Title-effectiveness and safety of Danshen injection for acute kidney injury in primary nephrotic syndrome.

OBJECTIVE

To assess the clinical effectiveness and safety of Danshen injection 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.