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目的:观察重组人血管内皮抑制素(YH-16)联合长春瑞滨(navelbine,NVB)和顺铂(cisplatin,DDP)治疗非小细胞肺癌(non-smallcelllungcancer,NSCLC)的近期疗效、生存期和安全性。方法:将2007年5月-2010年5月收治的80例晚期NSCLC患者随机分为治疗组[长春瑞滨联合顺铂(NP)+YH-16]和对照组(NP)。每2个化疗周期评价疗效和不良反应,并随访生存期。结果:治疗组39例以及对照组36例可评价疗效。NP+YH-16组的疾病稳定率为53.8,高于对照组的27.8(χ2=5.25,P=0.022),治疗组的临床获益率为76.9,高于对照组的55.6(χ2=3.85,P=0.050);治疗组的疾病进展率为23.1,低于NP组的44.4(χ2=3.85,P=0.050)。治疗组与对照组的疾病进展时间和总生存时间差异无统计学意义(P>0.05)。2组患者的不良反应主要为骨髓抑制和消化系统反应,发生率差异无统计学意义;治疗组的心电图异常较对照组多(χ2=16.27,P=0.001)。结论:NP+YH-16一线治疗晚期NSCLC能够提高疾病稳定率和临床获益率,降低疾病进展率,增加心脏电生理异常发生率,总体安全性较好。
OBJECTIVE: To observe the short-term efficacy, survival and survival of patients with non-small cell lung cancer (NSCLC) treated with recombinant human vascular endostatin (YH-16) and NVP and cisplatin safety. Methods: Eighty patients with advanced NSCLC who were treated between May 2007 and May 2010 were randomly divided into treatment group (NP + YH-16) and control group (NP). The efficacy and adverse reactions were evaluated every 2 cycles of chemotherapy and the survival was followed up. Results: 39 cases in the treatment group and 36 cases in the control group were evaluated. The disease stability of NP + YH-16 group was 53.8, higher than that of the control group (χ2 = 5.25, P = 0.022). The clinical benefit rate of the treatment group was 76.9, which was higher than that of the control group 55.6 (χ2 = 3.85, P = 0.050). The disease progression rate in the treatment group was 23.1, which was lower than 44.4 in the NP group (χ2 = 3.85, P = 0.050). There was no significant difference in disease progression time and total survival time between treatment group and control group (P> 0.05). Adverse reactions of the two groups were mainly myelosuppression and digestive system reaction. There was no significant difference in incidence between the two groups (χ2 = 16.27, P = 0.001). Conclusion: The first-line treatment of NP + YH-16 in advanced NSCLC can improve disease stability and clinical benefit rate, reduce the rate of disease progression, and increase the incidence of cardiac electrophysiological abnormalities, the overall safety is better.