消积饮对ⅢB/Ⅳ期非小细胞肺癌EGFR野生型患者无进展生存时间及生存质量的影响

The Effects of Xiaoji Beverage(消积饮)on Progression Free Survival Time and Quality of Life in StageⅢB/ⅣNon-Small Cell Lung Cancer Patients with EGFR Wild-Type

目的评价消积饮对ⅢB/Ⅳ期非小细胞肺癌表皮生长因子受体(EGFR)野生型患者维持治疗的疗效及生存质量的影响。方法74例ⅢB/Ⅳ期非小细胞肺癌EGFR野生型患者随机分为中医组23例,西医组24例,联合组27例。中医组给予消积饮口服治疗,每日1剂,连服21天为1个疗程;西医组给予替吉奥胶囊口服,根据体表面积换算每次用药剂量,每日2次,连续14天,停药7天,为1个疗程;联合组给予消积饮联合替吉奥胶囊治疗,用药方法同上。3组均重复用药直至肿瘤进展或副反应不可耐受或死亡。记录各组患者25%、50%、75%无进展生存时间(PFS),计算治疗3、6个月PFS发生率;治疗前及治疗第(42±3)天(设为治疗后)采用肺癌症状量表(LCSS)进行评分评价生存质量。结果3组患者25%PFS、50%PFS、75%PFS比较差异无统计学意义(P=0.34)。西医组患者治疗3、6个月PFS发生率分别为29.17%、8.33%,中医组分别为21.74%、17.39%,联合组分别为29.63%、25.93%,各时间点3组比较差异无统计学意义(P=0.789,P=0.257)。西医组和联合组治疗后LCSS评分均较本组治疗前升高(P=0.038,P=0.046),中医组治疗前后LCSS评分差异无统计学意义(P=0.195)。治疗后中医组LCSS评分低于西医组(P=0.005)。结论消积饮用于ⅢB/Ⅳ期非小细胞肺癌EGFR野生型患者的维持治疗,可延长无进展生存时间,疗效与替吉奥胶囊相当,在改善患者生存质量方面优于替吉奥胶囊。

Objective To evaluate the effect of Xiaoji Beverage(消积饮)as a maintenance treatment on quality of life in stageⅢB/Ⅳnon-small cell lung cancer(NSCLC)patients with epidermal growth factor receptor(EGFR)wild-type.Methods Seventy-four NSCLC patients with EGFR wild-type were randomly divided into three groups,with 23 patients in the traditional Chinese medicine(TCM)group,24 patients in the western medicine(WM)group,and 27 patients in the combination group.Xiaoji Beverage was orally administered in TCM group,one dose daily,for 21 days as a course.Tiggio capsules were orally taken in WM group,with dosage calculated based on body surface area,twice daily for 14 days,and a medication stop for 7 days,totally 21 days as a course.The combination group provided Xiaoji Beverage plus tiggio capsules,and the administration ways were the same as the other two groups.Patients received treatment until the cancer had progressed,or side effects became intolerable,or patients had died.The first quartile(25%),median(50%),and third quartile(75%)progression free survival(PFS)time were calculated,as well as the 3-month and 6-month PFS rates.Lung cancer symptom scale(LCSS)was used to evaluate the quality of life before and after treatment[(42±3)days].Results There were no statistically significant differences among three groups in PFS time(P=0.34).The 3-month PFS rate of WM group,TCM group and combination group were 29.17%,21.74%and 29.63%respectively(P=0.789),and the 6-month PFS rate of three groups were 8.33%,17.39%,and 25.93%respectively(P=0.257);the comparison among three groups in 3-month PFS rate and 6-month PFS rate were not statistically significant.The LCSS scores significantly increased after treatment compared to before treatment in WM group(P=0.038)and in combination group(P=0.046),while there was no difference in TCM group(P=0.195).After treatment,the LCSS score of TCM group was significantly lower than that of WM group(P=0.005).Conclusion Xiaoji Beverage,as a maintenance treatment for stageⅢB/ⅣNSCLC patients with EGFR wild-type,can prolong the progression free survival time,and is better than tiggio capsules in improving the quality of life.