中华血液学杂志
中華血液學雜誌
중화혈액학잡지
Chinese Journal of Hematology
2012年
4期
311-315
,共5页
白血病,髓样,慢性%伊马替尼%干扰素-α
白血病,髓樣,慢性%伊馬替尼%榦擾素-α
백혈병,수양,만성%이마체니%간우소-α
Leukemia,myelocytic,chronic%Imatinib%Interferon-α
目的 探讨联合应用伊马替尼和IFN-α治疗慢性髓性白血病(CML)的临床效果.方法 选择155例CML慢性期患者为研究对象,根据治疗方法 分为伊马替尼组和伊马替尼联合INF-αt组,观察并比较两组患者的完全细胞遗传学反应率(CCyR)、主要分子学反应率(MMR)和完全分子学反应率(CMR)以及总体生存(OS)率、无进展生存(PFS)率.结果 在用药6个月时联合组的CCyR率高于伊马替尼组(60.6%对41.6%,P<0.05),从12个月时开始差异无统计学意义.用药6个月和12个月时联合组的MMR+CMR率高于伊马替尼组(71.2%对34.8%,77.3%对52.8%,P<0.05),从24个月时开始差异无统计学意义.根据Sokal积分进行风险分层后,低、中危患者的CCyR率在6个月时联合组均高于伊马替尼组(77.8%对52.6%,75.0%对46.7%,P<0.05),从12个月开始差异无统计学意义;低、中危患者的MMR+CMR率在6和12个月时联合组均高于伊马替尼组(6个月:85.2%对36.8%,90.0%对36.7%,P<0.05;12个月:88.9%对57.9%,90.0%对56.7%,P<0.05),从24个月时开始差异无统计学意义,而两组高危患者之间差异一直无统计学意义.伊马替尼组和联合组在用药6、12、24和36个月时的OS率分别为100%、100%、96.8%、90.0%和100%、100%、97.9%、93.1%,PFS率分别为97.8%、95.5%、91.9%、85.5%和98.5%、95.5%、91.5%、86.2%,OS率(μ=0.427,P=0.514)、PFS率(μ=0.556,P=0.456)两组差异无统计学意义.两组常见不良反应均有血细胞减少、水肿、体重增加、骨痛、皮疹和肌肉痉挛,联合组还有流感症状、肝功能损伤、甲状腺功能异常和肢体感觉障碍等,联合组有Ⅲ、Ⅳ级血细胞减少发生率增加的趋势.结论 联合应用伊马替尼和IFN-α能够更快地获得细胞遗传学反应和分子学反应,尤其对于低、中危患者,而高危患者联合用药无明显意义.在用药36个月内,联合用药并未明显提高生存率,且有增加药物不良反应的可能.
目的 探討聯閤應用伊馬替尼和IFN-α治療慢性髓性白血病(CML)的臨床效果.方法 選擇155例CML慢性期患者為研究對象,根據治療方法 分為伊馬替尼組和伊馬替尼聯閤INF-αt組,觀察併比較兩組患者的完全細胞遺傳學反應率(CCyR)、主要分子學反應率(MMR)和完全分子學反應率(CMR)以及總體生存(OS)率、無進展生存(PFS)率.結果 在用藥6箇月時聯閤組的CCyR率高于伊馬替尼組(60.6%對41.6%,P<0.05),從12箇月時開始差異無統計學意義.用藥6箇月和12箇月時聯閤組的MMR+CMR率高于伊馬替尼組(71.2%對34.8%,77.3%對52.8%,P<0.05),從24箇月時開始差異無統計學意義.根據Sokal積分進行風險分層後,低、中危患者的CCyR率在6箇月時聯閤組均高于伊馬替尼組(77.8%對52.6%,75.0%對46.7%,P<0.05),從12箇月開始差異無統計學意義;低、中危患者的MMR+CMR率在6和12箇月時聯閤組均高于伊馬替尼組(6箇月:85.2%對36.8%,90.0%對36.7%,P<0.05;12箇月:88.9%對57.9%,90.0%對56.7%,P<0.05),從24箇月時開始差異無統計學意義,而兩組高危患者之間差異一直無統計學意義.伊馬替尼組和聯閤組在用藥6、12、24和36箇月時的OS率分彆為100%、100%、96.8%、90.0%和100%、100%、97.9%、93.1%,PFS率分彆為97.8%、95.5%、91.9%、85.5%和98.5%、95.5%、91.5%、86.2%,OS率(μ=0.427,P=0.514)、PFS率(μ=0.556,P=0.456)兩組差異無統計學意義.兩組常見不良反應均有血細胞減少、水腫、體重增加、骨痛、皮疹和肌肉痙攣,聯閤組還有流感癥狀、肝功能損傷、甲狀腺功能異常和肢體感覺障礙等,聯閤組有Ⅲ、Ⅳ級血細胞減少髮生率增加的趨勢.結論 聯閤應用伊馬替尼和IFN-α能夠更快地穫得細胞遺傳學反應和分子學反應,尤其對于低、中危患者,而高危患者聯閤用藥無明顯意義.在用藥36箇月內,聯閤用藥併未明顯提高生存率,且有增加藥物不良反應的可能.
목적 탐토연합응용이마체니화IFN-α치료만성수성백혈병(CML)적림상효과.방법 선택155례CML만성기환자위연구대상,근거치료방법 분위이마체니조화이마체니연합INF-αt조,관찰병비교량조환자적완전세포유전학반응솔(CCyR)、주요분자학반응솔(MMR)화완전분자학반응솔(CMR)이급총체생존(OS)솔、무진전생존(PFS)솔.결과 재용약6개월시연합조적CCyR솔고우이마체니조(60.6%대41.6%,P<0.05),종12개월시개시차이무통계학의의.용약6개월화12개월시연합조적MMR+CMR솔고우이마체니조(71.2%대34.8%,77.3%대52.8%,P<0.05),종24개월시개시차이무통계학의의.근거Sokal적분진행풍험분층후,저、중위환자적CCyR솔재6개월시연합조균고우이마체니조(77.8%대52.6%,75.0%대46.7%,P<0.05),종12개월개시차이무통계학의의;저、중위환자적MMR+CMR솔재6화12개월시연합조균고우이마체니조(6개월:85.2%대36.8%,90.0%대36.7%,P<0.05;12개월:88.9%대57.9%,90.0%대56.7%,P<0.05),종24개월시개시차이무통계학의의,이량조고위환자지간차이일직무통계학의의.이마체니조화연합조재용약6、12、24화36개월시적OS솔분별위100%、100%、96.8%、90.0%화100%、100%、97.9%、93.1%,PFS솔분별위97.8%、95.5%、91.9%、85.5%화98.5%、95.5%、91.5%、86.2%,OS솔(μ=0.427,P=0.514)、PFS솔(μ=0.556,P=0.456)량조차이무통계학의의.량조상견불량반응균유혈세포감소、수종、체중증가、골통、피진화기육경련,연합조환유류감증상、간공능손상、갑상선공능이상화지체감각장애등,연합조유Ⅲ、Ⅳ급혈세포감소발생솔증가적추세.결론 연합응용이마체니화IFN-α능구경쾌지획득세포유전학반응화분자학반응,우기대우저、중위환자,이고위환자연합용약무명현의의.재용약36개월내,연합용약병미명현제고생존솔,차유증가약물불량반응적가능.
Objective To investigate the clinical effect of chronic myelocytic leukemia (CML) patients treated with imatinib (IM ) and interferon (IFN ) -α. Methods One hundred and fifty five CML patients at chronic phase were included in the study. All patients were divided into two groups according to treatment regimen; IM + IFN group and IM group. Complete cytogenetic response ( CCyR) rate, major molecular response (MMR) rate, complete molecular response (CMR) rate, overall survival (OS) and progression free survival (PFS) were observed and compared in both groups. Results The CCyR rate was higher in the IM + IFN group than that in the IM group at 6 months (60. 6% vs 41. 6 % , P < 0. 05 ) , but no difference was observed later on. The MMR + CMR rate was higher in the IM + IFN group than that in the IM group at 6 months and 12 months(71.2% vs 34. 8% , 77. 3% vs 52. 8% , respectively, P <0. 05) , but no difference after that. After stratification according to Sokal risk, the CCyR rate of low- and intermediate-risk patients was higher in the IM + IFN group than that in the IM group at 6 months (77. 8% vs 52. 6% , 75. 0% vs 46. 7% , P < 0. 05 ) , but not from 12 months on; the MMR + CMR rate of low- and intermediate-risk patients was higher in the IM + IFN group than that in the IM group at 6 months and 12 months (85. 2% vs 36. 8% , 90. 0% vs 36.7% , P <0.05; 88.9% vs 57.9% , 90.0% vs 56. 7% , P < 0. 05) , but not from 24 months on. There was no significant difference in high-risk patients. OS in IM and IM + IFN group at 6, 12, 24 and 36 months was 100% , 100% , 96. 8% and 90. 0% , and 100% , 100% , 97. 9% and 93.1% , respectively. PFS in IM and IM + IFN group at 6, 12, 24 and 36 months was 97. 8% , 95. 5% , 91. 9% and 85. 5% , and 98. 5% ,95.5% , 91. 5% and 86. 2% , respectively. There was no significant difference in OS ( u = 0. 427, P = 0.514) or PFS (u =0.556, P= 0.456). The side effects in both groups included pancytopenia, edema, weight gain, ostalgia, rash and muscle spasm. In addition, patients in the IM + IFN group suffered from flu-like symptoms, impaired liver function, abnormal thyroid function and extremity sensory disturbance. It seemed that grade JI or IV pancytopenia occurred more commonly in the patients in the IM + IFN group, however, there was no statistically significance. Conclusions The response to IM + IFN is more rapid than that to IM alone, especially for the low- and intermediate-risk patients. It seems no benefit of the addition of IFN to treatment of high-risk patients. During the period of 36 months, survival rate in the IM + IFN group is not higher than that in IM group, and it is possible to increase the side effects of pharmaceutical drugs.
