【作者】 王琦；

【导师】 郑锴；

【作者基本信息】 天津医科大学 ， 外科学 胸心外科（专业学位）， 2018， 硕士

【摘要】 目的设立榄香烯联合多西他赛及奥沙利铂观察组及多西他赛联合奥沙利铂对照组行新辅助化疗,针对局部中晚期食管鳞癌患者治疗2周期后进行疗效评价,同时观察两组患者KPS评分的变化、化疗毒副作用、对免疫T细胞及NK细胞的影响,为局部中晚期食管鳞癌术前新辅助化疗提供优选策略。方法选取2017年2月-2018年1月在天津医科大学总医院诊治的食道鳞癌患者,排除Ⅰ、Ⅱa、Ⅳ期及存在手术禁忌症者,采取信封法将符合入组标准的44例存在手术可能的局部中晚期食管鳞癌患者随机分为观察组和对照组给予术前新辅助化疗。其中观察组21例,予榄香烯口服乳联合DTX/OXA化疗,对照组23例,予DTX/OXA化疗,21d定为1周期,均在2周期后对治疗效果进行评估。分别记录食管病灶大小变化、体重增减程度,评价血常规、肝功能、肾功能及免疫细胞水平,观测生活质量、临床症状的改变及化疗所致毒副作用的大小。结果1.在病灶变化方面,治疗后观察组的总有效率(CR+PR)为58.3%(14/21),疾病控制率(CR+PR+SD)为90.4%(19/21)。对照组总有效率(CR+PR)为40.9%(9/22),疾病控制率(CR+PR+SD)为86.3%(19/22)。观察组的总有效率及疾病控制率较对照组存在优势,但经统计学检测两组有效率及控制率均无统计学差异(P>0.05)。2.在临床症状改善方面,通过KPS评分评估。观察组患者生活质量升高13例、稳定5例、下降3例,对照组生活质量升高5例、稳定9例、下降8例,经统计学检验分析,P<0.05,两组比较具有统计学差异;两组组内比较治疗后观察组的生活质量比治疗前提高,P<0.05,具有统计学差异,对照组治疗后生活质量比治疗前略有降低,P>0.05,无统计学差异。3.在体重变化方面,治疗后两组患者行组间比较观察组患者体重增加12例、稳定6例、下降3例,对照组增加5例、稳定8例、下降9例,经卡方检验两者比较P<0.05,具有统计学差异。4.在毒副反应发生情况方面,两组都有部分患者在化疗后都出现了骨髓抑制、消化道症状及一过性肝肾功能损伤,但观察组发生例数较少,毒副反应较轻,在WBC减少、PLT减少、ALT升高、恶心呕吐及腹泻5项中经统计学检验P<0.05,具有统计学差异。在控制血红蛋白减少及胆红素、ALP、AST、Cr、BUN升高方面观察组也较对照组有效,但经统计学检测无差异性(P>0.05)。5.在增强患者机体免疫方面,观察组化疗后的NK、CD4+/CD8+水平较对照组明显升高,具有统计学差异(P<0.05)。结论1、榄香烯联合多西他赛及奥沙利铂较对照组能增加患者体重、增强患者免疫,明显改善患者生活质量,提升手术耐受性。2、榄香烯联合多西他赛及奥沙利铂方案较单用多西他赛联合奥沙利铂方案在治疗局部中晚期食管鳞癌2周期后临床疗效总有效率和疾病控制率均较高,但两者相比无统计学差异。3、多西他赛联合奥沙利铂新辅助化疗方案副作用主要是骨髓抑制、消化道毒性、肝肾毒性,相比对照组联合榄香烯组能明显降低化疗毒副反应发生率,增加患者尤其是局部中晚期、年老体弱患者的化疗耐受性。更多还原

【Abstract】 Objective:The establishment of Elemene combined with Docetaxel and Oxaliplatin in the observation group and the combination of Docetaxel and Oxaliplatin control group for neoadjuvant chemotherapy,To evaluate the curative effect of the patients with locally advanced esophageal cancer after the treatment of 2 cycles,observe the changes of the KPS score,the side effects of chemotherapy and the effects on the immune T cells and NK cells in the two groups at the same time to provide a possible optimization strategy for neoadjuvant chemotherapy for esophageal cancer surgery.Methods:Selection of esophageal squamous cell carcinoma patients in our hospital from February 2017 to January 2018,exclusion of patients with stage I,II A,IV and surgical contraindications,44 cases of locally advanced esophageal squamous cell carcinoma were randomly divided into the control group and the observation group by the envelope method,and received neoadjuvant chemotherapy.21 cases in the observation group were treated with Elemene Oral Emulusion combined DTX/OXA,23 cases in the control group were given DTX/OXA alone,21 day was a 1 cycle,all of which were evaluated after 2 cycles of treatment.The change of tumor size and weight change,examination of blood routine,liver and kidney function,immune function,the change of quality of life,clinical symptoms and Chemotherapeutic side reaction were recorded respectively after treatment.Results:1.The change of tumor size.The ORR(CR+PR)was 58.3%(10/21)and the DCR(CR+PR+SD)was 90.4%(18/21)in the observation group after treatment.The ORR(CR+PR)of the control group was 40.9%(6/22),and the DCR(CR+PR+SD)was 86.3%(17/22)after treatment.The results showed that the efficiency and stability of the observation group were higher than those of the control group,but there was no statistically significant difference between the two groups of ORR and DCR(P>0.05).2.Improvement of clinical symptoms.Through KPS score assessment,the quality of life in the observation group was increased in 13 cases,stable in 5 cases,and decreased in 3 cases.In the control group,the quality of life increased in 5 cases,stable in 9 cases,and decreased in 8 cases.The results of statistical test showed that P<0.05 was statistically significant in the two groups,the quality of life in the observation group of the two groups was significantly higher than that before the treatment,P<0.05,with statistical significance.The quality of life in the control group was lower than that before treatment,and the quality of life assessment and were not statistically significant(P>0.05).3.Body weight change.The two groups were compared between groups,the weight gain in the observation group was 12 cases,stable in 6 cases,and decreased in 3 cases after treatment,the control group increased 5 cases,stabilized 8 cases,and decreased 9 cases.After statistical examination,(P<0.05)showed statistical significance.4.In the occurrence of toxic and side effects.The two groups of patients had different degrees of bone marrow depression,digestive tract reaction and liver and kidney function injury after chemotherapy,the number of cases in the observation group was less than that in the control group,and the side effects were mild.Especially in the 5 items of WBC reduction,PLT reduction,ALT elevation,nausea and vomiting and diarrhea,P<0.05 was statistically significant.The decrease of hemoglobin and the increase of bilirubin,ALP,AST,Cr and BUN in the observation group were also more effective than those in the control group,but there was no statistical significance(P>0.05).5.In terms of enhancing body immunity,rank sum test showed that the level of NK and CD4+/CD8+ in the observation group was significantly higher than that in the control group after treatment(P<0.05).Conclusion:1.Elemene combined with Docetaxel and Oxaliplatin can increase the weight of the patients,enhance the immunity,improve the quality of life and enhance the tolerance of patients to operation compared with the control group..2.After 2 cycles of treatment,Elemene combined with Docetaxel and Oxaliplatin regimen is more effective than docetaxel plus oxaliplatin alone in the treatment of locally advanced esophageal squamous cell carcinoma,But there was no statistical difference between the two groups.3.Toxicity of Docetaxel and Oxaliplatin for advanced esophageal cancer treated with neoadjuvant chemotherapy in bone marrow suppression,gastrointestinal toxicity,abnormal liver function.Elemene combined with Docetaxel and Oxaliplatin compared to the control group can significantly reduce the toxicity of chemotherapy and increase the tolerance to chemotherapy of patients,especially in local advanced and elderly patients.更多还原