国产基因重组人白细胞介素-11治疗化疗致重度血小板减少症25例

目的观察国产基因重组人白细胞介素-11(rhIL-11)对化疗致重度血小板减少症(TBP)的临床疗效。方法61例大剂量化疗后出现Ⅲ~Ⅳ度骨髓抑制患者,治疗组25例给予国产基因重组人白细胞介素-11(rhIL-11),每次1.5μg或3μg,每日1次,疗程7 d。对照组36例应用甲强龙40 mg,每日1次,疗程7 d。记录每日血小板(PLT)化验结果,观察PLT开始回升时间、恢复至正常时间及不良反应。结果治疗组d4 PLT达到安全线以上(50×109.L-1),d14均达到正常,并顺利进入下一周期化疗。对照组d14平均达到70×109.L-1,仅有16例进入下一周期化疗,20例暂停化疗。对照组有7例因出血倾向输注PLT,而治疗组无1例输注PLT。两组经统计检验,P<0.05。治疗组Ⅲ度抑制者13例平均4 d恢复正常,Ⅳ度抑制者12例平均6 d恢复正常,且停药后有后续升血小板作用。主要不良反应为局部红肿、硬结、结膜充血、水肿等。结论国产rhIL-11可有效治疗大剂量化疗致PLT重度抑制,保证大剂量高强度化疗的实施。

Domestic-made recombinant human interleukin-11 for the treatment of 25 cases of severe thrombopenia induced by chemotherapy

Objective To observe clinical efficacy of domestic-made recombinant human interleukin-11(rhIL-11)in treatment of severe thrombopenia(TBP) induced by chemotherapy.Methods Sixty-one patients with Ⅲ°～Ⅳ° myelosuppression induced by chemotherapy with large dose were randomly divided into treatment group(25 cases) and control group(36 cases).Treatment group were performed with 1.5 μg or 3 μg domestic-made rhIL-11 per day for 7 days.Control group were performed with 40 mg urbason per day for 7 days.Detection of platelet(PLT) was recorded.Time of PLT rising again and recovery to normal and adverse effects were observed.Results Level of PLT of patients in treatment group achieved safe level(50×10~9·L~(-1))after 4 days,achieved normal level at the fourteenth day and entered successfully next periodical chemotherapy.Level of PLT in control group averaged 70×10~9·L~(-1) after 14 days.Among 36 patients in control group,only 16 patients could enter next periodical chemotherapy and other 20 patients suspended chemotherapy.Seven patients were infused PLT due to hemorrhagic tendency in control group and none was infused PLT in treatment group(P<0.05),Time of level of PLT recovered to normal of 13 patients with Ⅲ°myelosuppression in treatment group averaged 4 days and that of 12 patients with Ⅳ° myelosuppression averaged 6 days and after discontinuation there remained effects of elevating level of PLT.Major adverse effects were including regional red swelling of the skin,induration,conjunctival congestion and dropsy etc.Conclusion Domestic-made rhIL-11 for the treatment of severe thrombopenia induced by chemotherapy was effective and can guarantee high intensity application of chemotherapy.