中文摘要：

目的对伊马替尼治疗慢性粒细胞白血病（CML）患者的安全性和疗效进行分析。方法从2003年12月起对151例CML患者给予伊马替尼治疗，评估其疗效、不良反应、总生存（OS）和疾病进展情况，并对相关影响因素进行分析。结果可评估的患者142例，中位伊马替尼治疗时间21.5（6—78）个月。①慢性期患者累积获得的完全血液学缓解（CHR）、主要细胞遗传学缓解（MCyR）、完全细胞遗传学缓解（CCyR）和完全分子学缓解（CMoR）率分别为98．9％、82，6％、76．1％和29，3％，与加速期和急变期患者比较差异有统计学意义（P〈0．0001）。②慢性期患者1年、2年和3年OS率分别为100％、（97，3±1.9）％和（95．8±2.4）％；加速期患者分别为（84.7±8．2）％、（77.0±10．4）％和（69.3±11．9）％；急变期患者分别为（62．9±8，9）％、（41．9±9．2）％和（28.5±9.1）％，三组差异有统计学意义（P〈0.0001）。慢性期患者1年、2年和3年疾病无进展生存（PFS）率分别为（98．9±1．1）％、（93.9±2．7）％和（93．9±2.7）％；加速期患者分别为（68，9±10.6）％、（61．3±11．9）％和（61．3±11.9）％；急变期患者分别为（36．4±8．8）％、（25.4±8．1）％和（10.1±8，2）％，三组差异也有统计学意义（P〈0，0001）。③对92例慢性期患者进行分析，初发组获得MCyR和CCyR的比例显著高于干扰素治疗失败组（P值分别为0.015和0.010）；伊马替尼治疗12个月获得的疗效与疾病进展显著相关，获得CCyR患者疾病进展比例低于获得部分细胞遗传学缓解（PCyR）和未获得MCyR患者（P=0.0099）；根据Sokal评分，低危组患者获得MCyR和CCyR的比例显著高于中危和高危组患者（P值分别为0.0013和0.0024），且与疾病进展显著相关（P=0．0467）。④伊马替尼治疗的不良反应主要为Ⅰ-Ⅱ级，患者多可耐受。结论伊马替尼?

英文摘要：

Objective To evaluate the safety and efficacy of imatinib in treatment of chronic myeloid leukemia （CML） patients. Methods From December 2003 to March 2007, 151 patients entered Glivec In- ternational Patient Assistance Program（GIPAP） in our center and received imatinib therapy. The overall and progression free survival, hematologic, cytogenetic and molecular response, and adverse events were evaluated. The factors associated with outcome of imatinib therapy were also analysed. Results One hundred and forty-two patients were evaluable with a median follow-up duration of 21.5 （6 -78） months. （1） The rate of cumulative complete hematologic response （ CHR）, major cytogenetic response （ MCyR）, complete cytogenetic response （CCyR） and complete molecular response （CMoR） in chronic phase （CP） CML patients were 96.9%, 82.6%, 76.1% and 29.4%, respectively. These rates were significantly higher in patients with CP than in those with accelerated phase （AP） and blast crisis （BC） （ P 〈 0. 0001 ）. （2）The overall survival （OS） rates at 1,2 and3 year were 100%, （97.3 ±1.9）% and （95.8 ±2.4）% for CP patients, they were （84.7 ±8.2）% , （77.0 ±10.4）% and （69.3 ±11.9）% for AP patients, and （62.9 ±8.9）% , （41.9 ± 9.2） % and （28.5 ± 9. 1 ）% for BC patients, respectively （P 〈 0. 0001 ）. The progression-free survival （PFS） rates at 1, 2 and3 year were （98.9±1.1）%, （93.9＋2.7）%, （93.9±2.7）% for CP patients, （68.9±10.6）%, （61.3 ±11.9）%, （61.3 ±11.9）% for AP patients, （36.4±8.8）%, （25.4±8.1 ） %, （ 10.1± 8.2） % （ P 〈 0.0001 ） for BC patients respectively. （3） Among 92 CP patients, the rates of MCyR and CCyR in newly diagnosed patients were significantly higher than those in interferon therapy failure patients （P=0.015, P=0.010）. Patients obtained CCyR at 12 months after the initiation of imatinib treatment were associated with longer PFS （ P = 0. 0099 ）. According to the Sok