西黄丸联合TP方案治疗中晚期乳腺癌的临床研究

Clinical study on Xihuang Pills combined with TP regimen in treatment of middle and advanced breast cancer

目的观察西黄丸联合紫杉醇注射液联合注射用顺铂(TP方案)治疗中晚期乳腺癌的临床疗效。方法收集开封市中心医院2014年1月—2016年2月确诊的中晚期乳腺癌患者123例为研究对象,根据抗肿瘤方案分为对照组(59例)和治疗组(64例)。对照组接受TP方案治疗:第1天静脉滴注紫杉醇注射液,150 mg/m^2,1次/d;第2~4天静脉滴注注射用顺铂,25 mg/m^2,1次/d。3周为1个化疗周期,共完成4个化疗周期。治疗组在对照组治疗的基础上口服西黄丸,3 g/次,2次/d,连续使用12周。评价两组患者临床疗效,同时比较治疗前后生活质量评分、血清肿瘤标志物水平、毒性反应和1、2年生存情况。结果治疗后,对照组、治疗组客观缓解率分别为40.7%、75.0%,疾病控制率分别为74.6%、87.5%,两组临床疗效比较差异具有统计学意义(P<0.05)。治疗后,两组患者KPS评分、FACT-B评分均显著升高,同组治疗前后比较差异具有统计学意义(P<0.05);且治疗组患者生活质量评分明显高于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,治疗组癌胚抗原(CEA)、糖类抗原125(CA125)、糖类抗原153(CA153)水平均显著降低,同组治疗前后比较差异具有统计学意义(P<0.05);且治疗组血清肿瘤标志物水平明显低于对照组,两组比较差异具有统计学意义(P<0.05)。治疗期间两组均有化疗毒性反应出现,治疗组毒性反应发生率低于对照组,但差异不具有统计学意义。治疗组1年生存率、2年生存率明显高于对照组,两组比较差异具有统计学意义(P<0.05)。结论西黄丸联合TP方案治疗中晚期乳腺癌具有较好的疗效,改善生活质量,降低血清肿瘤标志物水平,安全性好,具有一定的临床推广应用价值。

Objective To explore the effects of Xihuang Pills combined with TP regimen in treatment of middle and advanced breast cancer. Methods Patients（123 cases） with breast cancer in Kaifeng City Center Hospital from January 2014 to February 2016 were divided into control（59 cases） and treatment group（64 cases） according to the anti-tumor scheme. Patients in the control group were given TP regimen, and patients were iv administered with Paclitaxel Injection 150 mg/m^2, once daily, and were iv administered with Cisplatin for injection（25 mg/m^2） at the second to fourth day. Three weeks was a chemotherapy cycle, and four chemotherapy cycles were completed. Patients in the treatment group were po administered with Xihuang Pills on the basis of the control group, 3 g/time, twice daily, and were treated for 12 weeks. After treatment, the clinical efficacies were evaluated, and quality of life score, serum levels of tumor marker, toxic reaction, and survival rate in two groups were compared. Results After treatment, the objective remission rates in the control and treatment groups were 40.7% and 75.0%, respectively, and disease control rates in the control and treatment groups were 74.6% and 87.5%, respectively, and there was difference between two groups（P〈0.05）. After treatment, KPS scores and FACT-B scores in two groups were significantly increased, and the difference was statistically significant in the same group（P〈0.05）. And the quality of life scores in the treatment group were significantly higher than those in the control group, with significant difference between two groups（P〈0.05）. After treatment, the levels of CEA, CA125, and CA153 in two groups were significantly decreased, and the difference was significant in the same group（P〈0.05）. And the serum levels of tumor markers in the treatment group were significantly lower than those in the control group, with significant difference between two groups（P〈0.05）. Chemotoxicity was observed in both groups during the treatment period. The incidence of toxic reaction in the treatment group was lower than that in the control group, but there was not statistically significant difference. The one-year survival rate and two-year survival rate in the treatment group were significantly higher than those in the control group, with significant difference between two groups（P〈0.05）. Conclusion Xihuang Pills combined with TP regimen has clinical curative effect in treatment of middle and advanced breast cancer, can improve the quality of life, reduce the levels of tumor markers, with good safety, which has a certain clinical application value.