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目的观察重组人血管内皮抑制素(YH-16)联合吉西他滨+顺铂(GP)治疗晚期非小细胞肺癌(NSCLC)的临床疗效。方法将晚期NSCLC患者70例随机分为观察组和对照组,每组35例,对照组给予GP方案化疗,观察组在对照组治疗基础上给予YH-16治疗。比较2组患者临床疗效及不良反应发生情况。结果观察组RR为31.43%(11/35)略高于对照组的22.86%(8/35),但差异无统计学意义(P>0.05);观察组CBR为85.71%(30/35)明显高于对照组的62.86%(22/35),差异有统计学意义(P<0.05)。2组患者不良反应发生率比较差异无统计学意义(P>0.05)。观察组疾病进展时间(TTP)为10.2个月(95%CI:7.6~11.1个月)长于对照组的5.6个月(95%CI4.1~5.9个月),差异有统计学意义(P<0.05)。结论 YH-16联合GP方案化疗治疗NSCLC临床疗效显著,临床受益率高,可在临床推广应用。
Objective To observe the clinical efficacy of recombinant human endostatin (YH-16) combined with gemcitabine and cisplatin (GP) in the treatment of advanced non-small cell lung cancer (NSCLC). Methods Seventy patients with advanced NSCLC were randomly divided into observation group and control group, with 35 cases in each group. The control group received GP regimen chemotherapy. The observation group received YH-16 treatment based on the control group. The clinical efficacy and adverse reactions of the two groups were compared. Results The RR of observation group was 31.43% (11/35), which was slightly higher than that of control group (22.86%, 8/35), but the difference was not statistically significant (P> 0.05). The CBR of observation group was 85.71% (30/35) Higher than that of the control group (62.86%, 22/35), the difference was statistically significant (P <0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P> 0.05). The duration of disease progression (TTP) in the observation group was 10.2 months (95% CI: 7.6 to 11.1 months) longer than that in the control group (5.6%, 95% CI 4.1 to 5.9 months, P < 0.05). Conclusion The clinical efficacy of YH-16 combined with GP regimen in the treatment of NSCLC is significant. The clinical benefit rate is high and can be widely used in clinical practice.