不同剂量白介素-11治疗化疗后血小板减少的临床对比研究

A clinical comparative study on the efficacy of different dosages of rhIL-11 on chemotherapy-induced thrombocytopenia

目的:研究不同剂量重组人白介素-11(rhIL-11)对恶性肿瘤患者化疗所致血小板减少的疗效及不良反应。方法:采用随机对照的方法,对46例因化疗引起血小板II度以上减少的恶性肿瘤患者给予rhIL-11治疗。A组22例,rhIL-11用量为1.5mg/d,B组24例,3mg/d,皮下注射,血小板升高至正常时停止给药。结果:rhIL-11治疗后,血小板严重减少(20×109/L)的持续天数,B组少于A组(p=0.031);血小板恢复至正常的时间,A、B组的中位数分别为11天和8天,有统计学意义。B组血小板最低值高于A组,PLT<50×109/L持续天数,出血并发症以及减少血小板输注的例数,B组亦少于A组,但两组比较没有显著性差异(p>0.05)。主要不良反应:四肢、腰背肌肉酸痛伴骨骼及关节疼痛、乏力、发热、头痛及头晕,均为I-II度,两组比较没有显著性差异(p>0.05),停药后或口服"百服宁"均恢复。结论:rhIL-11是一种有效且安全的治疗恶性肿瘤患者化疗所致血小板减少药物,可以在临床常规应用。对比1.5mg,每天皮下注射3.0mg的剂量疗效可能更好些,不良反应可以耐受。

Objective：To investigate the effects of different dosages of recombinant human interleukin-11（ rhIL-11） in the management of chemotherapy-induced thrombocytopenia in malignant tumor patients. Methods：46 malignant tumor patients,who developed Grade II or greater thrombocytopenia in response to chemotherapy,were treated with subcutaneous injection of 1.5mg/d rhIL-11 or 3mg/d rhIL-11 for 3 to 20 consecutive days until their platelet count returned to normal level,Patients were naturally divided into two different groups,group A（n=22） and group B（n=23） . Results：Group B had significant shorter duration of thrombocytopenia defined by platelet count 20×109 /L after rhIL-11 treatment compared with group A（p=0.031） ;The time patient recovered to the normal platelet count was 5～25d（median 11d） for group A versus 3～18d（median 8d） for group B,and the difference was statistically significant（p=0.048） ;The minimum level of platelet was higher for in group B,and the duration of PLT 50 ×109 /L,the number of cases suffering from hemorrhage complication and receiving infusion of apheresis platelets in group A were lower than group B,but without significant difference（p〉0.05） . The major adverse reactions relatived to rhIL-11 treatment were soreness of limb and lumbodorsal muscle complicated with skeleton and joint pain,hypodynamia,and fever,and grade I-II fever with headache and dizziness,these symptoms,however,were relieved when rhIL-11 was withdrawn or oral administration of Bufferin was applied. Conclusions：rhIL-11 is effective and safe in the treatment of chemotherapy-induced thrombocytopenia in malignant tumor patients,and well suited for routine use in clinic. However 3.0mg/daily regimen（approximately 50ug/kg/d） might be superior to 1.5mg/daily regimen（approximately 25ug/kg/d） when efficacy and adverse effects are concerned.