健脾解郁汤治疗轻中度抑郁症心脾虚证患者的疗效和安全性：一项多中心随机对照研究

CHEN Xu; CHEN Jiu-xi; HAN Xue-yan; ZHAO Yang; CAO Jing; JIAO Xiu-zhen; LIU Hong-mei; GUO Chun-li; MENG Shuo; LIANG Shuai; QI Jiang-xia; CHEN Dong; LI Ming-xia; JIAO Yun-xia; WANG Ting-ting; HONG Xia

doi:10.1007/s11655-022-3685-6

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健脾解郁汤治疗轻中度抑郁症心脾虚证患者的疗效和安全性：一项多中心随机对照研究

Original Article | Updated：2023-04-05

- 健脾解郁汤治疗轻中度抑郁症心脾虚证患者的疗效和安全性：一项多中心随机对照研究
- Efficacy and Safety of Jianpi Jieyu Decoction for Patients with Mild-to-Moderate Depression of Xin (Heart)-Pi (Spleen) Deficiency Syndrome: A Multi-centre Randomized Controlled Study
- 中国结合医学杂志（英文版） 2023年29卷第4期页码：299-307
- Affiliations：
  
  1.Xiyuan Clinical Medical College, Beijing University of Chinese Medicine, Beijing (100091), China
  2.Department of Encephalopathy, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing (100091), China
  3.First College of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan (250355), China
  4.Institute of Clinical Pharmacology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing (100091), China
  5.Department of Encephalopathy, Botou Traditional Chinese Medicine Hospital of Hebei Province, Botou (062150), China
  6.Institute of Basic Medicine, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing (100091), China
  7.Department of Nephrology, Pinggu Hospital, Beijing Hospital of Traditional Chinese Medicine, Beijing (101299), China
- Author bio：
  
  Prof. HONG Xia, E-mail: 970236538@qq.com
- Funds：
  
  Special Funds for Fundamental Research Funds of Central-Level Public Welfare Research Institutes(ZZ0908001);Science and Technology Innovation Project (Major Research Project)(CI2021A01312);Traditional Chinese Medicine Prevention and Treatment of Encephalopathy Inheritance and Innovation Team of China Academy of Chinese Medical Sciences(CI2021B006)
- DOI：10.1007/s11655-022-3685-6
  中图分类号：
- 纸质出版日期：2023-04，
  
  网络出版日期：2022-10-27，
  
  录用日期：2022-08-24
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健脾解郁汤治疗轻中度抑郁症心脾虚证患者的疗效和安全性：一项多中心随机对照研究[J]. 中国结合医学杂志（英文版）, 2023,29(4):299-307.

CHEN Xu, CHEN Jiu-xi, HAN Xue-yan, et al. Efficacy and Safety of Jianpi Jieyu Decoction for Patients with Mild-to-Moderate Depression of Xin (Heart)-Pi (Spleen) Deficiency Syndrome: A Multi-centre Randomized Controlled Study[J]. Chinese Journal of Integrative Medicine, 2023,29(4):299-307.
健脾解郁汤治疗轻中度抑郁症心脾虚证患者的疗效和安全性：一项多中心随机对照研究[J]. 中国结合医学杂志（英文版）, 2023,29(4):299-307. DOI： 10.1007/s11655-022-3685-6.

CHEN Xu, CHEN Jiu-xi, HAN Xue-yan, et al. Efficacy and Safety of Jianpi Jieyu Decoction for Patients with Mild-to-Moderate Depression of Xin (Heart)-Pi (Spleen) Deficiency Syndrome: A Multi-centre Randomized Controlled Study[J]. Chinese Journal of Integrative Medicine, 2023,29(4):299-307. DOI： 10.1007/s11655-022-3685-6.

摘要

目的:

评价健脾解郁汤(JJD)治疗轻中度抑郁症心脾虚证患者的疗效和安全性.

方法:

2017年12月至2019年12月

该项多中心、随机、对照研究共纳入中国中医科学院西苑医院和泊头中医院140例轻度至中度抑郁症心脾虚证患者. 采用随机数字表法将患者随机分为JJD组和帕罗西汀组

每组70例. JJD组每日给予JJD(早晚两次

每次100 mL)

帕罗西汀组给予帕罗西汀(第1周每日10 mg; 第2-6周每日20 mg)

两次口服共6周. 主要指标为汉密尔顿抑郁评分量表(HAMD-17)在第6周与基线比较的变化. 次要结果指标包括汉密尔顿焦虑量表(HAMA)评分、中医症状量表评分、临床总体印象量表(CGI)评分及治疗第6周结束时

患者HAMD-17缓解(得分降低>50%)和HAMD-17减轻(得分降低≤7分)情况

并记录研究过程中的不良事件.

结果:

从基线到第6周

JJD组和帕罗西汀组患者HAMD-17评分分别下降了10.2±4.0和9.1±4.9分(

=0.689); HAMD-17缓解率分别为45.7%和30% (

=0.128). 两组患者在第2周和第4周HAMD-17评分比较

差异有统计学意义(

=0.001

=0.014). JJD组和帕罗西汀组患者HAMA评分从基线到第6周分别下降了8.1±3.0和6.9±4.3分(

=0.905)

治疗4周两组HAMA评分比较

差异有统计学意义(

=0.037). JJD组和帕罗西汀组患者中医评分分别下降11.4±5.1和10.1±6.8分(

=0.080). JJD组的不良事件发生率明显低于帕罗西汀组(7.14% /22.86%

0.05).

结论:

与帕罗西汀比较

健脾解郁汤治疗轻中度抑郁症心脾虚证患者6周有效率未见差异

而不良事件发生率明显降低(试验注册号: ChiCTR2000040922).

Abstract

Objective:

To evaluate the efficacy and safety of Jianpi Jieyu Decoction (JJD) for treating patients with mild-to-moderate depression of Xin (Heart)-Pi (Spleen) deficiency (XPD) syndrome.

Methods:

In this multi-center

randomized

controlled study

140 patients with mild-to-moderate depression of XPD syndrome were included from Xiyuan Hospital of China Academy of Chinese Medical Sciences and Botou Hospital of Traditional Chinese Medicine from December 2017 to December 2019. They were randomly divided into JJD group and paroxetine group by using a random number table

with 70 cases in each group. The patients in the JJD group were given JJD one dose per day (twice daily at morning and evening

100 mL each time)

and the patients in the paroxetine group were given paroxetine (10 mg/d in week 1; 20 mg/d in weeks 2–6)

both orally administration for a total of 6 weeks. The primary outcome was the change of 17-item Hamilton Depression Rating Scale (HAMD-17) score at week 6 from baseline. The secondary outcomes included the Hamilton Anxiety Scale (HAMA) score

Traditional Chinese Medicine Symptom Scale (TCMSS)

and Clinlcal Global Impression (CGI) scores at the 2nd

4th

and 6th weekends of treatment

HAMD-17 response (defined as a reduction in score of >50%) and HAMD-17 remission (defined as a score of ≤7) at the end of the 6th week of treatment. Adverse events (AEs) were also recorded.

Results:

From baseline to week 6

the HAMD-17 scores decreased 10.2±4.0 and 9.1±4.9 points in the JJD and paroxetine groups

respectively (

=0.689). The HAMD-17 response occurred in 60% of patients in the JJD group and in 50% of those in the paroxetine group (

=0.292); HAMD-17 remission occurred in 45.7% and 30% of patients

respectively (

=0.128). The differences of CGI scores at the 6th week were not statistically significant (

0.05). There were significant differences in HAMD-17 scores between the two groups at 2nd and 4th week (

=0.001 and

=0.014). The HAMA scores declined 8.1±3.0 and 6.9±4.3 points from baseline to week 6 in the JJD and paroxetine groups

respectively (

=0.905 between groups). At 4th week of treatment

there was a significant difference in HAMA between the two groups (

=0.037). TCMSS decreased 11.4±5.1

and 10.1±6.8 points in the JJD and paroxetine groups

respectively (

=0.080 between groups). At the 6th week

the incidence of AEs in the JJD group was significantly lower than that in the paroxetine group (7.14%

. 22.86%

0.05).

Conclusion:

Compared with paroxetine

JJD was associated with a significantly lower incidence of AEs in patients with mild-to-moderate depression of XPD syndrome

with no difference in efficacy at 6 weeks. (Trial registration No. ChiCTR2000040922)

关键词

Keywords

depressionXin (Heart)-Pi (Spleen) deficiency syndromeChinese medicineJianpi Jieyu Decoctiondepressionefficacysafety

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