基于真实世界观察抗瘤减毒方联合化疗对非小细胞肺癌患者近期疗效及生活质量的影响

Effect of Kangliu Jiandu Formula combined with chemotherapy on short-term effect and quality-of-life in patients with non-small cell lung cancer:based on real world study

目的基于真实世界观察抗瘤减毒方联合化疗对精气两亏型中晚期非小细胞肺癌(NSCLC)患者近期疗效及生活质量的影响。方法采用回顾性真实世界研究方法,根据是否服用抗瘤减毒方将526例精气两亏型中晚期NSCLC患者分为观察组214例和对照组312例,对照组予单纯化疗,观察组予化疗联合抗瘤减毒方,观察时间均为2个化疗周期。比较2组近期疗效、中医证候改善率及中医证候疗效、KPS评分变化、肺癌患者生活质量测定量表(QLQ-LC43)评分。结果观察组近期疾病控制率(DCR)为89.25%(191/214),对照组为67.95%(212/312),观察组DCR高于对照组(P<0.05)。观察组中医证候神疲乏力、腰痠腿软、头晕耳鸣、纳谷不馨改善率分别为70.75%(75/106)、81.61%(71/87)、69.01%(49/71)、78.38%(58/74),对照组分别为29.00%(58/200)、33.33%(60/180)、21.74%(30/138)、30.26%(46/152),观察组均高于对照组(P<0.05)。观察组中医证候总有效率为71.03%(152/214),对照组为36.86%(115/312),观察组高于对照组(P<0.05)。观察组KPS评分提高率及总有效率分别为36.45%(78/214)、93.46%(200/214),对照组分别为18.91%(59/312)、58.97%(184/312),观察组均高于对照组(P<0.05)。观察组治疗后QLQ-C30功能领域、症状领域及QLQ-LC13评分均较本组治疗前下降,QLQ-C30总体健康状况评分较本组治疗前升高(P<0.05)。对照组治疗后QLQ-C30功能领域、总体健康状况评分均较本组治疗前降低,QLQ-LC13评分较本组治疗前升高(P<0.05)。组间比较显示,治疗后观察组QLQ-C30功能领域、总体健康状况评分高于对照组,QLQ-C30症状领域和QLQ-LC13评分均低于对照组(P<0.05)。结论抗瘤减毒方联合化疗治疗精气两亏型中晚期NSCLC能提高近期疗效,改善患者症状,提高患者生活质量。

Objective To observe the effect of Kangliu Jiandu Formula combined with chemotherapy on short-term effect and quality-of-life in patients with middle-advanced non-small cell lung cancer(NSCLC)of essence and qi deficiency based on real world study(RWS).Methods The retrospective real world study included 526 patients with middle-advanced NSCLC(essence and qi deficiency),and divided them into observation group(n=214)and control group(n=312)as whether to take Kangliu Jiandu Formula.Patients in control group were treated with chemotherapy alone,and patients in observation group with chemotherapy combined with Kangliu Jiandu Formula.The observation continued for 2 chemotherapy cycles,aiming to compare short-term effect,improvement rate of traditional Chinese medicine(TCM)syndrome,curative effect of TCM syndrome,karnofsky performance status(KPS)score,European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Lung Cancer(EORTC QLQ-LC43).Results The recent disease control rate(DCR)in observation group and control group was 89.25%(191/214)and 67.95%(212/312),respectively,DCR being better in observation group than control group(P<0.05);improvement rate of TCM syndrome(tiredness,soft waist and legs,dizziness and tinnitus,loss of appetite)in observation group was better than that in control group[70.75%(75/106),81.61%(71/87),69.01%(49/71),78.38%(58/74)vs 29.00%(58/200),33.33%(60/180),21.74%(30/138),30.26%(46/152),(P<0.05),respectively];the total effective rates of TCM syndrome were 71.03%(152/214)in observation group,higher than that of 36.86%(115/312)in control group(P<0.05);the increasing rate and total effective rates of KPS score in observation group were higher than those in control group[36.45%(78/214)vs 18.91%(59/312),93.46%(200/214)vs 58.97%(184/312),(P<0.05),respectively].After treatment,the functional field and symptom field of EORTC Quality of Life Questionnaire-Core 30(QLQ-C30),and Quality of Life Questionnaire-Lung Cancer Module 13(QLQ-LC13)in observation group were decreased,overall health status of QLQ-C30 was increased,and with statistically significant difference(P<0.05);functional field and overall health status of QLQ-C30 in control group were decreased,QLQ-LC13 was increased,the difference being significant(P<0.05);functional field and overall health status of QLQ-C30 were higher in observation group than in control group,while symptom fieldof QLQ-C30 and QLQ-LC13 were lower than control group,with statistically significant difference(P<0.05).Conclusion For patients with middle-advanced NSCLC(essence and qi deficiency),Kangliu Jiandu Formula combined with chemotherapy can improve short-term effect,symptoms,quality-of-life.