脱氧核苷酸注射液联合化疗治疗中晚期非小细胞肺癌的随机临床对照研究  

The Randomized Placebo-controlled Trial of Deoxynucleotide Injection Combined with Chemotherapy in Treatment of Middle-late Non-small Cell Lung Cancer

作　　者：刘荣强[1] 李晓光[2] 赵纯荣 周天 

机构地区：[1]福建医科大学附属南平市第一医院,福建南平353000 [2]北华大学附属医院 [3]吉林省临江市人民医院

出　　处：《中国医学创新》2015年第8期1-3,共3页Medical Innovation of China

摘　　要：目的:观察并比较脱氧核苷酸注射液联合化疗药物治疗人非小细胞肺癌的临床疗效和不良反应。方法:采用多中心、随机对照试验将62例人非小细胞肺癌患者随机分为试验组和对照组,试验组30例,对照组32例。对照组给予化疗联合粒细胞集落刺激因子,治疗组在对照组治疗基础上联合脱氧核苷酸注射液200 mg/d。评价化疗第2、7、14天的白细胞、血小板水平,并记录Ⅲ度+Ⅳ度骨髓抑制发生例数,同时评估患者的免疫功能、体重、生活质量评分。结果:治疗组7 d后WBC计数为(4.2±1.2)×109/L,血小板计数为(67.4±13.2)×109/L,WBC恢复正常例数占73.3%,Ⅲ+Ⅳ度骨髓抑制发生率为13.3%。对照组分别为(3.1±1.1)×109/L、(46.8±17.8)×109/L、31.3%、56.3%,两组比较差异具有统计学意义(P<0.05)。两组随访14 d后,治疗组CD3+、CD4+、NK细胞、CD4+/CD8+分别为(54.7±8.2)%、(39.2±4.5)%、(31.2±10.2)%、(1.33±0.29),对照组分别为(48.3±6.6)%、(31.3±5.0)%、(24.3±8.9)%、(1.01±0.18),两组比较差异均具有统计学意义(P<0.05)。随访21 d,治疗组肌肉酸痛/乏力事件、肝损伤(ALT、AST或TBI异常)发生率分别为6.6%、3.3%。对照组分别为40.6%、21.9%,另外治疗组体重平均增加(1.8±0.3)kg,对照组为(-0.4±0.2)kg,两组比较差异具有统计学意义(P<0.05)。结论:脱氧核苷酸注射液可减轻化疗所导致的骨髓抑制程度,提高患者的体重、免疫功能及生活质量评分。Objective： To observe and compare the clinical efficacy and adverse reaction of deoxynucleotide injection combined with chemotherapy in of human middle-late non-small cell lung cancer. Method： 62 cases of nonsmall cell lung cancer patients were selected by multicenter and randomized controlled clinical trial method from March 2013 to March 2014. All patients were divided into two groups,the control group of 32 cases who were treated with chemotherapy and granulocyte colony-stimulating factor, and the experimental group of 30 cases who were treated with deoxynucleotide injection 200 mg/d on the base of control group.After 2,7,14 d continuous treatment,the levels of white blood cells and platelet were assessed, the occurrence of III＋IV bone marrow suppression was recorded, the immune function,weight,and quality life scores of patients were assessed.Result： The treatment group after 7 d WBC count was（4.2±1.2）×109/L,platelet count was（67.4±13.2）×109/L,WBC normal persons accounted for 73.3%,the III＋IV bone marrow suppression rate was 13.3%;the control group was respectively（3.1±1.1）×109/L,（46.8±17.8）×109/L,31.3%,56.3%,the differences were statistically significant（P0.05）.Followed 14 d, the treatment group of CD3＋,CD4＋,CD4＋/CD8＋,NK cells were respectively（54.7±8.2）%,（39.2±4.5）%,（31.2±10.2）%,（1.33±0.29）; the control group of CD3＋,CD4＋,CD4＋/CD8＋,NK cells were respectively（48.3±6.6）%,（31.3±5.0）%,（24.3±8.9）%,（1.01±0.18）, the treatment group＇s levels were better than the control group, the differences were statistically significant（P0.05）. Followed 21 d, the treatment group muscle aches/weakness events,liver injury（ALT,AST,or TBI exception） incidence rate was respectively 6.6%,3.3%,the control group was respectively 40.6%, 21.9%, another treatment group gained an average of（1.8±0.3）kg, the control group of（-0.4±0.2）kg,the differences were statistically significant（P0.05）.Conclusion： Deoxynucleotide injecti

关 键 词：脱氧核苷酸 非小细胞肺癌 骨髓抑制 

分 类 号：R734.2[医药卫生—肿瘤]