Ramesh Sharanya, Mann Michelle C, Holroyd-Leduc Jayna M, Wilton Stephen B, James Matthew T, Seely Ellen W, Ahmed Sofia B
Faculty of Medicine, University of Calgary, 3330 Hospital Drive NW, Calgary, T2N 4N1, Alberta, Canada.
Libin Cardiovascular Institute of Alberta, 1403 29 Street NW, Calgary, T2N 2T9, Alberta, Canada.
Syst Rev. 2015 Apr 8;4:44. doi: 10.1186/s13643-015-0020-8.
Chronic kidney disease affects approximately one in ten North Americans and is associated with a high risk of cardiovascular disease. Chronic kidney disease in women is characterized by an abnormal sex hormone profile and low estradiol levels. Since low estradiol levels are associated with an increased cardiovascular risk in healthy women, our objective is to determine the effect of hormone therapy on all-cause mortality, cardiovascular mortality, and cardiovascular morbidity in women with chronic kidney disease.
METHODS/DESIGN: Studies examining hormone therapy for adult women with chronic kidney disease will be included. The primary outcome is all-cause or cardiovascular mortality and morbidity. We will search electronic bibliographic databases (MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL)) along with relevant conference proceedings, table of contents of journals, and review articles. Two investigators will independently screen identified abstracts and select observational cohort studies, case-control studies, and randomized controlled trials examining hormone therapy in women with chronic kidney disease. These investigators will also independently abstract data from relevant full-text journal articles and assess risk of bias. Where possible, these data will be summarized using pooled or combined estimates for the risk ratio or hazard ratio of all-cause mortality, cardiovascular mortality, and cardiovascular morbidity in women with chronic kidney disease with and without hormone therapy. A random effects model will be used, and meta-regression and subgroup analyses will be used to explore potential source of heterogeneity.
Given the high burden of cardiovascular disease in women with chronic kidney disease, this study will help guide clinical practice by summarizing current evidence on the use of hormone therapy for prevention of all-cause mortality, cardiovascular mortality, and cardiovascular morbidity in this population.
The final protocol was registered with PROSPERO ( CRD42014014566) .
慢性肾脏病影响着约十分之一的北美洲人,并与心血管疾病的高风险相关。女性慢性肾脏病的特征是性激素谱异常和雌二醇水平低。由于雌二醇水平低与健康女性心血管风险增加有关,我们的目标是确定激素疗法对慢性肾脏病女性全因死亡率、心血管死亡率和心血管发病率的影响。
方法/设计:将纳入研究激素疗法用于成年慢性肾脏病女性的研究。主要结局是全因或心血管死亡率及发病率。我们将检索电子文献数据库(MEDLINE、EMBASE和Cochrane对照试验中心注册库(CENTRAL))以及相关会议论文集、期刊目录和综述文章。两名研究人员将独立筛选已识别的摘要,并选择观察性队列研究、病例对照研究以及研究慢性肾脏病女性激素疗法的随机对照试验。这些研究人员还将独立从相关全文期刊文章中提取数据并评估偏倚风险。在可能的情况下,将使用合并估计值汇总这些数据,以得出接受和未接受激素疗法的慢性肾脏病女性全因死亡率、心血管死亡率和心血管发病率的风险比或风险比的合并估计值。将使用随机效应模型,并采用meta回归和亚组分析来探索潜在的异质性来源。
鉴于慢性肾脏病女性心血管疾病负担较重,本研究将通过总结目前关于激素疗法用于预防该人群全因死亡率、心血管死亡率和心血管发病率的证据,帮助指导临床实践。
最终方案已在国际前瞻性系统评价注册库(PROSPERO)注册(CRD42014014566)。