化疗联合腹腔循环热灌注治疗对恶性肿瘤合并腹水疗效及安全性临床研究
发布时间：2018-11-20 21:09
【摘要】：研究目的:观察化疗联合腹腔循环热灌注治疗对恶性肿瘤合并腹水患者的疗效及安全性。疗效主要包括近期疗效(客观有效率、疾病控制率)、生活质量改善(Karnofsky活动状态评分、EORCT QLQ-C30生活质量评分)、远期疗效(腹水无进展生存期、2年累积生存率)以及安全性,为化疗联合腹腔循环热灌注治疗恶性腹水的临床方法提供理论依据。研究方法:采用开放、非随机对照的方法,200例患者均接受全身化疗,同时分为腹腔循环热灌注组(试验组,CCCHP)和腹腔穿刺治疗组(对照组,IPC)。所有患者均为我中心住院患者,均有病理或细胞学证据证明为恶性腹水,在对照组100例患者中有78例为近5年来曾在我中心住院治疗随访患者。分组完成后对两组患者的基线情况进行均衡性检验,所有患者在接受局部治疗的同时接受全身联合化疗,总计4周期。在第1、3周期开始前及治疗后4周评价各项观察指标,疗效观察指标包括近期疗效、生活质量改善情况、远期疗效以及不良反应。疗效评价按WHO关于恶性腹水治疗疗效评价标准执行;生活质量采用Karnofsky活动状态评分、EORCT QLQ-C30生活质量量表评价;不良反应依据(NCI-CTC)3.0版标准进行评估。研究结果:200例恶性腹水患者入组,治疗前基线均衡性检验无差异(P0.05)。热灌注组(100例)与传统组(100例)治疗客观有效率(ORR)分别为65%和47%(P=0.01);疾病控制率(DCR)分别为85%和73%(P=0.037)。在生活质量方面,EORCT-QLQ C30量表评分结果显示热灌注组的躯体功能领域(P=0.042)、总体健康状况(P=0.039),疼痛(P=0.022)、气短(P=0.03)、失眠(P=0.025)、食欲丧失(P=0.004)及便秘(P=0.04)的改善情况优于非热灌注组。但接受热灌注治疗的患者经济困难状况表现更加突出(P=0.026)。Karnofsky活动状态评分提高方面,热灌注组优于非热灌注组(χ2=5.172,P=0.023),以病种为亚组分析两组患者中位腹水无进展时间(APFT)显示:胃癌(P=0.018)、卵巢癌(P=0.032)、大肠癌(P=0.042)试验组在腹水无进展时间优于对照组,而肝癌合并腹水患者的APFT则没有表现出与对照组的优势(P=0.645)。2年累积生存率则两组无统计学差异(P0.05)。不良反应的发生率两组患者无统计学差异(P0.05),试验组出现轻微的化学性腹膜炎,但未影响患者的治疗。结论:化疗联合腹腔循环热灌注的治疗方法,对晚期恶性肿瘤合并腹水患者有较好的疗效及安全性,并能延长胃癌、卵巢癌、大肠癌的腹水无进展时间,但在肝癌患者目前未发现此方法对腹水无进展时间有延长作用,而且试验组未显示出对患者2年累积生存率有更加积极作用。
[Abstract]:Objective: to observe the efficacy and safety of chemotherapy combined with peritoneal circulatory hyperthermic perfusion in patients with malignant tumor complicated with ascites. The efficacy included short-term efficacy (objective effective rate, disease control rate), improvement of quality of life (Karnofsky activity status score, EORCT QLQ-C30 quality of life score), long-term efficacy (ascites non-progressive survival period). The 2-year cumulative survival rate and safety provide a theoretical basis for the treatment of malignant ascites with chemotherapy combined with peritoneal circulatory hyperthermic perfusion. Methods: 200 patients received systemic chemotherapy and were divided into two groups: the experimental group (, CCCHP) and the peritoneal puncture group (, IPC). All the patients were hospitalized in our center and were proved to be malignant ascites by pathological or cytological evidence. 78 out of 100 patients in the control group were followed up in our center in the past 5 years. After the grouping was completed, the baseline conditions of the two groups were tested. All the patients received local treatment and combined systemic chemotherapy for a total of 4 cycles. The observation indexes were evaluated before the beginning of the 1st cycle and 4 weeks after treatment. The observation indexes of curative effect included short-term curative effect, improvement of quality of life, long-term curative effect and adverse reaction. The therapeutic effect was evaluated according to the WHO criteria for the treatment of malignant ascites; the quality of life was evaluated by Karnofsky activity status scale and EORCT QLQ-C30 quality of life scale; and the adverse reactions were evaluated according to NCI-CTC version 3.0. Results: there was no difference in baseline balance test before treatment in 200 patients with malignant ascites (P0.05). The objective effective rates of heat perfusion group (100 cases) and traditional group (100 cases) were 65% and 47% (P0. 01), and the disease control rate (DCR) were 85% and 73% (P0. 037) respectively. In terms of quality of life, the score of EORCT-QLQ C30 scale showed the physical function area (P0. 042), general health status (P0. 039), pain (P0. 022), shortness of breath (P0. 03), insomnia (P0. 025) in the hyperthermia group. The improvement of appetite loss (P0. 004) and constipation (P0. 04) was better than that of non-thermal perfusion group. However, the patients who received hyperthermic perfusion showed more significant economic difficulties (P < 0.026). Karnofsky activity score increased, the hyperthermia group was superior to the non-hyperthermic perfusion group (蠂 ~ 2 = 5.172), P < 0.05), but the hyperthermia group was better than the non-hyperthermic perfusion group (蠂 ~ 2 = 5.172). The median ascites no progression time (APFT) in the two groups was analyzed by subgroup: gastric cancer (P0. 018), ovarian cancer (P0. 032), colorectal cancer (P0. 042), the time of no progression in ascites was better in the trial group than in the control group. However, the APFT of HCC patients with ascites was not superior to that of the control group (P0. 645), but the 2 year cumulative survival rate was not significantly different between the two groups (P0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P0.05). The patients in the trial group had mild chemical peritonitis but did not affect the treatment of the patients. Conclusion: chemotherapy combined with peritoneal circulatory hyperthermic perfusion has good efficacy and safety in patients with advanced malignant tumor complicated with ascites, and can prolong ascites progression of gastric cancer, ovarian cancer and colorectal cancer. However, this method has not been found to prolong the time of ascites progression in patients with liver cancer, and the trial group did not show a more positive effect on the 2-year cumulative survival rate.
【学位授予单位】：第四军医大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R730.58
本文编号：2346033
[Abstract]:Objective: to observe the efficacy and safety of chemotherapy combined with peritoneal circulatory hyperthermic perfusion in patients with malignant tumor complicated with ascites. The efficacy included short-term efficacy (objective effective rate, disease control rate), improvement of quality of life (Karnofsky activity status score, EORCT QLQ-C30 quality of life score), long-term efficacy (ascites non-progressive survival period). The 2-year cumulative survival rate and safety provide a theoretical basis for the treatment of malignant ascites with chemotherapy combined with peritoneal circulatory hyperthermic perfusion. Methods: 200 patients received systemic chemotherapy and were divided into two groups: the experimental group (, CCCHP) and the peritoneal puncture group (, IPC). All the patients were hospitalized in our center and were proved to be malignant ascites by pathological or cytological evidence. 78 out of 100 patients in the control group were followed up in our center in the past 5 years. After the grouping was completed, the baseline conditions of the two groups were tested. All the patients received local treatment and combined systemic chemotherapy for a total of 4 cycles. The observation indexes were evaluated before the beginning of the 1st cycle and 4 weeks after treatment. The observation indexes of curative effect included short-term curative effect, improvement of quality of life, long-term curative effect and adverse reaction. The therapeutic effect was evaluated according to the WHO criteria for the treatment of malignant ascites; the quality of life was evaluated by Karnofsky activity status scale and EORCT QLQ-C30 quality of life scale; and the adverse reactions were evaluated according to NCI-CTC version 3.0. Results: there was no difference in baseline balance test before treatment in 200 patients with malignant ascites (P0.05). The objective effective rates of heat perfusion group (100 cases) and traditional group (100 cases) were 65% and 47% (P0. 01), and the disease control rate (DCR) were 85% and 73% (P0. 037) respectively. In terms of quality of life, the score of EORCT-QLQ C30 scale showed the physical function area (P0. 042), general health status (P0. 039), pain (P0. 022), shortness of breath (P0. 03), insomnia (P0. 025) in the hyperthermia group. The improvement of appetite loss (P0. 004) and constipation (P0. 04) was better than that of non-thermal perfusion group. However, the patients who received hyperthermic perfusion showed more significant economic difficulties (P < 0.026). Karnofsky activity score increased, the hyperthermia group was superior to the non-hyperthermic perfusion group (蠂 ~ 2 = 5.172), P < 0.05), but the hyperthermia group was better than the non-hyperthermic perfusion group (蠂 ~ 2 = 5.172). The median ascites no progression time (APFT) in the two groups was analyzed by subgroup: gastric cancer (P0. 018), ovarian cancer (P0. 032), colorectal cancer (P0. 042), the time of no progression in ascites was better in the trial group than in the control group. However, the APFT of HCC patients with ascites was not superior to that of the control group (P0. 645), but the 2 year cumulative survival rate was not significantly different between the two groups (P0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P0.05). The patients in the trial group had mild chemical peritonitis but did not affect the treatment of the patients. Conclusion: chemotherapy combined with peritoneal circulatory hyperthermic perfusion has good efficacy and safety in patients with advanced malignant tumor complicated with ascites, and can prolong ascites progression of gastric cancer, ovarian cancer and colorectal cancer. However, this method has not been found to prolong the time of ascites progression in patients with liver cancer, and the trial group did not show a more positive effect on the 2-year cumulative survival rate.
【学位授予单位】：第四军医大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R730.58
【参考文献】
相关期刊论文 前3条
1 窦倩;商海涛;叶进;徐可树;侯晓华;宋宇虎;刘芳;;血清及腹水肿瘤标志物对良恶性腹水的鉴别诊断价值[J];华中科技大学学报(医学版);2014年01期
2 吴春艳;王伟;陈鑫;陈冬云;芮景;;重组人血管内皮抑素治疗小鼠恶性腹腔积液疗效及作用机制研究[J];中国临床药理学与治疗学;2014年05期
3 金永男;窦宇;聂俊杰;许秉全;;188Re放射性锡胶体对恶性腹水模型小鼠的治疗作用[J];中国医学创新;2014年24期
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