重组人白细胞介素-11防治化疗诱发的严重血小板减少症  

Clinical study of rhIL-11 on severe thrombocytopenia in cancer patients after chemotherapy

作　　者：张燕军[1] 任军[1] 范黎[1] 刘文超[1] 尤向辉[1] 黄若宇[1] 黄颍[1] 斯晓明[1] 潘伯荣[1] 

机构地区：[1]第四军医大学西京医院肿瘤中心,陕西西安710033

出　　处：《第四军医大学学报》2004年第15期1410-1412,共3页Journal of the Fourth Military Medical University

基　　金：卫生部下达Ⅱ期临床试验项目 ([2 0 0 3]II0 4 84)

摘　　要：目的 :评价重组人白介素 1 1 (rhIL 1 1 )促进化疗后肿瘤患者血小板增殖的疗效和耐受性 .方法 :采用开放、自身交叉、空白对照方法 ,患者第 1周期化疗后观察为空白对照周期 (A周期 ) ,第 2周期化疗后使用rhIL 1 1为治疗周期 (B周期 ) .rhIL 1 1于第 2周期化疗后 2 4h开始 ,5 0 μg/kg皮下注射 ,每日一次 ,连续用药 1 4d或连续 2次检查血小板计数至≥3× 1 0 1 1 /L时停药 .结果 :共入选 30例患者 ,2例患者因B周期输注血小板而被剔除 ,2 8例可评价疗效 ,30例可评价毒性反应 .A周期和B周期化疗前的PLT均值无差异 ;从化疗后序日第 7～ 2 1日 ,B周期PLT的均值高于A周期 ,起效时间位于化疗后第 7日 ;B周期的最低值序日提前 ,最高值序日后延 ;对白细胞、血红蛋白和肝肾功能没有影响 .治疗相关的不良反应主要为发热、水肿、头晕痛、肌骨痛、气短和呼吸困难、皮疹、局部痛、红肿、硬结、颜面潮红、结膜充血和皮肤出血点 ,均为WHOⅠ Ⅱ度毒性 .结论 :rhIL 1 1具有明显的促进血小板增殖作用 ,缩短化疗后血小板下降的持续时间 。AIM: To evaluate the influence of recombinant human interleukin 11 (rhIL 11) on thrombocytes in cancer patients after chemotherapy. METHODS: By using open, self cross over and negative control methods, the patients were treated by two cycles: cycle A and cycle B. In cycle A, the first cycle chemotherapy, the patients were treated only with chemotherapy without rhIL 11. In cycle B, the second cycle chemotherapy, the patients were treated with rhIL 11 after the same chemotherapy as that in the first cycle. 50 μg/kg of rhIL 11 was administered subcutaneously once daily 24 h after the completion of the chemotherapy in cycle B. The administration of rhIL 11 lasted for at least 7 d and at most 14 d, and would cease if the patient’s platelet count was ≥3×10 11 /L for two successive days. RESULTS: Of the 30 patients enrolled in this study, 2 were excluded because of the platelet transfusion in cycle B. The other 28 patients were eligible for the evaluation of curative effects and all the 30 patients were eligible for the evaluation of toxicity. There was not statistics difference of PLT between cycle A and cycle B before chemotherapy, but from the 7th d to the 21st d after chemotherapy, the patients in cycle B had a significant higher platelet level than the patients in cycle A. The administration of rhIL 11 also prolonged the duration of increment of PLT counts and shortened the duration of the PLT counts decline. No toxicity to WBC was observed in both cycles. The mean value of Hb was lower on the eighteenth day in A group than that in B group. The toxicities mainly included fever, fatigue, nausea, ache of injected skin, edema, headache and myalgia, but they could be well tolerated. CONCLUSION: rhIL 11 has strong thrombopoietic activity and can be well tolerated for cancer patients undergoing chemotherapy.

关 键 词：重组人白细胞介素-11 血小板生成 血小板减少症 

分 类 号：R969.4[医药卫生—药理学]