托瑞米芬对比他莫昔芬治疗乳腺癌安全性的系统评价

发布时间：2018-08-19 11:59

【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、相关期刊论文、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 evaluate the safety of tamoxifen in the treatment of breast cancer and provide evidence-based reference for clinical practice. Methods: a computer-based search of Medline PubMeden was conducted in the Library of Cochrane, the full text Database of Chinese Journals, the Database of Chinese Biomedical Literature, the Database of Chinese Sci-tech Journals and the Database of Wanfang Library. A randomized controlled study (RCT) and a cohort study of the safety of tamoxifen in the treatment of breast cancer were collected. The data were extracted and the quality was evaluated. The Meta analysis was performed with Rev Man 5.0 statistical software. Results: a total of 10 RCT and 9 retrospective cohort studies were included. There was no significant difference in the overall incidence of adverse drug reactions between the tolemiphene group and tamoxifen group [RRN 0.88 + 95 CI (0.73 卤1.06)], and the subgroup analysis according to the dose of Toremifene showed that there was no significant difference in the incidence of adverse drug reactions (ADR) between the Toremifen group and the tamoxifen group. There was no significant difference between conventional and high dose tolemiphene groups and tamoxifen groups. There was no significant difference in the incidence of severe adverse reactions between Toremifen group and tamoxifen group. The incidence of thrombotic events in patients with conventional dose of Toremifen [ORO 0.7795 95 CI (0.600.98) P0. 03], adverse reactions of digestive system [ORP 0. 81 + 95 CI (0. 70 0. 94) P 0. 006], the incidence of irregular menstruation [OR0. 619 95 CI (0. 399 0. 94) P0. 03], fever with / without chills [OR0. 56% 95 CI (0. 34 0. 92) P0.02] were better than those in tamoxifen group. The difference was statistically significant. There was no significant difference in the incidence of adverse reactions of high dose toremifen group compared with that of tamoxifen group. Conclusion: compared with tamoxifen, conventional dose of Toremifen has better safety in adverse reactions of digestive tract, thrombus, irregular menstruation, fever with or without shivering and other adverse drug reactions in the treatment of breast cancer.
【作者单位】：成都市第三人民医院西药科;
【基金】：四川省预防医学会药物应用安全科研(孵化)项目(No.川预学[2013]70号)
【分类号】：R737.9

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