Trial reportPloS one2017
Safety and tolerability of high-dose ulinastatin after 2-hour intravenous infusion in adult healthy Chinese volunteers: A randomized, double-blind, placebo-controlled, ascending-dose study.
Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 24 citations in OpenAlex.
- Immunomodulatory effects of ulinastatin combined with continuous blood purification in sepsis: a systematic review and meta-analysis.Frontiers in pharmacology · 2025Pooled it
- The impact of ulinastatin on wound infection and healing in patients with burn wounds: A meta-analysis.International wound journal · 2024Pooled it
- Pooled it
- Efficacy and Safety of Ulinastatin in Post-traumatic Sepsis: A Randomized Controlled Trial.Drugs in R&D · 2025Trial
- A risk prediction model for medication safety: assessing cardiopulmonary adverse outcomes in 11,252 patients treated with ulinastatin.Frontiers in pharmacology · 2026Article
- Effects of different doses of ulinastatin on organ protection of deep hypothermic circulatory arrest in rats.Journal of cardiothoracic surgery · 2025Article
- The effect of ulinastatin on acute kidney injury in patients undergoing off-pump cardiac bypass surgery.Journal of cardiothoracic surgery · 2024Article
- Efficacy of Ulinastatin in the Treatment of COVID-19: A Retrospective Study.International journal of general medicine · 2024Article
- Real-world safety of ulinastatin: a post-marketing surveillance of 11,252 patients in China.BMC pharmacology & toxicology · 2022Article
- Treatment of patients with Covid-19 with a high dose of ulinastatin.Experimental and therapeutic medicine · 2022Article
- Cytokine release syndrome in COVID-19: a major mechanism of morbidity and mortality.International reviews of immunology · 2022Article
- High-dose ulinastatin to prevent late-onset acute renal failure after orthotopic liver transplantation.Renal failure · 2020Article
- The severe COVID-19: A sepsis induced by viral infection? And its immunomodulatory therapy.Chinese journal of traumatology = Zhonghua chuang shang za zhi · 2020Review
- Research progress of ulinastatin in the treatment of liver diseases.International journal of clinical and experimental pathology · 2020Review
- Intravenous infusion of ulinastatin attenuates acute kidney injury after cold ischemia/reperfusion.International urology and nephrology · 2019Article
- The Protective Roles of Urinary Trypsin Inhibitor in Brain Injury Following Fat Embolism Syndrome in a Rat Model.Cell transplantation · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Ulinastatin, is a broad-spectrum protease inhibitor purified from human urine, inhibits endogenous proteases such as trypsin, α-chymotrypsin, hyaluronidase, and plasmin. It is widely being used at increasingly higher doses for the treatment of acute or chronic pancreatitis, severe infection, and acute organ failure. We aimed to evaluate the safety and tolerability of high-dose ulinastatin in healthy volunteers in our single center, randomized, double-blind, placebo-controlled, single-dose escalation study. Fifty-one healthy Chinese subjects were enrolled in 9 dose cohorts (3×105 U, 6×105 U, 12×105 U, 20×105 U, 30×105 U, 45×105 U, 60×105 U, 70×105 U, or 80×105 U of ulinastatin) and randomized to UTI or matching placebo (n = 1). Each dose cohort was composed of 3-7 subjects. All subjects were required to have 2 h of intravenous infusion. Safety and tolerability were assessed throughout the study via monitoring of vital signs, physical examinations, clinical laboratory tests, 12-lead electrocardiograms, and interviews with the subjects about adverse events. Fifty-one subjects (35 men and 16 women) completed the study. A total of 13 AEs were reported by 10 subjects: 11 adverse events in the ulinastatin groups and 2 adverse events in the placebo group. Twelve of the adverse events were possibly related to the study drug. The most common drug-related adverse events included dizziness, pain at injection site, and a decrease in white blood cell count. All adverse events were of mild severity; none were serious. In conclusion, 2 hours of intravenous infusion of ulinastatin (3×105 to 80×105 U) was well tolerated by healthy Chinese subjects.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.