培门冬酶诱导治疗儿童初发急性淋巴细胞白血病的疗效观察

Efficacy observation of polyethylene glycol conjugated asparaginase for induction treatment of children with newly diagnosed acute lymphoblastic leukemia

目的 观察国产培门冬酶诱导治疗儿童初发急性淋巴细胞白血病（ALL）的疗效.方法 2010年1月至2012年8月中国医学科学院血液病医院儿童血液病诊疗中心收治的初发ALL患儿268例,所有患儿均参照中国小儿白血病协作组（CCLG）-2008方案,分别采用含培门冬酶的长春新碱联合柔红霉素、培门冬酶、地塞米松方案（培门冬酶组）和含左旋门冬酰胺酶的长春新碱联合柔红霉素、左旋门冬酰胺酶、地塞米松方案（左旋门冬酰胺酶组）进行诱导治疗.分别统计化疗第15天（D15）及第33天（D33）骨髓状态（M1,M2,M3）.结果 268例初发ALL患儿,标危组、中危组、高危组比例分别为37.3％ （n=100）、32.1％ （n =86）、30.6％（n =82）.左旋门冬酰胺酶组159例,培门冬酶组109例,两组在年龄、性别、初诊白细胞数、肿瘤细胞免疫分型及对泼尼松预治疗反应方面差异无统计学意义（P＞0.05）.培门冬酶组在诱导化疗D15的骨髓状态分别为M1状态64.2％（n=70）、M2状态21.1％ （n =23）、M3状态14.7％ （n=16）;而左旋门冬酰胺酶组则分别为M1状态70.4％（n=112）、M2状态13.2％ （n =21）、M3状态16.4％（n =26）,两组间差异无统计学意义（x2=2.938,P=0.230）.培门冬酶组化疗D33的骨髓状态分别为M1状态96.3％（n=105）、M2状态2.8％（n=3）、M3状态0.9％（n=1）;而左旋门冬酰胺酶组则分别为M1状态96.9％（n=154）、M2状态3.1％（n=5）、M3状态0％（n=0）,两组间差异无统计学意义（x2=1.494,P=0.474）.结论 与左旋门冬酰胺酶比较,国产培门冬酶诱导治疗儿童初发ALL的疗效相当.不仅可以作为左旋门冬酰胺酶过敏患儿的备用选择,亦可作为初发患儿的一线治疗药物.

Objective To observe the efficacy of polyethylene glycol conjugated asparaginase （pegasp） for induction treatment of children with newly diagnosed acute lymphoblastic leukemia （ALL）.Method A total of 268 newly diagnosed children with ALL enrolled in CCLG-2008 from January,2010 to August,2012 were analyzed.Patients received either native Escherichia coli asparaginase or pegaspargase along with multiagent chemotherapy during remission induction treatment.Status of bone marrow aspiration was assessed on day 15,day 33 （M1,M2,M3）.Result Of the 268 patients stratified,37.3% （n =100） were SR,32.1% （n =86） were IR,and 31.6% （n =82） were HR; 159 patients received native Escherichia coli asparaginase and 109 patients received pegaspargase.Characteristics of two groups in age,sex,blood count at diagnosis,immunophenotype and response to prednisolone had no significant difference （P 〉0.05）.Bone marrow status on day 15 in pegaspargase group was M1 in 70 （64.2%） cases,M2 in 23 （21.1%） and M3 in 16 （14.7%）,while in native Escherichia coli asparaginase group,M1 in 112 （70.4%） cases,M2 in 21 （13.2%） and M3 in 26 （16.4%）,respectively （x2 =2.938,P =0.230）.Bone marrow status on day 33 was M1 in 105 （96.3%）,M2 in 3 （2.8%） and M3 in 1 （0.9%） in pegaspargase group,while it was M1 in 154 （96.9%） cases,M2 in 5 （3.1%） and M3 in native Escherichia coli asparaginase group,respectively （x2 =1.494,P =0.474）.Conclusion Domestic pegaspargase of our country can achieve the similar efficacy in induction treatment for ALL patients as compared with native Escherichia coli asparaginase.The drug could be considered as not only the choice for allergic patients but also a first-line alternative for new patients.