摘要目的 观察重组人p53腺病毒注射液结合放疗治疗鼻咽癌的不良反应.方法 选取中山大学附属第五医院放疗科2005年6月至2005年12月20例放疗后复发的鼻咽非角化型癌(WHO病理分型).将患者随机分为基因治疗+放疗组(GIRT)10例和单纯放疗组(RT)10例.GIRT患者应用重组人p53腺病毒注射液(rAd-p53)瘤内注射1次/周×8,放疗在rAd-p53注射后3 d开始.两组放疗剂量和方法相同.结果 采用意向性分析,比较两组治疗不良反应.结果 两组病例的性别、年龄、一般状况评分、分期方法及临床分期等均具有可比性.10例GIRT患者接受80人次rAd-p53治疗,Ⅰ度发热(＜38℃)41人次,发生频率51.3%;Ⅱ度发热(38℃～40℃)24人次,发生频率30%;Ⅲ度发热(＞40℃)15人次,发生频率18.7%.1例发生针道种植转移,发生率1.3%.无其他可纳入统计的不良反应.结论 复发鼻咽癌再程放疗同期局部注射rAd-p53的不良反应可耐受.

abstractsObjective To evaluate the toxicity of recombinant adenovirus p53 agent injection (rAdp53 ) combince with radiotherapy in treatment of local recurrent nasopharyngeal carcinoma( NPC ). Methods Between June 2005 and December 2005,20 cases patients that had non-keratinizing( WHO classification) local recurrent nasopharyngeal carcinoma were enrolled in the study, randomly divided into two groups:gene therapy +radiotherapy group( GIRT group) 10 cases, radiotherapy group( RT group), l0 cases. The GIRT group was injected rAd-p53 once a week for 8 weeks, and received radiotherapy 3 days after injection. Two groups received same dose of radiation. All patients were assessed by intent-to-treat analysis. The toxicity of rAd-p53 were evaluted.(The efficacy of rAd-p53 will be reported on another paper). Results The two groups were well balanced in the distribution of all prognostic factors and RT parameters, such as sex, age, performance status, staging method and clinical stage. 10 cases of GIRT group received 80 person-times rAd-p53 injections, o fever 41 person-times,the incidence is 51.3% ,o fever 24 person-times,the incidence is 30% ,o fever 15 person-times,the incidence is 18.7%. One cases was noted needle track implantation, the incidence is 1.3%. No others adverse events were noted. Conclusion Toxicity of recombinant adenovirus p53 agent injection combince with radiotherapy in treatment of local recurrent nasopharyngeal carcinoma is tolerable.