Clinical efficacy and mechanisms of <italic style="font-style: italic">Shugan Yidan Formula</italic> in treating primary premature ejaculation with liver depression and gallbladder deficiency syndrome

HAN Qiang; ZENG Ying; WANG Fu; GUO Jun; ZHAO Ziwei; WANG Xuyun; LIU Na; WANG Renyuan

doi:10.16025/j.1674-1307.2025.07.007

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Clinical efficacy and mechanisms of Shugan Yidan Formula in treating primary premature ejaculation with liver depression and gallbladder deficiency syndrome

更新时间：2025-09-11

- Clinical efficacy and mechanisms of Shugan Yidan Formula in treating primary premature ejaculation with liver depression and gallbladder deficiency syndrome
- Beijing Journal of Traditional Chinese Medicine Vol. 44, Issue 7, Pages: 847-851(2025)
- 作者机构：
  
  1.首都医科大学附属北京中医医院男科，北京 100010
  2.中国中医科学院西苑医院男科，北京 100091
- 作者简介：
- 基金信息：
- DOI：10.16025/j.1674-1307.2025.07.007
  CLC：
- Received：27 May 2024，
  
  Published：25 July 2025
- 稿件说明：
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韩强，曾银，王福，等.疏肝益胆方治疗肝郁胆虚型原发性早泄的临床观察及作用机制分析［J］.北京中医药，2025，44（7）：847-851.

HAN Qiang,ZENG Ying,WANG Fu,et al.Clinical efficacy and mechanisms of Shugan Yidan Formula in treating primary premature ejaculation with liver depression and gallbladder deficiency syndrome[J]. Beijing Journal of Traditional Chinese Medicine,2025,44(07):847-851.
韩强，曾银，王福，等.疏肝益胆方治疗肝郁胆虚型原发性早泄的临床观察及作用机制分析［J］.北京中医药，2025，44（7）：847-851. DOI： 10.16025/j.1674-1307.2025.07.007.

HAN Qiang,ZENG Ying,WANG Fu,et al.Clinical efficacy and mechanisms of Shugan Yidan Formula in treating primary premature ejaculation with liver depression and gallbladder deficiency syndrome[J]. Beijing Journal of Traditional Chinese Medicine,2025,44(07):847-851. DOI： 10.16025/j.1674-1307.2025.07.007.

摘要

目的

观察疏肝益胆方治疗肝郁胆虚型原发性早泄（PE）的临床疗效，同时观察外周血浆中5-HT、DA对PE治疗的影响。

方法

选取2022年10月—2023年10月于首都医科大学附属北京中医医院男科门诊就诊的原发性PE患者90例，采用随机数表法分为2组。观察组予疏肝益胆方治疗，对照组予盐酸达泊西汀片治疗，2组均治疗6周，随访2周。观察比较2组治疗前后射精潜伏期（IELT）、早泄诊断工具（PEDT）评分、早泄谱（PEP）评分、中医证候评分。分别于治疗前后检测患者外周血多巴胺（DA）及5-羟色胺（5-HT）水平。研究期间记录2组安全性指标情况。

结果

治疗后，2组PEDT、PEP、中医证候评分均较治疗前改善（

0.05），且观察组中医证候评分低于对照组（

0.05）。治疗后，2组IELT均较治疗前改善（

0.05），组间差异无统计学意义（

0.05）。治疗前后2组间血浆DA、5-HT水平比较，差异均无统计学意义（

0.05）；治疗后观察组血浆DA、5-HT水平较治疗前升高，但差异无统计学意义（

0.05）。治疗过程中，2组安全性指标均未见异常。

结论

疏肝益胆方临床有效性与达泊西汀无明显差异，但可改善患者情绪，且作用机制与外周血浆中的5-HT、DA水平无关。

Abstract

Objective

To observe the clinical efficacy of

Shugan Yidan Formula

in the treatment of primary premature ejaculation （PE） with liver depression and gallbladder deficiency syndrome， and to investigate the influence of peripheral plasma 5-hydroxytryptamine （5-HT） and dopamine （DA） on PE treatment.

Methods

Ninety patients with primary PE who visited the Andrology Department of Beijing Hospital of Traditional Chinese Medicine， Capital Medical University， from October 2022 to October 2023 were enrolled and randomly divided into two groups using a random number table. The observation group was treated with

Shugan Yidan Formula

， and the control group was treated with dapoxetine hydrochloride tablets. Both groups received treatment for six weeks and were followed up for two weeks. Intravaginal ejaculation latency time （IELT）， Premature Ejaculation Diagnostic Tool （PEDT） scores， premature ejaculation profile （PEP） scores， and traditional Chinese medicine （TCM） syndrome scores of th

e two groups were compared before and after treatment. Peripheral plasma levels of DA and 5-HT were measured before and after treatment. Safety indicators were recorded throughout the study.

Results

After treatment， PEDT， PEP， and TCM syndrome scores improved in both groups compared with baseline （

0.05）， with the TCM syndrome score in the observation group lower than that in the control group （

0.05）. IELT increased in both groups after treatment （

0.05）， with no significant difference between groups （

0.05）. There were no significant differences in plasma DA and 5-HT levels between the groups before or after treatment （

0.05）. Although DA and 5-HT levels in the observation group increased after treatment， the changes were not statistically significant （

0.05）. No abnormalities were observed in safety indicators in either group.

Conclusion

Shugan Yidan Formula

has comparable clinical efficacy to dapoxetine， can improve patients' emotional state， and its mechanism of action is not related to peripheral plasma levels of 5-HT or DA.

关键词

Keywords

references

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Clinical efficacy and mechanisms of Shugan Yidan Formula in treating primary premature ejaculation with liver depression and gallbladder deficiency syndrome

DOI：10.16025/j.1674-1307.2025.07.007

摘要

Abstract

关键词

Keywords

references