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皮下注射硼替佐米治疗多发性骨髓瘤的疗效及安全性分析
Safety and Efficacy of Subcutaneous Administration of Bortezomib in the Treatment of Multiple Myeloma
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摘要: 目的 比较硼替佐米皮下和静脉给药治疗多发性骨髓瘤(MM)患者的疗效和安全性。 方法 回顾性分析26例接受BDT（硼替佐米+地塞米松+沙利度胺）方案治疗的MM患者。12例接受硼替佐米皮下注射（皮下组），14例接受硼替佐米快速静脉注射（静脉组）。比较两组患者的临床疗效及毒副反应。 结果 两组患者临床特征一致。皮下组和静脉组分别获得75.00%和71.43%的总有效率，其中非常好的部分缓解+完全缓解（VGPR+CR）率分别为50.00%和47.14%，CR率分别为16.67%和28.57%，两组比较差异无统计学意义(P>0.05)。两组给药方式起效时间相当，均在第1疗程半数达部分缓解（PR），第4疗程半数达CR(P>0.05)。安全性比较：皮下组周围神经病变发生率低于静脉组〔16.67%（2/12） vs. 64.29%(9/14)，P=0.021〕，其中静脉组中≥3级周围神经病变占7.14%(1/14)；相较静脉组(0%)，皮下组皮疹发生率高达66.67%（8/12），但局限、短暂、无需处理；其余血液与非血液毒副反应的发生在两组间比较差异无统计学意义。 结论 硼替佐米皮下给药的疗效与传统静脉给药的疗效相当，皮疹发生率增加但症状轻，周围神经病变发生率减少，安全性更好。Abstract: Objective To analyze the efficacy and safety of subcutaneous administration of bortezomib in the treatment of multiple myeloma（MM） patients. Methods A tota1 of 26 MM patients were enrolled in this study and treated with BDT (bortezomib-dexamethasone-thalidomide). In the 26 MM patients, 12 patients received subcutaneous administration of Bortezomib while 14 patients received conventional intravenous administration. The outcomes and adverse effects of two groups were retrospectively evaluated and compared. Results Overall response(OR) rates in the two groups were 75.00% and 71.43% respectively, in which complete remission (CR) plus very good complete remission (VGPR) rates were 50.00% and 47.14%, while CR rates were 16.67% and 28.57%. There were no statistically significant difference (P>0.05). Time to achieve effectiveness in two groups was similar(P>0.05). More than half patients in both groups achieved partial remission after the first treatment course and CR after the fourth course. Compared to the intravenous group, peripheral neuropathy rates remained significantly lower in subcutaneous group （16.67% vs. 64.29%，P=0.021）. The intravenous group had 7.14% grade 3 or worse, peripheral neuropathy but none found in the subcutaneous group. Rash occurred only in subcutaneous group (66.67%), but it was local, mild and transitional. No significant differences of other adverse events between the two groups were observed. Conclusion Subcutaneous administration of bortezomib offers similar efficacy to standard intravenous administration in the treatment of multiple myelom, with an improved safety for lower rate of peripheral neuropathy.
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期刊类型引用(14)
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