华蟾素胶囊联合新辅助化疗方案治疗HER2阳性乳腺癌临床研究OA
Clinical Study on Cinobufagin Capsules Combined with Neoadjuvant Chemotherapy Regimen in the Treatment of HER2 Positive Breast Cancer
目的:探讨华蟾素胶囊联合新辅助化疗方案治疗HER2 阳性乳腺癌的临床效果.方法:纳入 2022 年 2 月—2023 年 2 月于南昌市人民医院就诊的 86 例HER2 阳性乳腺癌患者,使用随机数字表法将患者分为观察组和对照组,各 43 例,对照组予以曲妥珠单抗+帕妥珠单抗+紫杉类联合铂类新辅助化疗方案,观察组在对照组新辅助化疗方案基础上加用华蟾素胶囊治疗.比较两组临床疗效、肿瘤退缩分级、血清相关指标[血清癌胚抗原(CEA)、糖类抗原 153(CA153)、组织多肽特异抗原(TPS)、免疫球蛋白(Ig)A、IgM和T淋巴细胞亚群(CD3+、CD4+、CD8+)]、生活质量[乳腺癌患者生活质量测定量表中文版(FACT-B)]及不良反应.结果:两组客观缓解率(51.16%vs 41.86%)、疾病控制率(81.40%vs 74.42%)比较,差异均无统计学意义(P>0.05);两组肿瘤退缩分级比较,差异无统计学意义(P>0.05);治疗后,两组CEA、CA153、TPS水平均较治疗前降低,观察组均低于对照组(P<0.05);治疗后,观察组IgA、IgM、CD3+、CD4+水平均高于对照组(P<0.05);两组治疗前后CD8+水平比较,差异无统计学意义(P>0.05);治疗后,观察组生理状况、情感状况、社会/家庭状况、附加关注评分均高于对照组,差异均有统计学意义(P<0.05);观察组头痛头晕、消化道不适、心脏毒性反应、肝肾损伤及骨髓抑制发生率均低于对照组(P<0.05).结论:华蟾素胶囊联合新辅助化疗方案治疗HER2 阳性乳腺癌,可在一定程度上抑制肿瘤进展,改善患者免疫失衡及生活质量水平,降低化疗毒副反应.
Objective:To explore the clinical efficacy of Cinobufagin Capsules combined with neoadjuvant chemotherapy regimen in the treatment of HER2 positive breast cancer.Method:A total of 86 patients with HER2 positive breast cancer admitted to Nanchang People's Hospital from February 2022 to February 2023 were included and divided into observation group and control group according to the random number table method,with 43 cases in each group.The control group was given neoadjuvant chemotherapy regimen of Trastuzumab + Pertuzumab + Taxanes combined with Platinum,and the observation group was additionally treated with Cinobufagin Capsules on the basis of neoadjuvant chemotherapy regimen.Clinical efficacy,tumor regression grading,serum related indicators[serum carcinoembryonic antigen(CEA),carbohydrate antigen 153(CA153),tissue polypeptide specific antigens(TPS),immunoglobulin(Ig)A,IgM and T lymphocyte subsets(CD3+,CD4+,CD8+)],quality of life[functional assessment of cancer therapy-breast(FACT-B)]and adverse reactions were compared between two groups.Result:There were no statistically significant differences in the objective response rate(51.16%vs 41.86%)and disease control rate(81.40%vs 74.42%)between the two groups(P>0.05).The tumor regression grading was not statistically different between the two groups(P>0.05).After treatment,the levels of CEA,CA153 and TPS in both groups were lower than those before treatment,and those in observation group were lower than those in control group(P<0.05).The levels of IgA,IgM,CD3+ and CD4+ in observation group after treatment were higher than those in control group(P<0.05).There was no statistical significance in CD8+ level between the two groups before and after treatment(P>0.05).After treatment,the scores of physiological status,emotional status,social/family status and additional attention in the observation group were higher than those of the control group(P<0.05).The incidence rates of headache and dizziness,digestive tract discomfort,cardiotoxicity,liver-kidney injury and myelosuppression in observation group were lower than those in control group(P<0.05).Conclusion:Cinobufagin Capsules combined with neoadjuvant chemotherapy regimen in the treatment of HER2 positive breast cancer can inhibit the tumor progression to a certain extent,improve the immune imbalance and quality of life,and reduce the toxic and side effects of chemotherapy.
叶露;陈鸿;陆巧妮
南昌市人民医院药剂科 江西 南昌 330009
华蟾素胶囊新辅助化疗HER2阳性乳腺癌生活质量肿瘤退缩
Cinobufagin CapsulesNeoadjuvant chemotherapyHER2 positive breast cancerQuality of lifeTumor regression
《中国医学创新》 2024 (011)
134-139 / 6
江西省中医药管理局科技计划项目(2023B0077)
评论