儿童急性淋巴细胞性白血病诱导化疗修正方案的近期临床评估

目的比较上海交通大学医学院附属上海儿童医学中心1999年开始使用的儿童急性淋巴细胞性白血病（ALL）治疗方案（以下简称99方案）,和在99方案基础上减轻治疗强度并从2005年开始使用的修正方案（以下简称05方案）诱导治疗的疗效、安全性,以提高儿童ALL的疗效。方法纵向对比1999年1月1日至2006年3月1日初治的311例ALL患儿临床资料;以2005年5月1日为分界线分为99方案组和05方案组。99方案组243例,05方案组68例。对两组患儿起病时临床资料、治疗反应、缓解情况、治疗相关的感染情况等进行统计分析。结果两组病例起病时各项临床资料（性别、年龄、诊断时外周血白细胞计数）差异均无统计学意义（P均〉0．05）,两组的缓解率（91．8％弧95．6％,P=0．29）和缓解时微小残留病（MRD）监测结果（P=0．17）差异也无统计学意义,99方案组与05方案组达到缓解所需时间（34．18±4．96d vs．32．34±3．36d）、治疗相关的感染率（54．7％伽．23．5％）、重症感染的发生率（9．1％vs.0）和病死率（3．7％vs.0）差异均有统计学意义。结论05方案和99方案在儿童ALL的诱导缓解治疗上都能取得良好的疗效,而05方案在疗效确切的同时具有更高的安全性。

Evaluation of a modified induction chemotherapy in children with acute lymphoblastic leukemia

OBJECTIVE: To improve the treatment outcome of children with acute lymphoblastic leukemia (ALL), and to evaluate the efficacy and safety of a modified induction chemotherapy between the two protocols used to treat children with ALL in Shanghai Children's Medical Center. METHODS: From Jan. 1st, 1999 to Mar. 1st, 2006, 311 patients with newly diagnosed childhood ALL, who underwent induction chemotherapy for over 10 days, were eligible for analysis. Group 99 (n = 243) patients who were admitted before May 1st, 2005, were treated with ALL-XH-99 Protocol, whereas 68 patients admitted afterwards, defined as Group 05, were treated with ALL Protocol 2005 which was based on ALL-XH-99 Protocol but the treatment intensity was reduced to decrease treatment associated mortality. Clinically, the distributions of the initial data from the patients, treatment responses, complete remission rates after therapy, and treatment-associated infections in the two groups were evaluated. RESULTS: Patients from the two groups obtained similar complete remission rate (91.8% vs. 95.6%, P = 0.29), while patients from Group 05 were benefited more from their therapy. They had lower therapy associated infection rate (23.5% vs. 54.7% in Group 99, P < 0.01), and no severe infection (0 vs. 9.1% in Group 99) and no infection related death occurred (0 vs. 3.7% in Group 99). Patients in the Group 05 also had shortened period from the beginning day of the initial therapy to complete remission (32.34 +/- 3.36 days vs. 34.18 +/- 4.96 days, P < 0.01). CONCLUSIONS: ALL Protocol 2005 had the same efficacy as ALL-XH-99 Protocol had in the induction therapy in treating children with ALL, but it was safer than ALL-XH-99.