Meta-analysis of the efficacy and safety of Ginkgolide Meglumine Injection combined with Butylphthalide in the treatment of Acute Ischemic Stroke

PLoS One. 2024 Jan 5;19(1):e0296508. doi: 10.1371/journal.pone.0296508. eCollection 2024.

Abstract

Objective: To evaluate the efficacy and safety of Ginkgolide Meglumine Injection (GMI) combined with Butylphthalide in the treatment of Acute Ischemic Stroke (AIS), and provide reference for rational clinical medication.

Methods: PubMed, Embase, Web of science, CNKI, Wanfang, VIP and other databases were searched for published studies on the treatment of AIS with GMI combined with Butylphthalide in both Chinese and English. The search period was from the establishment of the database to July 2023. The included studies that met the inclusion criteria were analyzed using RevMan 5.3 software for Meta-analysis.

Results: A total of 25 studies involving 2362 patients (experimental group = 1182, control group = 1180) were included. The results of meta-analysis showed that the overall effective rate of the experimental group was significantly higher than that of the control group [RR = 1.21, 95% CI (1.16, 1.26), P< 0.00001]. In addition, compared with the control group, the experimental group showed significant improvement in NIHSS score [SMD = -1.59, % CI (-2.00-1.18), P< 0.00001] and ADL score [SMD = 2.12, 95% CI (1.52, -2.72), P<0.00001], significant decrease in CRP [SMD = -2.24, 95% CI (-3.31, -1.18), P<0.0001] and TNF-α [SMD = -2.74, 95% CI (-4.45, -1.03), P< 0.005] levels, and improvement in plasma viscosity [SMD = -0.86, 95% CI (-1.07, -0.66), P< 0.00001]. However, the influence on homocysteine level remains inconclusive. Furthermore, there was no significant difference in the incidence of adverse reactions between the two groups [SMD = 0.95, 95% CI (0.71, 1.28), P> 0.05].

Conclusion: GMI combined with Butylphthalide shows good clinical application effects and good safety in the treatment of AIS. However, more large-sample, multicenter, randomized controlled are needed to confirm these findings.

Publication types

  • Meta-Analysis

MeSH terms

  • Benzofurans* / adverse effects
  • Ginkgolides / adverse effects
  • Humans
  • Ischemic Stroke*
  • Meglumine
  • Multicenter Studies as Topic

Substances

  • 3-n-butylphthalide
  • Benzofurans
  • Ginkgolides
  • Meglumine

Grants and funding

This work was supported by Fund of Nantong university (No.2022JZ005, 2022JY004), Fund of drug policy and pharmaceutical care of Nantong City (No.2023NTPA05), Jiangsu Pharmaceutical Association-HengRui Hospital Pharmacy Fund (No. H202047), Nantong Health Commission Fund (No. QA2021007, QA2021006, QA2021014) and Development Fund of KangDa college of Nanjing medical university (No. KD2021KYJJZD127). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. There was no additional external funding received for this study.