6-巯嘌呤片剂不同分割法治疗儿童急性淋巴细胞白血病的疗效和不良反应比较

Comparison of Efficacy and Adverse Reactions of 6-Mercaptopurine Tablets with Different Partition Methods in Children with Acute Lymphoblastic Leukemia

目的:评估6-巯嘌呤(6-MP)50 mg规格片剂不同剂量分割的合理性,探讨6-巯嘌呤片剂不同分割法治疗儿童急性淋巴细胞白血病(ALL)的疗效和不良反应。方法:6-MP 50 mg规格片剂根据1/2、1/3、1/4分割方法设为三组,每组10片药物,分割后,称质量,计算均数、标准差。选取2015年3月至2020年12月ALL病例314例,根据6-MP用药情况分为两组,A组为1/2分割给药,B组为1/4分割给药,比较两组患儿年龄、性别、危险度、无复发生存率(RFS)及维持阶段不良事件(AE)发生情况。结果:3种分割法,1/2片分割距离目标量最接近,离散程度最小;1/3、1/4分割方法距离目标量较远,离散程度大。A、B两组患儿年龄、性别、危险度分层比较差异无统计学意义,两组患儿6年EFS比较差异无统计学意义,A组和B组在维持阶段用药过程中不良事件发生次数比较差异无无统计学意义。结论:1/2药片是进行药物分割的合理方法,可以比较准确得到相应剂量,药片相对完整,不易造成药品的浪费。以1/2(25 mg)为最小分割单位进行给药或是以1/4片(12.5 mg)为最小分割单位进行给药,对患者的远期生存率并无影响。两种不同给药方法,并没有增加6-MP不良反应。

Objective: To evaluate the rationality of different doses of 50 mg 6-mercaptopurine(6-MP) tablets, and explore their efficacy and adverse reactions in the treatment of childhood acute lymphoblastic leukemia(ALL). Methods: According to the 1/2, 1/3, and 1/4 division method, 50 mg 6-MP tablets were divided into three groups, with 10 tablets in each group. After division, the tablets were weighed and the means and standard deviations were calculated. According to the 6-MP medication situation, a total of 314 cases of ALL from March 2015 to December 2020 treated in our department were selected and divided into two groups. Group A was given 1/2 divided administration, and group B was given 1/4 divided administration. The age, gender, risk status, the relapse-free survival(RFS) and the occurrence of adverse events(AE) in the maintenance stage of the two groups of patients were compared. Results: There were three segmentation methods, 1/2 segmentation was the closest to the target, and the degree of dispersion was the smallest;1/3 and 1/4 division methods were far away from the target, and the degrees of dispersion were large. There was no significant difference in age, gender, and risk stratification between groups A and B. There was no significant difference in the 6-year RFS between the two groups of patients, and there was no significant difference in the AE between groups A and B. Conclusion: The 1/2 pill is a reasonable division method, and the corresponding dose can be obtained more accurately. The pill is relatively complete, and it is not easy to cause waste of medicine. Dosing with 1/2 tablet(25 mg) as the smallest division unit or 1/4 tablet(12.5 mg) as the smallest division unit has no effect on the long-term survival rate of patients. The two different administration methods have not increased the adverse effects of 6-MP.