首页> 中文期刊> 《疑难病杂志》 >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

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

         

摘要

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 Selected 91 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 chemo-therapy , 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 observa-tion 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% CI 28.609-29.459) months, the cumulative probability of survival was (0.232 ±0.011), (0.088 ±0.008), showed a statis-tically 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 .%目的:观察并探讨艾迪注射液联合奥沙利铂( L-OHP)+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+DXL 4周期化疗方案,观察组在此基础上静脉滴注艾迪注射液,50 ml/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 30.752~31.308)个月、28.884(95%CI 28.609~29.459)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。

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