皮下硼替佐米治疗多发性骨髓瘤疗效和安全性的系统评价和Meta分析  

Systematic review and Meta analysis of efficacy and safety of subcutaneous bortezomib in the treatment for multiple myeloma

作　　者：庄韵[1] 金志超[2] 季鸥[1] 沈群[1] 

机构地区：[1]南京中医药大学第一附属医院江苏省中医院血液科,南京210029 [2]中国中医科学院广安门医院肿瘤科,北京100053

出　　处：《中国临床药理学杂志》2017年第9期841-844,共4页The Chinese Journal of Clinical Pharmacology

基　　金：国家自然科学基金资助项目(81274139)

摘　　要：目的系统性评价2种不同给药方式(皮下和静脉)以硼替佐米治疗多发性骨髓的有效性和安全性。方法在Clinical trial网站和Cochrane协作网,检索硼替佐米皮下和静脉治疗的临床试验,并通过Pub Med、Em Base等文献数据库检索相关文献。比较硼替佐米的皮下与静脉这2种给药方式治疗的疗效及不良事件数据,用Rev Man5.3软件进行Meta分析。结果共纳入11篇文献。其中,随机对照试验(RCT)3篇,回顾性队列研究(RCS)8篇。包括2021例患者。皮下和静脉治疗比较,其总有效率[OR=1.06,95%CI(0.84,1.33)]和完全缓解率[OR=0.93,95%CI(0.65,1.31)]差异无统计学意义。皮下给药,可明显降低周围神经病变[OR=0.44,95%CI(0.35,0.56)]和≥3级神经病变[OR=0.30,95%CI(0.19,0.46)]的发生率,较静脉给药差异有显著统计学意义(P<0.001)。结论硼替佐米皮下给药与传统静脉给药的疗效相当,但皮下给药周围神经病变明显减少,安全性更好。Objective To systematically assess the effectiveness and safety of subcutaneous bortezomibin comparison with intravefi0us horte- zomib for treating multiple myeloma. Methods Data frofii relative clini- cal trials were from Clinicahrials. gov and Cochrane Collaboration. A comprehensive literature search was performed from data bases such as PubMed and EmBase. The data of effective and safety On subcutaneous and intravenous administration was comparison. The Meta analyzed by RevManS. 3 Software. Results Three randomized controlled trials （RCT） and 8 retrospective cohort studies（RCS）, 11 reseamh papers in total met inclusion criteria, including 2021 cases. There were no signifi- cant differences between the subcutaneous bortezomib group and the in- travenous bortezomib group in the overall responses rate [ OR = 1.06, 95% CI （0. 84, 1.33 ） ] and complete response [ OR = 0. 93,95% CI （0. 65,1.31 ） ]. In terms of safety, the incidence of peripheral neuropa- thy and grade 〉13 peripheral neuropathy were significantly lower in subcu- taneous bortezomib group than those in intravenous bortezomib group with siginificance [ OR - 0.44, 95% CI （0. 35, O. 56） ; OR = O. 30, 95% CI （0. 19,0.46）, respectively] （P 〈0.001）. Conclusion Subcutaneous bortezomib is as effective as intravenous bortezomib in multiple myeloma and reduce the incidence of peripheral neuropathy.

关 键 词：多发性骨髓瘤 皮下 静脉 硼替佐米 神经系统并发症 META分析 

分 类 号：R979.1[医药卫生—药品]