目的 比較貝伐珠單抗注射液與注射用洛鉑腹腔灌注治療惡性腹腔積液的療效和毒副反應(yīng)。方法 選取2013年10月-2015年10月在中國(guó)醫(yī)科大學(xué)附屬盛京醫(yī)院住院治療的48例惡性腹腔積液患者,隨機(jī)分為對(duì)照組和治療組,每組各24例。對(duì)照組行腹腔灌注注射用洛鉑,30 mg/m²用生理鹽水50 mL稀釋,1次/周。治療組行腹腔灌注貝伐珠單抗注射液,5 mg/kg用生理鹽水50 mL稀釋,1次/周。兩組患者均連續(xù)灌注2周,最多灌注3次。觀(guān)察兩組的臨床療效,用藥前及用藥后3 d檢測(cè)血管內(nèi)皮生長(zhǎng)因子(VEGF)和癌胚抗原(CEA)水平,比較生活質(zhì)量評(píng)分,評(píng)價(jià)毒副反應(yīng)。結(jié)果 治療后,對(duì)照組、治療組總有效率分別為50.0%、79.2%,兩組比較差異有統(tǒng)計(jì)學(xué)意義(P<0.05)。治療后,兩組患者VEGF和CEA水平顯著降低,同組治療前后差異有統(tǒng)計(jì)學(xué)意義(P<0.05);且治療組VEGF水平降低更明顯,兩組比較差異有統(tǒng)計(jì)學(xué)意義(P<0.05)。治療后,治療組患者腹脹評(píng)分、厭食評(píng)分均低于對(duì)照組,兩組比較差異具有統(tǒng)計(jì)學(xué)意義(P<0.05、0.01)。兩組患者均無(wú)嚴(yán)重的III~IV度不良反應(yīng)發(fā)生。結(jié)論 貝伐珠單抗注射液腹腔灌注治療惡性腹腔積液療效優(yōu)于注射用洛鉑,且耐受性良好,具有一定的臨床推廣應(yīng)用價(jià)值。

Objective To compare the efficacy and toxicities of Bevacizumab Injection and Lobaplatin for injection by intraperitoneal perfusion in treatment of malignant ascites. Methods Patients (48 cases) with malignant ascites in Shengjing Hospital of China Medical University from October 2013 to October 2015 were randomly divided into control and treatment group, and each group had 24 cases. Patients in the control group were received intraperitoneal perfusion with Lobaplatin for injection, 30 mg/m² diluted with normal saline 50 mL, once weekly. Patients in the treatment group were received intraperitoneal perfusion with Bevacizumab Injection, 5 mg/kg diluted with normal saline 50 mL, once weekly. The patients in two groups were treated for 2 weeks, 3 times at most. After treatment, the efficacy was evaluated, and levels of VEGF and CEA in ascites were determined before treatment and treated for 3 d. Scores of life quality in two groups were compared, and adverse reactions between two groups were studied. Results After treatment, the clinical efficacies in the control and treatment groups were 50.0% and 79.2%, respectively, and there was difference between two groups (P < 0.05). After treatment, levels of VEGF and CEA in two groups were significantly decreased, and the difference was statistically significant in the same group (P < 0.05). After treatment, the levels of VEGF in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P < 0.05). After treatment, abdominal distension score and anorexia score in two groups were significantly decreased, and the difference was statistically significant between group (P < 0.05). No grade III - IV toxicities were found in two groups. Conclusion Bevacizumab Injection has better efficacy than Lobaplatin for injection in treatment of malignant ascites, and has good tolerance, which has a certain clinical application value.

國(guó)家自然科學(xué)基金資助項(xiàng)目(81201803)