托瑞米芬对比他莫昔芬治疗乳腺癌安全性的系统评价
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篇名: | 托瑞米芬对比他莫昔芬治疗乳腺癌安全性的系统评价 |
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摘要: | 目的:系统评价托瑞米芬对比他莫昔芬治疗乳腺癌的安全性,为临床提供循证参考。方法:计算机检索Medline、PubMed、EMBase、 Cochrane图书馆、中国期刊全文数据库、中国生物医学文献数据库、中文科技期刊数据库和万方库数据库,收集托瑞米芬对比他莫昔芬治疗乳腺癌安全性的随机对照研究(RCT)及队列研究,提取资料并评价质量后,采用Rev Man 5.0统计软件进行Meta分析。结果:共纳入10项RCT和9项回顾性队列研究,合计9 182例患者。Meta分析结果显示,托瑞米芬组患者总体药品不良反应发生率与他莫昔芬组比较差异无统计学意义[RR=0.88,95%CI (0.73,1.06),P=0.18 ];按托瑞米芬剂量进行亚组分析显示,常规剂量和高剂量托瑞米芬组患者与他莫昔芬组比较差异均无统计学意义。托瑞米芬组患者严重不良反应发生率与他莫昔芬组比较差异无统计学意义[OR=0.60,95%CI(0.23,1.52),P=0.28 ]。常规剂量托瑞米芬组患者血栓事件发生情况[OR=0.77,95%CI(0.60,0.98),P=0.03]、消化系统不良反应发生情况[OR=0.81,95%CI(0.70,0.94),P=0.006]、月经不规则的发生率[OR=0.61,95%CI(0.39,0.94),P=0.03]、出现发热伴/不伴寒战情况[OR=0.56,95%CI(0.34,0.92),P=0.02]等方面均优于他莫昔芬组,差异均有统计学意义。高剂量托瑞米芬组患者对比他莫昔芬的各类不良反应发生情况,差异均无统计学意义。结论:相较于他莫昔芬,常规剂量托瑞米芬治疗乳腺癌时在消化道不良反应、血栓事件、月经不规则、发热伴/不伴寒战等药品不良反应方面安全性较好。 |
ABSTRACT: | OBJECTIVE: To systematically review the safety of toremifene versus tamoxifen in the treatment of breast cancer, and provide evidence-based reference for clinic. METHODS: Retrieved from Medline, PubMed, EMBase, Cochrane Library, CJFD, CBM , VIP and Wanfang Database, randomized controlled trails (RCT) and cohort study about toremifene versus tamoxifen in the treatment of breast cancer were collected. Meta-analysis was performed by using Rev Man 5.0 software after data extraction and quality evaluation. RESULTS: Totally 10 RCTs and 9 retrospective cohort studies were enrolled, involving 9 182 patients. Results of Meta-analysis showed, compared with tamoxifen group, there was no significant difference in the incidence of overall adverse reactions in toremifene group [RR=0.88,95%CI(0.73,1.06),P=0.18]; the subgroup analysis based on the dose of toremifene showed, compared with tamoxifen group, there were no significant differences in conventional dose group and high-dose group. Compared with tamoxifen group, there was no significant difference in the incidence of serious adverse reactions in toremifene group [OR=0.60,95%CI(0.23,1.52),P=0.28]. The incidences of thrombotic events [OR=0.77,95%CI(0.60,0.98),P=0.03], adverse reactions in the digestive system [OR=0.81,95%CI(0.70,0.94),P=0.006], irregular menstruation [OR=0.61,95%CI(0.39,0.94),P=0.03] and fever with or without chills [OR=0.56,95%CI(0.34,0.92),P=0.02] in toremifene conventional dose group were superior to tamoxifen group, with statistical significance. Compared with tamoxifen group, there were no significant difference in the incidence of various types of adverse reactions in toremifene high-dose group. CONCLUSIONS: Compared with tamoxifen, conventional dose of toremifene shows better safety in terms of adverse reactions in the digestive system, thrombotic events, irregular menstruation, fever with or without chills and other adverse reactions in the treatment of breast cancer. |
期刊: | 2017年第28卷第3期 |
作者: | 兰瑛,胡蝶,何琴 |
AUTHORS: | LAN Ying,HU Die,HE Qin |
关键字: | 托瑞米芬;他莫昔芬;乳腺癌;安全性;系统评价 |
KEYWORDS: | Toremifene; Tamoxifen; Breast cancer; Safety; Systematic review |
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