Clinical Observation on the Target Therapy of Rh-Endostin, Combined with Chemotherapy in Advanced Non-Small Cell Lung Cancer

背景与目的 晚期非小细胞肺癌（non-small cell lung cancer, NSCLC）化疗处于瓶颈，抗血管靶向治疗逐渐显示优势。本文研究重组人血管内皮抑素（rh-Endostin，恩度YH-16）联合化疗靶向治疗晚期非小细胞肺癌的临床疗效、毒性反应和对生活质量的影响。方法 62例晚期非小细胞肺癌患者随机分为2组：血管内皮抑素组32例采用重组人血管内皮抑素加一线化疗方案，对照组30例仅选用一线化疗方案。2个周期后评价近期临床有效率、临床受益率以及生活质量的改善程度，同时观察毒副作用。结果 血管内皮抑素组临床有效率为46.87％，临床受益率为81.25％，而对照组分别为26.66％和53.33％。两组有效率尚不具有统计学意义（χ2=1.912, P=0.166），但两组受益率差异明显，具有统计学意义（χ2=4.3185, P=0.0377）。对照组和血管内皮抑素组进行治疗后生活质量（QoL）均有所改善，血管内皮抑素组则更为明显，二者相比差异具有统计学意义（χ2=11.233, P=0.0008）。治疗后患者所发生的毒性反应为恶心、呕吐，骨髓抑制，周围神经毒性，主要为化疗所致的副反应，两组在这些方面差异无统计学意义（P>0.05）。血管内皮抑素组有3例感觉心前胸不适，出现心电图改变，表现为ST-T轻微下移，给予对症治疗后消失，但两组比较差异无统计学意义（χ2=1.2701, P=0.2597）。结论 血管内皮抑素未增加化疗的毒副作用，临床应用安全，耐受性良好；血管内皮抑素联合化疗药物对晚期NSCLC具有较好的疗效，尤其在改善病人生存质量方面具有优势。 Background and objective The chemotherapy of advanced non-small cell lung cancer is in a Bottleneck. The target therapy of Anti-angiogenesis gradually shows an advantage in the therapy of patients with advanced NSCLC. To investigate the short-term efficacy, safety and the quality of life of the target therapy of rh-Endostin combined with chemotherapy in patients with advanced NSCLC. Methods Sixty-two advanced NSCLC patients were randomly divided into either the trial group with chemotherapy plus rh-Endostin or control group with chemotherapy alone. The efficacy and toxicity were evaluated after 2 cycles according to RECIST criteria. Results The trial groups efficiency rate was 46.87%, while the control group was 26.66%, there was no significant differences of two groups (χ2=1.912, P=0.166). The clinical benefit rate was 81.25% in the trial group and 53.33% in control group. There was significant difference of the clinical benefit rate between the trial group and the control group (χ2=4.3185, P=0.0377). The score of quality of life in the trial group was significantly higher than that the control group after the treatment (χ2=11.233, P=0.0008). There was no significant difference of incidence of toxicities between the trial group and the control group (P>0.05). Conclusion Rh-Endostin combined with chemotherapy was effective, reasonable, safe and well tolerated for advanced NSCLC.