重组人粒细胞-巨噬细胞集落刺激因子治疗放射性肠炎的临床分析  

A CLINICAL TRIAL OF RHGM-CSF FOR THE TREATMENT OF HEALING RADIATION ENTERITIS

作　　者：余建云[1] 李林均[1] 陈萍[1] 张军[1] 许涛[1] 程雄飞[1] 

机构地区：[1]湖北医药学院附属人民医院肿瘤中心,湖北十堰442000

出　　处：《内蒙古医科大学学报》2016年第1期54-57,共4页Journal of Inner Mongolia Medical University

基　　金：湖北省自然科学基金(2013CDZ048)

摘　　要：目的:评估和观察重组人粒细胞-巨噬细胞集落刺激因子(rh GM-CSF)灌肠治疗放射性肠炎的安全性和有效性,为放射性肠炎的治疗提供新的临床治疗药物和临床研究资料。方法:采用随机、单盲、治疗前后自身对照的研究方法,将102例放射性肠炎病人随机分为治疗组(A组、32例)、对照组(B组、35例)和联合组(C组、35例)。治疗组采用rh GM-CSF局部保留灌肠21 d,治疗前后进行自身对照,并与对照组(地塞米松加黄连素)及联合组(地塞米松加黄连素加rh GM-CSF)的治疗病例进行对比分析。观察用药前后症状积分,局部不良反应和用药21 d的总有效率。数据处理采用SPSS 16.0统计学软件,P<0.05表明有统计学意义。结果:治疗组总有效率93.75%,对照组总有效率68.57%,联合组总有效率92.29%。治疗组与联合组间差异无统计学意义(P=1.0),治疗组与对照组间差异有统计学意义(P=0.013)。用药后出现的局部不良反应主要表现为局部刺激,个别病人出现局部轻微疼痛,可自行消退。结论:重组人粒细胞-巨噬细胞集落刺激因子治疗放射性肠炎安全有效。Objective：To evaluate and observe the efficiency and safety of topical rhGM-CSF treatment for radiation enteritis and help find new clinical treatment drugs and clinical research information. Methods：By taking the methods of randomized, single-blind and self-controlled, one hundred and two patients with radiation-induced enteritis were divided into group A（32 patients with ration-induced enteritis,treatment of rhGM-CSF） ,group B（35 patients with ration-induced enteritis, treatment of Huang Lian Su and Dexamethasone ） , and group C （ 35 patients with ration-induced enteritis,treatment of rhGM-CSF,Huang Lian Su and Dexamethasone） ,which were treated for 21 days totally. The scores of symptoms before and after treatment,local reaction and total effective rate in the 21 days after treatment were investigated. The statistical analysis was done by SPSSl 6. 0 software. A two-sided P〈0. 05 was considered significant. Results：The total effective rates in group A（93. 75%） and group C（92.29%）were both significantly higher than that in group B（68.57%）（P=0.013）. There was no significant difference of therapeutic efficiency between group A and group C（P=1. 0）. E-valuation results of safety：The main adverse event of locally administered rhGM-CSF on wounds was local irritating. Local slight red and swollen with mild pain were found in the wound of a few cases, which disappeared without management. Any systemic adverse reaction related to rhGM-CSF was not observed. Conculusion：rhGM-CSF is safe and efficient in healing raduation-induced enteritis.

关 键 词：肠疾病 放疗 放射性肠炎 创伤 创面修复 细胞因子 

分 类 号：R818.74[医药卫生—放射医学]