重组人白细胞介素-11治疗化疗引起的血小板减少症的II期临床研究  

Phase Ⅱ study of recombinant human interleukin-11 treatment for chemotherapy-induced thrombocytopenia

作　　者：曹军宁[1] 许立功[1] 吴晴[2] 冯继锋[3] 张沂平[4] 秦凤展[5] 徐建华[6] 战榕[7] 谭清和[8] 吴昌平[9] 

机构地区：[1]复旦大学附属肿瘤医院肿瘤内科 [2]上海市第一人民医院肿瘤科,上海200085 [3]江苏省肿瘤医院肿瘤内科,江苏南京210009 [4]浙江省肿瘤医院肿瘤内科,浙江杭州310022 [5]蚌埠医学院附属医院肿瘤内科,安徽蚌埠233004 [6]湖南省肿瘤医院肿瘤内科,湖南长沙410006 [7]福建省协和医院血液科,福建福州350001 [8]南通市肿瘤医院肿瘤内科,江苏南通226361 [9]常州市第一人民医院肿瘤科,江苏常州213003

出　　处：《中国癌症杂志》2005年第2期141-144,共4页China Oncology

摘　　要：目的:评价重组人白细胞介素11(rhIL11)对化疗引起的血小板减少症的疗效和安全性。方法:采用多中心、非随机、自身对照试验。对照周期单用化疗,治疗周期化疗后给予rhIL1150μg/(kg·d),皮下注射,连续给药10～14天,或PLT>300×109/L后停药。结果:共入组106例患者,可评价疗效100例。PLT最低值(中位数)对照周期为49(5～76)×109/L,治疗周期为69(6～221)×109/L,P<0.001。PLT≤75×109/L的中位天数对照周期为7(0～26)天,治疗周期为3.5(0～28)天,P<0.001。PLT≤50×109/L的中位天数对照周期为2(0～20)天,治疗周期为0(0～23)天,P<0.01。PLT≤20×109/L的中位天数对照周期为0(0～9)天,治疗周期为0(0～5)天,P>0.05。从PLT最低点恢复到80×109/L的中位天数对照周期为5(1～18)天,治疗周期为2(0～28)天,P<0.001。对照周期输注血小板人数为6例,治疗周期为6例,无统计学差异。主要不良反应为发热、心悸、水肿、肌肉关节痛、感冒样症状等。结论:rhIL11对化疗引起的血小板减少症有防治作用,临床不良反应可以耐受,未发生严重不良事件。Purpose:To evaluate the efficacy and the safety of recombinant human interleukin-11 (rhIL-11) for patient with chemotherapy induced thrombocytopenia. Methods:It was a multicenter non-randomized self-control study. Patients received chemotherapy in control cycle versus chemotherapy plus rhIL-11 50 μg/(kg·d) in the study cycle. RhIL-11 was administered as a daily SC injection for 10-14 days, or discontinued when platelet count >300×10^(9)/L. Results:One hundred and six patients were enrolled into this study. Of the 106 patients, 100 patients completed the study and were evaluable for efficacy. The median nadir of platelet was 49(5-76)×10^(9)/L in the control cycle and 69(6-221)×10^(9)/L in the study cycle. Median durations of PLT≤75×10^(9)/L, ≤50×10^(9)/L, and ≤20×10^(9)/L were 7 (0-26), 2 (0-20), and 0 (0-9) days in control cycle versus 3.5 (0-28) (P<0.001), 0 (0-23) (P<0.01), and 0 (0-5) (P>0.05) days in study cycle, respectively. The median duration of platelet recovery to 80×10^(9)/L was 5 (1-18) days in control cycle versus 2(0-28) days in study cycle (P<0.001). There was no difference between control and study cycle in the number of platelet transfusion (6 vs 6). The most common side effects were fever, palpitation, edema, arthralgia , flu-like symptom. Conclusions:This study has demonstrated that rhIL-11 is effective in the treatment of chemotherapy-induced thrombocytopenia. It is well tolerated in cancer patients.

关 键 词：重组人白细胞介素-11 血小板减少症 化疗 Ⅱ期临床试验 

分 类 号：R730.53[医药卫生—肿瘤]