探究扶正驱邪方联合新辅助化疗对三阴性乳腺癌（TNBC）患者肿瘤复发、血清胸苷激酶1（TK1）水平及免疫功能 的影响。【方法】将80例TNBC气阴两虚型患者随机分为联合组和对照组，每组各40例。对照组给予AC-T序贯化疗方案 （多柔比星与环磷酰胺联合并序贯多西他赛）治疗，联合组在对照组的基础上加用扶正驱邪方治疗。1个疗程为21 d，连续治 疗4个疗程。观察2组患者治疗前后中医证候积分、生活质量Karnofsky功能状态（KPS）评分、肿瘤标志物[糖类抗原125 （CA125）、糖类抗原153（CA153）、TK1]水平及T淋巴细胞亚群的变化情况，比较2组患者的临床疗效以及肿瘤的转移、复发 情况。【结果】（1）治疗4个疗程后，联合组的总有效率为87.50%（35/40），对照组为67.50%（27/40），组间比较（χ2检验），联 合组的疗效明显优于对照组（P＜0.05）。（2）治疗后，2组患者的中医证候积分均较治疗前明显降低（P＜0.05），KPS评分均较 治疗前明显升高（P＜0.05），且联合组对中医证候积分的降低幅度及对KPS评分的升高幅度均明显优于对照组（P＜0.05或 P＜0.01）。（3）治疗后，2组患者的血清CA125、CA153、TK1水平均较治疗前明显降低（P＜0.05），且联合组对血清CA125、 CA153、TK1水平的降低幅度均明显优于对照组（P＜0.01）。（4）治疗后，2组患者的T细胞CD3+、CD4+水平和CD4+/CD8+比值 均较治疗前明显升高（P＜0.05），CD8+水平均较治疗前明显降低（P＜0.05），且联合组对T细胞CD3+、CD4+水平和CD4+/CD8+ 比值的升高幅度及对CD8+水平的降低幅度均明显优于对照组（P＜0.05或P＜0.01）。（5）经过1年的随访调查，联合组的肿瘤复 发率和肿瘤转移率分别为7.50%（3/40）和12.50%（5/40），明显低于对照组的25.00%（10/40）和35.00%（14/40），组间比较，差 异均有统计学意义（P＜0.05）。【结论】扶正驱邪方联合新辅助化疗对于TNBC气阴两虚型患者的治疗效果较好，能有效改善 患者的免疫功能，降低血清肿瘤标志物水平，提高患者的生活质量，降低肿瘤复发和转移的发生率

To investigate the effects of Fuzheng Quxie Prescription （mainly with the actions of supporting healthy qi and dispelling pathogens）combined with neoadjuvant chemotherapy on tumor recurrence， serum thymidine kinase 1（TK1）level and immune function in patients with triple-negative breast cancer（TNBC）. Methods Eighty patients with TNBC of qi and yin deficiency type were randomly divided into a combination group and a control group， with 40 patients in each group. The control group was treated with AC- T sequential chemotherapy（Doxorubicin combined with Cyclophosphamide plus sequential Docetaxel），and the combination group was treated with Fuzheng Quxie Prescription on the basis of treatment for the control group. One course of treatment covered 21 days，and the two groups were treated for 4 consecutive courses. The changes of traditional Chinese medicine（TCM）syndrome scores，Karnofsky Performance Status（KPS）score，levels of tumor markers of carbohydrate antigen 125（CA125），carbohydrate antigen 153（CA153）and TK1，and T lymphocyte subset levels in the two groups were observed before and after the treatment. Moreover， the clinical efficacy and tumor metastasis and recurrence in the two groups were compared. Results（1）After 4 courses of treatment，the total effective rate of the combination group was 87.50%（35/40），and that of the control group was 67.50%（27/40），and the intergroup comparison（tested by chi- square test）showed that the efficacy of the combination group was significantly superior to that of the control group（P＜0.05）.（2）After treatment，the TCM syndrome scores in the two groups were significantly decreased compared with those before treatment（P＜0.05）， and the KPS scores were significantly increased compared with those before treatment（P＜0.05），and the decrease of TCM syndrome scores and the increase of KPS scores in the combination group were significantly superior to that in the control group（P＜0.05 or P＜0.01）.（3）After treatment，the serum CA125，CA153 and TK1 levels of patients in the two groups were significantly decreased compared with those before treatment（P＜0.05）， and the decrease of serum CA125，CA153 and TK1 levels in the combination group was significantly superior to that in the control group（P＜0.01）.（4）After treatment，the T lymphocyte subset CD3+，CD4+ levels and CD4+/CD8+ ratio in the two groups were significantly increased compared with those before treatment（P＜0.05），and the CD8+ level was significantly decreased compared with that before treatment（P＜0.05）. The post-treatment intergroup comparison showed that the increase of the T lymphocyte subset CD3+ ， CD4+ levels and CD4+/CD8+ ratio as well as the decrease of the CD8+ level in the combination group was all significantly superior to that in the control group（P＜ 0.05 or P＜0.01）.（5）The one-year follow-up showed that the tumor recurrence rate and tumor metastasis rate in the combination group were 7.50%（3/40）and 12.50%（5/40）respectively，significantly lower than 25.00%（10/40） and 35.00%（14/40）in the control group ， and the differences were statistically significant when comparing between the two groups（P＜0.05）. Conclusion The combination of neoadjuvant chemotherapy with Fuzheng Quxie Prescription has a better therapeutic effect on TNBC patients with qi and yin deficiency syndrome， which can effectively improve the immune function of the patients，decrease the level of serum tumor markers，improve the quality of life of the patients，and reduce the incidence of tumor recurrence and metastasis.

R273.379

河北省中医药管理局科研项目（编号：2021296）