重组人血管内皮抑素联合化疗治疗骨肉瘤的前瞻性对照非随机临床研究

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目的:探讨重组人血管内皮抑素(恩度)联合新辅助化疗治疗II期经典型骨肉瘤的疗效。方法:2013年1月至2014年7月我院骨肿瘤科治疗72例II期经典型骨肉瘤患者,根据病人意愿将病人分为新辅助化疗联合恩度组和单纯化疗组。单纯化疗组化疗方案为:阿霉素30 mg/m2静滴,d1-d3,顺铂120 mg/m2静滴,d4;甲氨蝶呤10-12 g/m2静滴,d1;异环磷酰胺3 g/m2静滴,d1-d5。新辅助化疗联合恩度组在化疗基础上加用恩度,初期8个病例恩度15 mg/d,d1-d5,配合化疗每周期4次,术前术后各一个周期,总剂量40支;后期14个病例,恩度15 mg/d,d1-d10,配合化疗每周期4次,术前术后各一个周期,总剂量80支。化疗后根据化疗结果进行手术治疗,术后对手术标本进行组织学评估和免疫组化染色,测量化疗前后联合组和对照组肿瘤坏死率、血管内皮生长因子(vascular endothelial growth factor,VEGF)及微血管密度(microvessel density,MVD)。结果:72例患者入组,剔除资料不全5例,共纳入评价67例,其中联合组22例,对照组45例。术后进行随访,随访时间3-19个月,平均随访时间11.5个月。两组在肿瘤坏死率无明显差异,但术前术后比较,VEGF染色和MVD联合组较对照组有明显下降。结论:本研究显示恩度联合新辅助化疗并不能提高肿瘤坏死率,但恩度能有效抑制肿瘤新生血管生成。 Objective: To investigate the efficacy of recombinant human endostatin (Endostar) combined with neoadjuvant chemotherapy in the treatment of stage II classic osteosarcoma. Methods: From January 2013 to July 2014, 72 patients with stage II classic osteosarcoma were treated by Department of Oncology in our hospital. Patients were divided into neoadjuvant chemotherapy group and entecavir group according to their wishes. Chemotherapy of chemotherapy alone group: doxorubicin 30 mg / m2 intravenous infusion, d1-d3, cisplatin 120 mg / m2 intravenous infusion, d4; methotrexate 10-12 g / m2 intravenous infusion, d1; Amide 3 g / m2 intravenous infusion, d1-d5. Neoadjuvant chemotherapy combined Endue group on the basis of chemotherapy with grace, the initial eight cases of grace 15mg / d, d1-d5, with chemotherapy four times per cycle, one cycle before and after surgery, the total dose of 40 ; The latter 14 cases, the first degree of 15 mg / d, d1-d10, with chemotherapy four times per cycle, one cycle before and after surgery, the total dose of 80. After chemotherapy, the patients were treated according to the results of chemotherapy. Postoperatively, histological evaluation and immunohistochemical staining of the specimens were performed. The tumor necrosis rate, vascular endothelial growth factor (VEGF) and microvessel Microvessel density (MVD). Results: 72 patients were enrolled in the study, excluding 5 cases with incomplete data, and included 67 cases in total, including 22 cases in combination group and 45 cases in control group. Follow-up postoperatively was followed up for 3-19 months with an average follow-up of 11.5 months. There was no significant difference between the two groups in tumor necrosis rate, but compared with preoperative and postoperative, VEGF staining and MVD combined group significantly decreased compared with the control group. Conclusion: This study shows that Endo combined with neoadjuvant chemotherapy can not increase tumor necrosis rate, but Endeng can effectively inhibit tumor angiogenesis.
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