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
ARTICLE HIGHLIGHTS
Research background

Severe acute pancreatitis (AP) is one of the most common diseases of the gastrointestinal tract, is the leading cause of hospitalization due to gastrointestinal diseases. Surgical treatment is currently the mainstay in clinical practice, is associated with multiple complications, postoperative body pain, and delayed postoperative recovery. Ulinastatin (UTI) is a serine protease inhibitor, which seemed to show a beneficial effect for acute respiratory distress syndrome patient treatment but lacked a larger sample size of randomized controlled trials.

Research motivation

To evaluate the clinical value and safety of UTI in severe AP.

Research objectives

This research was conducted to determine whether UTI might be used to improve the outcomes of patients with severe AP.

Research methods

Patients with severe AP who were transferred to intensive critical care units were enrolled in the current study. Patients were assigned at random (ratio of 1:1) using a computer to receive either a UTI (400000 IU) or a placebo. The seven-day mortality rate, clinical efficacy, and drug-associated side events were evaluated.

Research results

No statistically significant differences in baseline clinical data between the two groups. When compared with the results obtained from the placebo category, both the clinical efficacy and the seven-day mortality rate for the UTI category showed significant improvements. UTI therapy was shown to protect against hyperinflammation, attenuate coagulation dysfunction and infection, and even improve liver and kidney functioning. Hospitalization durations for UTI-treated patients were much lower than those in the placebo category.

Research conclusions

Treatment with UTI may enhance therapeutic efficacy for individuals with severe AP and is associated with fewer side effects.

Research perspectives

A large number study with varied dosages, and long-term outcome follow-up are needed.