格尼可一线治疗47例慢性髓系白血病患者的疗效与安全性观察

吕敬龙; 陈永平; 肖青; 张榜硕

doi:10.13201/j.issn.1004-2806.2016.03.014

格尼可一线治疗47例慢性髓系白血病患者的疗效与安全性观察

- 1 重庆三峡中心医院血液科(重庆万州, 404000);
- 2 重庆医科大学附属第一医院血液科
基金项目:
中国肝炎防治基金会天晴肝病研究基金(No:cfhpc20132128)

详细信息

通讯作者: 陈永平,E-mail:13608388377@163.com

中图分类号: R733.72

收稿日期: 2015-12-22

Curative effect and safety analysis of 47 patients with chronic myeloid leukemia after imatinib mesylate treatment

- 1 Department of Hematology, Chongqing Three Gorges Center Hospital, Wanzhou, 404000, China;
- 2 Department of Hematology, the First Affiliated Hospital of Chongqing Medical University

More Information

Corresponding author: CHEN Yongping, E-mail: 13608388377@163.com

Received Date: 22 December 2015

摘要

摘要: 目的: 评价国产甲磺酸伊马替尼(商品名格尼可)一线治疗慢性髓系白血病慢性期患者的血液学、细胞遗传学、分子生物学反应和安全性,为临床用药提供循证学依据。方法: 纳入年龄 ≥ 14岁,除羟基脲、干扰素外既往未使用任何酪氨酸激酶抑制剂的慢性髓系白血病慢性期患者47例,给予国产伊马替尼一线治疗(每次400 mg,口服,每日1次),对患者在接受国产伊马替尼治疗第3、6、12个月时的血液学、细胞遗传学、分子生物学反应和安全性进行评价。结果: 47例患者接受国产伊马替尼治疗时间 ≥ 3个月,其中32例治疗时间 ≥ 6个月,21例治疗时间 ≥ 12个月。治疗3个月时,完全血液学反应(CHR)率为93.6%(44/47),完全细胞遗传学反应(CCyR)率为38.3%(18/47),主要分子学反应(MMR)率为10.6%(5/47);治疗6个月时,CHR率为96.9%(31/32),CCyR率为56.3%(18/32),MMR率为18.8%(6/32);治疗12个月时,CHR率为100.0%(21/21),CCyR率为61.9%(13/21),MMR率为28.6%(6/21)。国产伊马替尼的不良反应以非血液学常见,其发生率依次为浮肿(76.6%)、恶心呕吐(40.4%)、肌肉酸痛(31.9%)、骨骼疼痛(23.4%)、头痛头晕(12.8%)、皮疹(10.6%)、腹泻(8.5%)和肝功能异常(4.3%);血液学不良反应发生率依次为血小板减少(34.0%)、白细胞减少(31.9%)和贫血(23.4%);无药物毒性相关性死亡。结论: 国产伊马替尼对慢性髓系白血病慢性期患者的血液学、细胞遗传学和分子生物学反应良好,安全性高。
- 白血病,髓系,慢性 /
- 慢性期 /
- 治疗反应 /
- 药物毒性 /
- 甲磺酸伊马替尼
Abstract: Objective: To evaluate hematologicall,cytogeneticand molecular response and safety of patients with chronic myeloid leukemia after imatinib mesylate treatment,and provide some evidence for clinical medication.Method: Forty-seven patients with chronic myeloid leukemia,aged equal to or older than 14,did not have any therapy history of tyrosine kinase inhibitor besides hydroxyurea and interferon were given imatinib mesylate (400 mg each time,oral,single daily dosage).Then we evaluated hematology,cytogenetics,molecular biology and security of patients after imatinib mesylate treatment at the time of the third,sixth and twelfth month.Result: Forty-seven patients after imatinib mesylate treatment for more than 3 month,among them,32 patients for more than 6 months and 21 patients for more than 12 months.After 3-month intervention,the completely hematology reaction (CHR) was 93.6% (44/47),the completely cytogenetic response (CCyR) was 38.3% (18/47) and the main molecular reaction (MMR) was 10.6% (5/47);After 6-month intervention,CHR was 96.9% (31/32),CCyR was 56.3% (18/32) and MMR was 18.8% (6/32);After 12-month,CHR was 100.0% (21/21),CCyR was 61.9% (13/21) and MMR was 28.6% (6/21).The common adverse reaction of imatinib mesylate was not in hematology.The occurrence rate is edema (76.6%),nausea and vomiting (40.4%),and muscle pain (31.9%),bone pain (23.4%),headache dizziness (12.8%),rash (10.6%),diarrhea (8.5%) and abnormal liver function (4.3%).The adverse reaction of hematology was thrombocytopenia (34.0%),leukopenia (31.9%),and anemia (23.4%) and no drug toxicity related death.Conclusion: Imatinib mesylate is curative and safe to patients with chronic myeloid leukemia.
- chronic myeloid leukemia /
- chronic phase /
- therapeutic reaction /
- drug toxicity /
- imatinib mesylate

HTML全文

参考文献(10)

[1]	Deninger MO,Brien SG,Guilhot F,et al.International randomized study of interferon vs STl571(IRIS)8-year follow up sustained survival and low risk for progression or events in patients with newly diagnosed chronic myeloid leukemia in chronic-phase (CML-CP) treated with imatinib[J].Blood,2009,114:462.
[2]	Wang AH,Wang YY,Yao Y,et al.Summary of 615 patients of chronic myeloid leukemia in Shanghai from 2001 to 2006[J].J Exp Clin Cancer Res,2010,29:20.
[3]	葛均波,徐永健.内科学[M].8版.北京:人民卫生出版,2013:586-589.
[4]	NCCN clinical practice guide lines in oncology (NCCN guidelines):chronic myelogenous leukemia[S/OL].Version I.2015[2014-08-28].
[5]	Baccarani M,Deininger MW,Rosti G,et al.European LeukemiaNet recommendations for the management of chronic myeloid leukemia:2013[J].Blood,2013,122:872-884.
[6]	Kim DD,Hamad N,Lee HG,et al.BCR/ABL level at 6 months identifies good risk CML subgroup after failing early molecular response at 3 months following imatinib therapy for CML in chronic phase[J].Am J Hematol,2014,89:626-632.
[7]	Jabbour E,Kanta6ian HM,Saglio G,et al.Early response with dasatinib or imatinib in chronic myeloid leukemia:3-year follow-up from a randomized phase 3 trial (DASISION)[J].Blood,2014,123:494-500.
[8]	江倩,赵东陆,金洁,等.国产甲磺酸伊马替尼治疗慢性髓性白血病慢性期早期疗效和安全性的前瞻性、多中心临床研究[J].中华血液学杂志,2015,36(8):651-655.
[9]	陈莹莹,曾庆曙,杨明珍,等.伊马替尼治疗慢性髓系白血病临床疗效的相关影响因素分析[J].安徽医科大学学报,2014,49(9):1325-1328,1356.
[10]	陈娟,周励,杜圣红,等.国产伊马替尼治疗初发慢性髓性白血病的疗效与安全性观察[J].中华血液学杂志,2015,36(3):235-237.