Randomized Controlled Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Jul 6, 2023; 11(19): 4601-4611
Published online Jul 6, 2023. doi: 10.12998/wjcc.v11.i19.4601
Ulinastatin in the treatment of severe acute pancreatitis: A single-center randomized controlled trial
Su-Qin Wang, Wei Jiao, Jing Zhang, Ju-Fen Zhang, Yun-Na Tao, Qing Jiang, Feng Yu
Su-Qin Wang, Qing Jiang, Feng Yu, Department of General Surgery, The 904th Hospital of Joint Logistic Support Force, Wuxi 214044, Jiangsu Province, China
Wei Jiao, Jing Zhang, Department of Nursing, The 904th Hospital of Joint Logistic Support Force, Wuxi 214044, Jiangsu Province, China
Ju-Fen Zhang, Yun-Na Tao, Department of Neurosurgery, The 904th Hospital of Joint Logistic Support Force, Wuxi 214044, Jiangsu Province, China
Author contributions: Wang SQ and Jiao W contributed equally to this work; Wang SQ, Jiao W, Zhang J, Tao YN and Yu F designed the research study; Wang SQ, Zhang JF, Tao YN and Jiang Q performed the research; Wang SQ and Zhang JF contributed new reagents and analytic tools; Wang SQ, Jiao W and Yu F analyzed the data and wrote the manuscript; All authors have read and approve the final manuscript.
Supported by Wuxi Science and Technology Development Fund, No. WX03-02B0205-072001-10.
Institutional review board statement: The protocol approval from the Clinical Research Ethics Committees of the 904th Hospital of PLA endorsed the methodology used in the present research (2018-YXLL-097) and was following the Declaration of Helsinki.
Clinical trial registration statement: This study was registered at Hospital clinical trial registry (date: 9/Sep/2018), No. CWXH-IPR-2018015.
Informed consent statement: Written informed consent was obtained from patients whose competence was established by their accurate orientation for time, place, and person, as well as an understanding of the recruiter’s description of the trial or from their next of kin or legal representative.
Conflict-of-interest statement: The authors declare that there are no conflicting interests.
Data sharing statement: The datasets used and/or analyzed during the current study, including the redacted study protocol, redacted statistical analysis plan, and individual participant data supporting the results reported, are available from the corresponding authors upon reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Feng Yu, MM, Doctor, Department of General Surgery, The 904th Hospital of Joint Logistic Support Force, No. 101 Xing Yuan North Road, Wuxi 214044, Jiangsu Province, China. yufeng904@21cn.com
Received: March 22, 2023
Peer-review started: March 22, 2023
First decision: May 12, 2023
Revised: May 16, 2023
Accepted: June 2, 2023
Article in press: June 2, 2023
Published online: July 6, 2023
Processing time: 100 Days and 6.3 Hours
Abstract
BACKGROUND

Severe acute pancreatitis (AP) is one of the most common diseases of the gastrointestinal tract and carries a significant financial burden with high disability and mortality. There are no effective drugs in the clinical management of severe AP, and there is an absence of evidence-based medicine concerning the treatment of severe AP.

AIM

To explore whether ulinastatin (UTI) can improve the outcome of severe AP.

METHODS

The present research included patients who were hospitalized in intensive critical care units (ICUs) after being diagnosed with severe AP. Patients received UTI (400000 IU) or placebos utilizing computer-based random sequencing (in a 1:1 ratio). The primary outcome measures were 7-d mortality, clinical efficacy, inflammatory response, coagulation function, infection, liver function, renal function, and drug-related adverse effects were evaluated.

RESULTS

A total of 181 individuals were classified into two groups, namely, the placebo group (n = 90) and the UTI group (n = 91). There were no statistically significant differences in baseline clinical data between the two groups. The 7-d mortality and clinical efficacy in the UTI group were remarkably improved compared with those in the placebo group. UTI can protect against hyperinflammation and improve coagulation dysfunction, infection, liver function, and renal function. UTI patients had markedly decreased hospital stays and hospitalization expenditures compared with the placebo group.

CONCLUSION

The findings from the present research indicated that UTI can improve the clinical outcomes of patients with severe AP and has fewer adverse reactions.

Keywords: Ulinastatin; 7-day mortality; Severe acute pancreatitis; Randomized controlled trial; Outcome

Core Tip: One of the most prevalent gastrointestinal tract gastrointestinal disorders, severe acute pancreatitis (AP), is the leading cause of hospitalization due to gastrointestinal diseases. The present study suggests that ulinastatin (UTI) can reduce the risk of overall 7-d mortality in severe AP patients and is associated with a higher total effective rate vs the placebo control group. We also found that UTI can protect against hyperinflammation. It also did not significantly increase the incidence rate of severe adverse effects.