康莱特联合多西紫杉醇和奥沙利铂治疗晚期NSCLC的临床研究

Kanglaite injection combined with docetaxel and oxaliplatin in treatment of advanced NSCLC

目的观察康莱特注射液联合多西紫杉醇和奥沙利铂治疗晚期非小细胞肺癌的疗效。方法 72例Ⅲ～Ⅳ期非小细胞肺癌患者随机分为联合治疗组40例和单纯化疗组32例。联合治疗组应用多西紫杉醇和奥沙利铂化疗同时加用康莱特注射液,单纯化疗组为多西紫杉醇联合奥沙利铂化疗。结果联合治疗组近期有效率为50.0%,单纯化疗组为37.5%,两组差异无统计学意义(P=0.139)。联合治疗组生存质量优于单纯化疗组(P=0.003);联合治疗组改善体质量方面亦优于单纯化疗组,差异有统计学意义(P=0.009)。在化疗不良反应方面,联合治疗组Ⅱ度以上骨髓抑制和神经毒性发生率均低于单纯化疗组(P=0.047,P=0.027)。结论康莱特注射液在联合多西紫杉醇和奥沙利铂治疗晚期非小细胞肺癌中,有增效减毒的作用,值得临床应用。

Objective To investigate the efficacy and adverse reactions of Kanglaite（KLT） injection combined with docetaxel and oxaliplatin in treatment of advanced non-small cell lung cancer（NSCLC）.Methods Seventy-two patients with stage Ⅲ ~ Ⅳ NSCLC were randomly divided into two groups：40 patients received KLT combined with docetaxel and oxaliplatin（combined treatment group） and 32 patients were treated with docetaxel and oxaliplatin alone（control group）.Results The short-term response rate of combined treatment group was 50.0% and that of control group was 37.5%;there was no statistically significant difference between two groups（P=0.139）.The quality of life in combined treatment group was better than that in control group（P=0.003）.Similarly,combined treatment group was better than control group in improving body weight（P=0.009）.The incidence of the garde Ⅱ or above bone marrow suppression and neurotoxicity in combined treatment group were significantly lower than those in control group（P=0.047,P=0.027）.Conclusion KLT injection with docetaxel and oxaliplatin in treatment of advanced NSCLC can improve the efficacy and reduce the toxicity of chemotherapy,which is worth of clinical application.