标准剂量与低剂量口服雌二醇治疗绝经后潮热安全性的Meta分析  

Safety of standard dose versus lower dose oral estradiol for postmenopausal hot flashes: a meta-analysis

作　　者：杨娟[1] 吕映华[1] 尹芳[1] 何迎春[1] 

机构地区：[1]上海中医药大学药物临床研究中心,上海201203

出　　处：《中国新药与临床杂志》2016年第11期791-796,共6页Chinese Journal of New Drugs and Clinical Remedies

基　　金：上海中医药大学预算内项目(2014YSN17);上海市进一步加快中医药事业发展三年行动计划(2014年-2016年;ZY3-CCCX-3-1001);2013年中药学一流学科创新研究基金项目(ZYX-CXYJ-003);085支持项目(085ZY1202)

摘　　要：目的系统评价口服雌二醇标准剂量(1 mg·d^(-1))与低剂量(0.5 mg·d^(-1))治疗绝经后潮热的安全性。方法计算机检索Pubmed、Web of Science和Cochrane Library数据库,检索时限为建库至2016年3月。由2位评价员独立筛选文献、提取资料和评价纳入研究的方法学质量后,采用RevMan 5.2软件进行Meta分析。结果最终纳入4个随机对照临床试验,均为高质量研究,疗程8~13周,包括664例患者。Meta分析结果显示:口服雌二醇标准剂量组阴道出血发生率高于低剂量组[RR=2.16,95%CI(1.24,3.77),P=0.006],而乳房疼痛发生率、腹痛发生率、头痛发生率、因不良事件退出发生率两组比较均无显著差异(P>0.05)。结论口服雌二醇标准剂量较低剂量有增加阴道出血发生率的风险,而其他安全性指标两组无差异。AIM To assess the safety of standard dose versus lower dose oral estradiol in the treatment of postmenopausal hot flashes. METHODS Databases including PubMed, Web of Science and the Cochrane Library were searched to collect randomized controlled trials about oral estradiol in the treatment of postmenopausal hot flashes from inception to Mar. 2016. Two reviewers independently screened literature, extracted data, and assessed the methodological quality of included studies. Then meta-analysis was conducted by RevMan 5.2 software. RESULTS A total of 4 randomized controlled trials, involving 664 patients, were included. The results of meta-analysis showed that, compared with the lower dose group, the standard dose group could increase the rate of vaginal bleeding （RR = 2.16, 95%CI （1.24, 3.77）, P = 0.006）. However, the rates of breast pain, abdominal pain, headache pain, and discontinuation because of adverse events were not statistically different （P 〉 0.05） between the two groups. CONCLUSION Current evidence shows that compared with the lower dose estradiol, the standard dose estradiol has a risk increasing the rate of vaginal bleeding.

关 键 词：投药 口服 雌二醇 标准剂量 低剂量 潮热 META分析 

分 类 号：R984[医药卫生—药品]