大豆异黄酮对围绝经期和绝经后妇女安全性的Meta分析  

Meta analysis of the safety of soybean isoflavones in perimenopausal and postmenopausal women

作　　者：王莹[1,2] 田蜜 贺红[1] 杜金玲[1] WANG Ying;TIAN Mi;HE Hong;DU Jin-ling(Department of Cardiology,Qilu Hospital,Shandong University,Jinan Shangdong 250012,China;General Hospital of Shandong Rong Jun,Jinan Shangdong 250000,China)

机构地区：[1]山东大学齐鲁医院心内科,山东济南250012 [2]山东省荣军总医院,山东济南250000

出　　处：《毒理学杂志》2018年第4期277-286,共10页Journal of Toxicology

摘　　要：目的通过Meta分析,综合相关文献系统评价大豆异黄酮对围绝经期和绝经后妇女的安全性,为临床合理用药提供循证医学证据。方法检索Pubmed、Science Direct和Google学术数据库,全面搜集关于大豆异黄酮用于围绝经期和绝经后妇女的所有文献,制定纳入标准,剔除不符合要求的文献。根据Cochrane手册推荐使用的Cochrane风险偏倚评估工具对纳入的文献进行质量评价,利用Rev Man5.3统计软件对纳入的文献数据进行Meta分析。结果检索到129篇文献,最终纳入34篇文献,试验组病例数2 133例,对照组病例数1 740例。Meta分析结果显示:应用大豆异黄酮试验组出现不良反应数为1 090,应用安慰剂对照组出现不良反应数为1 017,合并的OR值统计学检验结果P>0.05(P=0.40),差异无统计学意义。不良反应分类中绝经后出血、乳房触痛、神经系统症状和心脏不适的统计学检验结果P>0.05,差异无统计学意义;胃肠道反应的统计学检验结果 P<0.01,差异有统计学意义。以摄入大豆异黄酮时间6个月为界限对各不良反应做亚组分析,各亚组分析中,只有摄入时间大于6个月时胃肠道反应的统计学检验结果P<0.00001,差异有统计学意义。结论大豆异黄酮用于围绝经期和绝经后妇女具有良好的安全性,不增加绝经后出血、乳房触痛、神经系统症状以及心脏不适的不良反应,仅在摄入时间超过6个月时存在一定的胃肠道反应。Objective To evaluate the safety of soy isoflavones in perimenopausal and postmenopausal women through meta-analysis and comprehensive literature review to provide evidence-based medical evidence for clinical rational use of drug. Methods Pubmed,Science Direct,Google Scholar database were searched,and all literature on soy isoflavones for perimenopausal and postmenopausal women was collected comprehensively,inclusion criteria were established,and articles that did not meet the requirements were excluded. For the included literature,the Cochrane risk bias assessment tool recommended by the Cochrane Handbook was used for quality assessment,and Rev Man 5. 3 statistical software was used for meta-analysis. Results One hundred and twenty-nine articles were retrieved and 34 articles were eventually included. The number of cases in the trial group was 2 133,and the number of cases in the control group was 1 740. Metaanalysis showed that the number of adverse reactions in the soy isoflavone test group was 1 090; the number of adverse reactions in the placebo control group was 1 017; the P value of the combined OR value test was more than 0. 05（ P = 0. 40）,indicating that the difference between the test and control groups was not significant. Further analyses showed that no statistical significance was found in the adverse reactions such as postmenopausal bleeding,breast tenderness,nervous system symptoms and heart discomfort（ P〈0.05）,the statistical significance was only found in gastrointestinal reactions（ P〈0.01）. Subgroup analyses demonstrated that when the intake time of isoflavones is more than 6 month,the incidence of gastrointestinal reactions was higher in the test group than the control group（ P〈0.00001）,and no significant difference was found when the intake time of isoflavones is less than 6 months. Conclusion Soy isoflavones is safe for perimenopausal and postmenopausal women. Intake of isoflavones does not increase postmenopausal bleeding,breast pain,nervous system symptoms and heart di

关 键 词：大豆异黄酮 安全性 围绝经期和绝经后妇女 META分析 

分 类 号：R99[医药卫生—毒理学]