Clinical observation of recombinant human erythropoietin combined with iron agent in treatment of acute lymphoblastic leukemia complicated with mild to moderate anemia
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摘要:目的
探讨急性淋巴细胞白血病(ALL)合并轻中度贫血患者应用重组人促红细胞生成素(rHuEPO)联合铁剂治疗的疗效及安全性。
方法选取ALL合并轻中度贫血患者，按照掷硬币法将诱导缓解治疗后达到完全缓解(CR)的200例患者分为对照组与观察组，每组100例。对照组给予铁剂治疗，观察组给予rHuEPO联合铁剂治疗，连续治疗3个月。观察2组临床治疗效果; 比较治疗1、2、3个月时2组促红细胞生成素(EPO)浓度; 比较2组治疗前后血红蛋白(Hb)、血细胞比容(Hct)、红细胞(RBC)、铁蛋白(SF)水平及药物不良反应。
结果广义估计方程分析结果显示, 2组治疗2、3个月时血清EPO水平低于治疗1个月时，且观察组治疗1、2、3个月时血清EPO水平均低于对照组，差异有统计学意义(P < 0.05)。治疗3个月时, 2组Hb、Hct、RBC水平高于治疗前，且观察组高于对照组，差异有统计学意义(P < 0.05)。2组患者治疗期间药物不良反应情况比较，差异无统计学意义(χ2=1.229, P=0.268)。
结论rHuEPO联合铁剂治疗可调节ALL合并轻中度贫血患者的血清EPO水平，增加红细胞数量，升高Hb、Hct、RBC、SF水平，且用药安全性较高。
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关键词:
- 急性淋巴细胞白血病 /
- 轻中度贫血 /
- 重组人促红细胞生成素 /
- 铁剂
Abstract:ObjectiveTo investigate the efficacy and safety of recombinant human erythropoietin (rHuEPO) combined with iron agent in treatment of patients with acute lymphoblastic leukemia (ALL) complicated with mild to moderate anemia.
MethodsALL patients with mild to moderate anemia were selected, and 200 patients who achieved complete response (CR) after induced response therapy were divided into control group and observation group with 100 patients in each group by coin toss. The control group was treated with iron, and the observation group was treated with rHuEPO combined with iron for 3 months. The clinical therapeutic effect of two groups was observed; the concentration of erythropoietin (EPO) was compared between the two groups after 1 month, 2 and 3 months of treatment; the levels of hemoglobin (HB), hematocrit (HCT), red blood cell (RBC), ferritin (SF) and adverse drug reactions before and after treatment were compared between the two groups.
ResultsThe results of generalized estimation equation analysis showed that the serum EPO levels of the two groups at 2 and 3 months of treatment were significantly lower than that at 1 month, and the serum EPO levels of the observation group at 1 month, 2 and 3 months of treatment were significantly lower than that of the control group (P < 0.05). After 3 months of treatment, Hb, Hct and RBC levels in two groups were significantly higher than before treatment, and the observation group was significantly higher than the control group (P < 0.05). There was no significant difference in adverse drug reactions between the two groups (χ2=1.229, P=0.268).
ConclusionThe rHuEPO combined with iron agent can regulate the level of serum EPO, increase the number of red blood cells and the levels of Hb, Hct, RBC and SF in patients with ALL complicated with mild to moderate anemia, and the drug safety is high.
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表 1 2组不同时点血清EPO水平(x±s)
U/L 组别 n 治疗1个月 治疗2个月 治疗3个月 对照组 100 60.30±6.04 45.17±5.11* 41.01±4.62* 观察组 100 56.44±5.54# 41.43±4.92*# 34.22±4.73*# 与治疗1个月比较, *P < 0.05; 与对照组比较, #P < 0.05。 
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表 2 2组之间血清EPO的广义估计方程分析
变量 $\hat{\beta}$ S. E. $\hat{\beta}$ 95%CI Wald χ2 P 截距 60.302 0.601 59.124~61.480 10 061.332 < 0.001 观察组 -3.858 0.816 -5.457~-2.259 22.361 < 0.001 对照组 0 — — — — 治疗3个月时 -19.294 0.727 -20.719~-17.868 703.931 < 0.001 治疗2个月时 -15.130 0.785 -16.667~-13.592 371.845 < 0.001 治疗1个月时 0 — — — — 观察组*治疗3个月时 -2.936 1.021 -4.937~-0.934 8.264 0.004 观察组*治疗2个月时 0.111 1.027 -1.902~2.123 0.012 0.914 观察组*治疗1个月时 0 — — — —
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表 3 2组Hb、Hct、RBC、SF水平比较(x±s)
组别 n 时点 Hb/(g/L) Hct/% RBC/(×1012/L) SF/(μg/L) 对照组 100 治疗前 81.28±4.15 26.41±3.02 2.60±0.33 108.63±16.87 治疗3个月 112.82±6.71* 28.28±2.90* 2.92±0.33* 169.64±17.65* 观察组 100 治疗前 81.50±4.48 26.14±2.80 2.59±0.29 110.24±16.73 治疗3个月 120.68±6.71*# 32.36±2.90*# 3.08±0.38*# 178.43±17.80*# Hb: 血红蛋白; Hct: 血细胞比容; RBC: 红细胞; SF: 铁蛋白。与治疗前比较, *P < 0.05; 与对照组比较, #P < 0.05。
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表 4 2组药物不良反应比较[n(%)]
组别 n 头痛 恶心呕吐 腹泻 肌肉酸痛 合计 对照组 100 3(3.00) 2(2.00) 0 0 5(5.00) 观察组 100 4(4.00) 0 3(3.00) 2(2.00) 9(9.00)
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