Case Control Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Jul 26, 2022; 10(21): 7265-7274
Published online Jul 26, 2022. doi: 10.12998/wjcc.v10.i21.7265
Efficacy of Guhong injection versus Butylphthalide and Sodium Chloride Injection for mild ischemic stroke: A multicenter controlled study
Wei-Wei Zhang, Jiang Xin, Guang-Yu Zhang, Qi-Jin Zhai, Hua-Min Zhang, Cheng-Si Wu
Wei-Wei Zhang, Department of Neurology, The Seventh Medical Center of PLA General Hospital, Beijing 100039, China
Jiang Xin, Department of Neurology, Liaoning Provincial People’s Hospital, Shenyang Liaoning Provincial People's Hospital, Shenyang 110016, Liaoning Province, China
Guang-Yu Zhang, Department of Neurology, Cangzhou City People’s Hospital, Cangzhou 061000, Hebei Province, China
Qi-Jin Zhai, Department of Neurology, Huai’an Second People’s Hospital, Huai’an 223002, Jiangsu Province, China
Hua-Min Zhang, Department of Neurology, Ganyu People’s Hospital of Lianyungang, Ganyu 222100, Jiangsu Province, China
Cheng-Si Wu, Department of Neurology, The First Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China
Author contributions: Zhang WW wrote the paper; Wu CS, Xin J, and Zhang GY supervised the report; Zhao LD contributed to the analysis; Zhang HM provided clinical advice; all authors designed and performed the research, and gave final approval for the version to be submitted.
Institutional review board statement: The present study was approved by the Ethics Committee of the Seventh Medical Center of General PLA hospital (2020-001).
Informed consent statement: Patients were not required to give informed consent to the study because the analysis used anonymous clinical data that were obtained after each patient agreed to treatment by written consent.
Conflict-of-interest statement: There are no conflicts of interest to declare.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at amy_1119@163.com.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
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: Cheng-Si Wu, MD, Associate Chief Physician, Department of Neurology, The First Affiliated Hospital of Nanchang University, No. 17 Yongwai Street, Nanchang 330006, Jiangxi Province, China. amy_1119@163.com
Received: December 2, 2021
Peer-review started: December 2, 2021
First decision: January 10, 2022
Revised: February 7, 2022
Accepted: May 28, 2022
Article in press: May 28, 2022
Published online: July 26, 2022
Processing time: 220 Days and 22.5 Hours
ARTICLE HIGHLIGHTS
Research background

Efforts should be made to restore microcirculation in ischemic regions as quickly as possible to protect the brain nerves maximally, and there are many neuroprotective drugs in clinical application.

Research motivation

Most studies on Guhong injection have involved a single center with a small sample size, with a low level of clinical evidence.

Research objectives

To assess the safety and efficacy of Guhong injection for mild ischemic stroke (IS).

Research methods

IS patients who met the inclusion and exclusion criteria were enrolled from six hospital in China and divided into two groups treated with Guhong injection or Butylphthalide and Sodium Chloride Injection. The National Institute of Health Stroke Scale (NIHSS) scores and modified Rankin scale (mRS) were compared between the two groups after treatment. Conditional logistic regression was used to calculate the propensity scores of the two groups. After performing the 1:1 nearest-neighbor matching, we compared the efficacy between the two groups.

Research results

The marked response rates were increased significantly in the experimental group compared with the control group. The overall response rate was significantly different at the second (days 14 ± 2) and third visit (days 21 ± 3). At the first and second visits, the change in mRS scores was -2 and -1 in the two groups, which were significantly different. There was no significant difference in the incidence of adverse events between the two groups. No severe adverse events occurred in either group. The results showed that Guhong injection had greater clinical efficacy than Butylphthalide and Sodium Chloride Injection for IS in a large sample.

Research conclusions

The research suggested that Guhong injection compared with Butylphthalide and Sodium Chloride Injection increases the response rate and shortened the length of hospital stay in patients with IS. Guhong injection has greater clinical efficacy for IS.

Research perspectives

Further study on the mechanism of Guhong injection for treatment of IS is required.