中华血液学杂志
中華血液學雜誌
중화혈액학잡지
Chinese Journal of Hematology
2014年
5期
388-392
,共5页
陈峰%王景霞%侯明%赵洪国%杨恩芹%冉学红%王明林%于文征%徐瑞荣
陳峰%王景霞%侯明%趙洪國%楊恩芹%冉學紅%王明林%于文徵%徐瑞榮
진봉%왕경하%후명%조홍국%양은근%염학홍%왕명림%우문정%서서영
吡柔比星%白血病,髓样,急性%治疗结果
吡柔比星%白血病,髓樣,急性%治療結果
필유비성%백혈병,수양,급성%치료결과
Pirarubicin%Leukemia,myeloid,acute%Treatment outcome
目的 研究吡柔比星为主联合化疗治疗复发难治性急性髓系白血病(AML)的疗效及不良反应.方法 采用随机、前瞻性、开放性研究方法.采用简单随机化分组方法将患者分为研究组和对照组,研究组应用TAE方案(吡柔比星+阿糖胞苷+依托泊苷),对照组应用MAE方案(米托蒽醌+阿糖胞苷+依托泊苷),观察其疗效及不良反应.结果 多中心共56例复发难治性AML患者进入临床研究,TAE组完全缓解(CR)率为79.0％,总有效(OR)率为86.8％,MAE组分别为55.6％和88.9％,TAE组CR率高于MAE组(P=0.035),但两组oR率差异无统计学意义(P＞0.05).血液学及非血液学不良反应发生率两组之间差异无统计学意义,但TAE组平均G-CSF用量、平均红细胞及血小板悬液输注数量略低于MAE组.总生存率和无复发生存率两组之间差异无统计学意义(P值分别为0.979和0.756).结论 TAE方案治疗复发难治性AML疗效肯定,且化疗结束后造血恢复较快,与MAE方案均可作为AML二线治疗的安全有效方案.
目的 研究吡柔比星為主聯閤化療治療複髮難治性急性髓繫白血病(AML)的療效及不良反應.方法 採用隨機、前瞻性、開放性研究方法.採用簡單隨機化分組方法將患者分為研究組和對照組,研究組應用TAE方案(吡柔比星+阿糖胞苷+依託泊苷),對照組應用MAE方案(米託蒽醌+阿糖胞苷+依託泊苷),觀察其療效及不良反應.結果 多中心共56例複髮難治性AML患者進入臨床研究,TAE組完全緩解(CR)率為79.0％,總有效(OR)率為86.8％,MAE組分彆為55.6％和88.9％,TAE組CR率高于MAE組(P=0.035),但兩組oR率差異無統計學意義(P＞0.05).血液學及非血液學不良反應髮生率兩組之間差異無統計學意義,但TAE組平均G-CSF用量、平均紅細胞及血小闆懸液輸註數量略低于MAE組.總生存率和無複髮生存率兩組之間差異無統計學意義(P值分彆為0.979和0.756).結論 TAE方案治療複髮難治性AML療效肯定,且化療結束後造血恢複較快,與MAE方案均可作為AML二線治療的安全有效方案.
목적 연구필유비성위주연합화료치료복발난치성급성수계백혈병(AML)적료효급불량반응.방법 채용수궤、전첨성、개방성연구방법.채용간단수궤화분조방법장환자분위연구조화대조조,연구조응용TAE방안(필유비성+아당포감+의탁박감),대조조응용MAE방안(미탁은곤+아당포감+의탁박감),관찰기료효급불량반응.결과 다중심공56례복발난치성AML환자진입림상연구,TAE조완전완해(CR)솔위79.0％,총유효(OR)솔위86.8％,MAE조분별위55.6％화88.9％,TAE조CR솔고우MAE조(P=0.035),단량조oR솔차이무통계학의의(P＞0.05).혈액학급비혈액학불량반응발생솔량조지간차이무통계학의의,단TAE조평균G-CSF용량、평균홍세포급혈소판현액수주수량략저우MAE조.총생존솔화무복발생존솔량조지간차이무통계학의의(P치분별위0.979화0.756).결론 TAE방안치료복발난치성AML료효긍정,차화료결속후조혈회복교쾌,여MAE방안균가작위AML이선치료적안전유효방안.
Objective To compare the efficacy and toxicity of the chemotherapeutic regimen containing pirarubicin and mitoxantrone on the treatment of relapsed or refractory acute myeloid leukemia (AML) in adults.Methods In this open prospective multicentre study,we randomly assigned patients with relapsed or refractory AML to receive TAE regimen (pirarubicin+cytarabine+etoposide)versus MAE regimen (mitoxantrone + cytarabine + etoposide).The efficacy and toxicity were compared between the two groups.Results 56 patients entered this clinical trial.The complete remission (CR)rate on TAE arm was 79.0％ versus 55.6％ on MAE arm with the overall response (OR) rates of 86.8％ versus 88.9％,respectively.The CR was higher on TAE arm(P=0.035)but with no significant difference between the two groups regarding the overall response (OR)rate.The regimens were well tolerated in both groups.Hematologic and non-hematologic toxicity were similar except relatively lower the mean dosage of G-CSF,red blood cells and platelets transfusion on TAE arm.No significant differences were seen between the two groups regarding the overall survival and relapse free survival rates.Conclusion TAE regimen might be an effective salvage therapy in patients with relapsed or refractory AML.
