Main Caroline, Knight Beatrice, Moxham Tiffany, Gabriel Sanchez Rafael, Sanchez Gomez Luis Maria, Roqué i Figuls Marta, Bonfill Cosp Xavier
Peninsula Technology Assessment Group (PenTAG), Peninsula College of Medicine and Dentistry, Exeter, UK.
Cochrane Database Syst Rev. 2013 Apr 30(4):CD002229. doi: 10.1002/14651858.CD002229.pub3.
Evidence from systematic reviews of observational studies suggest that hormone replacement therapy (HT) may have beneficial effects in reducing the incidence of cardiovascular disease (CVD) events in post-menopausal women. This is an updated version of a Cochrane review first published in 2005 (Gabriel-Sanchez 2005).
To assess the effects of HT for the prevention of CVD in post-menopausal women, and whether there are differential effects between use of single therapy alone compared to combination HT and use in primary or secondary prevention.
We searched the following databases to April 2010: Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library, MEDLINE, EMBASE and LILACS.
Randomised controlled trials (RCTs) of women comparing orally administered HT with placebo with a minimum of six-months follow-up.
Two authors independently assessed study quality and extracted data. Risk Ratios (RR) with 95% confidence intervals were calculated for each outcome. Results were combined using fixed-effect meta-analyses, and where possible, further stratified analyses conducted to assess the effect of time on treatment. Additionally, univariate meta-regression analyses were undertaken to assess whether length of trial follow-up, single or combination treatment, or whether treatment for primary or secondary prevention were potential predictors for a number of CVD outcomes in the trials.
Four new trials were identified through the update; one trial included in the previous review was excluded. Therefore the review included 13 trials with a total of 38,171 post-menopausal women. Overall, single and combination HT in both primary and secondary prevention conferred no protective effects for all cause mortality, CVD death, non-fatal MI, or angina. There were no significant differences in the number of coronary artery by-pass procedures or angioplasties performed between the trial arms. However there was an increased risk of stroke for both primary and secondary prevention when combination and single HT was combined, RR 1.26 (95% CI 1.11 to 1.43), in venous thromboembolic events, RR 1.89 (95% CI 1.58 to 2.26) and in pulmonary embolism RR 1.84 (95% CI 1.42 to 2.37) relative to placebo. The associated numbers needed-to-harm (NNH) were 164, 109 and 243 for stroke, venous thromboembolism and pulmonary embolism respectively.
AUTHORS' CONCLUSIONS: Treatment with HT in post-menopausal women for either primary or secondary prevention of CVD events is not effective, and causes an increase in the risk of stroke, and venous thromboembolic events. HT should therefore only be considered for women seeking relief from menopausal symptoms. Short-term HT treatment should be at the lowest effective dose, and used with caution in women with predisposing risk factors for CVD events.
观察性研究的系统评价证据表明，激素替代疗法（HT）可能对降低绝经后女性心血管疾病（CVD）事件的发生率具有有益作用。这是Cochrane综述的更新版本，该综述于2005年首次发表（Gabriel-Sanchez，2005年）。
评估HT预防绝经后女性CVD的效果，以及单独使用单一疗法与联合HT相比、在一级预防或二级预防中使用时是否存在差异效应。
我们检索了以下数据库至2010年4月：Cochrane图书馆中的Cochrane对照试验中心注册库（CENTRAL）、MEDLINE、EMBASE和LILACS。
将口服HT与安慰剂进行比较的女性随机对照试验（RCT），随访时间至少为6个月。
两位作者独立评估研究质量并提取数据。计算每个结局的风险比（RR）及其95%置信区间。结果采用固定效应荟萃分析进行合并，并在可能的情况下进行进一步的分层分析以评估时间对治疗的影响。此外，进行单变量荟萃回归分析以评估试验随访时间长短、单一或联合治疗，或一级或二级预防治疗是否是试验中一些CVD结局的潜在预测因素。
通过更新确定了4项新试验；之前综述中纳入的1项试验被排除。因此，该综述纳入了13项试验，共有38171名绝经后女性。总体而言，在一级和二级预防中，单一和联合HT对全因死亡率、CVD死亡、非致命性心肌梗死或心绞痛均无保护作用。试验组之间进行冠状动脉搭桥手术或血管成形术的数量没有显著差异。然而，联合和单一HT用于一级和二级预防时，中风风险增加，RR为1.26（95%CI 1.11至1.43）；静脉血栓栓塞事件中，RR为1.89（95%CI 1.58至2.26）；肺栓塞中，RR为1.84（95%CI 1.42至2.37），相对于安慰剂而言。中风、静脉血栓栓塞和肺栓塞的相关伤害所需人数（NNH）分别为164、109和243。
绝经后女性使用HT进行CVD事件的一级或二级预防无效，且会增加中风和静脉血栓栓塞事件的风险。因此，HT仅应考虑用于寻求缓解绝经症状的女性。短期HT治疗应采用最低有效剂量，并在有CVD事件易感风险因素的女性中谨慎使用。
