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目的观察扶正化瘤方联合吉西他滨与顺铂在转移性三阴性乳腺癌中的临床效果。方法选取2012年1月至2016年12月间南京中医药大学第一附属医院收治的68例转移性三阴性乳腺癌患者,采用随机数表法分为研究组与对照组,每组34例。对照组采用吉西他滨联合顺铂治疗,研究组在对照组治疗基础上辅以扶正化瘤方治疗,观察两组患者临床效果、治疗前后血清肿瘤标志物水平及不良反应。结果研究组患者临床有效率为44.1%,临床控制率为82.4%,对照组治疗有效率为35.3%,控制率为61.8%,两组相比,差异均有统计学意义(均P<0.05)。治疗后研究组患者癌胚抗原(CEA)、糖类抗原CA15-3和CA125浓度分别为(5.2±2.5)μg/ml、(35.2±14.1)IU/ml和(40.3±18.5)IU/ml,对照组患者分别为(7.8±3.6)μg/ml、(52.2±11.2)IU/ml和(61.3±21.3)IU/ml,两组相比,差异均有统计学意义(均P<0.05)。研究组患者治疗后KPS评分为(88.8±6.1)分,对照组为(78.8±5.8)分,两组相比,差异有统计学意义(P<0.05)。两组患者治疗过程中,中性粒细胞减少、血小板减少、恶心、呕吐及脱发等不良反应发生率比较,差异均无统计学意义(均P>0.05)。结论扶正化瘤方联合吉西他滨与顺铂治疗转移性三阴性乳腺癌效果好,安全性高,值得临床推广。
Objective To observe the clinical effect of Fuzheng Huayu Decoction combined with gemcitabine and cisplatin in metastatic triple negative breast cancer. Methods Sixty-eight patients with metastatic triple-negative breast cancer who were admitted to the First Affiliated Hospital of Nanjing University of Traditional Chinese Medicine from January 2012 to December 2016 were randomly divided into study group and control group with 34 cases in each group. The control group was treated with gemcitabine combined with cisplatin. The study group was supplemented with Fuzheng Huayu Fang on the basis of the control group, and the clinical effect, serum tumor marker levels and adverse reactions before and after treatment were observed. Results The clinical effective rate was 44.1%, the clinical control rate was 82.4%, the control group was 35.3% and the control rate was 61.8%. There was significant difference between the two groups (all P <0.05) . The CEA, CA15-3 and CA125 concentrations in the study group were (5.2 ± 2.5) μg / ml, (35.2 ± 14.1) IU / ml and (40.3 ± 18.5) IU / ml, The patients in control group were (7.8 ± 3.6) μg / ml, (52.2 ± 11.2) IU / ml and (61.3 ± 21.3) IU / ml respectively. There were significant differences between the two groups (all P <0.05). The KPS score of the study group was (88.8 ± 6.1) points after treatment, compared with that of the control group (78.8 ± 5.8) points, the difference was statistically significant (P <0.05). There was no significant difference in the incidence of adverse reactions between the two groups in the course of treatment, such as neutropenia, thrombocytopenia, nausea, vomiting and hair loss (all P> 0.05). Conclusion Fuzheng Huayu decoction combined with gemcitabine and cisplatin in the treatment of metastatic triple negative breast cancer has good effect and high safety, which is worthy of clinical promotion.