CAJ | 학술논문

目的评价国产甲磺酸伊马替尼(商品名昕维,江苏豪森药业股份有限公司产品)治疗新诊断慢性髓性白血病慢性期(CML-CP)患者的早期血液学、细胞遗传学、分子学反应和安全性.方法 107例年龄≥18岁、初次确诊、除羟基脲外未接受其他任何抗CML治疗的CML-CP患者,给予国产甲磺酸伊马替尼400 mg每日1次治疗,评价3、6个月时的血液学、细胞遗传学和分子学反应及安全性.结果 107例患者均治疗≥3个月,其中54例患者治疗≥≥6个月.治疗3个月时,完全血液学反应(CHR)率为98.1％(105/107);57例进行了细胞遗传学检测的患者中47例(82.5％)获得主要细胞遗传学反应(MCyR),其中20例(35.1％)获得完全细胞遗传学反应(CCyR);106例进行了分子学检测的患者中77例(72.6％)国际标准化BCR-ABL转录本水平(BCR-ABLIs)≤10％,其中11例(10.4％)BCR-ABLIS≤0.1％.治疗6个月时,CHR率为100％(54/54);CCyR率为71.8％(28/39);37例(68.5％)BCR-ABLIS≤1％,其中18例(33.3％) BCR-ABIS≤0.1％.Ⅲ级白细胞减少、血小板减少和贫血发生率分别为19.5％、23.0％和13.8％,无Ⅳ级血液学不良反应发生.最常见的非血液学不良反应依次为水肿(74.7％)、恶心(48.3％)、骨关节痛(42.5％)、皮疹(36.8％)、腹泻(34.5％)、发热(23.0％)、肌肉痉挛(11.5％)和肝功能损害(3.4％).无一例患者出现Ⅳ级非血液学不良反应.无药物毒性相关性死亡.结论国产甲磺酸伊马替尼初始治疗新诊断CML-CP的早期血液学、细胞遗传学和分子学反应优异,安全性良好.
목적 평개국산갑광산이마체니(상품명흔유,강소호삼약업고빈유한공사산품)치료신진단만성수성백혈병만성기(CML-CP)환자적조기혈액학、세포유전학、분자학반응화안전성.방법 107례년령≥18세、초차학진、제간기뇨외미접수기타임하항CML치료적CML-CP환자,급여국산갑광산이마체니400 mg매일1차치료,평개3、6개월시적혈액학、세포유전학화분자학반응급안전성.결과 107례환자균치료≥3개월,기중54례환자치료≥≥6개월.치료3개월시,완전혈액학반응(CHR)솔위98.1％(105/107);57례진행료세포유전학검측적환자중47례(82.5％)획득주요세포유전학반응(MCyR),기중20례(35.1％)획득완전세포유전학반응(CCyR);106례진행료분자학검측적환자중77례(72.6％)국제표준화BCR-ABL전록본수평(BCR-ABLIs)≤10％,기중11례(10.4％)BCR-ABLIS≤0.1％.치료6개월시,CHR솔위100％(54/54);CCyR솔위71.8％(28/39);37례(68.5％)BCR-ABLIS≤1％,기중18례(33.3％) BCR-ABIS≤0.1％.Ⅲ급백세포감소、혈소판감소화빈혈발생솔분별위19.5％、23.0％화13.8％,무Ⅳ급혈액학불량반응발생.최상견적비혈액학불량반응의차위수종(74.7％)、악심(48.3％)、골관절통(42.5％)、피진(36.8％)、복사(34.5％)、발열(23.0％)、기육경련(11.5％)화간공능손해(3.4％).무일례환자출현Ⅳ급비혈액학불량반응.무약물독성상관성사망.결론 국산갑광산이마체니초시치료신진단CML-CP적조기혈액학、세포유전학화분자학반응우이,안전성량호.
Objective To evaluate the early hematologic,cytogenetic and molecular responses in newly diagnosed patients with chronic myelogenous leukemia in chronic phase (CML-CP) and initially treated with a generic imatinib (Xinwei),manufactured by Jiansu Hansoh Pharmaceutical Group Co.,Ltd.Methods 107 newly diagnosed patients of CML-CP,whose ages were above 18-year-old and who had never received any tyrosine kinase inhibitor (TKI) were treated with Xinwei 400 mg QD.The hematologic,cytogenetic and molecular responses were assessed at 3-and 6-month,and adverse effects were evaluated throughout the study.Results 107 patients were treated with Xinwei for at least 3 months,54 of them were treated for 6 months or more.At 3-month,the complete hematologic responses (CHR) rate were 98.1％ (105/107);47/57 (82.5％) patients achieved major cytogenetic response (MCyR),and 20/57 (35.1％) patients complete cytogenetic response (CCyR);BCR-ABLIS was ≤10％ in 77/106 patients (72.6％),11 of them (10.4％) achieved major molecular response (MMR,BCR-ABLIS was ≤0.1％).At 6-month,the CHR rate was 100％ (54/54);28/39 patients (71.8％) achieved CCyR;BCR-ABLIS was ≤1％ in 37/54 patients (68.5％),18 of them (33.3％) achieved MMR.The grade Ⅲ leukopenia,thrombocytopenia and anemia rates were 19.5％,23.0％ and 13.8％,respectively.No grade Ⅳ hematologic toxicity occurred.The common non-hematologic toxicities were edema (74.7％),nausea (48.3％),bone pain(42.5％),rash (36.8％),diarrhea (34.5％),fever (23.0％),cramp (11.5％) and impaired liver function (3.4％).No patient experienced grade Ⅳ non-hematologic toxicity.No adverse effects related death occurred.Conclusions Our results revealed the excellent early haematology,cytogenetic and molecular responses and safety of Xinwei in treating patients with CML-CP.