CAJ | 학술논문

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.
목적 관찰중조인p53선병독주사액결합방료치료비인암적불량반응.방법 선취중산대학부속제오의원방료과2005년6월지2005년12월20례방료후복발적비인비각화형암(WHO병리분형).장환자수궤분위기인치료+방료조(GIRT)10례화단순방료조(RT)10례.GIRT환자응용중조인p53선병독주사액(rAd-p53)류내주사1차/주×8,방료재rAd-p53주사후3 d개시.량조방료제량화방법상동.결과 채용의향성분석,비교량조치료불량반응.결과 량조병례적성별、년령、일반상황평분、분기방법급림상분기등균구유가비성.10례GIRT환자접수80인차rAd-p53치료,Ⅰ도발열(＜38℃)41인차,발생빈솔51.3%;Ⅱ도발열(38℃～40℃)24인차,발생빈솔30%;Ⅲ도발열(＞40℃)15인차,발생빈솔18.7%.1례발생침도충식전이,발생솔1.3%.무기타가납입통계적불량반응.결론 복발비인암재정방료동기국부주사rAd-p53적불량반응가내수.
Objective 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.