【摘要】：目的:系統(tǒng)評(píng)價(jià)托瑞米芬對(duì)比他莫昔芬治療乳腺癌的安全性,為臨床提供循證參考。方法:計(jì)算機(jī)檢索Medline、PubMed、EMBase、Cochrane圖書(shū)館、相關(guān)期刊論文、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)、中文科技期刊數(shù)據(jù)庫(kù)和萬(wàn)方庫(kù)數(shù)據(jù)庫(kù),收集托瑞米芬對(duì)比他莫昔芬治療乳腺癌安全性的隨機(jī)對(duì)照研究(RCT)及隊(duì)列研究,提取資料并評(píng)價(jià)質(zhì)量后,采用Rev Man 5.0統(tǒng)計(jì)軟件進(jìn)行Meta分析。結(jié)果:共納入10項(xiàng)RCT和9項(xiàng)回顧性隊(duì)列研究,合計(jì)9 182例患者。Meta分析結(jié)果顯示,托瑞米芬組患者總體藥品不良反應(yīng)發(fā)生率與他莫昔芬組比較差異無(wú)統(tǒng)計(jì)學(xué)意義[RR=0.88,95%CI(0.73,1.06),P=0.18];按托瑞米芬劑量進(jìn)行亞組分析顯示,常規(guī)劑量和高劑量托瑞米芬組患者與他莫昔芬組比較差異均無(wú)統(tǒng)計(jì)學(xué)意義。托瑞米芬組患者嚴(yán)重不良反應(yīng)發(fā)生率與他莫昔芬組比較差異無(wú)統(tǒng)計(jì)學(xué)意義[OR=0.60,95%CI(0.23,1.52),P=0.28]。常規(guī)劑量托瑞米芬組患者血栓事件發(fā)生情況[OR=0.77,95%CI(0.60,0.98),P=0.03]、消化系統(tǒng)不良反應(yīng)發(fā)生情況[OR=0.81,95%CI(0.70,0.94),P=0.006]、月經(jīng)不規(guī)則的發(fā)生率[OR=0.61,95%CI(0.39,0.94),P=0.03]、出現(xiàn)發(fā)熱伴/不伴寒戰(zhàn)情況[OR=0.56,95%CI(0.34,0.92),P=0.02]等方面均優(yōu)于他莫昔芬組,差異均有統(tǒng)計(jì)學(xué)意義。高劑量托瑞米芬組患者對(duì)比他莫昔芬的各類不良反應(yīng)發(fā)生情況,差異均無(wú)統(tǒng)計(jì)學(xué)意義。結(jié)論:相較于他莫昔芬,常規(guī)劑量托瑞米芬治療乳腺癌時(shí)在消化道不良反應(yīng)、血栓事件、月經(jīng)不規(guī)則、發(fā)熱伴/不伴寒戰(zhàn)等藥品不良反應(yīng)方面安全性較好。
[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 鹵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.
【作者單位】： 成都市第三人民醫(yī)院西藥科;
【基金】：四川省預(yù)防醫(yī)學(xué)會(huì)藥物應(yīng)用安全科研(孵化)項(xiàng)目(No.川預(yù)學(xué)[2013]70號(hào))
【分類號(hào)】：R737.9

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