钙镁合剂干预奥沙利铂所致周围神经毒性疗效及安全性的荟萃分析

Systematic Evaluation of Efficacy and Safety of Calcium and Magnesium for Preventing Oxaliplatin-induced Peripheral Neurotoxicity

目的荟萃分析钙镁合剂对奥沙利铂所致周围神经毒性(OIPN)的干预作用。方法计算机检索PubMed、ScienceDirect、VIP、CNKI以及万方数据库,检索时间从建库至2016年8月,纳入钙镁合剂干预OIPN的随机对照试验(RCTs),并进行质量评价和资料提取,采用RevMan5.3软件进行荟萃分析。结果共纳入24个RCT,1961例患者。荟萃分析结果表明:钙镁合剂与空白对照组在OIPN总发生率〔RR=0.64,95%CI(0.53,0.77),P<0.00001〕、严重OIPN发生率〔RR=0.66,95%CI(0.58,0.75),P<0.00001〕以及急性OIPN发生率〔RR=0.73,95%CI(0.63,0.84),P<0.00001〕方面均有统计学差异,但在客观缓解率和疾病控制率方面无差异。亚组分析表明,OIPN总发生率及严重OIPN总发生率在奥沙利铂的中、低剂量组有统计学差异,而在高剂量组无差异。结论钙镁合剂能有效干预OIPN的发生,且不影响化疗疗效,安全性较好。

OBJECTIVE To evaluate the efficacy and safety of calcium and magnesium for preventing oxaliplatin-induced peripheral neurotoxicity(OIPN).METHODS PubMed,ScienceDirect,VIP,CNKI and WanFang Data were searched to collect the randomized controlled trials(RCTs)of calcium and magnesium for OIPN from the date of establishment until August 2016.Two reviewers independently evaluated the quality of literature and extracted data.RevMan5.3 software was used for Meta-analysis.RESULTS Twenty-four RCTs(1961 patients)were included.The results of Meta-analyses showed statistically significant differences in favor of calcium and magnesium group compared with control group for all incidence of OIPN〔RR=0.64,95%CI(0.53,0.77),P<0.00001〕,incidence of serious OIPN〔RR=0.66,95%CI(0.58,0.75),P<0.00001〕and incidence of acute OIPN〔RR=0.73,95%CI(0.63,0.84),P<0.00001〕.No differences were observed in objective response rate(ORR)and disease control rates between two groups.The results of subgroup analysis showed as the following:there was statistically significant difference between low-dose oxaliplatin group and middle-dose oxaliplatin group for all incidence of OIPN and incidence of serious OIPN.No differences were observed in high-dose oxaliplatin group.CONCLUSION Calcium and magnesium is safe and effective on the prevention of OIPN and did not affect the efficacy of chemotherapy.