ArticleBMC pharmacology & toxicology2022
Real-world safety of ulinastatin: a post-marketing surveillance of 11,252 patients in China.
Article in BMC pharmacology & toxicology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 18 citations in OpenAlex.
- Efficacy and Safety of Ulinastatin in Post-traumatic Sepsis: A Randomized Controlled Trial.Drugs in R&D · 2025Trial
- Ulinastatin in the treatment of radiotherapy-induced oral mucositis in locoregionally advanced nasopharyngeal carcinoma: a phase 3 randomized clinical trial.Nature communications · 2025Trial
- A risk prediction model for medication safety: assessing cardiopulmonary adverse outcomes in 11,252 patients treated with ulinastatin.Frontiers in pharmacology · 2026Article
- Ulinastatin inhibits macrophage M1 polarization to improve acute pancreatitis-associated intestinal barrier dysfunction by promoting Nrf2 signaling pathway activation.European journal of medical research · 2025Article
- Targeting c-Jun orchestrates heat stroke-induced myocardial injury and reveals its biomarker potential.Frontiers in immunology · 2025Article
- The Preventive Effect of Ulinastatin on Blood-Brain Barrier Dysfunction in Rats with Postoperative Cognitive Dysfunction After General Anaesthesia with Isoflurane.International journal of molecular sciences · 2024Article
- Continuous renal replacement therapy combined with ulinastatin in acute respiratory distress syndrome: A systematic review and meta-analysis.Annals of thoracic medicineReview
- Ulinastatin shortens the length of ICU stay in critical patients with organ failure: A 7-year real-world study.Science progressArticle
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Authors and funding
10 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe safety assessment of ulinastatin can guide clinical practice. The present study aimed to investigate the real-world safety of ulinastatin in China.
methodsThis 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.
resultsA 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 < 0.001).
conclusionsThe incidence of ADRs/ADEs of ulinastatin is < 5‰. The ADRs/ADEs involved limited organs, mainly the skin, gastrointestinal tract, and blood. In most cases, the ADRs/ADEs gradually alleviated or recovered after drug withdrawal. The inappropriate/off-label use of ulinastatin should be the focus of surveillance.
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