疏肝健脾法治疗阈下抑郁肝郁脾虚证随机对照双盲研究

张艺; 曲淼; 孙文军; 郑琴

doi:10.3969/j.issn.2095-6606.2021.02.002

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疏肝健脾法治疗阈下抑郁肝郁脾虚证随机对照双盲研究

临床研究 | 更新时间：2021-05-20

- 疏肝健脾法治疗阈下抑郁肝郁脾虚证随机对照双盲研究
- 暂无标题
- 现代中医临床 2021年28卷第2期页码：3-8
- 作者机构：
  
  1.北京中医药大学第三附属医院　北京　 100029
  2.首都医科大学宣武医院
- 作者简介：
  
  张艺，女，在读硕士生
  #郑琴，女，副主任医师，硕士生导师，E-mail：13691383573@163.com
- 基金信息：
  
  国家自然科学基金资助项目(No.81573905),北京市科技计划课题(No.Z171100001017227),北京中医药大学新奥奖励基金(No.2017-XAJLJJ-021)()
- DOI：10.3969/j.issn.2095-6606.2021.02.002
  中图分类号： R256.49
- 纸质出版日期：2021-03-30，
  
  收稿日期：2020-07-06，
- 稿件说明：
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张艺, 曲淼, 孙文军, 等. 疏肝健脾法治疗阈下抑郁肝郁脾虚证随机对照双盲研究[J]. 现代中医临床, 2021,28(2):3-8.
张艺, 曲淼, 孙文军, 等. 疏肝健脾法治疗阈下抑郁肝郁脾虚证随机对照双盲研究[J]. 现代中医临床, 2021,28(2):3-8. DOI： 10.3969/j.issn.2095-6606.2021.02.002.

DOI：

摘要

目的

观察疏肝健脾法治疗阈下抑郁肝郁脾虚证的临床疗效。

方法

采用随机、对照、双盲的研究方法，将100例阈下抑郁肝郁脾虚证患者随机分为对照组和治疗组，每组各50例，剔除脱落病例后，对照组47例、治疗组48例。治疗组患者服用解忧开郁方，对照组患者服用安慰剂，治疗12周，随访1年，观察临床疗效、汉密尔顿17项抑郁量表(17-item Hamilton depression scale，HAMD-17)和中医证候量表的评分，并进行安全性评估。

结果

治疗12周，HAMD-17评定结果示：对照组47例中，临床控制2例、显著进步4例、进步12例、无效29例，总有效18例，总有效率为38.30%；治疗组48例中，临床控制12例、显著进步11例、进步15例、无效10例，总有效38例，总有效率为79.16%。经广义估计方程分析，Wald

=18.383，

0.001，说明治疗组临床疗效优于对照组。治疗12周，中医证候量表评定结果示：对照组47例中，临床控制0例、显著进步4例、进步10例、无效33例，总有效14例，总有效率为29.79%；治疗组48例中，临床控制20例、显著进步14例、进步10例、无效4例，总有效44例，总有效率为91.67%。经广义估计方程分析，Wald

=44.861，

0.001，说明治疗组中医证候疗效优于对照组。治疗后12个月随访，对照组12例转化为抑郁症，转化率为25.53%，治疗组6例转化为抑郁症，转化率为12.50%。治疗期间未发生严重不良反应。

结论

疏肝健脾法对阈下抑郁肝郁脾虚证具有较好的临床疗效，并且可防止其向抑郁症的发展。

Abstract

Objective

To observe the clinical efficacy of soothing the liver and invigorating the spleen in the treatment of subthreshold depression of liver depression and spleen deficiency.

Methods

The method of random

controlled and double-blind was conducted. 100 cases of subthreshold depression with liver depression and spleen deficiency syndrome were randomly divided into control group and treatment group

50 cases in each group. After excluding the falling off cases

47 cases were in the control group and 48 cases were in the treatment group. The patients in the treatment group were treated with Jie-you-kai-yu recipe

while the patients in the control group were given placebos. After 12 weeks of treatment and 1 year of follow-up

the clinical efficacy

Hamilton Depression Scale and TCM Syndrome Scale were observed

and the safety was evaluated.

Results

After 12 weeks of treatment

the results of Hamilton Depression Scale showed that: in the control group

2 cases were clinically controlled

4 cases had significant progress

12 cases had progress

29 cases were ineffective

18 cases were effective

and the total effective rate was 38.30%; in the treatment group

12 cases were clinically controlled

11 cases were significant progress

15 cases were progress

10 cases were ineffective

38 cases were effective

and the total effective rate was 79.16%. Generalized linear analysis

Wald chi square =18.383

0.001

showed that the clinical efficacy of the treatment group was better than that of the control group. After 12 weeks of treatment

TCM syndrome scale evaluation results showed that: in the control group

there was 0 case which were clinically controlled

4 cases of significant progress

10 cases of progress

33 cases of ineffective

14 cases of effective

and the total effective rate was 29.79%; in the treatment group of 48 cases

20 cases of clinical control

14 cases of significant progress

10 cases of progress

4 cases of no effect

the total effective rate was 91.67%. According to the generalized linear analysis

Wald chi square = 44.861

0.001

indicating that the therapeutic effect of the treatment group was better than that of the control group. After 12 months of follow-up

12 cases in the control group were transformed into depression

with the conversion rate of 25.53%

and 6 cases in the treatment group were transformed into depression

with the conversion rate of 12.50%. No serious adverse reactions occurred during the treatment.

Conclusions

The method of soothing the liver and invigorating the spleen has a definite effect on subthreshold depression of liver depression and spleen deficiency

and can prevent it from developing into depression.

关键词

阈下抑郁疏肝健脾法解忧开郁方随机对照双盲汉密尔顿抑郁量表中医证候量表

Keywords

Subthreshold depressionSoothing the liver and invigorating the spleenJie-you-kai-yu recipeRandomized controlled double-blindHamilton Depression scaleTCM Syndrome scale

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