较慢开始治疗更年期可缓解症状


  【24drs.com】根据针对5篇第3阶段试验进行的事后分析,并用结合型雌激素与bazedoxifene(商品名Duavee, Pfizer药厂)可有效减少更年期症状,不论是在停经开始时或在停经5年后开始治疗。
  
  北美更年期协会(NAMS)执行主任、维吉尼亚大学医学中心JoAnn Pinkerton医师表示,在「SMART — Selective Estrogen, Menopause, and Response to Therapy 」临床试验中,前述并用疗法可降低热潮红的频率与严重度。
  
  她表示,它也增加骨密度、减少骨转换标记值、减轻外阴部萎缩、改善一些睡眠检测数据,且新发生停经妇女的停经相关生活质量问卷分数有所改善。
  
  Pinkerton医师在奥兰多举办的NAMS 2016年会中表示,不过,许多医师们的一大问题是,这些效益对于已经停经一段时间的妇女是否依旧存在。
  
  在2013年,美国食品药物管理局根据SMART试验的证据,核准并用结合型雌激素与bazedoxifene于治疗与更年期相关的中度到严重血管舒缩症状,以及预防停经后骨质疏松。
  
  在他们针对5篇SMART试验之数据进行的事后分析中,Pinkerton医师与其研究团队想要确定,根据相对于更年期时间何时开始治疗,并用的效果是否有所不同。
  
  他们的分析包括了两种剂量(0.45 mg 与0.625 mg)的结合型雌激素,并用bazedoxifene 20 mg。
  
  SMART试验的妇女大部份年龄为40-75岁、白人、已停经;已停经的时间范围介于1-35年,不过平均范围是4-8年。
  
  分析显示,不论是在停经开始后5年内或在停经开始5年之后开始并用疗法,症状改善程度相当。
  
  Pinkerton医师报告指出,两种剂量结合型雌激素之间,不论这些妇女是提早或延后开始服用并用疗法,在减少令人困扰的热潮红、预防骨质流失、改善睡眠、改善生活质量、改善外阴部变化方面,没有可辨别的差异。
  
  她解释,在某些时间点,有些结果,根据自何时开始停经而略有统计上的显著影响,但是,对于5年内或5年以上,在评估的各方面效益上没有明显的统计差异或模式。
  
  Pinkerton医师指出,重要的研究发现是停经妇女大部份可以预期停经症状之改善,不论是在开始停经的5年内或5年后开始治疗。
  
  她表示,我们并不是说,荷尔蒙治疗-不论是传统的还是这个新的并用方法-应在60岁后开始或在停经后10年才开始,而是当症状比较严重时,不论你是在开始停经的5年内或者5年后开始治疗都是有效的。
  
  宾州雷丁医院、费城汤玛斯杰佛逊大学的Peter Schnatz医师表示,Pinkerton医师等人的这篇新报告对医师们将会有所帮助。
  
  他表示,自从2002年「妇女健康促进计画」这篇研究发表之后,有许多妇女停用荷尔蒙治疗,其它有许多人则是避免开始使用。
  
  Schnatz医师表示,随著对风险与利益的更加了解,有比较多妇女愿意延后开始使用,这些资料将有帮助且是令人放心的。
  
  资料来源:http://www.24drs.com/
  
  Native link:Late-Start Treatment for Menopause Eases Symptoms

Late-Start Treatment for Menopause Eases Symptoms

By Fran Lowry
Medscape Medical News

The combination of conjugated estrogens and bazedoxifene (Duavee, Pfizer) effectively reduces the symptoms of menopause, whether started at the beginning of menopause or more than 5 years later, according to a posthoc analysis of data from five phase3 trials.

In the SMART — Selective Estrogen, Menopause, and Response to Therapy — clinical trials, "the combination reduced the frequency and severity of hot flushes," said JoAnn Pinkerton, MD, from the University of Virginia Medical Center in Charlottesville, who is executive director of the North American Menopause Society (NAMS).

It also "increased bone mineral density, reduced bone turnover marker levels, alleviated vulva–vaginal atrophy, improved some measures of sleep, and improved scores on the Menopause-Specific Quality-of-Life Questionnaire in newly menopausal women," she told Medscape Medical News.

"But the big question many clinicians have is whether these benefits would be similar in women who were further from menopause," Dr Pinkerton said at the NAMS 2016 Annual Meeting in Orlando.

The combination of conjugated estrogens and bazedoxifene was approved in 2013 by the US Food and Drug Administration — on the basis of evidence from the SMART trials — for the treatment of moderate to severe vasomotor symptoms associated with menopause and for the prevention of postmenopausal osteoporosis.

SMART Trials

In their posthoc analysis of data from the five SMART trials, Dr Pinkerton and her team wanted to determine whether the effects of the combination would differ, depending on when it was started in relation to menopause.

Their analysis involved two different doses of conjugated estrogens — 0.45mg and 0.625mg — in combination with bazedoxifene 20mg.

Most of the women in the SMART trials were 40 to 75 years of age, white, and postmenopausal. Years since menopause ranged from 1 to 35 years, but the mean range was approximately 4 to 8 years.

The analysis showed that menopausal symptoms improved to a similar degree, regardless of whether a woman started taking the combination less than 5 years after the start of menopause or more than 5 years after.

Whether the women started taking the combination sooner or later, there were no discernable differences in the reduction in bothersome hot flushes, prevention of bone loss, improvement in sleep, improvement in quality of life, or improvement in vulvovaginal changes — for either dose of conjugated estrogens — Dr Pinkerton reported.

"At some time points for some outcomes, there were a few statistically significant interactions by years since menopause, but there was no clear significant difference or pattern in benefits for less than or greater than 5 years in any of the areas that were evaluated," she explained.

The "important findings" are that postmenopausal women can largely expect improvement in menopausal symptoms, "regardless of whether they are less than or greater than 5 years since menopause," Dr Pinkerton added.

"We're not saying that hormone therapy — whether it is traditional or this new combination — should be started after age 60, or more than 10 years out from menopause, we are just saying that whether you are within that first 5 years when symptoms are often more severe, or out 5 years, it's effective," she said.

A Helpful, Reassuring Study

"This new report by Dr Pinkerton and her group will be helpful for clinicians," said Peter Schnatz, DO, from Thomas Jefferson University in Philadelphia and Reading Hospital in Pennsylvania.

"Since the release of the Women's Health Initiative in 2002, there have been large numbers of women stopping hormonal therapy, and others avoiding new starts," he told Medscape Medical News.

"With an improved understanding of the risks and benefits, and more women wanting to start at later time periods, these data are helpful and reassuring," Dr Schnatz said.

The study was sponsored by Pfizer. Dr Pinkerton reports financial relationships with Pfizer, Henry Stewart, and TherapeuticsMD. Dr Schnatz has disclosed no relevant financial relationships.

North American Menopause Society (NAMS) 2016 Annual Meeting: AbstractP-2. Presented October7, 2016.

    
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