艾迪注射液联合GP方案治疗晚期非小细胞肺癌临床观察

Clinical observation on Aidi injection combined with GP chemotherapy in treating advanced non-small cell lung cancer

目的观察中药复方制剂艾迪注射液联合国产吉西他滨（泽菲,GEM）加顺铂（DDP）方案（GP方案）治疗晚期非小细胞肺癌（NSCLC）的疗效、Karnofsky评分及毒副作用。方法将160例晚期NSCLC患者随机分为治疗组（艾迪＋GP）和对照组（GP）。对照组应用GEM1 000 mg/m2分别于第1、8天静滴,DDP 25 mg/m2,静滴,第2~4天;治疗组同时加用艾迪注射液60 ml/d静滴,连用2周,3周为一周期。结果治疗组临床获益率（CR＋PR＋SD）86.7%,对照组临床获益率71.4%,差异有显著性（P=0.039）;两组治疗后Karnofsky评分提高率分别为64.4%和45.7%,差异有显著性（P=0.01）。两组恶心呕吐、白细胞下降、血小板下降发生率比较差异有显著性,肝功能毒副反应发生率、肾功能毒副反应发生率比较差异无显著性。结论艾迪注射液联合GP方案治疗晚期非小细胞肺癌可提高疗效,改善生活质量,降低化疗的毒副反应。

Objective To evaluate the therapeutic effectiveness and KPS（scores of quality of life） and adverse reaction of Aidi injection combined with GP regimen in treating advanced non-small cell lung cancer（NSCLC）.Methods 160 cases of advanced NSCLC were divided into two groups randomly： 90 cases（combined group） were treated with combined therapy of Aidi injection with GP,while the other 70 cases（control group） treated with only chemotherapy.Results There was obvious difference in clinical benefit rates between the two groups.The clinical benefit rate（CR＋PR＋SD） was 86.7% in combined group and 71.4% in control group,with significant difference（P=0.039）.Improving rate of KPS was 64.4%（58/90）in the combined group,while in the other group was 45.7%（32/70）,P=0.01.The nausea and vomiting rates of Aidi plus GP was obviously decreased compared with control group.Rate of lenkopenia was 28.9%（26/90） in the combined group,and 44.3%（31/70） in the other group,P=0.03.The thrombocytopenia was 13.3%（12/90） in the combined group,and 32.9%（23/70） in the other group,P=0.03.Hepatic function and renal function toxicity has no statistically significant difference（P=0.03）.Conclusion The efficacy of Aidi injection combined with GP regimen is better than GP regimen alone,and score of quality of life of Aidi injection combined with GP regimen is better than GP regimen alone,the side effects are milder in combined group than in control group.