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目的：观察胸腔灌注重组人血管内皮抑素（恩度）联合顺铂（DDP）治疗乳腺癌恶性胸腔积液的疗效及安全性。方法将51例乳腺癌合并恶性胸腔积液患者随机分为恩度联合顺铂胸腔灌注组（试验组）和单药顺铂胸腔灌注组（对照组）。试验组：DDP 40 mg/m2 d1、d3；恩度45 mg d1，d3，d5，胸腔注射，每21 d为一个周期；对照组：DDP 40 mg/m2 d1、d3，每21 d为一个周期。比较2组的临床疗效、不良反应、患者的生活质量（QOL）及胸腔积液中VEGF和IL-6的表达变化差异。结果试验组客观缓解率（ORR）及QOL改善情况显著优于对照组（P＜0.05），且胸腔积液中VEGF、IL-6水平较治疗前显著降低。两组不良反应比较差异无统计学意义（P＞0.05）。结论胸腔内灌注恩度联合顺铂的疗效优于单纯顺铂，并能显著改善肿瘤微环境，且不增加不良反应，值得临床合理推广。“,”ObjectiveTo observe the effect and safety of intrapleural infusion with recombinant human endostatin (endostar) combined with cisplatin in breast cancer with malignant pleural effusion (MPE).Methods 51 breast cancer patients with malignant pleural effusion were randomly divided into trial group (intrapleural injection of endostar combined with cisplatin) and control group (intrapleural injection of cisplatin alone). Patients in the trail group received intrapleural injection of endostar (45 mg) on day 1, 3, 5 plus cisplatin (40 mg/m2) on day 1, 3 every 3 weeks while the control group was administered with cisplatin (40 mg/m2) on d1 and d3 alone. Clinical efficacy, adverse reactions and the quality of life (QOL) of the patients were compared between two groups. In addition, the expression levels of VEGF and IL-6 in malignant pleura effusion were assessed before and after treatment in two groups.Results The objective response rate (ORR) and improvement ratio of QOL in trial group was signiifcantly higher than in control group. Furthermore, the expression levels of VEGF and IL-6 were dramatically decreased more than 50% after treatment in trial group. However, there was no signiifcant differencein adverse effects between two groups.Conclusion Intrapleural injection of endostar and cisplatin is a safe and effective way to treat breast cancer patients with malignant pleural effusion. It is worthy of clinical application and further investigation.