<italic style="font-style: italic">Shugan Jianpi Granules</italic> （疏肝健脾颗粒） Combined with <italic style="font-style: italic">Chushi Zhiyang Oinement</italic> （除湿止痒软膏） for Atopic Dermatitis with Sleep Disturbance of Liver Constraint and Spleen Deficiency Syndrome： A Randomized Controlled Trial

LI Danyang; YIN Qiang; ZHU Zebing; DUAN Xingwu; ZHAO Jiuli

doi:10.13288/j.11-2166/r.2025.11.009

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Shugan Jianpi Granules （疏肝健脾颗粒） Combined with Chushi Zhiyang Oinement （除湿止痒软膏） for Atopic Dermatitis with Sleep Disturbance of Liver Constraint and Spleen Deficiency Syndrome： A Randomized Controlled Trial

更新时间：2025-05-28

- Shugan Jianpi Granules （疏肝健脾颗粒） Combined with Chushi Zhiyang Oinement （除湿止痒软膏） for Atopic Dermatitis with Sleep Disturbance of Liver Constraint and Spleen Deficiency Syndrome： A Randomized Controlled Trial
- Journal of Traditional Chinese Medicine Vol. 66, Issue 11, Pages: 1133-1139(2025)
- 作者机构：
  
  1.中国中医科学院望京医院，北京市朝阳区望京中环南路6号
  2.北京中医药大学东直门医院
  3.湖北省中医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2025.11.009
  CLC：
- Received：11 October 2024，
  
  Revised：2025-03-10，
  
  Published：02 June 2025
- 稿件说明：
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李丹阳,尹强,朱泽兵等.疏肝健脾颗粒联合除湿止痒软膏治疗特应性皮炎合并睡眠障碍肝郁脾虚证的随机对照试验[J].中医杂志,2025,66(11):1133-1139.

LI Danyang,YIN Qiang,ZHU Zebing,et al.Shugan Jianpi Granules （疏肝健脾颗粒） Combined with Chushi Zhiyang Oinement （除湿止痒软膏） for Atopic Dermatitis with Sleep Disturbance of Liver Constraint and Spleen Deficiency Syndrome： A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2025,66(11):1133-1139.
李丹阳,尹强,朱泽兵等.疏肝健脾颗粒联合除湿止痒软膏治疗特应性皮炎合并睡眠障碍肝郁脾虚证的随机对照试验[J].中医杂志,2025,66(11):1133-1139. DOI： 10.13288/j.11-2166/r.2025.11.009.

LI Danyang,YIN Qiang,ZHU Zebing,et al.Shugan Jianpi Granules （疏肝健脾颗粒） Combined with Chushi Zhiyang Oinement （除湿止痒软膏） for Atopic Dermatitis with Sleep Disturbance of Liver Constraint and Spleen Deficiency Syndrome： A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2025,66(11):1133-1139. DOI： 10.13288/j.11-2166/r.2025.11.009.

摘要

目的

观察疏肝健脾颗粒口服联合除湿止痒软膏外用治疗特应性皮炎合并睡眠障碍肝郁脾虚证患者的疗效，并探讨可能作用机制。

方法

将66例特应性皮炎合并睡眠障碍肝郁脾虚证患者随机分为治疗组及对照组各33例。两组均给予除湿止痒软膏外用，治疗组再予疏肝健脾颗粒口服，每日1剂；对照组再予盐酸西替利嗪片口服，每日10 mg，睡前服用。两组均治疗4周。治疗结束后统计特应性皮炎临床疗效，并分别于治疗前后记录两组患者特应性皮炎指数（SCORAD）评分、瘙痒视觉模拟量表（VAS）评分、失眠严重程度指数（ISI）评分、匹兹堡睡眠质量指数（PSQI）评分，检测血清褪黑素（MLT）、白细胞介素4（IL-4）、白细胞介素6（IL-6）、白细胞介素13（IL-13）、肿瘤坏死因子α（TNF-α）水平。治疗前后检测患者血常规、肝功能、肾功能，同时观察不良事件发生情况。

结果

治疗组特应性皮炎临床疗效总有效率为90.63%（29/32），明显高于对照组的66.67%（20/30，

＜0.05）。治疗后两组患者SCORAD评分、VAS评分、ISI评分、PSQI评分以及血清IL-4、IL-6、IL-13、TNF-α水平较本组治疗前下降，治疗组血清MLT水平上升（

＜0.05或

＜0.01）。治疗后两组间比较，治疗组SCORAD评分、ISI评分、PSQI评分、VAS评分、血清IL-4及IL-13水平均低于对照组，而MLT水平则高于对照组（

＜0.05或

＜0.01）。治疗前后两组血常规、肝功能、肾功能均无明显异常，治疗组不良反应发生率为9.38%（3/32），对照组为13.33%（4/30），两组比较差异无统计学意义（

＞0.05）。

结论

在除湿止痒软膏外用基础上联合应用疏肝健脾颗粒口服，可明显减轻特应性皮炎合并睡眠障碍肝郁脾虚证患者皮损和瘙痒程度，改善睡眠质量，其机制可能与调节免疫平衡、减少炎症因子分泌、提升MLT水平有关。

Abstract

Objective

To explore the effectiveness and potential mechanism of

Shugan Jianpi Granules

（疏肝健脾颗粒） combined with

Chushi Zhiyang Ointment

（除湿止痒软膏） in the treatment of atopic dermatitis with sleep disturbance of liver constraint and spleen deficiency syndrome.

Methods

Sixty-six patients with atopic dermatitis combined with sleep disturbance of liver constraint and spleen deficiency syndrome were randomly divided into 33 cases each in the treatment group and the control group. Both groups were treated with

Chushi Zhiyang Ointment

for external use. The treatment group additionally received

Shugan Jianpi Granules

orally， one dose per day； and the control group received cetirizine hydrochloride tablets orally， 10mg per day， taken before bedtime. Both groups were under the treatment for 4 weeks. Clinical effectiveness was evaluated after treatment， and the SCORing Atopic Dermatitis （SCORAD） index， pruritus visual analog scale （VAS） score， Insomnia Severity Index （ISI） score， and Pittsburgh Sleep Quality Index （PSQI） score were recorded before and after treatment， and serum levels of melatonin （MLT）， interleukin-4 （IL-4）， interleukin-6 （IL-6）， interleukin-13 （IL-13）， and tumor necrosis factor-α （TNF-α） were measured. The patients were also tested for blood routine， liver function and kidney function before and after treatment， and the occurrence of adverse events was also observed.

Results

The total effective rate in the treatment group （90.63%， 29/32） was significantly higher than that in the control group （66.67%， 20/30，

＜0.05）. After the interventions， the scores for SCORAD， VAS， ISI， and PSQI， as well as the levels of IL-4， IL-6， IL-13， and TNF-α， were significantly reduced in both groups. In contrast， the MLT levels in treatment group significantly e

levated compared to that before treatment （

＜0.05）. Comparing between the two groups after treatment， the scores of SCORAD， ISI， PSQI， and VAS， as well as the levels of serum IL-4 and IL-13 in the treatment group were significantly lower than those in the control group， while the MLT levels were markedly higher than that in the control group （

＜0.05 or

＜0.01）. There was no obvious abnormality in blood routine， liver function and kidney function in both groups when compared before and after treatment. The incidence rate of adverse reactions was 9.38% （3/32） in the treatment group and 13.33% （4/30） in the control group， and the difference between groups showed no statistical difference （

＞0.05）.

Conclusion

On the basis of topical application of

Chushi Zhiyang Ointment

， the combined application of

Shugan Jianpi Granules

can significantly alleviate the degree of skin lesions and itching， and improve the quality of sleep in atopic dermatitis patients with sleep disturbance of liver constraint and spleen deficiency syndrome， and its mechanism may be related to regulating the immune balance， reducing the secretion of inflammatory factors， and elevating the level of MLT.

关键词

Keywords

references

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Related Author

GAO Yuexuan

DUAN Xingwu

WU Zhimin

ZHU Zebing

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Dongzhimen Hospital，Beijing University of Chinese Medicine

Anhui University of Chinese Medicine

The Second Affiliated Hospital of Anhui University of Chinese Medicine

The First Affiliated Hospital of Anhui University of Chinese Medicine

Anhui Provincial Key Laboratory of Meridian and Zang-Fu Organs Interrelationships

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Shugan Jianpi Granules （疏肝健脾颗粒） Combined with Chushi Zhiyang Oinement （除湿止痒软膏） for Atopic Dermatitis with Sleep Disturbance of Liver Constraint and Spleen Deficiency Syndrome： A Randomized Controlled Trial

DOI：10.13288/j.11-2166/r.2025.11.009

摘要

Abstract

关键词

Keywords

references