培美曲塞联合奈达铂治疗晚期肺腺癌临床疗效及其安全性观察

Clinical efficacy and safety of pemetrexed and nedaplatin in treatment of advanced lung adenocarcinoma

目的探讨培美曲塞联合奈达铂治疗晚期肺腺癌临床疗效及安全性。方法选择2015年4月至2017年12月本科收治的晚期肺腺癌患者,按照随机数字法分成对照组和观察组。观察组使用培美曲塞联合奈达铂方案治疗,对照组使用培美曲塞联合顺铂方案治疗。剔除失访病例后,共有60例患者完成本实验,观察组31例,对照组29例。对比两组患者的临床疗效及随访结果、药物毒副作用、体力状况变化、PS标准评分及生活质量评分。结果 (1)临床疗效及患者随访结果:对照组总有效率为37.93%;观察组总有效率为41.94%,观察组及对照组有效率比较差异无统计学意义(χ2=0.073,P=0.735);两组中位无进展生存期及1年生存率比较,差异无统计学意义(P>0.05)。(2)化疗药物毒副作用:在白细胞减少的发生率上观察组Ⅲ度以上患者显著比对照组低(P<0.05)。观察组Ⅱ度以上恶心、呕吐发生率显著比对照组低(P<0.05)。(3)2组治疗前后变化PS评分比较及肿瘤患者的生活质量(quality of life,QOL)评分比较差异无统计学意义(P>0.05)。(4)治疗前后EORTC QLQ-C30评价比较:经过化学药物治疗之后,观察组患者总体的健康状态及一般情况(如困倦乏力、恶心、呕吐等)均明显优于对照组(P<0.05)。结论培美曲塞联合奈达铂方案与培美曲塞联合顺铂方案的临床疗效在晚期肺腺癌的治疗中无明显差异,但前者副作用小,安全性高,培美曲塞联合奈达铂化疗方案在针对晚期肺腺癌的治疗上值得推广。

Objective To investigate clinical efficacy and safety of pemetrexed combined with nedaplatin in the treatment of advanced lung adenocarcinoma. Methods All patients with advanced lung adenocarcinoma treated in our hospital from April 2015 to April 2017 were recruited in this study. They were randomly divided into control group （pemetrexed combined with cisplatin） and observation group （pemetrexed combined with nedaplatin）. After the patients lost in follow-up were eliminated, there were 60 patients finally subjected in this study, including 31 in the observation group and 29 in the control. The clinical efficacy, clinical outcome, toxic and side effects of chemical drugs, change of physical condition, performance status （ PS, Zubrod-ECOG-WHO score）, and quality of life （QOL） were separately evaluated in the 2 groups after treatment. Results （1） Clinical efficacy and outcomes： There were no significant differences in overall response rate （37.93% vs 41.94% , Chi-square = 0. 072 0, P = 0. 788 5） , median progression free survival （mPFS） or 1-year survival rate （ P 〉 0.05 ） between the control and observation groups. （2） Toxic and side effects of chemical drugs： The incidence rate of over grade m leukocytopenia was significantly lower in the observation group than the control （9.68% vs 27.59% , Chi-square = 4. 251 2, P = 0. 034 0）. And the former group also had lower incidence rate of over grade 11 nausea and vomiting （ P 〈 0. 05 ）. （3） No significant differences were seen in PS score and QOL score in the both groups before and after the treatment （P 〉 0.05）. （4） Evaluation and comparison of EORTC QLQ-C30 before and after treatment ： though the QOL of the 2 groups were declined after the treatment of chemical drugs, but the total health and general situation （ mental state, fatigue, nausea and vomiting） were significantly better in the observation group than the control group （P 〈 0.05 ）. Conclusion Though there are no significant differences in clinical efficacy between pemetrexed combined with nedaplatin and with cisplatin in the treatment of advanced lung adenocarcinoma, and the former regimen has the advantages of milder side effects, higher safety and little impact on the QOL of patients. Therefore, it is worthy of popularizing widely in the treatment.