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目的:观察重组人血管内皮抑素注射液(恩度)联合化疗治疗晚期恶性肿瘤的有效性和安全性。方法:经病理组织学或细胞学检查确诊的晚期恶性肿瘤患者30例,其中非小细胞肺癌(NSCLC)21例,乳腺癌4例,结肠癌3例,胰腺癌和小细胞肺癌各1例。将重组人血管内皮抑素注射液7.5mg.m-2加入生理盐水500mL中匀速缓慢静脉滴注,第1~14天连续给药,间歇7d重复,同时联合化疗药物,每21天为1个周期。按照WHO标准评价近期疗效和毒性反应,Karnofsky评分(KPS)变化评价生活质量(QOL)。用药1周期评价毒性,2周期后评价疗效。结果:全组30例患者共完成97个周期,平均3.2个周期,均可评价近期疗效和安全性。其中获PR16例,SD13例,PD1例,PR为53.3%(16/30),DCR为96.7%(29/30);14例(46.7%)QOL改善,14例QOL稳定(46.7%),仅2例QOL下降(6.7%);出现Ⅲ/Ⅳ级的毒性反应8例,包括白细胞下降(7/30)和肝功能损害(1/30)。结论:重组人血管内皮抑素注射液联合化疗可以改善和稳定晚期恶性肿瘤患者的生活质量,其安全性好,值得临床推广应用和深入观察。
Objective: To observe the efficacy and safety of recombinant human endostatin injection (Endo) combined with chemotherapy in the treatment of advanced malignancies. Methods: Thirty patients with advanced malignancy diagnosed by histopathology or cytology were examined. Among them, 21 were non-small cell lung cancer (NSCLC), 4 were breast cancer, 3 were colon cancer, and 1 was pancreatic cancer and small cell lung cancer. The recombinant human endostatin injection 7.5mg.m-2 was added to 500mL normal saline slow intravenous infusion, the first to 14 days of continuous administration, intermittent 7d repeat, combined with chemotherapy drugs, every 21 days for a cycle. Short-term efficacy and toxicity responses were evaluated according to the WHO criteria and changes in Karnofsky score (KPS) were assessed for quality of life (QOL). Toxicity evaluation of 1 cycle, 2 cycles after the evaluation of efficacy. Results: The whole group of 30 patients completed a total of 97 cycles, an average of 3.2 cycles, can evaluate the recent efficacy and safety. There were 16 cases of PR, 13 cases of SD and 1 case of PD. The PR was 53.3% (16/30) and DCR was 96.7% (29/30). QOL was improved in 14 cases (46.7%), QOL was stable in 14 cases (46.7% 2 cases of QOL decreased (6.7%); Ⅲ / Ⅳ grade toxicity occurred in 8 cases, including leukopenia (7/30) and liver damage (1/30). Conclusion: Recombinant human endostatin injection combined with chemotherapy can improve and stabilize the quality of life of patients with advanced malignant tumors, its safety is good, worthy of clinical application and in-depth observation.