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

doi:10.19852/j.cnki.jtcm.2026.01.021

Abstract

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.

Key words: acute kidney injury, nephrotic syndrome, Danshen (Radix Salviae Miltiorrhizae), Danshen injection

SHI Yanling, ZHU Jianfen, CHEN Bo, YOU Xiaohan, CHEN Xinxin, CHEN Tianxin. 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.

Figures/Tables 4

Figure 1 Description of cohort selection aDiabetic nephropathy (n = 528), lupus nephritis (n = 272), castleman syndrome (n = 2), cryoglobulinemia (n = 1), lymphoma (n = 5), systemic vasculitis (n = 9), hepatitis C associated nephritis (n = 1), hepatitis B associated nephritis (n = 13), monoclonal immunoglobulinemia (n = 32), amyloidosis (n = 30), Sjogren's disease (n = 3), myeloma (n = 14), macroglobulinemia (n = 1) and Henoch-Schonlein purpura nephritis (n = 21); bHemorrhage hypotension (n = 7), hemolytic-uremic syndrome (n = 1), IgA nephropathy with malignant hypertension (n = 1), IgG4 related tubulointerstial nephritis (n = 1), infection (n = 64), obstructive nephropathy (n = 7), heart failure (n = 5), nephrotoxic drug (n = 1). PNS: primary nephrotic syndrome; AKI: acute kidney injury; ADPKD: autosomal dominant polycystic kidney disease; SC group: patients receiving supportive care; DS group: patients receiving Danshen injection, 20 mL Danshen injection in 100 or 250 mL of 5% glucose was administered intravenously once daily for 5-15 d. IgA: immunoglobulin A; IgG4: immunoglobulin G4.

Table 1 Baseline characteristics after propensity score matching

Characteristic	Total (n = 380)	SC (n = 285)	DS (n = 95)	P value
Male [n (%)]	291 (76.6)	217 (76.1)	74 (77.9)	0.834
Age [years, median (IQR)]	62 (48, 71)	62 (48, 71)	63 (49, 71)	0.594
PNS duration [days, median (IQR)]	51 (38, 61)	51 (38, 61)	50 (30, 61)	0.423
Pathological diagnosis [n (%)]				0.110
Non biopsy^a	95 (25.0)	72 (25.3)	23 (24.2)
MCD	92 (24.2)	69 (24.2)	23 (24.2)
MN	149 (39.2)	105 (36.8)	44 (46.3)
Other^b	44 (11.6)	39 (13.7)	5 (5.3)
Baseline comorbidities [n (%)]
HP	243 (63.9)	185 (64.9)	58 (61.1)	0.579
DM	82 (21.6)	56 (19.6)	26 (27.4)	0.150
SBP (mm Hg, $\bar{x} \pm s$)	142±22	143±22	139±23	0.100
DBP (mm Hg, $\bar{x} \pm s$)	84±14	84±15	81±14	0.074
Normal value of Scr (μmol/L, $\bar{x} \pm s$)	76±11	76±11	76±11	0.550
Scr [μmol/L, median (IQR)]	144.5 (117.0, 191.2)	140.0 (117.0, 186.0)	156.0 (123.5, 207.5)	0.071
AKI stage [n (%)]				0.144
1	172 (45.3)	137 (48.1)	35 (36.8)
2	106 (27.9)	77 (27.0)	29 (30.5)
3	102 (26.8)	71 (24.9)	31 (32.6)
ACR [mg/g, median (IQR)]	4832 (3249, 6544)	5002 (3277, 6922)	4214 (3234, 6147)	0.170
ALB [g/L, median (IQR)]	19.0 (15.8, 23.9)	18.7 (16.1, 23.5)	21.1 (15.3, 26.1)	0.112
TG [mmol/L, median (IQR)]	2.25 (1.65, 3.10)	2.29 (1.69, 3.14)	2.11 (1.61, 2.82)	0.183
LDL [mmol/L, median (IQR)]	4.73 (3.30, 6.41)	4.90 (3.47, 6.43)	4.27 (2.70, 6.27)	0.009
Immunosuppresive therapy [n (%)]
Corticosteroids	316 (83.2)	242 (84.9)	74 (77.9)	0.154
CTX	55 (14.5)	36 (12.6)	19 (20.0)	0.110
FK506	59 (15.5)	28 (9.8)	31 (32.6)	<0.001
CsA	10 (2.6)	6 (2.1)	4 (4.2)	0.459
Rituximab	8 (2.1)	6 (2.1)	2 (2.1)	1.000
Diuretics treatment [n (%)]	216 (56.8)	179 (62.8)	37 (38.9)	<0.001

Figure 2 Comparison of recovery rate between two groups after propensity score matching A: complete recovery rate (DS vs SC) was 72.9% vs 65.1% (P = 0.130) at 6 months; B: partial recovery rate (DS vs SC) was 71.0% vs 37.5% (P = 0.011) at 6 months; C: all recovery rate (DS vs SC) was 93.4% vs 79.1% (P = 0.006) at 6 months. SC group: patients receiving supportive care; DS group: patients receiving Danshen injection; 20 mL Danshen injection in 100 or 250 mL of 5% glucose was administered intravenously once daily for 5-15 d. DS: Danshen injection; SC: supportive care. Comparisons of the primary outcome were performed by Kaplan-Meier curves and log-rank test. P values less than 0.05 were considered statistically significant.

Figure 3 Association between Danshen injection and renal recovery in intention-to-treat follow-up analysis after propensity score matching SC group: patients receiving supportive care; DS group: patients receiving Danshen injection. 20 mL Danshen injection in 100 or 250 mL of 5% glucose was administered intravenously once daily for 5-15 d. HR: hazard ratios; SC: supportive care; DS: Danshen injection; CI: confidence interval. HR and 95% CIs were assessed using Cox proportional hazards regression models. Diuretics subgroup means the patients receiving diuretics treatment. P values less than 0.05 were considered statistically significant.

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