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目的探究序贯使用他莫昔芬和第三代芳香化酶抑制剂与单独使用他莫昔芬或第三代芳香化酶抑制剂对绝经后激素受体阳性乳腺癌患者的有效性和安全性。方法计算机检索The Cochrane Library(2016年10期)、Pub Med、EMbase、CNKI、Wan Fang Data数据库,搜集他莫昔芬与芳香化酶抑制剂序贯治疗方案对比单药治疗方案治疗绝经后激素受体阳性乳腺癌的随机对照试验(RCT),检索时限均为从建库至2016年10月。由2位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用Rev Man 5.3软件进行Meta分析。结果共纳入9个RCT,包含22 005例患者。Meta分析结果显示:序贯治疗组的总生存期[HR=0.71,95%CI(0.52,0.98),P=0.04]和无复发生存期[HR=0.60,95%CI(0.46,0.79),P=0.000 3]明显优于他莫昔芬单药治疗组。序贯治疗组与芳香化酶抑制剂单药组在总生存期和无病生存期方面差异无统计学意义。在安全性方面,与他莫昔芬单药组相比,序贯治疗组降低了子宫内膜增生发生率[OR=0.22,95%CI(0.11,0.45),P<0.000 01]、死亡率[OR=0.74,95%CI(0.66,0.84),P<0.000 01]和远处转移率[OR=0.79,95%CI(0.68,0.91),P=0.001],但增加了骨折发生率[OR=1.31,95%CI(1.13,1.51),P=0.000 3]。结论序贯使用他莫昔芬与第三代芳香化酶抑制剂对比他莫西芬单药治疗绝经后激素受体阳性乳腺癌患者具有较好疗效和安全性,但序贯治疗方案对比芳香化酶抑制剂单药方案在生存获益上并无优势。
Objective To investigate the efficacy and safety of sequential use of tamoxifen and third generation aromatase inhibitors and tamoxifen or third generation aromatase inhibitors alone in postmenopausal women with hormone receptor-positive breast cancer . METHODS: The Cochrane Library (2016 Issue 10), Pub Med, EMbase, CNKI, Wan Fang Data database was collected to compare the sequential treatment regimens of tamoxifen and aromatase inhibitors. Single-agent regimens for the treatment of postmenopausal hormones Body-positive breast cancer randomized controlled trial (RCT), retrieval time from the construction of the library to October 2016. After two reviewers independently screened the literature, extracted data, and assessed the risk of being included in the study, Meta-analysis was performed using Rev Man 5.3 software. Results A total of 9 RCTs were included, including 22 005 patients. Meta-analysis showed that the overall survival (OR = 0.71, 95% CI 0.52, 0.98, P 0.04) and recurrence-free survival (RR 0.60, 95% CI 0.46, 0.79) P = 0.0003] was significantly better than tamoxifen monotherapy group. There was no significant difference in the overall survival and disease-free survival between the sequential treatment group and the aromatase inhibitor monotherapy group. In terms of safety, the sequential treatment group reduced the incidence of endometrial hyperplasia (OR = 0.22, 95% CI (0.11, 0.45), P <0.000 01], mortality compared with tamoxifen monotherapy (OR = 0.74, 95% CI 0.66, 0.84, P <0.000 01) and distant metastases [OR = 0.79, 95% CI 0.68, 0.91, P 0.001] but increased the incidence of fractures [ OR = 1.31, 95% CI (1.13, 1.51), P = 0.0003]. Conclusions Sequential use of tamoxifen and third-generation aromatase inhibitors compared with tamoxifen monotherapy for postmenopausal hormone receptor-positive breast cancer patients with good efficacy and safety, but the sequential treatment of aromatherapy Enzyme inhibitor monotherapy has no survival benefit.