CAJ | 학술논문

目的回顾性分析硼替佐米在治疗初治与复发难治性多发性骨髓瘤(MM)患者的临床疗效及不良反应.方法 32例MM患者中初治21例,复发11例,21例接受了BTD(硼替佐米+沙立度胺+地基米松)方案:硼替佐米1.0 mg/m2,静脉注射,第1、4、8、11天；沙立度胺100～200mg/d,口服,第1～21天；地塞米松20 mg/m2,静脉滴注,第1～4天,或者10 mg/m2,第1～4、9～12、17 ～ 20天；9例接受了BD(硼替佐米+地塞米松)方案:硼替佐米及地塞米松用法同前；2例接受了PAD(硼替佐米+阿霉素+地塞米松)方案:硼替佐米及地塞米松用法同前,阿霉素9 mg/m2,第1～4天；疗程均为3周；疗效评价采用EBMT标准,安全性评估参照NCI CTCAE第3版；中位随访时间17(2 ～32)个月；统计方法采用x2检验及Spearman秩相关分析.结果总反应率(CR+ nCR+ PR+ MR)为90.6％,初治组与复发难治组比较差异有统计学意义(P=0.27)；总较好缓解率(CR +nCR +PR)为71.8％,两组比较差异有统计学意义(P=0.04)；总完全缓解率(CR)为28.1％,两组比较差异有统计学意义(P=0.12)；总接近完全缓解率(CR+ nCR)为56.2％,两组比较差异有统计学意义(P=0.03)；疗程与缓解等级的相关系数为0.60,差异有统计学意义(P＜0.01)；不良反应中血液系统占56％,消化系统占49％,周围神经病变占32％,全身症状占27％,3例患者出现带状疱疹,1例出现皮疹.结论硼替佐米为主方案治疗初治和复发难治的MM患者有较好的疗效,初治患者比复发难治患者有较高的缓解率,疗程与缓解等级呈正相关,具有较高的安全性.
목적 회고성분석붕체좌미재치료초치여복발난치성다발성골수류(MM)환자적림상료효급불량반응.방법 32례MM환자중초치21례,복발11례,21례접수료BTD(붕체좌미+사립도알+지기미송)방안:붕체좌미1.0 mg/m2,정맥주사,제1、4、8、11천；사립도알100～200mg/d,구복,제1～21천；지새미송20 mg/m2,정맥적주,제1～4천,혹자10 mg/m2,제1～4、9～12、17 ～ 20천；9례접수료BD(붕체좌미+지새미송)방안:붕체좌미급지새미송용법동전；2례접수료PAD(붕체좌미+아매소+지새미송)방안:붕체좌미급지새미송용법동전,아매소9 mg/m2,제1～4천；료정균위3주；료효평개채용EBMT표준,안전성평고삼조NCI CTCAE제3판；중위수방시간17(2 ～32)개월；통계방법채용x2검험급Spearman질상관분석.결과 총반응솔(CR+ nCR+ PR+ MR)위90.6％,초치조여복발난치조비교차이유통계학의의(P=0.27)；총교호완해솔(CR +nCR +PR)위71.8％,량조비교차이유통계학의의(P=0.04)；총완전완해솔(CR)위28.1％,량조비교차이유통계학의의(P=0.12)；총접근완전완해솔(CR+ nCR)위56.2％,량조비교차이유통계학의의(P=0.03)；료정여완해등급적상관계수위0.60,차이유통계학의의(P＜0.01)；불량반응중혈액계통점56％,소화계통점49％,주위신경병변점32％,전신증상점27％,3례환자출현대상포진,1례출현피진.결론 붕체좌미위주방안치료초치화복발난치적MM환자유교호적료효,초치환자비복발난치환자유교고적완해솔,료정여완해등급정정상관,구유교고적안전성.
Objective To research the curative effect and adverse reactions of bortezomib in the treatment of newly diagnosed and relapsed or refractory multiple myeloma(MM).Methods Thirty-two patients including 21 newly diagnosed multiple myeloma patients and 11 relapsed or refractory multiple myeloma(RRMM)patients.Twenty-one patients were treated with BTD regimen,it consisted of bortezomib(1.0-1.3 mg/m2) by rapid intravenous injection on the 1 st,4 th,8 th and 11th day,and dexamethasone 20 mg/d by intravenous drip(day 1-4) or 10 mg/d by intravenous drip(day 1-4,day 9-12,day 17-20),and oral thalidomide (100-200 mg/d) was given for the whole course.Nine patients received BD regimen,usage as same as the former.Two patients were treated with PAD regimen,adriamycin(9 mg/m2) was used on dayl-4,other usage as same as the former.All regimen were repeated,every 21 days as one cycle.Response to Bortezommib was assessed according to the criteria of European Group for Blood and Marrow Transplantation,and adverse reaction were evaluated according to the criteria of National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0.The prognosis factors were analysed by chi-square test and Spearman rank correlation.Results The total clinical response(CR + nCR + PR + MR) was 90.6％,newly diagnosed patients compared with RRMM patients,the difference was significant (P =0.27).The total better response (CR + nCR + PR) was 71.8 ％,compared the two groups,the difference was significant (P =0.04).The total complete response (CR) was 71.8％,the difference was significant between the two groups (P =0.12).The total near complete response(CR + nCR) was 56.2％,the difference was significant between the two groups (P =0.03).The correlation coefficient of course and remission level was 0.60,the difference was significant (P ＜ 0.01).The major adverse events during treatment were blood hypocellular(56％),gastrointestinal disorder (49％),peripheral neuropathy (32％),systemic symptom (27％).Three patients got herpes zoster and one got rash.Conclusions Bortezomib based chemotherapy was well tolerated and effective in treatment of multiple myeloma,even newly diagnosed or RRMM patients.