硼替佐米不同给药途径对周围神经病变的发生率和风险的影响

Incidence and Risk of Peripheral Neuropathy Caused by Intravenous and Subcutaneous Injection of Bortezomib

目的:比较硼替佐米静脉和皮下注射的不同给药途径对病人周围神经病变发病率及其相对风险的影响。方法:计算机搜索了PubMed、Embase、Cochrance library、CNKI(中国知网)电子数据库及相关会议记录。数据全部来自随机对照研究(randomized controlled study,RCT)。根据统计学方法计算静脉和皮下注射给药致周围神经病变的发生率、相对危险度(relative risk,RR)和95%的置信区间。结果:选择4篇RCT研究荟萃分析表明,注射病人总共911例(皮下和静脉组分别为479例和432例)。周围神经病变在静脉注射组的发生率为41.4%(95%CI=0.137-0.692,P=0.003),>2级周围神经病变的发生率为15.6%(95%CI=0.005-0.308,P=0.043);皮下组相应的发生率分别是16%(95%CI=0.021-0.299,P=0.024)、3.4%(95%CI=-0.011-0.080,P=0.141)。与静脉注射组相比,皮下注射组发生周围神经病变RR=0.525,95%CI=0.297-0.928(P=0.027)和2级以上的周围神经病变RR=0.376,95%CI=0.196-0.722(P=0.003)。结论:治疗剂量下的硼替佐米皮下注射比静脉注射明显减少周围神经病变的发生率。

Objective:To compare the effects of intravenous and subcutaneous injection of bortezomib on incidence and relative risk of peripheral neuropathy in patients with multiple myeloma(MM).Methods:The electronic database of PubMed,Embase,Cochrance library,CNKI and related meeting records were searched by computers.The data were derived all from a matched randomized controlled studies.The incidence,relative risk(RR)and 95%confidence interval of peripheral neuropathy caused by intravenous and subcustaneous injections were calculated by the statistical methods.Results:Four RCT studies were selected for meta-analysis,with a total of 911 patients(479 cases and 432 cases in the subcutaneous injection and intravenous injection groups,respectively).The incidence of peripheral neuropathy in the intravenous injection group was 41.4%(95%CI=0.137-0.692,P=0.003),and the incidence of>2 grade of peripheral neuropathy was 15.6%(95%CI=0.005-0.308,P=0.043).The corresponding incidence rates of the subcutaneous injection group were 16%(95%CI=0.021-0.299,P=0.024)and 3.4%(95%CI=-0.011-0.080,P=0.141)respectively.Compared with the intravenous injection group,the RR of peripheral neuropathy and the relative risk of peripheral neuropathy above grade 2 were 0.525,95%CI=0.297-0.928(P=0.027)and 0.376,95%CI=0.196-0.722(P=0.003)respectively.Conclusion:Subcutaneous injection of bortezomib at therapeutic doses significantly reduces the incidence of peripheral neuropathy compared with intravenous injection.