重组人白细胞介素-11的Ⅱ期临床研究

PhaseⅡ Clinical Trial of rhIL-11

目的 :观察重组人白细胞介素 11(rhIL 11)促血小板增殖作用及其临床毒副反应。方法 :采用随机自身对照方法 ,患者随机分入AB组或BA组 ,AB即第 1周期化疗结束后使用rhIL 11(A周期 ) ,第2周期化疗给药结束后观察为空白对照 ;BA组则相反 ,观察rhIL 11的疗效及毒副作用。结果 :A周期的血小板 (PLT)最高值及化疗序日 2 1d的PLT值明显高于B周期 ,不良反应主要为头痛及头晕、骨骼及肌肉疼痛、乏力、发热 ,两组差异无显著意义。结论 :rhIL 11能升高外周血小板水平 ,促进因骨髓抑制所致血小板减少的恢复 ,不良反应轻 。

Objective To observe the effect of recombinant human interleukin-11(rhIL-11) on peripheral blood platelet counts and its side-effect.Methods With randomized self-contrast method,patients were divided into two groups:AB and BA.The ways were as following:in AB group rhIL-11 was administered firstly after chemotherapy (cycle A)then only using chemotherapy in the second cycle (cycle B),in BA group the way was contrary.The effect of rhIL-11 on peripheral blood platelet count and its side-effect was evaluated.Results The maximal count and count for 21d after chemotherapy in cycle A were significantly higher than that of cycle B.The side-effects included headache,dizzy,bone pain,maglaria,mailse,fever but there was no signicantly statistic difference between the two groups.Conclusions rhIL-11 is effective on increasing platelet count and accelerating earlier recovery of platelet count,and the side-effect is mild.