全中枢照射所致血小板减少的临床研究

目的 评价重组人白细胞介素-11(rhIL-11)预防全中枢照射所致血小板减少的疗效和不良反应。 方法 采用随机对照研究方法,将 100例患者随机分为A组(rhIL-11预防治疗组 50例)和B组(对照组 50例)。A组患者放疗过程中血小板计数<100×10⁹/L时或血小板计数较放疗前基线水平下降>50%即开始按50 μg·kg^-1·d^-1剂量给予rhIL-11皮下注射,1 次/d,直至血小板数≥200×10⁹/L时停药。B组患者当血小板计数<50×10⁹/L时则按同样方案进行,直至血小板数≥100×10⁹/L时停药。 结果 92例可评价疗效,rhIL-11可升高全中枢照射中血小板最低值(P<0.01),缩短血小板减少症持续时间(P<0.01),缩短放疗所需时间(P<0.01)。主要不良反应为注射部位疼痛、硬结、红肿、乏力等,但程度较轻。 结论 rhIL-11 具有明显的促血小板生成作用,可显著减少全中枢照射过程中血小板减少的发生,保证放疗的顺利进行,不良反应较轻且较易处理。

Clinical research of thrombocytopenia induced by craniospinal irradiation

Objective To evaluate the clinical efficacy and adverse events of recombinant human interleukin-11(rhIL-11) in the prevention of thrombocytopenia induced by craniospinal irradiation. Methods In this randomized control study, 100 patients were randomly divided into A (rhIL-11 group, n=50) and B groups (control group, n=50). In the A group, subcutaneous injection of rhIL-11 was delivered at a dose of 50 μg/kg/d, once daily when the platelet count was< 100×10⁹/L during radiotherapy or decreased by> 50% compared with the baseline level. The administration of rhIL-11 was terminated when the platelet count was ≥ 200×10⁹/L. In the B group, the same protocol was conducted when the platelet count was< 50×10⁹/L and terminated until the platelet count was ≥ 100×10⁹/L. The clinical efficacy was assessed in 92 patients. Subcutaneous injection of rhIL-11 could significantly elevate the minimal platelet count during craniospinal irradiation (P<0.01), considerably shorten the duration of thrombocytopenia (P<0.01) and effectively shorten the duration of radiotherapy (P<0.01). Main adverse events included mild pain at the injection site, sclerosis, redness and fatigue, etc. Conclusions Injection of rhIL-11 can significantly enhance the platelet count, effectively reduce the incidence of thrombocytopenia throughout craniospinal irradiation, guarantee the success of radiotherapy and yield mild adverse events.