CAJ | 학술논문

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＜0.1 00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l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l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.
목적 연구붕체좌미피하주사치료다발성골수류(MM)환자적료효급안전성.방법 회고성분석36례접수PAD(붕체좌미+아매소+지새미송)방안화개량PAD화료적MM환자자료,기중접수PAD방안(PAD조)치료자18례,접수개량PAD방안(개량PAD조)치료자18례.근거량조환자적치료결과급불량반응,분석불동치료방안적료효급안전성(솔적비교채용Fisher학절개솔법,P＜0.1 00위차이유통계학의의).결과 36례환자중제4례불가평고외,대32례환자진행료평고,중위수방시간위10.3(3.0～15.0)개월.경유도치료32례환자중19례(59.4％)획득비상호적부분완해(VGPR)급기이상료효,기중PAD조완전완해(CR)+VGPR솔위61.1％,개량PAD조적CR+VGPR솔위57.1％(14례중8례),차이무통계학의의(P=1.000),병차체도최대료효적시간차이무통계학의의(균재2개료정시접근최대료효).불량반응:PAD조18례환자중유l례(5.6％)인엄중폐부감염사망,령유8례(44.4％)인화료불량반응장붕체좌미감량혹중단화료,이개량PAD조18례환자중부l례(5.6％)인화료불량반응중단화료,차무화료상관사망.여PAD조비교,개량PAD조환자3급급이상불량반응발생솔명현강저,포괄립세포감소(33.3％대61.1％,P=0.086),혈소판감소(50.0％대61.1％),빈혈(16.7％대27.8％),감염(16.7％대50.0％,P=0.075),복사(5.6％대33.3％,P=0.088),주위신경병변(0대27.8％,P=0.045).결론 개량PAD방안통과장붕체좌미유정맥추주개위피하주사명현감소료불량반응,단불영향약물적료효,제고료붕체좌미림상응용적안전성.
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=1.000).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.