GM-CSF含服液防治食管癌患者放射性食管炎的随机对照研究

摘要

目的:研究重组人粒-巨噬细胞刺激因子含服液(GM-CSF)防治食管癌患者放射性食管炎的疗效.方法:采用随机对照研究,将105例符合入组条件的食管癌患者随机分为GM-CSF含服液组(研究组:55例)和安慰剂组(对照组:50例),观察两组患者放射性食管炎、疼痛、生活质量及治疗依从性.结果:研究组3、4级放射性食管炎明显少于对照组(P<0.05);放射性食管炎引起的疼痛,研究组重度疼痛明显少于对照组(P<0.05);两组患者治疗前生活质量相似,治疗后的全部功能性项目如总体健康状况(P<0.05)、躯体功能(P<0.05)、情感功能(P<0.05)、社会功能(P<0.05)、认知功能(P<0.05)及角色功能(P<0.05),研究组明显好于对照组;恶心呕吐(P<0.05)、食欲不振(P<0.05)、疼痛(P<0.05)、失眠(P<0.05)及呼吸困难(P<0.05),研究组明显好于对照组.研究组共有42例患者完成全部5周化疗,对照组27例(P<0.05);研究组无放疗中断患者,对照组6例患者放疗中断(P<0.05).结论:GM-CSF含服液能有效减少3、4级食管炎的发生率;减轻疼痛,改善患者的生活质量,提高治疗依从性.%Objective:To study the efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF) mouthwashes in the prevention of radiation-induced esophagitis.Methods:Total 105 patients were randomly divided into GM-CSF mouthwashes group (55 cases,study group) and placebo group (50 cases,control group).Radiation-induced esophagitis,pain,quality of life (QOL) and treatment compliance will be investigated.Results:The incidence of grade 3,4 esophagitis were lower in the control group than those in the study group (P<0.05),and severe pain in the control group were more than those in the study group (P<0.05).QOL was similiar in two groups before treatment.After treatment,general health status (P<0.05),physical function (P<0.05),emotional function (P<0.05),social function (P<0.05),cognitive function (P<0.05) and role function (P<0.05),in study group were significantly better than the control group.Nausea and vomiting (P<0.05),loss of appetite (P<0.05),pain (P<0.05),insomnia (P<0.05) and dyspnea (P<0.05) in the study group were significantly better than the control group.In the study group,42 patients completed all 5 weeks of chemotherapy and 27 patients in the control group (P<0.05).None of the patients was interrupteded in radiotherapy of the study group and 6 patients in the control group (P<0.05).Conclusion:GM-CSF mouthwashes can effectively reduce the incidence of grade 3,4 esophagitis,pain,and improve the quality of life and treatment compliance of patients.