Safety of cinepazide maleate injection in the treatment of stroke: a meta-analysis
10.3760/cma.j.cn114015-20210317-00319
- VernacularTitle:马来酸桂哌齐特注射液治疗脑卒中安全性的meta分析
- Author:
Jing ZHU
1
;
Yingying YAN
;
Suodi ZHAI
;
Yimin CUI
Author Information
1. 北京大学药学院药事管理与临床药学系，北京 100191
- Publication Type:Journal Article
- Keywords:
Drug-related side effects and adverse reactions;
Meta analysis;
Safety;
Evidence-based medicine;
Cinepazide maleate injection
- From:
Adverse Drug Reactions Journal
2021;23(5):252-259
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To systematically evaluate the safety of cinepazide maleate injection (cinepazide) in treatment of stroke.Methods:Randomized controlled trials (RCTs) of cinepazide combined or not combined with basic treatment (the trialed group) and basic treatment and other drugs except cinepazide alone or in combination (the control group) for stroke were collected by searching related databases at home and abroad (up to December 31, 2020). The outcome indicators were treatment-related adverse events (AEs), including symptoms such as headache, insomnia, drowsiness, and skin itching and abnormalities in laboratory tests such as liver and kidney function and blood system. The methodological quality of studies was evaluated using the Cochrane collaboration risk of bias tool. RevMan 5.3 software was used in meta-analysis and the effect values were expressed as relative risk ( RR) and its 95% confidence interval ( CI). Results:A total of 19 RCTs were included in the analysis, all of which were post-marketing studies conducted in China. The 19 RCTs involved 3 272 patients, including 1 650 in the trialed group and 1 622 in the control group. The quality evaluation results showed possibility of selection bias and measurement bias in the research. Meta-analysis showed that difference in the incidence of adverse events between the trialed group and the control group was not significant [6.90%(114/1 650) vs. 7.64%(124/1 622), RR=0.92, 95% CI: 0.72-1.17, P=0.49]. The analysis results of 5 subgroups divided according to different doses (80, 160, 240, 320 and 400 mg/d) showed that difference in the incidence of adverse events between the trialed group and the control group was not significant [8.77%(10/114) vs. 14.16%(16/113), RR=0.62, 95% CI: 0.29-1.31, P=0.21; 3.51%(4/112) vs. 0(0/101), RR=4.58, 95% CI: 0.55-38.49, P=0.16; 0.88%(1/114) vs. 1.85%(2/108), RR=0.64, 95% CI: 0.10-3.86, P=0.62; 7.53%(96/1 275) vs. 8.30%(105/1 265), RR=0.92, 95% CI: 0.71-1.19, P=0.51; 8.57%(3/35) vs. 2.86%(1/35), RR=3.00, 95% CI: 0.33-27.46, P=0.33]. Analysis of several concerned AEs showed differences in the incidences of adverse events such as headache, dizziness, insomnia, nausea, rash/itching, and hemocytopenia between the trialed group and the control group were not significant [3.45%(57/1 650) vs. 3.45%(56/1 622), RR=1.02, 95% CI: 0.70-1.47, P=0.46; 2.24%(37/1 650) vs. 2.40%(39/1 622), RR=0.95, 95% CI: 0.60-1.51, P=0.76; 0.84%(41/1 650) vs. 2.10%(34/1 622), RR=1.23, 95% CI: 0.77-1.94, P=0.69; 0.67%(11/1 650) vs. 0.12%(2/1 622), RR=0.96, 95% CI: 0.39-2.39, P=0.64; 0.36%(6/1 650) vs. 0.37%(6/1 622), RR=1.06, 95% CI: 0.45-2.49, P=0.89; 0.06%(1/1 578) vs. 0(0/1 552), RR=3.00, 95% CI: 0.12-74.47, P=0.50]. Conclusion:Cinepazide marketed in China has good clinical safety.
