调肝补肾消积法治疗晚期乳腺癌临床研究
A retrospective cohort study on treatment ofTiaogan-Bushen-Xiaoji recipe for the patients with advanced breast cancer
摘要目的 观察调肝补肾消积法对晚期乳腺癌患者总生存期(overall survival,OS)、无进展生存期(progress free survival,PFS)的影响.方法 将符合入选标准的105例术后第1次进展或首次发病的一线患者,以是否接受调肝补肾消积法分为综合治疗组49例和单纯西医组56例.单纯西医组按病情需要进行放化疗、靶向治疗、内分泌治疗及双膦酸盐治疗,观察终点为疾病第2次进展;综合治疗组在单纯西医组基础上联用调肝补肾消积法,治疗时间从开始服中药至观察结束,或疾病第2次进展,或死亡等终点事件而停止服药.观察并记录2组患者OS、PFS及卡氏生活质量评分(Karnofsky Performance Status,KPS).结果 综合治疗组OS[58.2(50.7~65.8)个月比43.8(30.6~51.6)个月,P=0.040]、PFS[30.7(23.8~37.7)个月比15.2(11.3~19.1)个月,P=0.001]、KPS评分[(88.6±10.0)分比(80.5±19.0)分,t=2.654]均高于单纯西医组.综合治疗组三阴性晚期乳腺癌患者PFS[25.1(12.1~38.0)个月比9.9(4.7~15.0)个月,P=0.038]高于单纯西医组(P<0.05).结论 调肝补肾消积法可延长晚期一线乳腺癌患者OS、PFS及三阴性乳腺癌患者的PFS,提高生活质量,治疗期间未发生毒副作用.
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abstractsObjective To explore the efficacy ofTiaogan-Bushen-Xiaoji recipe (TGBSXJ Recipe) on overall survival and progression free survival (PFS) in patients with advanced breast cancer.Methods A total of 105 patients with advanced breast cancer, who received the first-line treatment, were divided into two groups, 56 cases in the control group and 49 in the experimental group. The control group received standard therapy according to guidelines, including chemotherapy, targeted therapy, endocrine therapy and treatment of bisphosphonates.The experimental group received the treatment of TGBSXJ Recipe besides the standard therapy. The overall survival (OS), progression-free survival (PFS) and Karnofsky (KPS) of the patients in two groups were observed and compared. The treatment ended with the sighs of the observation ending, the second progress for the disease or death.Results The overall survival of the experimental group was significantly higher than that of the control group [OS: 58.2(50.7-65.8)/monthsvs. 43.8(30.6-51.6)/months,P=0.040]. The PFS of the experimental group was significantly higher than the control group [PFS: 30.7(23.8-37.7)/monthsvs. 15.2(11.3-19.1)/months,P=0.001]. The KPS of the experimental group was significantly higher than the control group (88.6 ± 10.0vs. 80.5 ± 19.0,t=2.654). The PFS of the triple negative breast cancer (TNBC) in the experimental group was significantly higher than control group [(25.1(12.1-38.0)/monthsvs. 9.9(4.7-15.0)/months,P=0.038].Conclusions The TGBSXJ recipe could extend the OS and PFS and improve the life quality of the patients with advanced breast cancer. In this study, no severe adverse effects had been found in the experimental group.
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