重组人血管内皮抑素联合化疗治疗晚期恶性肿瘤30例临床观察

The clinical observation of recombinant human endostatin combined with chemotherapy for 30 patients with advanced malignant tumors

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（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），MR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 rh endostatin injection （Endostar） combined with chemothera py on 30 cases of advanced malignancies. METHODS Endostar combined with chemotherapy were administrated to 30 malignant cases confirmed by histopathology or cytopathology. Endostar dissolved in 500 mL of normal saline was slow intravenously dropped from day 1 to day 14 and the chemotherapy agents were given simultaneously,repeated every 21 days. The efficacy and quality of life （QOL） were evaluated according to WHO criteria and Karnofsky scores after 2 cycles. The safety was evaluated according to WHO criteria after 1 cycle. RESULTS Totally 97 cycles were completed and mean cycle was 3.2. Among 30 cases,there were 16 cases achieved PR, 13 cases of SD,and 1 case of PD. The response rate was 53. 3%（16/30） and disease control rate was 96. 7%（29/30） ; The quality of life were improved on 14 cases （46. 7%）, stabled on 14 cases （46. 7%）, and decreased on 2 cases （6. 7 % ）. The occurrence rates of GIII/IV toxic ities were neutropenia （7/30） and hepatic dysfunction （1/30）. CONCLUSION The QOL of patients with multiple kinds of advanced malignancies may be improved by endostar combined with chemotherapy. It is worthy of clinical generalization and further clinical observation.