 479-486.

参考文献

［1］Cardoso de Almeida J R, Phillips M L. Distinguishing between unipolar depression and bipolar depression: current and future clinical and neuroimaging perspectives［J］. Biol Psychiatry, 2013, 73(2): 111-118.
［2］Nierenberg A A, Agustini B, Köhler-Forsberg O, et al. Diagnosis and treatment of bipolar disorder: a review［J］. JAMA, 2023, 330(14): 1370-1380.
［3］ Judd L L, Schettler P J, Akiskal H, et al. Prevalence and clinical significance of subsyndromal manic symptoms, including irritability and psychomotor agitation, during bipolar major depressive episodes［J］. J Affect Disord, 2012, 138(3): 440-448.
［4］徐文炜, 查富树, 许律西, 等. 单相抑郁与双相情感障碍遗传效应及方式的对照研究［J］. 中华精神科杂志, 1997, 30(4): 199-202.
［5］云维生, 李俊清, 孙福刚. 抑郁反应, 抑郁发作, 双相障碍 (抑郁相) 同异源性的临床研究［J］. 中国民康医学(上半月), 2008,20(17): 1978-1981.
［6］Hirschfeld R M A, Lewis L, Vornik L A. Perceptions and impact of bipolar disorder: how far have we really come? Results of the national depressive and manic-depressive association 2000 survey of individuals with bipolar disorder［J］. J Clin Psychiatry, 2003, 64(2): 161-174.
［7］Rosa A R, Reinares M, Michalak E E, et al. Functional impairment and disability across mood states in bipolar disorder［J］. Value Health, 2010, 13(8): 984-988.
［8］Goodwin G M. Bipolar depression and treatment with antidepressants［J］. Br J Psychiatry, 2012, 200(1): 5-6.
［9］朱虹, 尹冬青, 李自艳, 等. 双相情感障碍中医证素特点的初步探索［J］. 现代中医临床, 2019, 26(4): 29-33.
［10］尹冬青, 贾竑晓, 李自艳, 等. 13372例住院双相情感障碍患者的五运六气禀赋特征［J］. 现代中医临床, 2019, 26(4): 34-39.
［11］尹冬青, 贾竑晓, 周方, 等. 内生火热与双相情感障碍发病的关系探讨［J］. 中华中医药学刊, 2017, 35(2): 482-484.
［12］陈沛, 郭雨萌, 阎锴娟, 等. 单、双相抑郁患者特征性舌象分析研究［J］. 湖南中医药大学学报, 2024, 44(12): 2222-2226.
［13］贾竑晓, 王娣. 叶天士清热解郁法对难治性抑郁证治疗的启示［J］. 中华中医药杂志, 2011, 26(6): 1346-1348.
［14］刘杰, 贾竑晓, 王建琴, 等. 解郁颗粒合并帕罗西汀治疗阴虚内热型难治性抑郁症的疗效观察［J］. 中国中西医结合杂志, 2013, 33(4): 462-465.
［15］美国精神医学学会.理解DSM-5精神障碍［M］.夏雅俐，张道龙，译.北京：北京大学出版社，2016：40-44.
［16］尹冬青, 贾竑晓. 双相情感障碍中医证候辨证分型标准专家共识［J］. 现代中医临床, 2021, 28(6): 1-8.
［17］方贻儒, 刘铁榜. 双相障碍抑郁发作药物治疗专家建议［J］. 中国神经精神疾病杂志, 2013, 39(7): 385-390.
［18］袁铭, 李素敏, 王雪芹, 等. 双相抑郁的特点、危害及药物治疗研究进展［J］. 中国全科医学, 2016, 19(10): 1229-1233.

清热解郁方治疗双相抑郁火热内郁证的随机双盲对照研究

Qingre Jiedu recipe in the treatment of bipolar depression with the syndrome of internal stagnation of fire-heat: a randomized double-blind controlled trial

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