改良多柔比星脂质体TAC方案治疗HER2阴性乳腺癌的临床研究

Clinical study on modified doxorubicin liposome TAC regimen in treatment of HER2-negative breast cancer

目的探究改良多柔比星脂质体TAC方案治疗HER2阴性乳腺癌的临床效果。方法选取2019年1月—2020年1月新乡市中心医院收治的98例HER2阴性乳腺癌患者进行前瞻性研究。随机分为对照组和治疗组,每组各49例。对照组患者采用TAC方案治疗,第1天静脉滴注注射用盐酸多柔比星,50 mg/m^(2);多西他赛注射液,75 mg/m^(2);注射用环磷酰胺,500 mg/m^(2)。治疗组患者采用改良多柔比星脂质体TAC方案,第1天静脉滴注盐酸多柔比星脂质体注射液,30 mg/m^(2);多西他赛注射液,75 mg/m^(2);注射用环磷酰胺,500 mg/m^(2)。21 d为1个周期,两组均治疗6个周期。观察两组患者临床疗效,比较治疗前后两组患者肿瘤标志物糖类抗原19-9(CA19-9)、癌胚抗原(CEA)和糖类抗原15-3(CA15-3)水平,左室射血分数(LVEF)水平,心肌酶谱心肌肌钙蛋白I(cTnI)、肌酸激酶(CK)和肌酸激酶同工酶(CK-MB)水平,血清胸苷激酶1(TK1)、组织多肽特异性抗原(TPS)和微小核糖核酸-132(miR-132)水平,生活质量核心量表(QLQ-C30)评分及不良反应情况。结果治疗后,治疗组疾病控制率(85.71%)较对照组(67.35%)明显升高(P<0.05)。治疗后,两组患者血清CA19-9、CEA、CA15-3水平均较治疗前显著降低(P<0.05),且治疗组较对照组降低更明显(P<0.05)。治疗后,两组LVEF水平较治疗前降低,而cTnI、CK、CK-MB较治疗前显著升高(P<0.05),但治疗组LVEF较对照组更高,cTnI、CK、CKMB较对照组更低(P<0.05)。治疗后,两组血清TK1、TPS水平均较治疗前明显下降,而miR-132明显升高(P<0.05);且治疗组血清TK1、TPS和miR-132水平明显好于对照组高(P<0.05)。治疗后,两组患者QLQ-C30评分均较治疗前降低(P<0.05),且治疗组较对照组更低(P<0.05)。治疗后,治疗组脱发发生率较对照组明显降低(P<0.05)。结论相较于TAC方案,采用改良多柔比星脂质体TAC方案治疗HER2阴性乳腺癌效果更为显著,可有效调节血清TK1、TPS、miR-132水平,降低肿瘤标志物水平,减轻心肌损伤,提高生活质量,安全性更高。

Objective To explore the clinical effect of modified doxorubicin liposome TAC regimen in treatment of HER2-negative breast cancer.Methods Patients(98 cases)with HER2-negative breast cancer in Xinxiang Central Hospital from January 2019 to January 2020 were randomly divided into control and treatment group,and each had 49 cases.Patients in the control group were treated with TAC regimen for the first day,they were iv administered with 50 mg/m^(2) of Doxorubicin Hydrochloride for injection,and 75 mg/m^(2) of Docetaxel Injection,500 mg/m^(2) of Doxorubicin Hydrochloride for injection.Patients in the treatment group were treated with modified doxorubicin liposome TAC regimen for the first day,they were iv administered with 30 mg/m^(2) of Doxorubicin Hydrochloride Liposome Injection,and 75 mg/m^(2) of Docetaxel Injection,500 mg/m^(2) of Doxorubicin Hydrochloride for injection.21 days was a cycle,and the two groups were treated for 6 cycles.After treatment,the clinical evaluation was evaluated,the levels of tumor marker levels CA19-9,CEA and CA15-3,LVEF levels,the levels of myocardial enzyme spectrum cTnI,CK and CK-MB,the levels of serum TK1,TPS and miR-132,QLQ-C30 scores,and adverse reactions in two groups before and after treatment were compared.Results After treatment,the disease control rate in the treatment group(85.71%)was significantly higher than that in the control group(67.35%)(P<0.05).After treatment,the serum levels of CA19-9,CEA and CA15-3 in the two groups were significantly lower than those before treatment(P<0.05),and the reduction in the treatment group was more obvious than that in the control group(P<0.05).After treatment,the levels of LVEF in the two groups were lower than those before treatment,while the levels of cTnI,CK and CK-MB were significantly higher than those before treatment(P<0.05),but the levels of LVEF in the treatment group were higher than those in the control group,and the levels of cTnI,CK and CK-MB were lower than those in the control group(P<0.05).After treatment,the serum TK1 and TPS levels of the two groups were significantly decreased compared with those before treatment,while Mir-132 was significantly increased(P<0.05).The serum levels of TK1,TPS and Mir-132 in the treatment group were significantly higher than those in the control group(P<0.05).After treatment,the QLQ-C30 scores of the two groups were lower than those before treatment(P<0.05),and the QLQ-C30 scores of the treatment group were lower than those of the control group(P<0.05).After treatment,the incidence of hair loss in the treatment group was significantly lower than that in the control group(P<0.05).Conclusion Compared with TAC regimen,modified doxorubicin liposome TAC regimen is more effective in the treatment of HER2 negative breast cancer,which can effectively regulate the levels of serum TK1,TPS and miR-132,reduce the level of tumor markers,reduce myocardial injury,improve the quality of life,and have higher safety.