艾迪注射液联合奥沙利铂、多西紫杉醇方案治疗晚期非小细胞肺癌的疗效观察

目的观察并探讨艾迪注射液联合奥沙利铂(L-0HP)+多西紫杉醇(DXL)治疗晚期非小细胞肺癌(NSCLC)的近远期疗效并安全性。方法入选2009年9月-2010年8月NSCLC患者91例并随机单盲分为观察组(47例)与对照组(44例),对照组采用L-OHP+DXL4周期化疗方案,观察组在此基础上静脉滴注艾迪注射液,50ml/d,连用14 d,周期同对照组,化疗结束后3个月对比2组近期疗效与生活质量,36个月后对比2组远期生存率。结果 (1)化疗结束3个月后,观察组与对照组患者总体有效率分别为72.3%和52.3%,KPS生活质量评分分别为(81.4±5.4)分、(78.7±5.7)分,差异均具有统计学意义(P<0.05)。(2)观察组与对照组化疗期间毒性反应发生率顺位依次为胃肠道反应、粒细胞减少、血小板减少、末梢神经毒性、肝功能损害、肾功能损害、皮疹,2组毒性反应级别构成、发生率差异均无统计学意义(P>0.05)。(3)化疗结束后36个月,观察组与对照组平均生存时间分别为31.030(95%CI 30.752³1.308)个月、28.884(95%CI 28.60931.308)个月、28.884(95%CI 28.609²9.459)个月,累积生存概率分别为(0.232±0.011)、(0.088±0.008),差异具有统计学意义(P<0.01)。结论 L-OHP+DXL方案基础上加用艾迪注射液能显著提高晚期NSCLC近期化疗有效率,延长化疗后生存时间,且具备较好的临床安全性。

Effect of Aidi injection combined with oxaliplatin and docetaxel in treatment of advanced non-small cell lung cancer

Objective To explore the short and long term efficacy and clinical safety of Aidi injection combined with oxaliplatin（L-OHP） and docetaxel（DXL） in treatment of advanced non-small cell lung cancer（NSCLC）.Methods Selected91 patients from September 2009 to August 2010 with NSCLC,they were randomly divided into single-blind observation group（47 cases） and control group（44 cases）.The control group using L-OHP ＋ DXL 4 cycles of chemotherapy,observation group added Aidi intravenous injection,50 ml/ d,in 14 d,same cycles as control group,three months after the end of chemotherapy,two groups were compared the efficacy and quality of life,36 months after the therapy,long-term survival comparison were performed between the two groups.Results（1）3 months after the end of chemotherapy,the observation group and the control group patients＇ overall response rate was 72.3%and 52.3%,respectively,KPS quality of life score was（81.4±5.4）points,and（78.7±5.7） points,respectively,the differences were statistically significant（P〈0.05）.（2） The observation group and the control group during chemotherapy overall incidence of toxicities are as follows,gastrointestinal reactions,neutropenia,thrombocytopenia,peripheral neurotoxicity,liver damage,kidney damage,skin rash,two groups＇ toxicity level constitute revealed no significant difference（P〉 0.05）.（3） 36 months after the end of chemotherapy,in the observation group and the control group,the average survival time was 31.030（95%CI 30.752-31.308） months,28.884（95%CI28.609-29.459） months,the cumulative probability of survival was（0.232±0.011）,（0.088±0.008）,showed a statistically significant difference（P〈0.01）.Conclusion Aidi injection combined with L-OHP ＋ DXL regimen in treatment of advanced NSCLC could significantly improve the recent efficiency,prolong survival duration after chemotherapy,and show good clinical safety.