Efficacy and safety of Shuganning injection in treatment of liver injury： A clinical analysis

Qiaoxin WEI; Mei LIU; Daimeng SHI; Shaoli YOU; Yu CHEN; Shuangsuo DANG; Dongliang YANG; Yuemin NAN; Mingliang CHENG; Zhongping DUAN

doi:10.12449/JCH260617

Volume 42 Issue 6

Jun. 2026

Turn off MathJax

Article Contents

Article Navigation > Journal of Clinical Hepatology > 2026 > 42(6): 1349-1357

PDF( 778 KB)

Efficacy and safety of Shuganning injection in treatment of liver injury： A clinical analysis

DOI: 10.12449/JCH260617

1.
Department of Oncology，Beijing YouAn Hospital，Capital Medical University，Beijing 100069，China
2.
Internal Medicine Ward，Center for Diagnosis and Treatment of Hepatobiliary Diseases，Nanyang First People’s Hospital，Nanyang，Henan 473000，China
3.
Department of Hepatology，The Fifth Medical Center of Chinese PLA General Hospital，Beijing 100039，China
4.
Fourth Department of Liver Disease Center，Beijing YouAn Hospital，Capital Medical University，Beijing 100069，China
5.
Department of Infectious Diseases，The Second Affiliated Hospital of Xi’an Jiaotong University，Xi’an 710004，China
6.
Department of Infectious Diseases，Union Hospital，Tongji Medical College，Huazhong University of Science and Technology，Wuhan 430030，China
7.
Department of Traditional and Western Medical Hepatology，The Third Hospital of Hebei Medical University，Shijiazhuang 050051，China
8.
Department of Infectious Diseases，The Affiliated Hospital of Guizhou Medical University，Guiyang 550004，China

Research funding:

Horizontal Project of Beijing You’an Hospital (2018-060);

Beijing Hospitals Authority’s Ascent Plan (DFL20221501)

More Information

Corresponding author: DUAN Zhongping， duan2517@163.com （ORCID： 0000-0002-8455-0426）
Received Date: 2025-06-15
Accepted Date: 2025-11-18
Published Date: 2026-06-25

Abstract

Abstract

Objective To investigate the efficacy and safety of Shuganning injection in the treatment of liver injury by observing the clinical outcome of patients with liver injury after treatment with Shuganning injection and comparing it with reduced glutathione （GSH）. Methods This study was conducted among 175 patients with liver injury who attended 6 hospitals in China （Beijing YouAn Hospital， Capital Medical University； Nanyang First People’s Hospital； The Second Affiliated Hospital of Xi’an Jiaotong University； The Fifth Medical Center of Chinese PLA General Hospital； The Third Hospital of Hebei Medical University； The Affiliated Hospital of Guizhou Medical University） from April 25， 2019 to February 28， 2022. The patients were divided into experimental group （89 patients treated with Shuganning injection） and control group （86 patients treated with GSH）， and the course of treatment was 4 weeks for both groups. Related indicators were recorded before treatment， after treatment， and after drug withdrawal for 8 weeks， including liver function parameters， blood biochemical parameters， blood lipids， coagulation profiles， liver fibrosis markers， traditional Chinese medicine （TCM） syndrome score， and ultrasound findings， as well as adverse events during treatment. The Wilcoxon rank-sum test was used for comparison of continuous data between two groups， and the chi-square test was used for comparison of categorical data between two groups. The Wilcoxon signed-rank test was used for comparison of observation indicators before treatment， at week 4 of treatment， and after drug withdrawal for 8 weeks. When the efficacy evaluation of TCM syndromes was used as the outcome， a pooled analysis was performed for the effective cases and the markedly effective cases， and a Logistic regression model was used to calculate the odds ratio （OR） and its 95%CI. Results After 4 weeks of treatment with Shuganning injection， the patients showed significant reductions in TCM syndrome score （P<0.001） and the levels of aspartate aminotransferase， alanine aminotransferase， total bilirubin， and direct bilirubin （all P<0.001） and a significant increase in the level of albumin （P=0.002）， and these significant improvements persisted after drug withdrawal for 8 weeks. Furthermore， compared with the control group， the experimental group had a significantly higher proportion of patients assessed as effective or markedly effective cases （48.31% vs 32.56%， P=0.033）. Compared with the control group， the experimental group had a significantly greater change in TCM syndrome score at weeks 1-4 of treatment and after drug withdrawal for 8 weeks （P<0.05）. At week 4 of treatment， the experimental group had a significantly greater reduction in alanine aminotransferase than the control group （P<0.05）， and at week 8 after drug withdrawal， the experimental group had a significantly greater reduction in alanine aminotransferase and aspartate aminotransferase than the control group （all P<0.05）. One patient in the experimental group （1.12%） experienced an adverse event， which was determined to be associated with the progression of viral hepatitis. Conclusion Shuganning injection can effectively improve liver injury， with good long-term efficacy and a low incidence rate of adverse reactions.
- Liver Injury,
- Shuganning Injection,
- Treatment Outcome

FullText(HTML)

References(27)

References

[1]	SAYED IM. Dual infection of hepatitis A virus and hepatitis E virus- what is known?[J]. Viruses, 2023, 15( 2): 298. DOI: 10.3390/v15020298.
[2]	DALTON HR, BENDALL R, IJAZ S, et al. Hepatitis E: An emerging infection in developed countries[J]. Lancet Infect Dis, 2008, 8( 11): 698- 709. DOI: 10.1016/S1473-3099(08)70255-X.
[3]	DEVARBHAVI H, ASRANI SK, ARAB JP, et al. Global burden of liver disease: 2023 update[J]. J Hepatol, 2023, 79( 2): 516- 537. DOI: 10.1016/j.jhep.2023.03.017.
[4]	FONTANA RJ, BJORNSSON ES, REDDY R, et al. The evolving profile of idiosyncratic drug-induced liver injury[J]. Clin Gastroenterol Hepatol, 2023, 21( 8): 2088- 2099. DOI: 10.1016/j.cgh.2022.12.040.
[5]	ZHAO Y, GENG CG, MA YB, et al. UFLC/MS-IT-TOF guided isolation of anti-HBV active chlorogenic acid analogues from Artemisia capillaris as a traditional Chinese herb for the treatment of hepatitis[J]. J Ethnopharmacol, 2014, 156: 147- 154. DOI: 10.1016/j.jep.2014.08.043.
[6]	ZHAO Q, REN X, CHEN M, et al. Effects of traditional Chinese medicine formula Le-Cao-Shi on hepatitis B: in vivo and in vitro studies[J]. J Ethnopharmacol, 2019, 244: 112132. DOI: 10.1016/j.jep.2019.112132.
[7]	WANG JB, LIU R, LIU BX, et al. Systems Pharmacology-based strategy to screen new adjuvant for hepatitis B vaccine from Traditional Chinese Medicine Ophiocordyceps sinensis[J]. Sci Rep, 2017, 7: 44788. DOI: 10.1038/srep44788.
[8]	TAN S, LIU YQ. Observation on therapeutic effect of Shuganning on drug-induced liver disease[J]. J China Tradit Chin Med Inf, 2012, 4( 5): 546- 547. 谭松, 刘友琴. 舒肝宁治疗药物性肝病的疗效观察[J]. 中国中医药咨讯, 2012, 4( 5): 546- 547.
[9]	WEI Y, YAO WX, ZHOU H, et al. Clinical observation on effectiveness of Shuganning in treatment of patients with hepatic injury caused by chemotherapy drug[J/CD]. Chin J Liver Dis Electron Version, 2010, 2( 2): 9- 11. DOI: 10.3969/j.issn.1674-7380.2010.02.003. 魏阳, 姚文秀, 周行, 等. 舒肝宁治疗化疗药物所致肝损伤的临床疗效观察[J/CD]. 中国肝脏病杂志(电子版), 2010, 2( 2): 9- 11. DOI: 10.3969/j.issn.1674-7380.2010.02.003.
[10]	TAI J, LIU F, YANG XR, et al. Clinical analysis of Shuganning injection in the treatment of 45 cases of acute icteric hepatitis[J]. J Clin Intern Med, 2007, 24( 2): 103. DOI: 10.3969/j.issn.1001-9057.2007.02.024. 台杰, 刘峰, 杨潇然, 等. 舒肝宁注射液治疗急性黄疸型肝炎45例临床分析[J]. 临床内科杂志, 2007, 24( 2): 103. DOI: 10.3969/j.issn.1001-9057.2007.02.024.
[11]	ZHANG QY, LI M, CHEN F. Efficacy and safety of Shuganning injection in the treatment of acute and chronic viral hepatitis[J]. Chin J Clin Ration Drug Use, 2025, 18( 19): 74- 77. DOI: 10.15887/j.cnki.13-1389/r.2025.19.020. 张琼月, 李明, 陈帆. 舒肝宁注射液治疗急慢性病毒性肝炎的疗效及安全性[J]. 临床合理用药, 2025, 18( 19): 74- 77. DOI: 10.15887/j.cnki.13-1389/r.2025.19.020.
[12]	CHI MY, FU CL, ZHANG X, et al. Effect of Shuganning injection on cytochrome CYP450 enzyme activity and its interaction with bicyclol[J/OL]. Chin J Chin Mater Med, 1- 11[ 2026-04-25]. https://doi.org/10.19540/j.cnki.cjcmm.20260105.203. DOI: 10.19540/j.cnki.cjcmm.20260105.203 迟明艳, 付昌丽, 张雄, 等. 舒肝宁注射液对细胞色素CYP450酶活性的影响及其与双环醇的相互作用研究[J/OL]. 中国中药杂志, 1- 11[ 2026-04-25]. https://doi.org/10.19540/j.cnki.cjcmm.20260105.203. DOI: 10.19540/j.cnki.cjcmm.20260105.203
[13]	LI FQ. Effect of Shuganning injection combined with tenofovir in the treatment of patients with chronic hepatitis B[J]. Med J Chin People’s Health, 2025, 37( 24): 109- 112. DOI: 10.3969/j.issn.1672-0369.2025.24.031. 李富强. 舒肝宁注射液联合替诺福韦治疗慢性乙型病毒性肝炎患者的效果[J]. 中国民康医学, 2025, 37( 24): 109- 112. DOI: 10.3969/j.issn.1672-0369.2025.24.031.
[14]	ZHENG XY. Guiding principles for clinical research of new Chinese medicines(trial implementation)[S]. Beijing: China Medical Science Press, 2002. 郑筱萸. 中药新药临床研究指导原则(试行)[S]. 北京: 中国医药科技出版社, 2002.
[15]	Hepatobiliary Specialized Committee of China Association of Chinese Medicine, Liver Diseases Specialized Committee of China Medical Associa- tion of Minorities. The clinical guidelines of diagnosis and treatment of chronic hepatitis B with traditional Chinese medicine(2018)[J]. J Clin Hepatol, 2018, 34( 12): 2520- 2525. DOI: 10.3969/j.issn.1001-5256.2018.12.007. 中华中医药学会肝胆病专业委员会, 中国民族医药学会肝病专业委员会. 慢性乙型肝炎中医诊疗指南(2018年版)[J]. 临床肝胆病杂志, 2018, 34( 12): 2520- 2525. DOI: 10.3969/j.issn.1001-5256.2018.12.007.
[16]	CARDOSO AC, FIGUEIREDO-MENDES C, VILLELA-NOGUEIRA CA, et al. Staging fibrosis in chronic viral hepatitis[J]. Viruses, 2022, 14( 4): 660. DOI: 10.3390/v14040660.
[17]	FAN R, PAPATHEODORIDIS G, SUN J, et al. aMAP risk score predicts hepatocellular carcinoma development in patients with chronic hepatitis[J]. J Hepatol, 2020, 73( 6): 1368- 1378. DOI: 10.1016/j.jhep.2020.07.025.
[18]	WANG C, WANG JA. Medicine[M]. 3rd ed. Beijing: People’s Medical Publishing House, 2015. 王辰, 王建安. 内科学[M]. 3版. 北京: 人民卫生出版社, 2015.
[19]	CHEN SH, SHAO JF, HE CM, et al. Shuganning injection in the treatment of 49 cases of acute icteric viral hepatitis[J]. J Emerg Tradit Chin Med, 2011, 20( 10): 1686- 1687. DOI: 10.3969/j.issn.1004-745X.2011.10.085. 陈曙红, 邵剑锋, 何灿明, 等. 舒肝宁注射液治疗急性黄疸型病毒性肝炎49例[J]. 中国中医急症, 2011, 20( 10): 1686- 1687. DOI: 10.3969/j.issn.1004-745X.2011.10.085.
[20]	LAO XN. Observation on therapeutic effect of Shugan decoction on drug-induced hepatitis[J]. J Chin Med Mater, 2004, 27( 6): 467- 468. 劳献宁. 舒肝汤治疗药物性肝炎的疗效观察[J]. 中药材, 2004, 27( 6): 467- 468.
[21]	HUANG L, CHEN Y, WU Q, et al. Effect of Shuganning injection on the model of cholestasis-type chlorpromazine-induced liver injury constructed by a new tissue-engineered liver[J]. J Clin Hepatol, 2022, 38( 3): 587- 593. DOI: 10.3969/j.issn.1001-5256.2022.03.018. 黄龙, 陈煜, 吴桥, 等. 舒肝宁注射液对于氯丙嗪引起的新型组织工程肝构建的胆汁淤积型药物性肝损伤模型的影响[J]. 临床肝胆病杂志, 2022, 38( 3): 587- 593. DOI: 10.3969/j.issn.1001-5256.2022.03.018.
[22]	WU N, CAI GM, HE Q. Oxidative stress and hepatic injury[J]. World Chin J Dig, 2008, 16( 29): 3310- 3315. DOI: 10.3969/j.issn.1009-3079.2008.29.012. 吴娜, 蔡光明, 何群. 氧化应激与肝脏损伤[J]. 世界华人消化杂志, 2008, 16( 29): 3310- 3315. DOI: 10.3969/j.issn.1009-3079.2008.29.012.
[23]	GAO W, ZHANG XH, ZHANG YZ, et al. Protective effect of Shuganning injection on NAFLD model of tissue engineering liver[J]. Chin J Integr Tradit West Med Liver Dis, 2022, 32( 3): 248- 251. DOI: 10.3969/j.issn.1005-0264.2022.03.017. 高文, 张晓慧, 张译之, 等. 舒肝宁注射液对非酒精性脂肪性肝病组织工程肝保护作用的机制研究[J]. 中西医结合肝病杂志, 2022, 32( 3): 248- 251. DOI: 10.3969/j.issn.1005-0264.2022.03.017.
[24]	YAO N. Clinical efficacy of reduced glutathione combined with compound monoammonium glycyrrhizinate S in the treatment of chronic hepatitis B[J]. J N Pharm, 2020, 17( 2): 33- 34. DOI: 10.3969/j.issn.1672-8351.2020.02.022. 姚楠. 还原型谷胱甘肽联合复方甘草酸单铵S治疗慢性乙型肝炎的临床疗效[J]. 北方药学, 2020, 17( 2): 33- 34. DOI: 10.3969/j.issn.1672-8351.2020.02.022.
[25]	ZANG XZ, ZHANG XJ, LI J. Comparative efficacy of shuganning with glutathione of acute liver injury[J]. Med Philos, 2013, 34( 2): 30- 32. 臧晓珍, 张晓健, 李静. 舒肝宁与还原型谷胱甘肽对急性肝损害的疗效比较[J]. 医学与哲学, 2013, 34( 2): 30- 32.
[26]	PENG SF. Clinical efficacy of Shuganning in the treatment of acute icteric viral hepatitis[J]. Chin J Clin Ration Drug Use, 2021, 14( 9): 123- 125. DOI: 10.15887/j.cnki.13-1389/r.2021.09.044. 彭双福. 舒肝宁治疗急性黄疸型病毒性肝炎的临床疗效[J]. 临床合理用药杂志, 2021, 14( 9): 123- 125. DOI: 10.15887/j.cnki.13-1389/r.2021.09.044.
[27]	SUN YM, ZHANG BJ. Clinical study of shuganning injection combined with reduced glutathione for injection in the treatment of drug-induced liver injury[J]. Chin J Integr Tradit West Med Liver Dis, 2019, 29( 6): 516- 519. DOI: 10.3969/j.issn.1005-0264.2019.06.013. 孙玉明, 张帮杰. 舒肝宁注射液联合还原型谷胱甘肽治疗药物性肝损伤的临床研究[J]. 中西医结合肝病杂志, 2019, 29( 6): 516- 519. DOI: 10.3969/j.issn.1005-0264.2019.06.013.

Relative Articles

Supplements(0)

Cited By

Proportional views

Proportional views

通讯作者: 陈斌, bchen63@163.com

1.
沈阳化工大学材料科学与工程学院沈阳 110142

Tables(6)

Get Citation

PDF

XML

Article Metrics

Article views (105) PDF downloads(18)

Efficacy and safety of Shuganning injection in treatment of liver injury： A clinical analysis

DOI: 10.12449/JCH260617

Abstract

References

Proportional views

Catalog

通讯作者: 陈斌, bchen63@163.com

Article Metrics

Proportional views

Related

About Journal

Submission Guideline

Journal Online

Hepatobiliary College

Guidelines

Export File

Citation

Format

Content