舒尼替尼联合重组人血管内皮抑制素胸腔注射治疗晚期肾癌合并胸腔积液的临床疗效

Sunitinib plus recombinant human endostatin in the treatment of advanced renal cell carcinoma with pleural effusion

目的研究舒尼替尼联合重组人血管内皮抑制素胸腔注射治疗晚期肾癌伴胸腔积液的有效性和安全性。方法选择20例晚期肾癌合并胸腔积液的患者为研究对象,依据随机数字表法将患者随机分为治疗组(n=11)和对照组(n=9)。对照组患者口服舒尼替尼50 mg,每天1次,服药2周,停药1周,同时给予胸腔引流。治疗组患者在对照组治疗方法的基础上给予重组人血管内皮抑制素30 mg,第1、4、7天胸腔注射,7天为1个疗程,共治疗2个疗程。随访截止至2017年3月30日。结果治疗组患者胸腔积液控制率81.82%,高于对照组的22.22%,差异有统计学意义(P﹤0.05)。治疗组患者的中位生存时间为19个月(95%CI:3.21～39.74),长于对照组患者的10个月(95%CI:4.40～13.78),差异有统计学意义(P﹤0.05)。治疗后,两组患者卡氏功能状态(KPS)评分均高于组内治疗前(P﹤0.05),且治疗组患者KPS评分高于对照组患者(P﹤0.05)。两组患者不良反应发生率比较,差异均无统计学意义(P﹥0.05)。治疗组出现2例一过性心律失常,对症处理后缓解。结论舒尼替尼联合重组人血管内皮抑制素胸腔注射治疗晚期肾癌合并胸腔积液安全有效,可改善患者生活质量,并可能延长总生存期。

Objective To evaluate the safety and efficacy of sunitinib plus recombinant human endostatin in the treatment of advanced renal cell carcinoma with pleural effusion.Method A total of 20 patients with advanced renal cell carcinoma and pleural effusion were recruited and randomized as study group(n=11)and control group(n=9),patients in control group received sunitinib 50 mg once daily for 2 weeks and 1 week off,and were administered with pleural drainage,while those in study group were given recombinant human endostatin 30 mg/d on 1,4,and 7 d by thoraric perfusion,with 7 days as a cycle for 2 cycles in addition to the same regimen of sunitinib and pleural drainage in control group.Result The control rate of pleural effusion was 81.82%in study group,which was higher than the 22.22%in control group,with statistically significant difference observed(P<0.05).Among those on recombinant human endostatin,the median overall survival time was 19 months(95%CI:3.21-39.74),and was higher than those in control group at 10 months(95%CI:4.40-13.78),showing statistically significant difference(P<0.05).After treatment,the karnofsky performance status(KPS)score improved significantly in two groups(P<0.05),and the KPS score in study group was significantly better than that of control group(P<0.05).No statistically significant difference was observed regarding the incidence of adverse reactions in the two groups(P>0.05),though there were 2 patients of transient arrythmia in study group which revolved after symptomatic treatment.Conclusion The regimen of Sunitinib plus thoracic perfusion of recombinant human endostatin is both effective and safe in the treatment of advanced renal cell carcinoma with pleural effusion,ameliorating patients’quality of life while prolonging the overall survival.