[关键词]
[摘要]
目的 研究重组人血小板生成素(rhTPO)联合白介素-11衍生物(rhIL-11Ala10)治疗化疗所致血小板减少症的临床疗效和安全性。方法 选取郑州大学第一附属医院2012年6月—2013年6月接受化疗期间出现血小板(Plt)≤50×109/L的实体瘤患者32例,采用自身交叉对照试验的方法将患者随机分为AB、BA两组,每组均接受两阶段治疗。A疗程为化疗结束后12~24 h皮下注射rhTPO 1.5×104 U/次,1次/d,连续给药2 d后换用rhIL-11Ala10皮下注射,1.5 mg/次,1次/d;B疗程为化疗结束后12~24 h单用rhIL-11Ala10皮下注射1.5 mg/次,1次/d。AB组第一阶段为A疗程,第二阶段为B疗程,BA组恰好相反。A、B疗程的治疗过程中当Plt的绝对值升高≥50×109/L,或Plt≥100×109/L,或用药达14 d即可停药。监测所有患者血小板生长情况和不良反应。结果 联合用药与单一用药相比,化疗后血小板下降的最低值平均升高5×109/L,血小板恢复的最高值平均升高78×109/L,持续用药的天数平均缩短了3.7 d,且不良反应发生率低。结论 联合应用rhTPO和rhIL-11Ala10治疗化疗后血小板减少症的临床效果更优,更经济,更安全。
[Key word]
[Abstract]
Objective To observe the efficacy and adverse reactions of recombinant human thrombopoietin (TPO) combined with recombinant human interleukin-11 derivative (rhIL-11Ala10) in treatment of thrombocytopenia induced by chemotherapy. Methods In this randomized cross-over self-controlled clinical trial, 32 patients with malignant tumor in The First Affiliated Hospital of Zhengzhou University from June 2012 to June 2013 whose platelet count (Plt) was under or equal to 50 × 109 /L after chemotherapy were divided randomly into AB and BA groups. All the patients underwent two identical periods of therapy. In cycle A, rhTPO (1.5 × 104 U) was sc given once daily after 12—24 h of chemotherapy for 2 d consecutively, then rhIL-11Ala10 (1.5 mg) was sc given once daily. In cycle B, only rhIL-11Ala10 (1.5 mg) was sc given once daily after 12—24 h of chemotherapy. The Plt was recorded consecutively and the adverse reactions were observed. In AB group, the first period treated with cycle A and the second period with cycle B, while in BA group, the treatment was by contrast method. Both in the treatment of cycle A and B, if the Plt was improved to higher than 50 × 109 /L or reached 100 × 109 /L or even more or the patients had been treated for 14 d, the treatment should be stopped. The Plt was recorded and the adverse reactions were observed. Results Compared with cycle B, the mean minimum Plt was 5 × 109/L higher in cycle A and the maximum Plt was 78 × 109 /L. The period of medication in cycle A was 3.7 d shorter than cycle B, and the adverse reaction rate was lower. Conclusion It is more effective, economical, and safer for TPO combined with rhIL-11Ala10 in the treatment of thrombocytopenia induced by chemotherapy.
[中图分类号]
[基金项目]