發(fā)布時(shí)間：2018-11-20 21:09

【摘要】：研究目的:觀察化療聯(lián)合腹腔循環(huán)熱灌注治療對惡性腫瘤合并腹水患者的療效及安全性。療效主要包括近期療效(客觀有效率、疾病控制率)、生活質(zhì)量改善(Karnofsky活動狀態(tài)評分、EORCT QLQ-C30生活質(zhì)量評分)、遠(yuǎn)期療效(腹水無進(jìn)展生存期、2年累積生存率)以及安全性,為化療聯(lián)合腹腔循環(huán)熱灌注治療惡性腹水的臨床方法提供理論依據(jù)。研究方法:采用開放、非隨機(jī)對照的方法,200例患者均接受全身化療,同時(shí)分為腹腔循環(huán)熱灌注組(試驗(yàn)組,CCCHP)和腹腔穿刺治療組(對照組,IPC)。所有患者均為我中心住院患者,均有病理或細(xì)胞學(xué)證據(jù)證明為惡性腹水,在對照組100例患者中有78例為近5年來曾在我中心住院治療隨訪患者。分組完成后對兩組患者的基線情況進(jìn)行均衡性檢驗(yàn),所有患者在接受局部治療的同時(shí)接受全身聯(lián)合化療,總計(jì)4周期。在第1、3周期開始前及治療后4周評價(jià)各項(xiàng)觀察指標(biāo),療效觀察指標(biāo)包括近期療效、生活質(zhì)量改善情況、遠(yuǎn)期療效以及不良反應(yīng)。療效評價(jià)按WHO關(guān)于惡性腹水治療療效評價(jià)標(biāo)準(zhǔn)執(zhí)行;生活質(zhì)量采用Karnofsky活動狀態(tài)評分、EORCT QLQ-C30生活質(zhì)量量表評價(jià);不良反應(yīng)依據(jù)(NCI-CTC)3.0版標(biāo)準(zhǔn)進(jìn)行評估。研究結(jié)果:200例惡性腹水患者入組,治療前基線均衡性檢驗(yàn)無差異(P0.05)。熱灌注組(100例)與傳統(tǒng)組(100例)治療客觀有效率(ORR)分別為65%和47%(P=0.01);疾病控制率(DCR)分別為85%和73%(P=0.037)。在生活質(zhì)量方面,EORCT-QLQ C30量表評分結(jié)果顯示熱灌注組的軀體功能領(lǐng)域(P=0.042)、總體健康狀況(P=0.039),疼痛(P=0.022)、氣短(P=0.03)、失眠(P=0.025)、食欲喪失(P=0.004)及便秘(P=0.04)的改善情況優(yōu)于非熱灌注組。但接受熱灌注治療的患者經(jīng)濟(jì)困難狀況表現(xiàn)更加突出(P=0.026)。Karnofsky活動狀態(tài)評分提高方面,熱灌注組優(yōu)于非熱灌注組(χ2=5.172,P=0.023),以病種為亞組分析兩組患者中位腹水無進(jìn)展時(shí)間(APFT)顯示:胃癌(P=0.018)、卵巢癌(P=0.032)、大腸癌(P=0.042)試驗(yàn)組在腹水無進(jìn)展時(shí)間優(yōu)于對照組,而肝癌合并腹水患者的APFT則沒有表現(xiàn)出與對照組的優(yōu)勢(P=0.645)。2年累積生存率則兩組無統(tǒng)計(jì)學(xué)差異(P0.05)。不良反應(yīng)的發(fā)生率兩組患者無統(tǒng)計(jì)學(xué)差異(P0.05),試驗(yàn)組出現(xiàn)輕微的化學(xué)性腹膜炎,但未影響患者的治療。結(jié)論:化療聯(lián)合腹腔循環(huán)熱灌注的治療方法,對晚期惡性腫瘤合并腹水患者有較好的療效及安全性,并能延長胃癌、卵巢癌、大腸癌的腹水無進(jìn)展時(shí)間,但在肝癌患者目前未發(fā)現(xiàn)此方法對腹水無進(jìn)展時(shí)間有延長作用,而且試驗(yàn)組未顯示出對患者2年累積生存率有更加積極作用。
[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.
【學(xué)位授予單位】：第四軍醫(yī)大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：R730.58

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