摘要
目的观察含培门冬酶注射液的VDPAP方案治疗儿童急性淋巴细胞白血病（ALL）的疗效和不良反应。方法选择儿童初治ALL患者，随机分成两组。试验组采用国产培门冬酶注射液组成的VDPAP方案，对照组采用左旋门冬酰胺酶（L—Asp）组成的VDLP方案。VDPAP方案：柔红霉素第8、9天，泼尼松28d后减量，长春新碱每周1次共4周，培门冬酶2500IU·m^-2·d^-1。治疗1个疗程后评价疗效及不良反应。在试验组选取11例患儿进行药代动力学研究。结果人组患者135例，可评价疗效131例，其中试验组65例，CR率为84．6％，总有效率为92．3％；对照组66例，CR率为89．4％，总有效率为93．9％，两组间疗效差异无统计学意义。试验组和对照组不良事件发生率分别为95．6％和98．5％，两组间差异无统计学意义。主要不良反应包括胃肠道反应、血常规指标下降、可逆性肝功能损害和凝血异常等。过敏反应的发生率试验组为4．4％（68例中3例），对照组为5．9％（67例中4例）。药代动力学结果显示，培门冬酶注射液半衰期为（170±45）h，约（7±2）d。给药后在诱导治疗期血清培门冬酶浓度均〉0．1IU／ml。结论采用含培门冬酶的VDPAP方案与含L-Asp的VDLP方案治疗儿童ALL，其疗效、不良反应相似，但前者具有作用时间长和使用方便的优点。
Objective To evaluate efficacy and side-effect of polyethylene glycol conjugated asparaginase （PEG-Asp） containing VDPAP regimen in newly diagnosed childhood acute lymphoblastic leukemia （ALL） . Methods One hundred and thirty five children with newly diagnosed ALL were randomized assignments to receive PEG-Asp containing VDPAP regimen or L-asparaginase containing VDLP regimen as control for induction therapy. The VDPAP regimen consisted of daunomycin on day 1, 2, prednisone for 28 days, vincristine once a week for 4 weeks, and PEG-Asp（2500 IU/m^2） intramuscularly once every two weeks for 4 weeks. In the VDLP regimen, the PEG-Asp was substituted by L-asparaginase （6000 IU/m^2, three times a week for 2 weeks）. The pharmacokinetics of PEG-Asp was investigated in 11 patients in VDPAP group. Resuits The complete remission （CR） rates were 84.6% and 89.4% , total response rates were 92.3% and 93.9% （ P 〈 0.05, respectively） , and the incidence of adverse effects was 95.6% and 98.5% （ P 〉 0.05） in the VDPAP and VDLP group, respectively. The major adverse effect was allergic response （4.4% and 5.9% in the VDPAP and VDLP group, respectively） and others included coagulopathy and gastrointestinal symptoms. Pharmacokinetics showed that the half-life of PEG-Asp was （ 170 ±45 ） hours [ about （7 ±2 ） days ], the serum PEG-Asp activity levels 〉 0.1 IU/ml throughout induction. Conclusion The effectiveness of PEG-Asp and L-asparaginase for treatment of pediatric ALL is similar and no difference in adverse effect. The advantage of PEG-Asp is more prolonged effect and convenient.
出处
《中华血液学杂志》
CAS
CSCD
北大核心
2008年第1期29-33,共5页
Chinese Journal of Hematology
