重组人白细胞介素11(迈格尔)对化疗引起骨髓抑制肿瘤病人的促血小板生成作用

Recombinant Human Interleukin 11(Mega) Promotes Thrombopoiesis in Cancer Patients with Chemotherapy-Induced Myelosuppression

观察国产重组人白细胞介素 11(rhIL 11,迈格尔 )对重度骨髓抑制病人的血小板恢复作用。采用随机双盲自身交叉对照方法进行研究。在化疗药物给药结束后 2 4小时开始给迈格尔 2 5μg kg ,皮下注射 ,每日 1次 ,连续用药 7- 14天或至血小板计数≥ 30 0× 10 9 L。对化疗后血小板值低于 5 0× 10 9 L(重度骨髓抑制 )的病例进行统计分析研究。结果表明 ,临床Ⅱ期试用的 118例可评价病例中 ,安慰剂对照周期血小板值低于 5 0× 10 9 L的例数为 2 9例 ,占 2 4 .5 8%,而迈格尔治疗周期仅 1例血小板值低于 5 0× 10 9 L ,占 0 .84 %;先给安慰剂后给迈格尔组安慰剂对照周期血小板值低于 5 0× 10 9 L的比例高于先给迈格尔后给安慰剂组 ,两者分别为 32 .2 0 %和 16 .95 %;迈格尔治疗周期血小板最低值和化疗第 2 1天血小板值分别是安慰剂对照周期的 3.0 4倍和 2 .4 3倍。本试验结果说明 ,迈格尔可促进重度骨髓抑制病人的血小板恢复 ,减少肿瘤病人化疗后重度血小板减少症的发生 ,缩短重度血小板减少症的持续时间 ,且具有一定的后续效应。

s A randomized, selfcross-over and placebo-controlled clinical trial has been taken to evaluated the curative efficacy of rhIL-11(Mega) for thrombocytopenia in 29 cancer patients with severe myelosuppression induced by chemotherapy. Twenty-five μg/kg of Mega or placebo was administered subcutaneously once daily starting 24 hours after the completion of chemotherapy, and continuing for 7 to 14 days or until the platelet count reached 300×10 9/L. The results from those in 118 cases performed phase Ⅱ clinical trial, showed that there were 29 cases with platelet count less than 50×10 9/L in placebo cycle, but there was only 1 case in Mega cycle. The percentage of the patients with platelet count less than 50×10 9/L in placebo cycle of placebo+Mega group was higher than that of Mega+placebo group. The nadir and platelet counts on day 21 after chemotherapy in Mega cycle were 2.04 and 1.43 times more than those in placebo cycle, respectively. The data show that Mega had significant thrombopoietic activity with a long lasting oction for the patients experienced severe myelosuppression. It significantly increases the likelyhood of avoiding thrombocytopenia in cancer patients undergoing chemotherapy and shortens the duration of thrombocytopenia.