重组人白细胞介素-11治疗重型再生障碍性贫血血小板减少的临床观察

Clinical efficacy of recombinant human interleukin 11 on thrombocytopenia in severe aplastic anemia

摘要:

目的  观察重组人白介素-11（rhIL-11）治疗重型再生障碍性贫血（SAA）患者血小板减少的疗效和安全性。方法  选取2005年6月-2014年12月该院SAA住院患者30例，所有患者接受猪抗人淋巴细胞球蛋白（p-ALG）治疗。将有无应用rhIL-11患者分为治疗组和对照组。治疗组所有患者在p-ALG治疗后给予rhIL-11治疗。用法为rhIL-11 3 mg，皮下注射，1次/d。当血小板计数（PLT）<10×109/L时，输注单采血小板。监测血常规并观察记录患者用药后的不良反应及单采血小板输注量。结果  两组PLT由最低恢复至≥20×109/L的时间分别为（43.43±11.78）和（53.42±10.80）d，差异有统计学意义（t =-2.672，P =0.012）；两组PLT由最低恢复至≥100×109/L的时间分别为（72.43±16.97）和（86.85±10.73）d，差异有统计学意义（t =-2.734，P =
0.011）；两组在PLT恢复至≥20×109/L时，输注血小板悬液的数量分别为（5.81±2.17）和（8.00±2.29）u，差异有统计学意义（t =-2.688，P =0.012）。主要不良反应为水肿、注射部位疼痛、结膜充血、乏力、发热等，无Ⅳ度不良反应，不良反应都较轻，可以耐受。结论  SAA血小板减少患者应用rhIL-11可促进血小板增生，加快血小板恢复，减少血小板输注量，从而减少出血等并发症的发生，节约费用，提高治疗的效果。其不良反应较轻，患者可耐受，值得推广应用。

Abstract:

Objective To evaluate the clinical efficacy and safety of recombinant human interleukin 11 (rhIL-11) in the treatment of thrombocytopenia of severe aplastic anemia (SAA). Methods All of the 30 patients, who were hospitalized for SAA in our hospital from June 2005 to December 2014, received the treatment of Porcine Anti-Human Lymphocyte Immunoglobulin (p-ALG). They were divided into rhIL-11 group and control group. After the treatment of p-ALG, the patients in the rhIL-11 group were given rhIL-11 3 mg/d. Platelets were transfused when the platelet count was below 10×109/L. Blood routine was monitored, adverse reactions of the patients after drug administration and the number of apheresis platelets transfusion were recorded. Results The average time of platelet count recovered from the lowest level to 20×109/L in the rhIL-11 group [(43.43 ± 11.78) d] was significantly shorter than that in the control group [(53.42 ± 10.80) d; t = -2.672, P = 0.012]; the recovery time from the lowest level to 100×109/L in the rhIL-11 group [(72.43 ± 16.97) d] was also significantly shorter than that in the control group [(86.85 ± 10.73) d; t = -2.734，P = 0.011]. The average number of apheresis platelets transfusion for platelet recovery to 20×109/L in the rhIL-11 group and the control group were (5.81 ± 2.17) u and (8.00 ± 2.29) u with significant difference (t = -2.688, P = 0.012). The main adverse reactions were edema, pain of injection site, conjunctival congestion, fatigue and fever which were tolerable. Conclusions rhIL-11 is able to promote platelet recovery, shorten the time of platelet recovery in patients with severe aplastic anemia. It can also effectively reduce the number of apheresis platelets transfusion and the risk of bleeding. The side-effects of the rhIL-11 treatment are mild. It has safety and good tolerance, and is worth further popularization in clinic.