脱氧核苷酸与G-CSF联合干预骨髓抑制多中心临床试验  

A multi-center randomized,placebo-controlled trial of Deoxynucleotides and granulocyte colony stimulating factor in treatment cancer chemotherapy-induced myelosuppression

作　　者：张明丽[1] 和云[2] 胡爱党 董建立[3] 李雪云[3] 沈康杰 李晓生[4] 

机构地区：[1]西安市第一医院干部病房消化肿瘤科,西安710002 [2]中国医科大学附属盛京医院肿瘤科 [3]中国医科大学附属第一医院肿瘤科 [4]辽宁省肿瘤医院肿瘤科

出　　处：《陕西医学杂志》2015年第3期294-297,共4页Shaanxi Medical Journal

基　　金：陕西省自然科学基金项目(2013JC2-14)

摘　　要：目的:观察脱氧核苷酸与重组人粒细胞集落刺激因子联合预防恶性肿瘤化疗所致的白细胞减少症的有效性与安全性。方法:将144例恶性肿瘤患者随机分为治疗组和对照组各72例,均采用常规一线化疗方案治疗,对照组化疗同时给予重组人粒细胞集落刺激因子。治疗组在对照组基础给予脱氧核苷酸注射液(200mg/d)。结果:治疗组WBC恢复正常所需的时间快于对照组,治疗组白细胞水平高于对照组。治疗组白细胞恢复正常87.5%,对照组白细胞恢复正常63.8%,对照组III度、IV度骨髓抑制达17.1%,治疗组5.6%,两组比较差异有统计学意义。治疗组治疗后CD3+、CD4+、CD4+/CD8+、NK细胞水平均明显高于对照组。治疗过程中,治疗组肌肉疼痛/乏力、肝损伤不良事件发生率分别为4.2%、1.4%,对照组为19.4%、9.7%,两组具有统计学差异。治疗组及对照组感染发生率分别为2.8%、12.5%。化疗后给予脱氧核苷酸治疗,可明显增强患者的体重,平均增加2.1±0.4kg,对照组体重平均下降-0.3±0.1kg,两组比较具有统计学差异。结论:脱氧核苷酸联合粒细胞集落刺激因子联合干预可以明显提高血小板水平,增加患者体重,减轻粒细胞集落刺激因子的不良反应。Objserve：To observe deoxynucleotide with recombinant human granulocyte colony-stimulating factor combined with the prevention of cancer chemotherapy-induced leukopenia efficacy and safety.Methods：144cases of cancer were randomly divided into treatment group 72 cases,72cases in the control group,all patients were treated with conventional first-line chemotherapy,chemotherapy control group administration of recombinant human granulocyte colony-stimulating factor.The treatment group received deoxynucleotide injection（200mg/d）in the control group basis.Results：The WBC returned to normal faster than the time required for the control group,white blood cell levels higher than the treatment group.WBC returned to normal treatment group and 87.5%in the control group to restore normal number of white blood cells 63.8 %in the control group of the Ⅲ,Ⅳ myelosuppression was 17.1%,while the treatment group was only 5.6%.Two groups with statistically significant differences.After treatment,CD3^＋,CD4^＋,CD4^＋/CD8^＋,NK cells levels were higher.The course of treatment,the treatment group muscle pain/weakness,liver injury incidence of adverse events were 4.2%,1.4 %in the control group was 19.4 %,9.7 %.Differences between the two groups was statistically.Treatment group and the control group the incidence of infection was 2.8 %,12.5 %,respectively.Deoxynucleotide given after chemotherapy treatment,can significantly enhance the patient＇s weight,an average increase of 2.1 ± 0.4kg,the control group lost an average-0.3± 0.1kg.A significant difference between the two groups.Conclusion：The combined deoxynucleotide granulocyte colony-stimulating factor combined can significantly improve platelet levels,increased patient weight,reduce granulocyte colony stimulating factor for adverse reactions.

关 键 词：脱氧核糖核苷酸类 粒细胞集落刺激因子 肿瘤 白细胞障碍 

分 类 号：R551[医药卫生—血液循环系统疾病]