Clinical efficacy of <italic style="font-style: italic">Kushen Tongguan Pills</italic> in the treatment of benign prostatic hyperplasia by regulating miRNA21/NF-κB/COX-2 signaling pathway to mediate ferroptosis

LIAO Zhihui; FENG Yuhong; WU Wei; SUN Yun; ZHAO Feng; ZHANG Zhe; LIU Zhiming; WANG Tianyi; XIAO Jing; GENG Qiang; CHEN Shaofeng

doi:10.16025/j.1674-1307.2026.03.002

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Clinical efficacy of Kushen Tongguan Pills in the treatment of benign prostatic hyperplasia by regulating miRNA21/NF-κB/COX-2 signaling pathway to mediate ferroptosis

更新时间：2026-06-02

- Clinical efficacy of Kushen Tongguan Pills in the treatment of benign prostatic hyperplasia by regulating miRNA21/NF-κB/COX-2 signaling pathway to mediate ferroptosis
- Beijing Journal of Traditional Chinese Medicine Vol. 45, Issue 3, Pages: 295-300(2026)
- 作者机构：
  
  1.天津中医药大学第一附属医院/中医国家临床医学研究中心，天津 300193
  2.天津医科大学第二医院泌尿外科，天津 300211
  3.宁夏回族自治区中医医院科研处，银川 750021
- 作者简介：
- 基金信息：
- DOI：10.16025/j.1674-1307.2026.03.002
  CLC：
- Received：13 October 2025，
  
  Published：25 March 2026
- 稿件说明：
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廖智慧，封玉宏，吴巍，等.苦参通关丸通过调控miRNA21/NF-κB/COX2信号通路介导铁死亡治疗良性前列腺增生的作用机制研究［J］.北京中医药，2026，45（3）：295-300.

LIAO Zhihui,FENG Yuhong,WU Wei,et al.Clinical efficacy of Kushen Tongguan Pills in the treatment of benign prostatic hyperplasia by regulating miRNA21/NF-κB/COX-2 signaling pathway to mediate ferroptosis[J]. Beijing Journal of Traditional Chinese Medicine,2026,45(03):295-300.
廖智慧，封玉宏，吴巍，等.苦参通关丸通过调控miRNA21/NF-κB/COX2信号通路介导铁死亡治疗良性前列腺增生的作用机制研究［J］.北京中医药，2026，45（3）：295-300. DOI： 10.16025/j.1674-1307.2026.03.002.

LIAO Zhihui,FENG Yuhong,WU Wei,et al.Clinical efficacy of Kushen Tongguan Pills in the treatment of benign prostatic hyperplasia by regulating miRNA21/NF-κB/COX-2 signaling pathway to mediate ferroptosis[J]. Beijing Journal of Traditional Chinese Medicine,2026,45(03):295-300. DOI： 10.16025/j.1674-1307.2026.03.002.

摘要

目的

探讨苦参通关丸对良性前列腺增生（BPH）患者的临床疗效及其潜在作用机制，验证其是否与调节微小RNA21（miRNA21）/核因子κB（NF-κB）/环氧化酶-2（COX2）信号通路介导的铁死亡有关。

方法

选取2025年6月—2025年10月于天津中医药大学第一附属医院男科门诊就诊的64例BPH患者，采用随机数字表法分为观察组和对照组，每组32例，研究过程中2组各脱落2例，最终各完成30例。观察组予苦参通关丸颗粒剂治疗，对照组予剂量为观察组10%的安慰剂治疗，疗程均为4周。治疗前后分别评估2组患者国际前列腺症状评分（IPSS）和中医证候积分；采用酶联免疫吸附试验（ELISA）检测前列腺液（EPS）中谷胱甘肽过氧化物酶4（GPx4）、COX2、超氧化物歧化酶（SOD）、丙二醛（MDA）、NF-κB p65、白细胞介素-6（IL-6）、肿瘤坏死因子-α（TNF-α）水平；采用聚合酶链反应（PCR）检测EPS中miRNA21表达水平。

结果

治疗后，观察组IPS

S、中医证候积分均较治疗前及对照组降低（

0.05）。与对照组比较，观察组EPS中GPx4、SOD水平升高（

0.05），而COX2、MDA、NF-κB p65、IL-6、TNF-α及miRNA21表达水平均显著降低（

0.05）。2组均未发生严重不良事件。

结论

苦参通关丸能有效改善BPH患者的临床症状，其机制可能与下调miRNA21表达、抑制NF-κB/COX2信号通路活性、调节铁死亡相关指标（GPx4、MDA）、减轻炎症反应（IL-6、TNF-α）与氧化应激损伤（SOD）有关。

Abstract

Objective

To investigate the clinical efficacy of

Kushen Tongguan Pills

in patients with benign prostatic hyperplasia （BPH） and to explore its potential mechanisms of action， with emphasis on whether it is related to regulation of the miRNA21/NF-κB/COX-2 signaling pathway mediated ferroptosis.

Methods

A total of 64 BPH patients treated in the Male Outpatient Department of the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine from June 2025 to October 2025 were enrolled. Patients were randomly assigned to an observation group and a control group using a random number table， with 32 cases in each group. During the study， 2 cases in each group were lost to follow-up， and 30 cases in each group completed the trial. The observation group received

Kushen Tongguan Pill

granules， while the control group received a placebo at 10% of the dosage of the observation group. The treatment course was 4 weeks. Before and after treatment， International Prostate Symptom Score （IPSS） and traditional Chinese medicine （TCM） syndrome scores were evaluated. Enzyme-linked immunosorbent assay （ELISA） was used to detect levels of glutathione peroxidase 4 （GPx4）， cyclooxygenase-2 （COX-2）， superoxide dismutase （SOD）， malondialdehyde （MDA）， nuclear factor-κB p65 （NF-κB p65）， interleukin-6 （IL-6）， and tumor necrosis factor-α （TNF-α） in expressed prostatic secretion （EPS）. Polymerase chain reaction （PCR） was used to determine miRNA21 expression in EPS.

Results

After treatment， IPSS and TCM syn

drome scores in the observation group were significantly lower than those before treatment and those in the control group （

0.05）. Compared with the control group， the observation group showed significantly increased levels of GPx4 and SOD in EPS （

0.05）， while levels of COX-2， MDA， NF-κB p65， IL-6， TNF-α， and miRNA21 expression were significantly decreased （

0.05）. No serious adverse events occurred in either group.

Conclusion

Kushen Tongguan Pills

can effectively improve clinical symptoms in patients with BPH. Its mechanism may be related to downregulation of miRNA21 expression， inhibition of NF-κB/COX-2 signaling pathway activity， regulation of ferroptosis-related indicators （GPx4， MDA）， and alleviation of inflammatory response （IL-6， TNF-α） and oxidative stress injury （SOD）.

关键词

Keywords

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Clinical efficacy of Kushen Tongguan Pills in the treatment of benign prostatic hyperplasia by regulating miRNA21/NF-κB/COX-2 signaling pathway to mediate ferroptosis

DOI：10.16025/j.1674-1307.2026.03.002

摘要

Abstract

关键词

Keywords

references