重组人白细胞介素-11对恶性实体瘤患者化疗所致血小板减少症一级预防的有效性和安全性  

Efficacy and safety of recombinant human interleukin-11 in primary prevention of chemotherapy-induced thrombocytopenia in patients with malignant solid tumors

作　　者：常丽 孙素芹[2] 任宏 张良[4] 边楠楠 甄春英 庞有铨 关雪晴 刘雪梅 CHANG Li;SUN Suqin;REN Hong;ZHANG Liang;BIAN Nannan;ZHEN Chunying;PANG Youquan;GUAN Xueqing;LIU Xuemei(First Ward,Department of Oncology,Harbin Chest Hospital,Harbin 150056,Heilongjiang,China;Department of Respiratory Medicine,Ha’nan Branch,the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine,Harbin 150060,Heilongjiang,China;Second Ward,Department of Respiratory,Harbin Chest Hospital,Harbin 150056,Heilongjiang,China;Department of Internal Medicine Clinic,Ha’nan Branch,the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine,Harbin 150060,Heilongjiang,China)

机构地区：[1]哈尔滨市胸科医院肿瘤一病区,哈尔滨150056 [2]黑龙江中医药大学附属第二医院哈南分院呼吸内科,哈尔滨1500600 [3]哈尔滨市胸科医院呼吸二病区,哈尔滨150056 [4]黑龙江中医药大学附属第二医院哈南分院内科门诊,哈尔滨1500600

出　　处：《癌症进展》2023年第24期2710-2714,共5页Oncology Progress

基　　金：黑龙江省卫生健康委科研课题(2020-059)。

摘　　要：目的探讨重组人白细胞介素-11(rhIL-11)对恶性实体瘤患者化疗所致血小板减少症(CIT)一级预防的有效性和安全性。方法采用随机数字表法将88例恶性实体瘤化疗患者分为观察组和对照组,每组44例,观察组患者应用rhIL-11一级预防CIT,对照组患者应用安慰剂。比较两组患者CIT发生率、血小板(PLT)变化情况、化疗相关不良事件发生情况、PLT输注情况、rhIL-11相关不良反应发生情况。结果一级预防后,两组患者CIT总发生率比较,差异无统计学意义(P>0.05);观察组患者Ⅲ~Ⅳ级CIT发生率为2.27%,低于对照组患者的18.18%,差异有统计学意义(P<0.05)。化疗第14、20天,观察组患者PLT水平均高于对照组(P<0.05)。至化疗第20天,观察组患者化疗相关不良事件总发生率为11.36%,低于对照组患者的29.55%,差异有统计学意义(P<0.05);两组患者PLT输注率比较,差异无统计学意义(P>0.05)。应用rhIL-11后,观察组5例患者出现了轻微的不良反应,对症治疗后症状消失,未停用rhIL-11。结论应用rhIL-11对恶性实体瘤CIT高出血风险和有危险因素的中出血风险人群进行一级预防,可减轻CIT严重程度,减少化疗相关不良事件,rhIL-11相关不良反应轻且易纠正,建议应用于临床。Objective To investigate the efficacy and safety of recombinant human interleukin-11(rhIL-11)in primary prevention of chemotherapy-induced thrombocytopenia(CIT)in patients with malignant solid tumors.Method A total of 88 patients with malignant solid tumors were randomly divided into observation group and control group by random number table,with 44 cases in each group.Patients in the observation group received rhIL-11 for primary prevention of CIT,while patients in the control group received placebo.The incidence of CIT,platelet(PLT)changes,chemotherapy-related adverse events,PLT infusion,and rhIL-11-related adverse reactions were compared between the two groups.Result After primary prevention,there was no significant difference in the total incidence of CIT between the two groups(P>0.05).The incidence of grade III-IV CIT in the observation group was 2.27%,lower than 18.18%in the control group(P<0.05).On the 14th and 20th day of chemotherapy,the PLT levels in the observation group were higher than those in the control group(P<0.05).By the 20th day of chemotherapy,the total incidence of chemotherapy-related adverse events in the observation group was 11.36%,lower than 29.55%in the control group,and the difference was statistically significant(P<0.05).There was no significant difference in PLT infusion rate between the two groups(P>0.05).After the application of rhIL-11,5 patients in the observation group had mild adverse reactions,symptoms disappeared after symptomatic treatment,and rhIL-11 was not discontinued.Conclusion The application of rhIL-11 in primary prevention of CIT in patients with high bleeding risk and moderate bleeding risk with risk factors can reduce the severity of CIT,reduce chemotherapy-related adverse events,and rhIL-11-related adverse reactions are mild and easy to be treated,so it is recommended for clinical use.

关 键 词：重组人白细胞介素-11 实体瘤 化疗所致血小板减少症 一级预防 

分 类 号：R730[医药卫生—肿瘤]