重组人血管内皮抑制素联合顺铂治疗恶性腹腔积液的临床研究

Clinical observation of recombinant human endostatin combined with cisplatin on treatment of malignant peritoneal effusion

目的观察腹腔灌注重组人血管内皮抑制素(恩度)联合顺铂治疗恶性腹腔积液的疗效及安全性。方法将86例患者随机分为恩度联合顺铂腹腔灌注组(试验组)和单药顺铂腹腔灌注组(对照组),比较2组的临床疗效、不良反应及患者的生活质量(QOL)。结果试验组总有效率(ORR)显著高于对照组,且疾病控制率(DCR)有高于对照组的趋势,但差异无统计学意义。试验组血性腹腔积液患者ORR显著高于对照组,非血性腹腔积液患者ORR略高于对照组,但差异无统计学意义。两组不良反应及QOL比较均无显著差异。结论腹腔内灌注恩度联合顺铂的疗效优于单纯顺铂,尤其对于血性恶性腹水者疗效更佳,且不增加不良反应,值得临床合理推广。

Objective To explore the efficacy and safety of intraperitoneal injection of recom- binant human endostatin （endostar） combined with cisplatin in the treatment of malignant peritoneal effusion. Methods 86 patients were randomly divided into trial group （ intraperitoneal injection of endostar combined with cisplatin） and control group （intraperitoneal injection of cisplatin alone）. Clinical efficacy, adverse reactions and the quality of life （QOL） of the patients were compared between two groups. Results The overall response rate （ORR） in trial group was significantly higher than control group, and disease control rate （DCR） was higher than control group, but there was no significant difference. The ORR in patients with bloody peritoneal effusion was significantly higher than control group, and ORR in patients with non-bloody peritoneal effusion was slightly higher than control group. Conclusion Efficacy of intraperitoneal infusion of endostar combined with cisplatin is better than cisplatin, especially for the patients with bloody malignant ascites, and it won＇t cause severe adverse reactions, so it is worthy of clinical application and popularization.