皮下注射硼替佐米的有效性和安全性循证评价

Evidence-based evaluation of efficacy and safety for subcutaneous injection of bortezomib

目的:对已发表的硼替佐米治疗多发性骨髓瘤的有效性和安全性的回顾性研究、随机对照研究、荟萃分析、临床指南进行再评价。方法:计算机检索CNKI、维普、万方、PubMed、Cochrane Library、clinicaltrial等数据库,搜索皮下注射硼替佐米治疗多发性骨髓瘤的回顾性研究、随机对照研究、荟萃分析、临床指南,药品说明书,检索时限均为建库至2018年7月,由两名独立研究人员进行筛选文献和提取资料,对不同类型的文献予以不同的评价方法。结果:初筛文献453篇,筛选后最终纳入分析23篇。其中回顾性研究11篇,前瞻性随机对照试验研究7篇,荟萃分析3篇,临床指南3篇,11篇药品说明书。除一篇研究认为硼替佐米皮下注射和静脉注射外周神经不良反应无差异外,其余均认为皮下注射硼替佐米可以显著降低外周神经系统不良反应,治疗效果无差异。结论:硼替佐米皮下注射可以作为临床实践中治疗多发性骨髓瘤的一线给药方法。

OBJECTIVE To re-evaluate the efficacy and safety of published retrospective studies, randomized controlled studies, meta-analyses, and clinical guidelines for the treatment of multiple myeloma with bortezomib. METHODS CNKI, VIP, Wanfang, PubMed, Cochrane Library, clinical trial and other databases from inception to July 2018 were searched for retrospective study, randomized controlled study, meta analysis, clinical guideline and package insert. Two independent researchers screened the literature and extracted the data. RESULTS There were 453 initially screened literatures, and 23 were finally included in the final analysis after screening, which included 11 retrospective studies, seven randomized controlled trials, three meta-analyses, three clinical guidelines, and 11 package inserts. All but one study concluded that there was no difference in adverse effects between subcutaneous and intravenous injection of bortezomib in the peripheral nervous system, and all others concluded that subcutaneous injection of bortezomib significantly reduced adverse effects in the peripheral nervous system with no difference in treatment efficacy. CONCLUSION Subcutaneous bortezomib injection can be used as a first-line method for the treatment of multiple myeloma in clinical practice.