神经节苷脂-单唾液酸预防化疗致周围神经病变有效性和安全性的Meta分析  

Efficacy and Safety of Ganglioside-monosialic Acid in Preventing Chemotherapy-induced Peripheral Neuropathy:A Meta-analysis

作　　者：王达聪 高珊 WANG Da-cong;GAO Shan(Preparation Department of the First Affiliated Hospital of Xiamen University,Xiamen 361000,China)

机构地区：[1]厦门大学附属第一医院制剂科,福建厦门361000

出　　处：《海峡药学》2022年第12期120-124,共5页Strait Pharmaceutical Journal

摘　　要：目的评价神经节苷脂-单唾液酸(GM1)预防化疗致周围神经病变(CIPN)有效性和安全性,为其临床应用提供循证依据。方法检索Pubmeb、Embase、Cochrane Library、ClinicalTrials.gov registry、中国知网、万方数据库和维普数据库(建库至2021年11月),筛选GM1与安慰剂或空白为对照预防CIPN的随机对照试验(RCT),提取有关数据后使用RevMan 5.3软件进行Meta分析。结果共纳入7项RCT,GM1组患者421例,对照组408例。Meta分析结果显示,GM1组的急性CIPN发生率低于对照组,差异有统计学意义(RR=0.82,95%(CI):0.76~0.89,P<0.01);GM1组NCI-CTCAE≥2级慢性CIPN发生率在统计学上显著低于对照组(RR=0.45,95%CI:0.27~0.76,P=0.003);不良反应方面的≥2级恶心呕吐(RR=0.91,95%CI:0.61~1.36,P=0.63)、腹泻(RR=0.72,95%CI:0.39~1.33,P=0.30)、疲劳(RR=0.25,95%CI:0.01~9.37,P=0.45)和≥3级中性粒细胞减少(RR=1.09,95%CI:0.64~1.86,P=0.76)的发生率两组之间的差异均无统计学意义。结论GM1能够有效预防急性CIPN和慢性的严重CIPN发生,并且不增加不良反应发生率,对患者的安全性良好。OBJECTIVE To evaluate the efficacy and safety of Ganglioside-monosialic acid(GM1)in preventing chemotherapy-induced peripheral neuropathy(CIPN)and to provide evidence-based reference in clinic.METHODS Pubmed,Embase,Cochrane Library,ClinicalTrials.gov registry,CNKI,Wangfang Database,Weipu Database from the inception to November 2021 were searched.Randomized controlled trials(RCT)which compared GM1 with placebo or blank in prevention of CIPN were selected and the relevant data were extracted for meta-analysis used RevMan 5.3 software.RESULTS A total of 7 RCTs including 421 patients in GM1 group and 408 patients in control group were enrolled into this study.The result of meta-analysis showed that the difference of the incidence of acute CIPN between the GM1 group and control group was statistically significant.〔relative risk(RR)=0.82,95%confidence interval(CI):0.76-0.89,P<0.01〕and the difference of the incidence of grade 2 or worse cumulative CIPN measured with National Cancer Institute Common Toxicity Criteria for Adverse Events(NCI-CTCAE)between the GM1 group and control group also was statistically significant(RR=0.45,95%CI:0.27-0.76,P=0.003).There were no significant differences in the incidence of grade 2 or worse nausea and vomiting(RR=0.91,95%CI:0.61-1.36,P=0.63),diarrhea(RR=0.72,95%CI:0.39-1.33,P=0.30),fatigue(RR=0.25,95%CI:0.01-9.37,P=0.45)and grade 3 or worse neutropenia(RR=1.09,95%CI:0.64-1.86,P=0.76)between the two groups.CONCLUSION GM1 is effective in preventing acute CIPN and severe cumulative CIPN,and is well safe in patients.

关 键 词：神经节苷脂-单唾液酸 预防用药 META分析 

分 类 号：R969.4[医药卫生—药理学]