重组人血管内皮抑制素联合GP方案治疗晚期非小细胞肺癌的近期疗效与安全性观察

Short-term Efficacy and Safety of Recombinant Human Endostatin Combined with GP Regimen in the Treatment of Advanced Non-small Cell Lung Cancer

目的：观察重组人血管内皮抑制素联合吉西他滨＋顺铂（GP）方案治疗晚期非小细胞肺癌（NSCLC）的近期疗效与安全性。方法：将76例NSCLC患者随机均分为对照组和试验组。对照组患者给予GP方案治疗,每周期的第1~8天给予注射用盐酸吉西他滨1 000 mg/m2静脉滴注,第1~3天给予顺铂25 mg/m2静脉滴注。试验组患者在治疗组的基础上于每周期第1~14天给予重组人血管内皮抑制素7.5 mg/m2,加入500 ml 0.9%氯化钠注射液中静脉滴注3~4 h。21 d为1个周期,治疗4个周期后评价两组患者的临床疗效,并观察患者不良反应的发生情况。结果：试验组患者的有效率和临床受益率分别为55.2%、89.5%,显著高于对照组患者（分别为31.6%、63.2%）,差异有统计学意义（P〈0.05）。两组患者不良反应发生率比较差异无统计学意义（P〉0.05）,且两组均无死亡病例。结论：重组人血管内皮抑制素联合GP方案可提高晚期NSCLC患者的临床疗效,且安全性良好。

OBJECTIVE：To observe the short-term efficacy and safety of rccombinant human endostatin combined with GP regimen（gemcitabine＋cisplatin）in the treatment of advanced non-small cell lung cancer（NSCLC）.METHODS：76 NSCLC patients were enrolled in the study were randomly divided into control group and trial group.Control group received GP regimen treatment： intravenous dripping of Gemcitabine hydrochloride for injection 1 000 mg/m2on 1st-8th day of each cycle and cisplatin 25 mg/m2 on 1st-3rd day.Trial group additionally received intravenous dripping of endostatin 7.5 mg/m2added in 500 ml normal saline for 3-4 h during the first 14 days per treatment cycle on the basis of GP regimen.A treatment course lasted from 21 days.After 4 cycles of treatment,clinical efficacies of 2 groups were evaluated and the occurrence of ADR was observed.RESULTS：The RR and CBR of trial group were 55.2% and 89.5%,which were significantly higher than those of control group（31.6%,63.2%）,there was statistical significance（P0.05）.There was no statistical significance in the incidence of ADR（P0.05）;there was no death case in 2 groups.CONCLUSIONS：Recombinant human endostatin combined with GP regimen could improve the clinical efficacy in advanced NSCLC with good safety.