荷尔蒙替代疗法与死亡率之间没有关联


  【24drs.com】根据一篇新的系统分析与统合分析,停经荷尔蒙替代疗法对于死亡率没有正面影响,也没有负面影响。
  
  这项得自43篇随机临床试验的结果,由梅约诊所、实证实务研究计画-知识与评估研究小组、博士后研究员Khalid Benkhadra医师在3月6日发表于内分泌协会年会(ENDO 2015)。
  
  这是首度针对解答此一问题进行的研究。他表示,妇女们不用害怕长期事件,不过,每个人都是个别案例。医师们应协同停经后妇女共享决策,以让她们达到共识。
  
  加州大学圣地牙哥分校医学院临床医学教授Cynthia A. Stuenkel医师认为,统合分析发现没有正面影响是更值得注意的结果;对于较年轻妇女的可能死亡率依旧有一些问题,令人欣慰的是,死亡率没有增加。
  
  Benkhadra医师等人查找多个在线资料库,从该资料库设立时间点查找到2013年8月止,共检视了43篇随机控制试验;这些试验都比较了停经荷尔蒙治疗与安慰剂或无治疗,报导了各种结果。Benkhadra 医师表示,指标性的「妇女健康研究(WHI)」也被纳入43篇研究中。
  
  分析的研究对象超过52,000名妇女,平均年龄62岁,平均追踪5年。
  
  使用停经荷尔蒙替代治疗和各种原因死亡率之间没有显著关联(风险比[RR],0.99),与荷尔蒙制剂类型或原有的心脏病皆无关。
  
  使用荷尔蒙与心肌梗塞(RR,1.04)、乳癌(RR,0.93)或中风(RR,1.49)等之死亡率无显著关联,在这所有案例中,95%信心区间超过1.0。
  
  个别分析时,与死于肺癌、卵巢癌或大肠/直肠癌的风险无关,只用雌激素治疗或并用雌激素与黄体素治疗的结果相似。
  
  不过,Benkhadra医师提醒,这些结果有一些是「低到中度」,且追踪期最多都只有5年。
  
  最近,Lancet期刊中发表的一篇文献指出,在停经后妇女中,荷尔蒙替代治疗与卵巢癌风险略为增加有显著关联。
  
  Stuenkel医师表示,妇女健康研究和其它研究中,只有使用雌激素的一些资料认为,停经荷尔蒙替代治疗的死亡率降低,此次统合分析的一个问题是,治疗意向分析时没有根据年龄分组,对于荷尔蒙治疗,一般认为应有时间因素、或是治疗机会的关键窗口。
  
  我认为,我们相当清楚,荷尔蒙替代治疗对于治疗停经症状是相当合理的选项,但是,我们踯躅在预防问题。如果一个健康的50岁妇女从停经开始就使用荷尔蒙治疗,她的结果或许和心血管疾病风险较高的70岁妇女有所不同?这是个吊诡的问题。
  
  不过,大部分有症状的妇女不想等那么久之后再寻求治疗。
  
  妇女健康研究这项研究已经改变了我们的实务,我们对于60岁以上妇女已经相当小心地开始治疗,因为我们知道我们的血管年龄。但是,有些妇女仍然是有症状的,所以,这是棘手的部分,然而大多数女性会越来越接近更年期的时间,所以,即使是55岁更年期时属于风险较高者,机会在于她们不要等待5年再治疗。
  
  资料来源:http://www.24drs.com/
  

No Link Seen Between Hormone Replacement Therapy, Mortality

By Miriam E. Tucker
Medscape Medical News

SAN DIEGO, California — Menopausal hormone replacement therapy does not appear to affect mortality either positively or negatively, according to a new systematic review and meta-analysis.

The findings, from 43 randomized clinical trials, were presented March 6 here at the Endocrine Society’s annual meeting, ENDO 2015, by Khalid Benkhadra, MD, a postdoctoral research fellow in the Evidence-Based Practice Research Program–Knowledge and Evaluation Research Unit, Mayo Clinic, in Rochester, Minnesota.

This is the first investigation specifically aimed at answering the question, Dr Benkhadra told Medscape Medical News.

"Women shouldn’t be fearful of long-term events, but each case is an individual.... Clinicians should engage postmenopausal women and share decision-making so they can reach an agreement," he said.

For Cynthia A. Stuenkel, MD, clinical professor of medicine at the University of California, San Diego, School of Medicine, the lack of benefit found in the meta-analysis was the more notable finding.

"I think there are still questions about the potential mortality benefit in younger women, but I would say this is reassuring about no increase in mortality," she told Medscape Medical News.

Meta-analysis Included WHI

Dr Benkhadra and colleagues identified the 43 randomized controlled trials with several online database searches dating back to their inceptions and continuing through August 2013. All compared menopausal hormone therapy with either placebo or no treatment and reported an effect size for outcomes. The landmark Women’s Health Initiative was among the 43 studies, Dr Benkhadra told Medscape Medical News.

The study population totalled more than 52,000 women with a mean age of 62 years and an average 5 years of follow-up.

There were no significant associations between use of menopausal hormone replacement therapy and all-cause mortality (risk ratio [RR], 0.99), and no associations related to hormone type or preexisting heart disease.

No significant associations were found between hormone use and mortality due to myocardial infarction (RR, 1.04), breast cancer (RR, 0.93), or stroke (RR, 1.49). In all those cases, the 95% confidence interval crossed 1.0.

When analyzed separately, there were also no associations with risks for death from cancers of the lung, ovary, or colon/rectum. Results were similar for estrogen-only therapy and for combined estrogen-progesterone therapy.

However, Dr Benkhadra cautioned that the certainty of these results is "low to moderate" and that the length of follow-up was limited to 5 years.

Most recently, hormone replacement therapy was reported to be significantly associated with a small but increased risk for ovarian cancer in postmenopausal women in an article published in the Lancet.

No Stratification by Age Is a Limiting Factor

Dr Stuenkel told Medscape Medical News that some of the estrogen-alone data from the Women's Health Initiative and other studies had suggested a decrease in mortality with menopausal hormone replacement, and one problem with the current meta-analysis is that there was no stratification by age at initiation of treatment. It is thought that there is a timing factor, or critical window of opportunity, for hormone therapy.

"I think we're very clear that hormone replacement therapy is a very reasonable option for treating the symptoms of menopause. But we dance around the question related to prevention.... If a healthy 50-year-old woman going through menopause starts hormone therapy, might her outcome be different from a 70-year-old woman, who...might have greater risk for cardiovascular disease? It's a tricky question."

However, she noted, most symptomatic women do not wait that long to seek treatment.

"The Women’s Health Initiative...has altered the way we practice in that we're really very cautious about initiating therapy even in women over age 60 because we know that our vasculature ages. But some women remain symptomatic, so that's the tricky part, although most women...will come in closer to the time of menopause, so even if they're at the far end of the bell curve going through their menopause at age 55, chances are they're not going to wait 5 years."

Dr Benkhadra and Dr Stuenkel have disclosed no relevant financial relationships.

ENDO 2015: The Endocrine Society Annual Meeting. Poster presented March 6, 2015.

    
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