重组人血管内皮抑素联合白介素-2灌注治疗恶性胸/腹腔积液的临床研究

Clinical Research on Recombinant Human Endostatin Combined with IL-2 in the Treatment of Patients with Malignant Pleural and Peritoneal Effusion

目的:观察重组人血管内皮抑素联合白介素-2(IL-2)治疗恶性胸/腹腔积液的疗效及安全性。方法:回顾性分析我院经病理学及细胞学检查证实为恶性胸/腹腔积液患者(PS评分>2)59例,随机分为2组,试验组应用重组人血管内皮抑素联合IL-2胸/腹腔内灌注,对照组应用IL-2胸/腹腔内灌注,均每周给药1次。评估2组近期疗效、KPS评分和毒副反应及中位总生存时间。结果:试验组有效率为36.7%,对照组为13.8%,差异有统计学意义(P=0.044);试验组临床获益率为60.0%,对照组为31.0%,差异有统计学意义(P=0.026)。试验组生活质量改善16例,稳定10例,下降4例;对照组生活质量改善7例,稳定11例,下降11例,2组差异有统计学意义(P=0.033)。2组毒副反应及总生存时间差异无统计学意义。结论:重组人血管内皮抑素联合IL-2治疗PS>2的晚期恶性胸/腹腔积液疗效好,毒副反应小,值得临床推广。

OBJECTIVE：To observe the clinical efficacy and safety of recombinant human endostatin combined with IL-2 in the treatment of patients with malignant pleural and peritoneal effusion.METHODS：59 patients with malignant pleural and peritoneal effusion,who were diagnosed by cytology or pathology （PS score2）,were randomly divided into two groups.Trial group were treated with pleural and peritoneal infusion of recombinant human endostatin and IL-2 once a week and control group were infused with IL-2 only.The short-term efficacy,KPS score and toxicity reaction were evaluated as well as medium overall survival time.RESULTS：The response rate was 36.7% for treatment group and 13.8% for control group,there was statistical significance （P=0.044）.Clinical benefit rate was 60.0% for trial group and 31.0% for control group,there was statistical significance （P=0.026）.In trial group,the living qualities of 16 cases were improved and stable cases of 10,decreasing cases of 4;in control group,the living qualities of 7 cases were improved and stable cases of 11,decreasing cases of 11.There was significant difference between two groups（P=0.033）.But there was no significant difference in toxic reaction and overall survival time between two groups.CONCLUSION：Recombinant human endostatin combined with IL-2 is an effective and safety therapy for malignant peritoneal or pleural effusion with few toxic reaction,which is worthy of spreading in the clinic.