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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 observe the curative effect, Karnofsky score and toxicities and side effects of Aidi Injection, a combined gemcitabine plus gemcitabine (DDP) regimen (GP regimen) in the treatment of advanced non-small cell lung cancer (NSCLC) Methods A total of 160 patients with advanced NSCLC were randomly divided into treatment group (Eddie + GP) and control group (GP). In the control group, GEM1 000 mg / m2 was intravenously administered on days 1 and 8, respectively, and intravenous infusion of DDP 25 mg / m2 was administered for 2 to 4 days. In the treatment group, Aidi Injection 60 ml / d 2 weeks, 3 weeks for a cycle. Results The clinical benefit rate (CR + PR + SD) was 86.7% in the treatment group and 71.4% in the control group (P = 0.039). The improvement rates of Karnofsky score after treatment were 64.4% and 45.7 %, The difference was significant (P = 0.01). The incidence of nausea and vomiting, leukopenia and thrombocytopenia in the two groups were significantly different. There was no significant difference in the incidence of liver toxicity and renal toxicity. Conclusion Aidi injection combined with GP regimen in the treatment of advanced non-small cell lung cancer can improve the curative effect, improve the quality of life and reduce the side effects of chemotherapy.