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目的比较重组人血小板生成素(rhTPO)与重组人白介素-11(rhIL-11)对促进白血病患者异基因造血干细胞移植术后血小板恢复的临床疗效及安全性。方法将114例行异基因造血干细胞移植的白血病患者分为IL-11组、TPO组和空白组,分别为36例、56例和22例,IL-11组及TPO组从移植后第6天开始分别给予rhIL-11 1.5 mg/d及rhTPO 15 000 u/d皮下注射,至血小板上升至100×109/L停药,如使用14 d未达正常亦停用。空白组患者不应用任何升血小板药物,血小板自然恢复。监测血常规并观察记录患者用药后的不良反应及30 d内血小板悬液输注量。结果IL-11组、TPO组和空白组血小板由最低恢复至≥20×109/L的中位时间分别为+13(8～20)d、+12(6～25)d和+19.5(12～32)d,IL-11组、TPO组的恢复时间均快于空白组(P值分别为0.003,0.001),但IL-11组和TPO组两组没有统计学差别(P=0.640);IL-11组、TPO组和空白组血小板由最低恢复至≥50×109/L的中位时间分别为+16.5(10～39)d、+15(11～48)d和+29(15～49)d,IL-11组、TPO组的恢复时间均快于空白组(P值分别为0.002,0.001),IL-11组和TPO组两组亦没有统计学差别(P=0.357);IL-11组、TPO组和空白组血小板由最低恢复至≥100×109/L的中位时间分别为+25(13～69)d、+18(14～48)d和+43(19～64)d,IL-11组、TPO组的恢复时间均快于空白组(P值分别为0.001,0.004),TPO组较IL-11组缩短7 d,两组差异有统计学意义(P=0.033)。+30 d内IL-11组、TPO组及空白组输注血小板悬液的中位数量分别为2(0～6)个治疗量、2(0～4)个治疗量和4(1～4)个治疗量,IL-11组和TPO组的血小板悬液输注量均少于空白组(P值分别为0.005,0.003),但该两组之间差异无统计学意义(P=0.499)。TPO组的不良反应发生率3.6%明显低于IL-11组的77.8%(P<0.001)。结论 rhTPO及rhIL-11均能够促进白血病患者异基因造血干细胞移植术后血小板计数的恢复,有效减少血小板悬液的输注量,降低移植出血相关风险;rhTPO较rhIL-11能缩短血小板升至正常的时间,从而提高患者对移植并发症的耐受性;rhTPO较rhIL-11的不良反应更少,具有良好的安全性,值得临床进一步推广应用。
Objective To compare the clinical efficacy and safety of recombinant human thrombopoietin (rhTPO) and recombinant human interleukin-11 (rhIL-11) in promoting platelet recovery after allogeneic hematopoietic stem cell transplantation in patients with leukemia. Methods 114 leukemia patients who underwent allogeneic hematopoietic stem cell transplantation were divided into IL-11 group, TPO group and blank group, 36 cases, 56 cases and 22 cases. IL-11 group and TPO group Initially, rhIL-11 1.5 mg / d and rhTPO 15 000 u / d were administered subcutaneously until platelets increased to 100 × 109 / L, and discontinued if they were not used for 14 days. Patients in the blank group should not use any platelet-stimulating drugs, and platelets naturally recovered. The blood routine was monitored and the adverse reaction and the infusion of platelet suspension within 30 days were recorded and recorded. Results The median time from the lowest recovery of platelets to ≥20 × 109 / L in IL-11, TPO and blank groups was +13 (8-20) d, +12 (6-25) d and +19.5 ~ 32) d. The recovery time of IL-11 and TPO groups was faster than that of blank group (P = 0.003 and 0.001 respectively), but there was no significant difference between IL-11 and TPO groups (P = 0.640) The median time from the lowest recovery to ≥50 × 109 / L for platelets in IL-11, TPO and blank groups were +16.5 (10-39) d, +15 (11-48) d and +29 49) d, the recovery time of IL-11 and TPO groups was faster than that of blank group (P = 0.002 and 0.001 respectively), IL-11 and TPO groups also had no significant difference (P = 0.357) -11 group, the median time from the lowest recovery of platelets to ≥100 × 109 / L in TPO group and blank group were +25 (13-69) d, +18 (14-48) d and +43 (19-64 ) d, the recovery time of IL-11 group and TPO group was faster than that of blank group (P = 0.001 and 0.004 respectively), TPO group shortened 7 days than IL-11 group, the difference was statistically significant ). The median number of platelet transfusion in IL-11, TPO and blank groups was 2 (0 ~ 6), 2 (0 ~ 4) and 4 ), The IL-11 and TPO groups had less platelet transfusion than the blank group (P = 0.005 and 0.003 respectively), but there was no significant difference between the two groups (P = 0.499) . The incidence of adverse reactions in the TPO group was significantly lower than in the IL-11 group (3.6% vs 77.8%, P <0.001). Conclusion Both rhTPO and rhIL-11 can promote the recovery of platelet count after allogeneic hematopoietic stem cell transplantation in patients with leukemia, effectively reduce the transfusion volume of platelet suspension and reduce the risk of transplanted hemorrhage. RhTPO can shorten the platelet up to normal than rhIL-11 Of the time, thereby increasing patient tolerance to transplant complications; rhTPO less adverse reactions than rhIL-11, with good safety, it is worth further clinical application.