【作者】 张然；

【导师】 姜相君；

【作者基本信息】 青岛大学 ， 内科学（消化系病）（专业学位）， 2020， 硕士

【摘要】 目的本研究将初步探索并分析内镜下瘤体注射重组人5型腺病毒治疗晚期消化道肿瘤的有效性和安全性。方法收集2012年8月12日至2019年7月8日于青岛市市立医院行内镜下瘤体注射重组人5型腺病毒治疗的晚期消化道肿瘤患者44例,其中联合常规化疗18例(联合组),单行内镜下瘤体注射重组人5型腺病毒26例(单用组)。比较两组的临床特征、短期疗效、生活质量、长期疗效、不良反应。统计学处理采用配对t检验、χ~2检验、Kaplan–Meier生存分析法。结果1.两组患者一般情况具有可比性(P>0.05);2.联合组及单用组的疾病控制率分别为83.33%、61.54%,差异无统计学意义(P>0.05),客观缓解率分别为66.67%、19.23%,具有显著差异(P<0.05);3.第一次注射治疗1周后联合组及单用组患者的吞咽困难评分(1.87±0.64、2.32±0.75)分均低于治疗前(3.47±0.92、3.48±0.96)分,联合组吞咽困难改善更明显(P<0.05),联合组及单用组第二次注射治疗1周后的Karnofsky评分(82.22±5.48、78.85±7.11)分均高于治疗前(77.22±5.75、75.38±5.08)分(P<0.05);4.联合组患者治疗后的血红蛋白及血清白蛋白(99.44±8.28、35.49±3.86)水平显著高于治疗前(73.39±9.06、28.36±4.18)(P<0.05),单用组患者治疗后的血红蛋白及血清白蛋白(87.81±5.91、32.09±2.17)高于治疗前(80.73±8.74、29.12±4.22),但无统计学差异(P>0.05);5.与内镜下注射重组人5型腺病毒治疗相关的不良反应主要为发热、流感样症状,偶有恶心、呕吐等,所有不良反应经对症处理后均可完全缓解;6.联合组的中位生存期及无进展生存期(16.50个月、7.75个月)较单用组(9个月、4个月)分别延长了7.50个月和3.75个月。结论1.内镜下瘤体注射重组人5型腺病毒治疗术联合常规化疗精准溶瘤,全身免疫,靶向多途径杀伤肿瘤细胞,有效缩小肿瘤体积,延长生存期,防控肿瘤的复发和转移;2.内镜下瘤体注射重组人5型腺病毒治疗术联合常规化疗,对晚期消化道肿瘤具有显著的疗效,使患者获益,为晚期消化道肿瘤病人提供新的选择。更多还原

【Abstract】 ObjectiveThis study aimed to explore and evaluate the clinical efficacy and safety of endoscopic tumor injection of recombinant human type-5 adenovirus for patients with advanced gastrointestinal tumors.MethodsFrom August 12 2012 to July 8 2019,a total of 44 patients with advanced gastrointestinal carcinoma who received intratumoral injection of recombinant human type-5 adenovirus and/or chemotherapy at Qingdao Municipal Hospital were retrospectively enrolled.18 patients in the combination group were treated with recombinant human type-5 adenovirus combined with conventional chemotherapy,26 patients in the single group were treated with recombinant human type-5 adenovirus alone.The clinical characteristics of patients,short-term and long-term outcomes,quality of life and complication were compared in the two groups.The methods of t test,Chi-square test and Kaplan-Meier were performed for statistical analysis.Results1.The two groups of patients were comparable(P> 0.05).2.Disease control rate(DCR)and objective response rate(ORR)in the combination group were 83.33% and 66.67%,respectively,which were lower than those(DCR:61.54%,ORR:19.23%)in the single group,the difference on ORR was significant(P< 0.05).3.After treatment,the dysphagia score of combined group(1.87±0.64)and single group(2.32±0.75)were lower than those(3.47±0.92,3.48±0.96)before treatment(P<0.05),respectively.After 2 cycles of treatment,the Karnofsky scores of the combined group and the single group(82.22±5.48,78.85±7.11)were higher than those(77.22±5.75,75.38±5.08)before treatment(P <0.05).4.The levels of hemoglobin and serum albuminin in the combination group(99.44±8.28,35.49±3.86)were higher than those(73.39±9.06,28.36±4.18)before treatment,and the difference was significant(P <0.05).The levels of hemoglobin and serum albumin in the single group(87.81±5.91,32.09± 2.17)after treatment were not significant higher than those(80.73±8.74,29.12±4.22)before treatment(P> 0.05).5.The main complications of intratumoral injection of recombinant human type-5adenovirus were fever,flu-like symptoms,occasional nausea and vomiting,withoutsignificant liver and kidney dysfunction,and bone marrow transplantation.All complications were improved after related symptomatic treatment.6.Compared with the median survival(OS)and median progression-free survival(PFS)of the single group(9 months and 4 months),the OS and PFS of patients in the combined group(16.50 months and 7.75 months)prolonged 7.50 months and 3.75 months,respectively.Conclusion1.Endoscopic injection of recombinant human type-5 adenovirus therapy combined with conventional chemotherapy can effectively reduce tumor volume,prolong survival,selectively kill tumor cells by target multiple ways,activate systemic immunity,prevent and control tumor recurrence and metastasis.2.Endoscopic injection of recombinant human type-5 adenovirus therapy combined with conventional chemotherapy has a significant effect on patients with advanced gastrointestinal tumors,which provide new options for patients with advanced gastrointestinal cancer.更多还原