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Background The safety assessment of ulinastatin can guide clinical practice. The present study aimed to investigate the real-world safety of ulinastatin in China. Methods This multicenter study retrospectively analyzed the post-marketing surveillance data of consecutive patients treated with ulinastatin between August 2014 and June 2017 in the general wards and the intensive care units (ICU) of nine hospitals in China. Adverse drug reactions/adverse drug events (ADRs/ADEs) were collected and evaluated in a post-marketing database. Results A total of 11,252 consecutive patients were included in the study: 7009 ICU patients and 4243 general ward patients. Eleven patients with ADRs/ADEs were observed, including nine ICU patients and two general ward patients. The clinical manifestations were liver dysfunction (n = 5 ICU cases, n = 1 general case), thrombocytopenia (n = 2 ICU cases, n = 1 general case), leukopenia (n = 1 ICU case), and rash (n = 1 ICU case). During the study period, the drug ADR/ADE rate of ulinastatin injection was 0.98‰ (11/11,252 × 1000‰). Among the 11,252 valid patients, only 327 received ulinastatin in accordance with the drug specifications. After excluding unreasonable drug use, the calculated ADR rate was 3.06‰ (1/327 × 1000‰) (95% confidence interval: 0.0‰-17.1‰). In ICU and general ward patients, the use of other drugs combined with ulinastatin was associated with the occurrence of ADRs/ADEs (100% with ADRs/ADEs vs. 0% in controls, P Conclusions The incidence of ADRs/ADEs of ulinastatin is

Spinal cord injury (SCI), mostly caused by sports injuries, falls, or traffic accidents, is a major cause of disability. The aim of current work was to investigate the therapeutic effect of isorhamnetin (ISO) on functional recovery in rats with SCI. The male adult rats were exposed to a clip-compression SCI and treated with ISO. ISO treatment improved locomotor function and reduced the loss of motor neurons in SCI rats. Treatment with ISO markedly relieved SCI-induced hypersensitivities to mechanical and thermal stimulation in rats. ISO treatment activated nuclear factor-erythroid 2-related factor 2 (Nrf2)/heme oxygenase 1 (HO-1) pathway and abated oxidative stress in injured spinal cords. ISO treatment partly suppressed microglial and glial activation and reduced expression of inflammatory cytokines including TNF-α, monocyte chemotactic protein-1 (MCP-1), and IL-1β in injured spinal cords. More importantly, ISO treatment promoted M2 macrophage activation in the injured region. lipopolysaccharide (LPS) or IL-4 was employed to stimulate macrophages/microglia into M1 or M2 phenotype in cultured BV2 cells in vitro. ISO treatment enhanced the expression of characteristic microglial anti-inflammatory polarization markers in BV2 cells. In conclusions, ISO treatment promotes functional recovery in rats with SCI by abating oxidative stress and modulating M1/M2 macrophage polarization.