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目的:评估氟维司群500 mg(F500)治疗晚期乳腺癌的有效性、安全性和经济性,为医保决策和临床用药提供证据支持。方法:以氟维司群250 mg(F250)为媒介,对F500与其他常用内分泌治疗药物进行比较。按纳入排除标准,系统检索已发表的卫生技术评估报告、系统评价/Meta分析、随机对照试验、药物经济学分析,提取数据并评价其研究质量。对随机对照试验进行Meta分析,对其他研究进行定性分析。结果:共纳入37篇文献,系统评价/Meta分析、随机对照试验及药物经济学分析分别为12、18和7篇。F250与其他常用内分泌治疗药物相比,有效性相似,并可降低部分不良事件发生率,具有显著的经济性优势;F500与F250、阿那曲唑相比,有效性具有显著优势,可显著延长疾病进展时间/无进展生存时间[HR=0.79(95%CI:0.68~0.91),HR=0.66(95%CI:0.47~0.92)]和总生存时间[HR=0.81(95%CI:0.69~0.96),HR=0.70(95%CI:0.50~0.98)],安全性指标差异无统计学意义,并具有显著的经济性优势。结论:F500治疗晚期乳腺癌具有良好的有效性、安全性和经济性。
OBJECTIVE: To evaluate the efficacy, safety and economy of fulvestrant 500 mg (F500) in the treatment of advanced breast cancer and provide evidence support for medical insurance decision-making and clinical use. Methods: Fulvestrant 250 mg (F250) was used as a vehicle to compare F500 with other commonly used endocrine drugs. By inclusion exclusion criteria, systematic reviews of published health technology assessment reports, systematic reviews / meta-analyzes, randomized controlled trials, pharmacoeconomic analyzes, data extraction and evaluation of the quality of research were conducted. Meta-analysis of randomized controlled trials, qualitative analysis of other studies. RESULTS: A total of 37 articles were included in the review, including systematic reviews, meta-analyzes, randomized controlled trials and pharmacoeconomic analyzes of 12, 18 and 7 articles respectively. Compared with other commonly used endocrine drugs, F250 has similar efficacy and can reduce the incidence of some adverse events, which has obvious economic advantages. Compared with F250 and Anastrozole, F250 has significant advantage and can significantly prolong the disease (95% CI: 0.68-0.91), HR = 0.66 (95% CI: 0.47-0.92), and overall survival (HR = 0.81; 95% CI: 0.69-0.96 ), HR = 0.70 (95% CI: 0.50-0.98)]. There was no significant difference in safety indicators with significant economic advantage. Conclusion: F500 treatment of advanced breast cancer has good efficacy, safety and economy.