恩度局部用药联合化疗治疗恶性胸腹水的临床研究

The Clinical Research of Endostar Topical Combined with Chemotherapy on Treating Malignant Hydrothorax and Ascites

目的:观察恩度(重组人血管内皮抑制素)联合化疗治疗恶性胸腹水的疗效、安全性及其对VEGF(血管内皮生长因子)的作用。方法:86例恶性胸腹水患者随机分为治疗组和对照组各43例,均行全身化疗、局部胸腹腔灌注化疗:治疗组予恩度+顺铂+5-氟尿嘧啶;对照组予顺铂+5-氟尿嘧啶;采用双抗夹心ELISA法测定血清及胸腹水中VEGF的含量。结果:治疗组有效率为72.09%,对照组有效率为46.51%,2组间差异有统计学意义(P<0.05)。治疗组中位无进展生存时间(PFS)3.4个月,中位生存期(OS)7.6个月;对照组中位无进展生存时间(PFS)2.8个月,中位生存期(OS)5.3个月,2组PFS间差异无统计学意义(P<0.05),而OS间差异有统计学意义(P<0.05);治疗组和对照组相比毒性反应未见明显增加;治疗组与对照组治疗后第7d及2组治疗前与治疗后第7d胸腹水及血清中VEGF含量分别相比较,差异均有统计学意义(P<0.05)。结论:恩度联合化疗治疗恶性胸腹水的近期疗效显著,不增加化疗的毒副反应,安全性好,其机制可能是通过抑制VEGF的表达实现的,是可供选择的治疗方案。

Objective To observe the efficacy and safety of Endostar （recombinant human endostatin） combined with chemotherapy in treating malignant hydrothorax and ascites, and the effects of its on VEGF（vascular endothelial growth factor）. Methods 86 Cases of malignant hydrothorax and ascites were randomly divided into treatment and control groups were treated with systemic chemotherapy, local intraperitoneal chemotherapy, Treatment group, endostatin ＋ cisplatin ＋ 5-fluorouracil; control group, cisplatin plus 5-fluorouracil, The double-antibody sandwich ELISA method determines the levels of VEGF in the serum and hydrothorax and ascites. Results 86 cases of malignant hydrothorax and ascites,the effective rate of the treatment group was 72.09%, while 46.51% of the control group, the difference of the two groups was significant （P〈0.05）;The median survival time/PFS of the treatment group and control groupwas 7.6 months and 5.4 monthsl3.4 months and 2.8 months, the PFS difference of the two groups was no significant （P〉0.05） ,hut the OS difference of the two groups was significant （P〉O.05）; No significant increase in treatment and control groups compared to the toxicity;Td after therapy, the VEGF levels in malignant hydrothorax/ and serum were significantly decreased,compared with prior-treatment the difference was significant（P〉0.05）,and there was also significant difference between the two groups（P〉0.05）. Conclusion The therapy of endostar combined with chemotherapy of malignant hydrothorax and ascites is obvious curative effect and good secure,which does not increase the toxicity of chemotherapy,the program of therapy can be achieved by inhibiting the expression of VEGF,and is alternative treatment options.