Original Articles

Title-effectiveness and safety of Danshen injection (丹参注射液) for acute kidney injury in primary nephrotic syndrome

  • Yanling SHI ,
  • Jianfen ZHU ,
  • Bo CHEN ,
  • Xiaohan YOU ,
  • Xinxin CHEN ,
  • Tianxin CHEN
Expand
  • 1 Department of Nephrology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325015, China
    2 Department of Internal Medicine Nursing and Endoscopy Center, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325015, China
SHI Yanling and ZHU Jianfen are co-first authors and contributed equally to this work

Received date: 2024-11-16

  Accepted date: 2025-04-14

  Online published: 2026-01-28

Supported by

Key Project of Science and Technology Program Co-constructed by the Science and Technology Department of the National Administration of Traditional Chinese Medicine of China and Administration of Traditional Chinese Medicine of Zhejiang Province: A Study on the Efficacy and Safety of Danshen (Radix Salviae Miltiorrhizae) in Treating Acute Kidney Injury in Patients with Primary Nephrotic Syndrome(GZY-ZJ-KJ-23085);Basic Research Project of Wenzhou Science and Technology Bureau: the Mechanism of Hypoxia Induicible Factor-1 alpha Down-regulating Angiotensin-converting Enzyme 2 in Proximal Renal Tubular Epithelial Cells Leading to Brush Border Shedding in Early Acute Kidney Injury Induced by Sepsis(Y20240071)

Abstract

OBJECTIVE: To assess the clinical effectiveness and safety of Danshen injection (丹参注射液) following immunosuppressive therapy in primary nephrotic syndrome (PNS) with acute kidney injury (AKI) patients.

METHODS: PNS with AKI patients selected from nephrotic syndrome inpatients between 2012 and 2022 were divided into two groups according to the treatment regimen: the DS group who were treated with the Danshen injection and the SC group who received supportive care. Propensity score matching was used to balance the confounding factors between the two groups. The outcomes were complete and partial renal function recovery for effectiveness analysis and severe bleeding events for safety analysis. Kaplan-Meier curves and log-rank tests were used to compare cumulative recovery rates. Outcome risks were assessed using Cox proportional hazard regression models.

RESULTS: The study enrolled 441 patients with PNS and AKI from a population of 3873 inpatients with nephrotic syndrome. Among them, 95 received Danshen injection, and 346 received supportive care. After propensity score matching, 95 patients in the DS group and 285 patients in the SC group were analyzed. No significant difference was observed in the complete recovery rate for the DS group vs SC group (72.9% vs 65.1%, P = 0.130) at 6 months. Compared with the SC group, the DS group was associated with a significantly higher partial recovery rate (71.0% vs 37.5%, P = 0.011) at 6 months and all recovery rates (93.4% vs 79.1%, P = 0.006) at 6 months.

CONCLUSION: In this real-world retrospective study of PNS with AKI patients, Danshen injection following immunosuppressive therapy and prophylactic anticoagulation with low molecular heparin significantly increased 6-month partial renal function recovery and had a safety profile. Further randomized clinical trials are warranted to confirm the benefit of Danshen (Radix Salviae Miltiorrhizae) in these patients.

Cite this article

Yanling SHI , Jianfen ZHU , Bo CHEN , Xiaohan YOU , Xinxin CHEN , Tianxin CHEN . Title-effectiveness and safety of Danshen injection (丹参注射液) for acute kidney injury in primary nephrotic syndrome[J]. Journal of Traditional Chinese Medicine, 2026 , 46(1) : 219 -225 . DOI: 10.19852/j.cnki.jtcm.2026.01.021

References

1. Menon S. Acute kidney injury in nephrotic syndrome. Front Pediatr 2019; 6: 428.
2. Lu H, Xiao L, Song M, Liu X, Wang F. Acute kidney injury in patients with primary nephrotic syndrome: influencing factors and coping strategies. BMC Nephrol 2022; 23: 90.
3. Chen T, Zhou Y, Chen X, Chen B, Pan J. Acute kidney injury in idiopathic membranous nephropathy with nephrotic syndrome. Ren Fail 2021; 43: 1004-11.
4. Chen T, Lü Y, Lin F, Zhu J. Acute kidney injury in adult idiopathic nephrotic syndrome. Renal Fail 2011; 33: 144-9.
5. KDIGO 2021 Clinical practice guideline for the management of glomerular diseases. Kidney Int 2021; 100: S1-S276.
6. Lian F, Wu L, Tian J, et al. The effectiveness and safety of a Danshen-containing Chinese herbal medicine for diabetic retinopathy: a randomized, double-blind, placebo-controlled multicenter clinical trial. J Ethnopharmacol 2015; 164: 71-7.
7. Lü J, Xue M, Li J, et al. Clinical effectiveness and safety of salvia miltiorrhiza depside salt combined with aspirin in patients with stable angina pectoris: a multicenter, pragmatic, randomized controlled trial. Phytomedicine 2021; 81: 153419.
8. Zhang Y, Xie Y, Liao X, et al. A Chinese patent medicine Salvia miltiorrhiza depside salts for infusion combined with conventional treatment for patients with angina pectoris: a systematic review and Meta-analysis of randomized controlled trials. Phytomedicine 2017; 25: 100-17.
9. Lameire NH, Levin A, Kellum JA, et al. Harmonizing acute and chronic kidney disease definition and classification: report of a kidney disease: Improving Global Outcomes (KDIGO) Consensus Conference. Kidney Int 2021; 100: 516-26.
10. KDIGO Work Group. Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney Int 2012; 2: 1-138.
11. KDIGO Work Group. Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for glomerulonephritis. Kidney Int 2012; 2: 1-143.
12. Johnston SC, Amarenco P, Denison H, et al. Ticagrelor and aspirin or aspirin alone in acute ischemic stroke or TIA. N Engl J Med 2020; 383: 207-17.
13. GUSTO Investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med 1993; 329: 673-82.
14. Anonymous (Eastern Han Dynasty). Shen Nong Ben Cao Jing. Beijing: Xueyuan Publishing House, 2008: 95-6.
15. Li, SZ (Qing Dynasty). Ben Cao Gang Mu. Beijing: Huaxia Publishing House, 2008: 476-7.
16. Dou JY, Zhang M, Cen H, et al. Salvia miltiorrhiza Bunge (Danshen) and bioactive compound tanshinone ⅡA alleviates cisplatin-induced acute kidney injury through regulating PXR/NF-κB signaling. Front Pharmacol 2022; 13: 860383.
17. Sun D, Cui S, Ma H, et al. Salvianolate ameliorates renal tubular injury through the Keap1/Nrf2/ARE pathway in mouse kidney ischemia-reperfusion injury. J Ethnopharmacol 2022; 293: 115331.
18. Diao HY, Zhu W, Liu J, et al. Salvianolic Acid A improves rat kidney injury by regulating MAPKs and TGF-β1/Smads signaling pathways. Molecules 2023; 28: 3630.
19. Zeng X, Chen X, Qin H, et al. Preventive effects of a natural anti-inflammatory agent Salvianolic acid A on acute kidney injury in mice. Food Chem Toxicol 2020; 135: 110901.
20. Cameron JS. The nephrotic syndrome and its complications. Am J Kidney Dis 1987; 10: 157-71.
21. Meyrier A, Niaudet P. Acute kidney injury complicating nephrotic syndrome of minimal change disease. Kidney Int 2018; 94: 861-9.
22. Jia Y, Huang F, Zhang S, Leung SW. Is Danshen (Salvia miltiorrhiza) dripping pill more effective than isosorbide dinitrate in treating angina pectoris? A systematic review of randomized controlled trials. Int J Cardiol 2012; 157: 330-40.
23. Jia Y, Leung SW. How efficacious is Danshen (Salvia miltiorrhiza) Dripping pill in treating angina pectoris? Evidence assessment for Meta-analysis of randomized controlled trials. J Altern Complement Med 2017; 23: 676-84.
24. Bai R, Yang Q, Xi R, et al. The effectiveness and safety of Chinese Patent Medicines based on syndrome differentiation in patients following percutaneous coronary intervention due to acute coronary syndrome (CPM trial): a nationwide cohort study. Phytomedicine 2023; 109: 154554.
25. Ren J, Fu L, Nile SH, Zhang J, Kai G. Salvia miltiorrhiza in treating cardiovascular diseases: a review on its pharmacological and clinical applications. Front Pharmacol 2019; 10: 753.
26. Fugh-Berman A. Herb-drug interactions. Lancet 2000; 355: 134-8.
27. Chen T, Zhou Y, Zhu J, Chen X, Pan J. Prediction model of renal function recovery for primary membranous nephropathy with acute kidney injury. BMC Nephrol 2022; 23: 247.
Outlines

/