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
Abstract
BACKGROUND

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

AIM

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

METHODS

A total of 399 IS patients treated at six hospitals from August 2018 to August 2019 were retrospectively analyzed. The patients were given Guhong injection (experimental group) or Butylphthalide and Sodium Chloride Injection (control group). Changes in National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) scores were observed before treatment and at 1, 2, and 3 wk after treatment in each group. The efficacy and safety of Guhong injection for IS were assessed. Other medications taken by the patients were confounding factors for efficacy assessment. These factors were controlled by propensity score matching, and the results were further analyzed based on the matching.

RESULTS

The marked response rates at three follow-up visits were 64.64%, 74.7%, and 66.7% in the experimental group, and 48.26%, 45.4%, and 22.2% in the control group. The marked response rates increased significantly in the experimental group compared with the control group (P < 0.05). The overall response rate at the first visit (days 7 ± 2) did not differ significantly between the two groups, but differed significantly at the second (days 14 ± 2) and third visits (days 21 ± 3) (P < 0.05). The proportion of patients without any symptoms in the experimental group was significant different at the first visit (P < 0.05), but not significantly different at the second visit. The two groups showed no significant difference in the baseline distribution of mRS scores. At the first and second visits, the change in mRS scores was -2 and -1 in the experimental and control groups, respectively, which were significantly different (P < 0.05). After propensity score matching, the overall response rate and marked response rate were 97.29% and 100% in the experimental group (P > 0.05) and 64.0% and 47.7% in the control group (P < 0.05) at the first visit, respectively. The decreased NIHSS scores in the two groups were significant different (P < 0.05). The overall response rate and marked response rate differed significantly between the two groups at the second visit (P < 0.05). There was no significant difference in the incidence of adverse events between the two groups. No severe adverse events occurred in either group.

CONCLUSION

Guhong injection is safe and more effective than Butylphthalide and Sodium Chloride Injection for treatment of IS.

Keywords: Guhong injection, Ischemic stroke, Propensity score matching, National Institutes of Health Stroke Scale

Core Tip: Guhong injection, composed of aceglutamide and safflower aqueous extract, is widely used for the treatment of ischemic stroke (IS). For treatment of IS, Guhong injection has greater clinical efficacy and similar safety as Butylphthalide and Sodium Chloride Injection.