平消胶囊与参丹散结胶囊辅助培美曲塞联合卡铂治疗Ⅳ期非小细胞肺癌的疗效比较

摘要

目的：比较平消胶囊与参丹散结胶囊辅助培美曲塞联合卡铂（CP方案）治疗Ⅳ期非小细胞肺癌（NSCLC）的疗效和安全性。方法：132例Ⅳ期NSCLC患者随机均分为CP组、CP+平消组、CP+参丹散结组。CP组患者给予CP方案治疗；在此基础上， CP+平消组患者给予平消胶囊6粒，口服，每日3次；CP+参丹散结组患者给予参丹散结胶囊6粒，口服，每日3次。各组患者均治疗21 d为1个周期，连续治疗2个周期后评价近期疗效，观察各组患者生存质量改善情况、无进展生存期、1年生存率及毒副反应。结果：CP+平消组、CP+参丹散结组患者近期有效率、疾病控制率、生存质量总改善率、无进展生存期、1年生存率均显著高于CP组，白细胞减少、血小板减少、消化道反应、血红蛋白下降发生率均显著低于CP组，差异均有统计学意义（P＜0.05）；但CP+平消组、CP+参丹散结组两组间比较差异均无统计学意义（P＞0.05）。结论：平消胶囊、参丹散结胶囊均可辅助CP方案治疗Ⅳ期NSCLC，近期疗效和安全性较单用CP方案好。%OBJECTIVE:To compare the efficacy and safety of Pingxiao capsule and Shendan Sanjie capsule combined with CP program in the treatment of non-small cell lung cancer (NSCLC) in stage Ⅳ. METHODS:132 NSCLC patients in stage Ⅳwere randomly divided into CP group,CP+Pingxiao group and CP+Shendan Sanjie group. CP group was treated with CP program;based on it,CP+Pingxiao group was orally treated with 6 Pingxiao capsules,3 times a day;CP+Shendan Sanjie group was orally treated with 6 Shendan Sanjie capsules,3 times a day. 21 d was a treatment period,and the efficacy was evaluated after 2 treat-ment periods,improvement of life quality,progression-free survival,1-year survival rate and toxicity reactions were observed. RE-SULTS:The recent effective rate,disease control rate,total improvement rate of life quality,progression-free survival and 1-year survival rate in CP+Pingxiao group and CP+Shendan Sanjie group were significantly higher than CP group,incidences of leukope-nia,thrombocytopenia,gastrointestinal tract and decreased hemoglobin were significantly lower than CP group,the differences were statistically significant(P<0.05);however,there was no significant difference between CP+Pingxiao group and CP+Shendan Sanjie group(P>0.05). CONCLUSIONS:Both Pingxiao capsule and Shendan Sanjie capsule can be combined with CP program in the treatment of NSCLC in stageⅣ,with good safety.