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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》2003年第17期1612-1614,共3页Journal of the Fourth Military Medical University
摘 要:目的 :评价重组人白细胞介素 11(rhIL 11)促进化疗后肿瘤患者血小板增值的疗效和耐受性 .方法 :采用随机、自身交叉、空白对照方法 ,患者按入组顺序随机分入AB或BA组 .AB组即第一周期化疗后使用rhIL 11为治疗周期 (A周期 ) ,第二周期化疗后观察为空白对照 (B周期 ) .BA组与AB组相反 ,即第一周期化疗后观察为空白对照 (B周期 ) ,第二周期化疗后使用rhIL 11(A周期 ) .rhIL 11于化疗后 2 4h开始用药 ,2 5 μg·kg-1皮下注射 ,每日 1次 ,连续用药 14d或连续 2次检查血小板计数至≥ 30 0× 10 9·L-1时停药 .结果 :共入选 19例患者 ,BA组 2例因第 1周期化疗后疾病进展 ,中止化疗而剔除 ,17例可评价疗效和毒性反应 .经统计学分析 ,治疗周期和对照周期化疗前的血PLT均值无差异 ;rhIL 11可升高化疗后患者PLT数的绝对值 ,起效时间位于化疗后第 10日 ;缩短PLT下降时间、延长PLT回升时间 ;对白细胞没有影响 ;于化疗后第 18日血红蛋白降低 .治疗相关的不良反应主要为发热、乏力、恶心呕吐、局部疼痛、水肿、头痛头晕和肌肉骨痛 ,均为WHOⅠ~Ⅱ度毒性 .结论 :rhIL 11可升高化疗后患者PLT数的绝对值、缩短PLT下降时间、延长PLT回升时间 .耐受性良好 .AIM: To evaluate the thrombopoietic activity and tolerability of recombinant human interleukin 11 (rhIL 11) in cancer patients after chemotherapy. METHODS: By using randomized, self cross over and negative control method, the patients were randomly divided into two treatment groups: group AB and group BA. Both groups had a treated circle (circle A) and a negative controlled circle (circle B). In group AB the patients received rhIL 11 after the first circle of chemotherapy and were only observed after the second circle of chemotherapy. Group BA was contrary to the group AB, in which the patients were only observed after the first circle of chemotherapy and received rhIL 11 after the second circle of chemotherapy. Twenty five microgram/kg of rhIL 11 was administered subcutaneously daily, starting 24 hours after the completion of chemotherapy and continuing for 7 to 14 days or until the platelet count reached above 300 ×10 9·L -1 . RESULTS: 19 patients were enrolled in this study. 2 of the 19 cases were excluded because of disease progression after the first circle of chemotherapy and withdrawal of rhIL 11. The other 17 were eligible for the evaluation of responses and toxicities. There was no statistics difference of PLT between A circle and B circle before and after chemotherapy. rhIL 11 could elevate PLT counts of the patients after chemotherapy from the tenth day post chemotherapy. It also could prolong the duration of increment of PLT counts and shorten the duration of the decline of PLT counts. There was no toxicity to WBC. Mean value of Hb was lower on the eighteenth day in A group than that in B group. Side effects mainly included fever, fatigue, nausea, ache of injected skin, edema, headache and myalgia, but they all could be well tolerated. CONCLUSION: rhIL 11 has strong thrombopoietic activity and can be well tolerated for cancer patients receiving chemotherapy.
关 键 词:重组人白细胞介素-11 血小板生成 血小板减少症
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