中药补康灵方联合安罗替尼靶向治疗晚期非小细胞肺癌临床疗效观察

Clinical Efficacy of Bukangling Formula Combined with Anrotinib in Targeted Treatment of Advanced NSCLC

目的:观察中药补康灵方联合安罗替尼治疗晚期非小细胞肺癌(NSCLC)的临床疗效及安全性。方法:选取江苏省南通大学附属肿瘤医院诊治的64例二线及以上化疗失败的晚期NSCLC患者为研究对象,按照1∶1随机分为观察组与对照组。对照组32例采用安罗替尼靶向治疗(12mg/d,d1~14,q21d),观察组32例采用补康灵方联合安罗替尼治疗,均以21d为1个治疗周期,持续观察每个周期评价疗效。记录并比较两组病例无进展生存时间(PFS)、客观缓解率(ORR)、疾病控制率(DCR)、血清VEGF、血浆TrxR表达、生活质量QOL评分、中医证候积分、不良反应发生率。结果:中位PFS观察组高于对照组:5.6月(95%CI,4.878~6.322)比4.2月(95%CI,3.111~5.289),观察组中位PFS较对照组延长1.4个月,差异无统计学意义(P>0.05);ORR、DCR观察组高于对照组:12.5%比9.38%,75%比65.6%,差异无统计学意义(P>0.05);VEGF、TrxR比较,治疗后较治疗前均有所下降,观察期末组间比较观察组均较对照组有改善(P<0.05);生活质量QOL评分两组治疗后均较前升高,观察期末组间比较,观察组QOL评分显著高于对照组(P<0.01);中医证候积分较治疗前下降,组间比较观察组低于对照组(P<0.01);不良反应发生率比较,高血压、手足综合征、乏力及腹泻的发生率观察组低于对照组(P<0.05);出血、肝功能损伤、蛋白尿的发生率差异无统计学意义(P>0.05)。结论:补康灵方联合安罗替尼治疗晚期NSCLC有延长PFS、提高ORR、DCR的趋势,能够显著降低血清VEGF、TrxR表达水平,同时能够提高生活质量,改善中医证候积分,减少高血压、手足综合征、乏力及腹泻的不良反应发生率。

Objective:To observe the clinical efficacy and safety of Bukangling Formula combined with Anrotinib in targeted treatment of advanced non-small cell lung cancer(NSCLC).Methods:64 patients with advanced NSCLC,who failed second-line or above chemotherapy,were randomly divided into the control group and the observation group,with 32 patients in each group.The control group was treated with Anrotinib(12 mg/d,d1-14,q21d);on which basis,the observation group was also treated with Bukangling Formula.21 days were taken as a treatment cycle in both groups,and two consecutive cycles were observed.Progression free survival(PFS),objective remission rate(ORR),disease control rate(DCR),serum VEGF,plasma TrxR,scores of quality of life(QOL)and TCM symptoms,as well as incidence of adverse reactions were compared between the two groups.Results:The mPFS was 5.6 m(95%CI,4.878-6.322)in the observation group,which was 1.4 m longer than 4.2 m(95%CI,3.111-5.289)in the control group,but there was no statistical difference between the two groups(P>0.05).ORR was 12.5%and DCR was 75%in the observation group,which was respectively higher than 9.38%and 65.6%in the control group,but there were no statistical differences between the two groups(P>0.05).The serum levels of VEGF and TrxR were significantly decreased after the treatment compared to those before the treatment in the two groups;of which the decreases in the observation group were more significant(P<0.05).QOL score was higher after the treatment than that before the treatment in the two groups,of which the observation was significantly higher than the control group(P<0.01).The score of TCM symptoms was decreased after the treatment than that before the treatment,of which the observation group was lower than the control group(P<0.01).The incidence of hypertension,hand-foot syndrome,fatigue and diarrhea was lower in the observation group than that in the control group(P<0.05);there was no statistical differences in the incidence of bleeding,liver function damage and proteinuria between the two groups(P>0.05).Conclusion:Bukangling Formula combined with Anlotinib has a trend of prolonging PFS and increasing ORR and DCR,and it can significantly reduce the serum levels of VEGF and TrxR,improve the scores of QOL and TCM symptoms,and reduce the incidence of hypertension,hand-foot synthesis,fatigue and diarrhea in the treatment of advanced NSCLC.