重组人白细胞介素-11（Ⅰ）治疗肿瘤患者放化疗后血小板减少临床观察

Efficacy and safety observation of recombinant human interleukin-11 in treatment of thrombocytopenia induced by chemoradiotherapy

目的 观察重组人白细胞介素-11（Ⅰ） [rhIL-11（Ⅰ）]对恶性实体瘤患者放化疗所致血小板减少的疗效及不良反应.方法 选择成都军区总医院2010年12月至2012年12月收治的放化疗后血小板计数（PLT）＜ 50×10^9/L的恶性实体瘤患者96例,采用随机数字表法将患者随机分为两组,观察组给予rhIL-11（Ⅰ）25 g·kg^-1·d^-1皮下注射,对照组给予常规治疗,当血小板升至正常（PLT≥100×10^9/L）或血小板升高绝对值＞50×10^9/L时停药.观察两组患者用药周期中患者生命体征、肝肾功能、凝血功能、心肺功能变化.结果 观察组患者放化疗后血小板最低值平均为（27.4±7.6）×10^9/L,与对照组平均值（28.1±7.9）×10^9/L相比,差异无统计学意义（t=1.083,P＞0.05）;但治疗后观察组血小板升高最高值平均为（116.3±22.8）×10^9/L,显著高于对照组的（76.2±21.3）×10^9/L,差异有统计学意义（t =21.092,P＜0.05）.观察组患者血小板＜50×10^9/L持续天数平均值为（4.3±1.7）d,血小板从最低值升至绝对值大于5万的平均时间为（6.8±2.4）d,均短于对照组,差异具有统计学意义（t=11.347,P＜0.05; t=15.196,P＜0.05）;且两组患者不良反应可耐受,未出现Ⅲ、Ⅳ度不良反应.结论 rhIL-11（Ⅰ）对于治疗恶性实体瘤患者放化疗后血小板减少疗效确切,不良反应耐受性好.

Objective To observe the efficacy and safety of recombinant human interleukin-11 （rnIL-11） in the treatment of thrombocytopenia induced by chemoradiotherapy in patients with solid tumor.Methods Solid tumor patients whose PLT count was lower than 50 × 10^9/L from December 2010 to December 2012 in PLA general hospital of Chengdu Commond were studied.They were divided into two groups randomly.The observed group was given subcutaneous injection of recombinant human interleukin-11 （Ⅰ） at the dose of 25 g · kg^-1 · d^-1,until the PLT rising subsolute value was more than 50 × 10^9/L.The control group was given usual treatment.The vital signs,hepatorenal function,coagulation function and cardio-pulmonary function of the patients were recorded during the whole process of treatment.Results The patients after chemotherapy had the platelet lowest average of （27.4 ± 7.6） × 10^9/L,and the average of the control group was （28.1 ± 7.9） × 10^9/L.The difference was not statistically significant （t =1.083,P 〉 0.05）,but treatment after the observation of elevated had the platelet highest average of （116.3 ± 22.8） × 10^9/L,which was significantly higher than that of （76.2 ± 21.3） × 10^9/L; the difference was significant （t =21.092,P 〈 0.05）.Platelets of patients in the observation group were 〈50 × 10^9/L for several days with an average of （4.3 ± 1.7） d,while platelets rose from the lowest value of the average absolute value greater than 50 000 hours （6.8 ± 2.4） d,shorter than the control group.By comparing the two groups,the differences were significant （t =11.347,P 〈 0.05 ; t =15.196,P 〈 0.05）.Two groups of patients can tolerate adverse reactions.Ⅲ,Ⅳ degree of adverse reaction was not observed.Conclusion This study shows that rhIL-11 is well tolerated and has thrombopoietic activity in the treatment of thrombocytopenia.