目的 比较贝伐珠单抗注射液与注射用洛铂腹腔灌注治疗恶性腹腔积液的疗效和毒副反应。方法 选取2013年10月-2015年10月在中国医科大学附属盛京医院住院治疗的48例恶性腹腔积液患者,随机分为对照组和治疗组,每组各24例。对照组行腹腔灌注注射用洛铂,30 mg/m²用生理盐水50 mL稀释,1次/周。治疗组行腹腔灌注贝伐珠单抗注射液,5 mg/kg用生理盐水50 mL稀释,1次/周。两组患者均连续灌注2周,最多灌注3次。观察两组的临床疗效,用药前及用药后3 d检测血管内皮生长因子(VEGF)和癌胚抗原(CEA)水平,比较生活质量评分,评价毒副反应。结果 治疗后,对照组、治疗组总有效率分别为50.0%、79.2%,两组比较差异有统计学意义(P<0.05)。治疗后,两组患者VEGF和CEA水平显著降低,同组治疗前后差异有统计学意义(P<0.05);且治疗组VEGF水平降低更明显,两组比较差异有统计学意义(P<0.05)。治疗后,治疗组患者腹胀评分、厌食评分均低于对照组,两组比较差异具有统计学意义(P<0.05、0.01)。两组患者均无严重的III~IV度不良反应发生。结论 贝伐珠单抗注射液腹腔灌注治疗恶性腹腔积液疗效优于注射用洛铂,且耐受性良好,具有一定的临床推广应用价值。

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.

国家自然科学基金资助项目(81201803)