参芪扶正注射液对三阴性乳腺癌新辅助化疗的增效减毒效果

Shenqi Fuzheng Injection increases efficacy and reduces toxicity of neoadjuvant chemotherapy for triple negative breast cancer:a mechanistic study

目的观察参芪扶正注射液对三阴性乳腺癌(TNBC)新辅助化疗的增效减毒效果。方法收集陕西省镇安县中医医院和陕西省人民医院88例TNBC患者,按随机数字表法分成对照组及参芪扶正组,每组44例,对照组给予TAC(紫杉类+蒽环类+环磷酰胺)方案治疗,参芪扶正组在此基础上联合参芪扶正注射液治疗,治疗后比较临床疗效,免疫功能指标[自然杀伤(NK)细胞、CD3^(+)、CD4^(+)、CD4^(+)/CD8^(+)]、炎症因子指标[白细胞介素-6(IL-6)、IL-8、肿瘤坏死因子-α(TNF-α)]及不良反应发生情况。结果参芪扶正组治疗后临床受益率均高于对照组(χ^(2)=4.470,P=0.034);治疗后,参芪扶正组NK细胞、CD3^(+)、CD4^(+)、CD4^(+)/CD8^(+)均高于对照组(P<0.05);参芪扶正组血清IL-6、IL-8低于对照组,TNF-α高于对照组(P<0.05);参芪扶正组不良发生率低于对照组(P<0.05)。结论参芪扶正注射液对TNBC新辅助化疗患者具有减毒增效作用,值得推广和应用。

Objective To investigate the effect and underlying mechanism of Shenqi Fuzheng Injection in increasing the efficacy and reducing the toxicity of neoadjuvant chemotherapy for triple negative breast cancer(TNBC).Methods Included in this study were 88 TNBC patients from Zhen′an County Hospital of Traditional Chinese Medicine and Shaanxi Provincial People′s Hospital,randomized by the random number table method and divided into the control group and the Shenqi Fuzheng group(n=44 each).The control group was treated on tax-ane,anthracycline plus cyclophosphamide(TAC regimen);in addition to this,the Shenqi Fuzheng group was given Shenqi Fuzheng Injection.After treatment,the two groups were compared for clinical efficacy,immune function(NK cell,CD3^(+)and CD4^(+)T cell counts,and CD4^(+)/CD8^(+)ratio),inflammatory cytokines[levels of interleukin(IL)-6,IL-8,and tumor necrosis factor-α(TNF-α)],and adverse reactions.Results Clinically,the patients in the Shenqi Fuzheng group benefited more significantly from the treatment than those in the control group(χ^(2)=4.470,P=0.034).After treatment,the Shenqi Fuzheng group showed higher counts of NK cell,CD3^(+)and CD4^(+)T cells,higher CD4^(+)/CD8^(+)ratio(P<0.05),lower serum levels of IL-6 and IL-8,and higher serum TNF-αlevel(P<0.05),compared with the control group.The incidence rate of adverse reactions was lower in the Shenqi Fuzheng group compared with the control group(P<0.05).Conclusion Shenqi Fuzheng Injection may reduce the toxicity and increase the efficacy of neoadjuvant chemotherapy for TNBC patients,and therefore warrants widespread use in clinical practice.