黄芪注射液对儿童急性淋巴细胞白血病近期预后的影响

Effect of Huangqi injection on short-term prognosis in children with acute lymphoblastic leukemia

摘要:

目的 探讨黄芪注射液对儿童急性淋巴细胞白血病（ALL）近期预后的影响。方法 回顾性分析2009 年1 月至2012 年12 月105 例初诊ALL 患儿的临床资料，随机分为治疗组49 例，其中低危型18 例，中危型7 例，高危型24 例；对照组56 例，其中低危型21 例，中危型7 例，高危型28 例；两组均按相同危险度分型给予相同的诱导缓解治疗方案，治疗组同时给予静脉滴注黄芪注射液，每日0.5~1.0 mL/kg；对照组用0.9%氯化钠注射液进行替代输注，至诱导缓解治疗结束。对影响两组预后的因素分布及两组诱导缓解治疗后的完全缓解（CR）率进行比较；同时比较两组患儿在诱导缓解治疗第19 天以及两组B-ALL 患儿在诱导缓解治疗结束达CR 时不同微小残留病（MRD）水平的发生率。结果 105 例ALL 患儿中，B-ALL 型99 例，T-ALL 型6 例。两组患儿各预后因素分布比较差异均无统计学意义（均P>0.05）。105 例患儿的总CR 率为79%，治疗组（82%）与对照组（77%）的CR 率比较差异无统计学意义（P>0.05），且不同临床危险度分型患儿CR 率在两组间比较差异亦均无统计学意义（均P>0.05）。诱导治疗第19 天，治疗组患儿MRD ≥ 10^-4 的发生率（69%）低于对照组（95%，P<0.05）；80 例达CR 的B-ALL 患儿中，对照组43 例，治疗组37 例，治疗组MRD ≥ 10^-4 的发生率（27%）低于对照组（58%，P<0.05）；且在上述两种情况下，治疗组高危型和低危型患儿MRD ≥ 10^-4 的发生率均低于对照组（均P<0.05）。结论 黄芪注射液联合化疗可增强抗肿瘤作用，改善儿童ALL 近期预后，提高儿童ALL的临床疗效。

Abstract:

Objective To investigate the effect of Huangqi injection on the short-term prognosis in childhood with acute lymphoblastic leukemia (ALL). Methods A retrospective analysis was performed on the clinical data of 105 children newly diagnosed with ALL between January 2009 and December 2012. These children were randomly divided into treatment group (18 low-risk cases, 7 medium-risk cases, and 24 high-risk cases) and control group (21 low-risk cases, 7 medium-risk cases, 28 high-risk cases). Both groups were given remission induction therapy based on the levels of risk. Throughout the remission induction therapy, the treatment group also received Huangqi injection (0.5-1.0 mL/kg per day) by intravenous infusion, while the control group was given 0.9% sodium chloride injection instead. The two groups were compared in terms of distribution of prognostic factors and complete remission (CR) rate after remission induction therapy, as well as the incidence of minimal residual disease (MDR) (≥ 10^-4 and < 10^-4) among all patients in the two groups on day 19 of remission induction therapy and among B-ALL patients in the two groups when achieving a CR at the end of remission induction therapy. Results Of the 105 children with ALL, 99 had B-ALL, and 6 had T-ALL. There were no significant differences in the distribution of prognostic factors between the two groups (P>0.05). The overall CR rate of 105 patients was 79%; there was no significant difference in CR rate between the treatment and control groups (82% vs 77%; P>0.05); also, no significant differences were found between the two groups in the CR rates among high-, medium-, and low-risk cases (P>0.05). On day 19 of remission induction therapy, the incidence of MRD ≥10^-4 in the treatment group was significantly lower than that in the control group (69% vs 95%; P<0.05); among 80 children with B-ALL who achieved a CR (43 cases in the control group and 37 cases in the treatment group), the incidence of MRD ≥10^-4 was significantly lower in the treatment group than in the control group (27% vs 58%; P<0.05); in both circumstances above, the high-and low-risk cases in the treatment group had a significantly lower incidence of MRD ≥10^-4 than the control group (P<0.05). Conclusions Huangqi injection combined with chemotherapy has an enhanced anti-tumor effect and can improve the short-term prognosis and clinical outcome in children with ALL.