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目的:系统评价硼替佐米皮下注射与静脉注射治疗多发性骨髓瘤的临床疗效与安全性,为临床工作提供参考。方法:计算机检索Pubmed、Embase、OVID、Cochrane图书馆、中国期刊全文数据库(CNKI)、万方数据库、维普数据库,并进一步对纳入文献的参考文献扩大检索。对纳入的随机对照研究采用Cochrane风险偏倚评估工具进行质量评估,采用RevMan5.3软件进行统计学分析。结果:本研究纳入了5篇文献,共990例患者,Meta分析结果显示皮下注射组与静脉注射组的缓解率差异无统计学意义[66.9%(337/504)∶71.6%(292/408),OR=0.97,95%CI0.72~1.32,P=0.87]。常见的不良反应中,血小板减少症在皮下注射组与静脉注射组间差异无统计学意义[15.5%(78/504)∶15.4%(63/408),OR=0.78,95%CI 0.52~1.18,P=0.24],而皮下注射组周围神经病变的发生率低于静脉注射组[15.1%(83/549)∶26.1%(115/441),OR=0.39,95%CI 0.28~0.55,P<0.01]。结论:硼替佐米皮下注射与静脉注射治疗多发性骨髓瘤的缓解率无明显差异,但可以降低周围神经病变的发生率。
OBJECTIVE: To systematically evaluate the clinical efficacy and safety of bortezomib subcutaneous injection and intravenous injection in the treatment of multiple myeloma, and provide reference for clinical work. Methods: Pubmed, Embase, OVID, Cochrane Library, CNKI, Wanfang Database and VIP database were searched by computer. The references of the included articles were further searched. The included randomized controlled trials were assessed for quality using the Cochrane Risk Bias Assessment Tool and RevMan 5.3 software was used for statistical analysis. Results: Five articles were included in this study, with a total of 990 patients. Meta-analysis showed that there was no significant difference in response rate between subcutaneous injection group and intravenous injection group [66.9% (337/504): 71.6% (292/408) , OR = 0.97, 95% CI 0.72-1.32, P = 0.87]. Among the common adverse reactions, there was no significant difference between the subcutaneous injection group and the intravenous injection group in thrombocytopenia [15.5% (78/504): 15.4% (63/408), OR = 0.78, 95% CI 0.52 ~ 1.18 , P = 0.24]. The incidence of peripheral neuropathy in subcutaneous injection group was lower than that in intravenous injection group [15.1% (83/549) vs 26.1% (115/441), OR = 0.39, 95% CI 0.28-0.55, P <0.01]. CONCLUSION: There is no significant difference in response rate between bortezomib subcutaneous injection and intravenous injection in the treatment of multiple myeloma, but it can reduce the incidence of peripheral neuropathy.