Liang Xiao-ling, Xian Ying, Dai Bi-tao, Xu You-hua, Su Yong-chun, Wang Shi-yi, Lu Ling-ling, Li Xin, Yu Jie
Department of Hematology/Oncology, Chongqing Children's Hospital, Chongqing Medical University, Chongqing 400014, China.
Zhonghua Er Ke Za Zhi. 2009 Dec;47(12):939-41.
To analyze the clinical and laboratory data from acute lymphoblastic leukemia (ALL) patients and the results of treatment using 04 Protocol (suggested by the Pediatric Hematology Group of Chinese Medical Association in 2004).
This study included 88 children with ALL below the age of 18 years during the period from October 1, 2004 to June 30, 2007. Minimal inhibitory concentration (MIC) and clinical risk classification were done and the new chemotherapy regimen was used according to the protocol. Patients were stratified into low-risk (LR), medium-risk (MR), and high-risk (HR) groups. Life table method was used to estimate survival rate and statistical analysis was done by using software SPSS for Windows.
From October 2004 to June 2007, 88 childhood ALL patients were treated with the 04 Protocol. Sixty-three (91.30%) patients attained complete remission (CR) and 17 patients lost to follow up. The overall 4-year-event-free survival (EFS) rate (+/- SE) was (59.73 +/- 7.22)%. EFS was (75.60 +/- 9.71)% in the LR (n = 30), (65.50 +/- 11.69)% in the MR (n = 20) and (44.03 +/- 12.36)% in the HR. Relapse occurred in 18.18% of patients. Seven (7.95%) of 88 patients with ALL died during he induction therapy. Infection was the most common cause of death.
The outcome of patients treated with the 04 Protocol was favorable. Clinical risk classification and the leukemia cells of D19 are independent predictors of prognosis of ALL. High dose methotrexate played an important role in prevention and treatment of central nervous system leukemia. The mortality rate of this chemotherapeutic protocol during induction therapy was high.
分析急性淋巴细胞白血病（ALL）患者的临床和实验室数据以及采用04方案（中华医学会儿科学分会血液学组2004年推荐）的治疗结果。
本研究纳入了2004年10月1日至2007年6月30日期间88例18岁以下的ALL患儿。进行了最低抑菌浓度（MIC）检测和临床风险分类，并根据方案采用新的化疗方案。患者被分为低危（LR）、中危（MR）和高危（HR）组。采用寿命表法估计生存率，并使用Windows版SPSS软件进行统计分析。
2004年10月至2007年6月，88例儿童ALL患者采用04方案治疗。63例（91.30%）患者获得完全缓解（CR），17例患者失访。4年无事件生存率（EFS）（±标准误）为（59.73±7.22）%。LR组（n = 30）的EFS为（75.60±9.71）%，MR组（n = 20）为（65.50±11.69）%，HR组为（44.03±12.36）%。18.18%的患者复发。88例ALL患者中有7例（7.95%）在诱导治疗期间死亡。感染是最常见的死亡原因。
采用04方案治疗的患者预后良好。临床风险分类和D19白血病细胞是ALL预后的独立预测因素。大剂量甲氨蝶呤在预防和治疗中枢神经系统白血病中起重要作用。该化疗方案在诱导治疗期间的死亡率较高。
