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作 者:王怡[1] 秦悦农[2] 孙霃平[2] 刘胜[2] WANG Yi;QIN Yue-nong;SUN Chen-ping;LIU Sheng(Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Breast Department of Integrated Traditional and Western Medicine,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China)
机构地区:[1]上海中医药大学,上海201203 [2]上海中医药大学附属龙华医院中西医结合乳腺科,上海200032
出 处:《中华中医药杂志》2020年第8期4242-4246,共5页China Journal of Traditional Chinese Medicine and Pharmacy
基 金:2015年国家中医药行业专项(No.201507001-1);上海市中医药事业发展三年行动计划(重大研究)项目(No.ZY3-LCPT-2-1002)。
摘 要:目的:文章采用回顾性队列研究的方法,观察三阴性乳腺癌(TNBC)在规范治疗的基础上联合中药——乳癌术后三阴方对3年无病生存率(DPS)的影响。方法:从复旦大学附属肿瘤医院乳腺科数据库及上海中医药大学附属龙华医院刘胜教授门诊数据库中抽取满足首次手术时间为2014年9月1日至2016年1月31日,且随访满3年的临床分期为Ⅰ-Ⅲ期TNBC共163例。将乳癌术后三阴方设定为暴露因素,按照1∶1队列配比原则,暴露组80例,非暴露组83例。观察两组3年DFS的差异及药物长期服用的安全性。结果:暴露组较非暴露组3年DFS率提高6.6%,差异不具有统计学意义(95%CI[39.939,44.345],P>0.05)。非暴露组出现重要脏器(肺、肝、脑)转移的较暴露组明显增多(P<0.05)。COX回归风险模型显示服用中药后乳腺癌复发转移风险降低22%(HR=0.78,95%CI[0.41,0.95])。通过本研究发现,淋巴结转移≤3枚、脉管浸润阳性可能为乳癌术后三阴方的潜在获益人群(P<0.05)。服用乳癌术后三阴方不良反应发生率为15%,集中表现在肝功能异常及胃脘不适。结论:乳癌术后三阴方有降低肿瘤复发转移的趋势,并且适宜长期服用。Objective:To investigate the effects of‘Sanyin Formula after Breast Cancer Surgery’on the 3-year diseasefree survival(DFS)rate of triple-negative breast cancer combined with standardized retrospective cohort study.Methods:The clinical stage of the I-III period was selected from the database of the Affiliated Tumor Hospital of Fudan University and the database of professor LIU Sheng of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine.The first operation time was 2014.9.1-2016.1.31,and the clinical stage of follow-up was 3 years.There are total of 163 cases of triple negative breast cancer.The‘Sanyin Formula after Breast Cancer Surgery’was set as the exposure factor.According to the principle of 1∶1 cohort,80 patients are in the exposed group and 83 in the non-exposure group.The difference in 3-year DFS between the two groups and the safety of long-term use of the drug were observed.Results:The DFS rate of the exposed group was 6.6%higher than that of the non-exposure 3 years.The difference was not statistically significant(95%CI[39.939,44.345],P>0.05).In the non-exposed group,there was an increase in the number of significant organs(lung,liver,brain)metastasis(P<0.05).The COX regression risk model showed a 22%reduction in the risk of breast cancer recurrence and metastasis after taking Chinese medicine(HR=0.78,95%CI[0.41,0.95]).Through this study found that lymphatic node metastasis≤3,vascular infiltration may be the potential benefit of postoperative Sanyin Formula after breast cancer surgery(P<0.05).The incidence of adverse reactions of Sanyin Formula after breast cancer surgery was 15%,which was concentrated in liver damage and stomach discomfort.Conclusion:‘Sanyin Formula after Breast Cancer Surgery’has a tendency to reduce tumor recurrence and metastasis,and is suitable for long-term use.
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