硼替佐米皮下注射治疗多发性骨髓瘤患者的疗效及安全性研究  

Efficacy and safety study of subcutaneous injection of bortezomib in the treatment of de novopatients with multiple myeloma

作　　者：刘辉[1] 傅琤琤[1] 薛胜利[1] 李渭阳[1] 吴倩[1] 顾斌[1] 金松[1] 朱霞明[1] 赵素芳[1] 辛雪[1] 马玲[1] 孙爱宁[1] 吴德沛[1] 

机构地区：[1]苏州大学附属第一医院血液科、江苏省血液研究所,卫生部血栓与止血重点实验室,215006

出　　处：《中华血液学杂志》2013年第10期868-872,共5页Chinese Journal of Hematology

基　　金：江苏省医学重点人才项目（RC2007074）;苏州市科技计划项目（YJS0914）;江苏省临床医学科技专项（BL2012005）;江苏省科教兴卫工程-临床医学中-G（ZX201102）;江苏高校优势学科建设工程资助项目

摘　　要：目的研究硼替佐米皮下注射治疗多发性骨髓瘤（MM）患者的疗效及安全性。方法回顾性分析36例接受PAD（硼替佐米＋阿霉素＋地塞米松）方案和改良PAD化疗的MM患者资料，其中接受PAD方案（PAD组）治疗者18例，接受改良PAD方案（改良PAD组）治疗者18例。根据两组患者的治疗结果及不良反应，分析不同治疗方案的疗效及安全性（率的比较采用Fisher确切概率法，P〈0．100为差异有统计学意义）。结果36例患者中除4例不可评估外，对32例患者进行了评估，中位随访时间为10．3（3．0～15．0）个月。经诱导治疗32例患者中19例（59．4％）获得非常好的部分缓解（VGPR）及其以上疗效，其中PAD组完全缓解（CR）＋VGPR率为61．1％，改良PAD组的CR＋VGPR率为57．1％（14例中8例），差异无统计学意义（P=1．000），并且达到最大疗效的时间差异无统计学意义（均在2个疗程时接近最大疗效）。不良反应：PAD组18例患者中有1例（5．6％）因严重肺部感染死亡，另有8例（44．4％）因化疗不良反应将硼替佐米减量或中断化疗，而改良PAD组18例患者中仅1例（5．6％）因化疗不良反应中断化疗，且无化疗相关死亡。与PAD组比较，改良PAD组患者3级及以上不良反应发生率明显降低，包括粒细胞减少（33．3％对61．1％，P=0．086），血小板减少（50．0％对61．1％），贫血（16．7％对27．8％），感染（16．7％对50．0％，P=0．075），腹泻（5．6％对33．3％，P=0．088），周围神经病变（0对27．8％，P=0．045）。结论改良PAD方案通过将硼替佐米由静脉推注改为皮下注射明显减少了不良反应，但不影响药物的疗效，提高了硼替佐米临床应用的安全性。Objective To explore the efficacy and safety of subcutaneous injection of bortezomib in the treatment of de novo multiple myeloma（MM）patients. Methods A total of 36 MM patients treated with bortezomib, adriamycin and dexamethason （PAD） from January 2012 to April 2013 were analyzed. Among them, 18 received improved PAD （improved PAD group） with the subcutaneous injection of bortezomib, another 18 received conventional PAD （PAD group）. The efficacy and safety of two groups were analyzed. Results Except 4 cases can not be assessed, 32 patients were evaluated. Of 32 cases, 19 （59.4%） achieved complete remission （CR） or very good partial remission （VGPR） after induction therapy, which were 61.1% and 57.1% for PAD group and improved PAD group, respectively （P=I.000）. No significant difference between the time to achieve maximum effectiveness in two groups was detected. In the PAD group, one patient （5.6%） died of serious lung infection and eight （44.4%） experienced grade 3 or higher adverse events, while only one （5.6%） discontinued treatment in improved PAD group due to similar toxicity. Compared to PAD group, grade 3 or worse adverse events was significantly reduced in improved PAD group, the most common symptoms were leucopenia （33.3% vs 61.1%, P=-0.086）,thrombocytopenia （50.0% vs 61.1%）, anaemia （27.8% vs 16.7%）, infection （16.7% vs 50.0%, P=0.075）, diarrhea （5.6% vs 33.3%, P=-0.088）, peripheral neuropathy （0 vs 27.8%, P=0.045）. Conclusions The improved PAD regimen by changing bortezomib from intravenous administration to subcutaneous injection significantly reduced adverse events, improved the safety of clinical application of bortezomib without affecting curative effect, and had great progress.

关 键 词：多发性骨髓瘤 注射 皮内 硼替佐米 

分 类 号：R733.3[医药卫生—肿瘤]