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| 氟维司群500 mg治疗晚期乳腺癌的卫生技术评估 |
| Fulvestrant 500mg in the Treatment of Advanced Breast Cancer: A Health Technology Assessment |
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| DOI： |
| 中文关键词: 氟维司群 晚期乳腺癌 内分泌治疗 卫生技术评估 临床用药 决策支持 |
| 英文关键词:Fulvestrant Advanced breast cancer Health technology assessment Medical treatment Decision support |
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| 中文摘要: |
| 摘 要 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。 |
| 英文摘要: |
| ABSTRACT Objective:To support decision making and clinical practice by evaluating efficacy, safety and economical efficiency of fulvestrant 500mg (F500) in the treatment of advanced breast cancer. Methods:F500 was compared with other commonly used endocrine therapy (ET) medicines via fulvestrant 250mg (F250). Published health technology assessment(HTA) reports, systematic reviews (SR) /Meta analyses, RCTs and pharmacoeconomic studies were retrieved according to defined inclusion criteria, of which quality were assessed. Included RCTs were pooled through Meta analysis, while other studies were analyzed qualitatively.Results:37 literatures were eligible, including 12 SR/Meta analyses, 18 RCTs and 7 pharmacoeconomic analyses. Compared with other active ET comparators, F250 showed significant advantages in some safety signals and pharmacoeconomic outcomes, while similar in efficacy profiles. Compared with F250 and anastrozole, F500 significantly improved time to progression/progression free survival [HR=0.79 (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)]. F500 showed significant advantage in pharmacoeconomic outcomes, while similar in safety profiles.Conclusion:F500 has favorable profiles in efficacy, safety and economical efficiency in the treatment of advanced breast cancer. |
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