[2007.5.24][转贴][APTX青山病院]“无月经期” 的避孕药Lybrel 获FDA批准

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'No-Period' Contraceptive Pill Gains FDA Approval

Lybrel may become popular with younger women, expert says

HealthDay
Tuesday, May 22, 2007



TUESDAY, May 22 (HealthDay News) -- Lybrel, a birth-control pill that does away with a woman's monthly period, was approved Tuesday by the U.S. Food and Drug Administration.

The estrogen-progestin hormonal pill differs from traditional birth-control pills in that it does not include the "week off" of placebo pills that leads to a cessation of artificial hormones and bleeding.

Lybrel is described as "continual contraception" but it "works the same way as the 21-days on, seven-days off [pill] cycle -- it stops the body's monthly preparation for pregnancy by lowering the production of hormones that make pregnancy possible," Dr. Daniel Shames, deputy director of the FDA's Office of Drug Evaluation III, at the Center for Drug Evaluation and Research, explained at a press conference late Tuesday.

A majority of women who decide to take Lybrel will encounter unscheduled bleeding, or spotting, that in most cases tapers off over the first year of use, Shames said. In the primary clinical trial leading up to approval, 59 percent of women who took Lybrel for one year reported no bleeding or spotting during the last month of the trial.

In terms of safety, two one-year clinical trials involving more than 2,400 18-to-49-year-old women showed no increased risk of endometrial cancer among those taking Lybrel. The risks of other side effects linked to the birth-control pill -- primarily blood clots -- were similar to those seen in other contraception regimens, Shames said.

"We don't expect any surprises in terms of long-term use of this product," he added, although he noted that the FDA has requested that the drug's maker, Wyeth Pharmaceuticals, conduct post-marketing studies to keep tabs on Lybrel's long-term safety.

Despite some women's reticence to do away completely with their monthly period, gynecologic experts agreed that there was no physiological "downside" to a period-free life. In fact, one expert noted that, for decades, many American women have been pharmaceutically ending their periods with more traditional birth-control pills with no resulting problems.

"There were other products, such as the long-acting progestin, Depo-Provera, that was given by injection," said Dr. Michael Petriella, vice chairman of obstetrics and gynecology at Hackensack University Medical Center, in Hackensack, N.J. "Women who were using that for contraception wouldn't get their period at all while on that product."

And for years, "some physicians have been allowing some women to take the Pill off-label -- allowing them to take two packages continuously, for example," Petriella said.

Another expert noted that the "period" women get while on conventional birth-control pills isn't connected to a natural cycle of egg production, anyway.

"It's not a natural period. It's an artificially induced period that happens because she stops taking the hormones for seven days. So, she gets some vaginal bleeding," explained Dr. Camelia Davtyan, a gynecologist and associate professor of medicine at the University of California, Los Angeles.

In fact, a no-period pill like Lybrel could have been a contraceptive norm for women from the get-go, Davtyan said. However, the doctors and pharmaceutical companies who developed the birth-control pill back in the 1960s assumed that women would want a regimen that mimicked the monthly cycle.

"I guess they were trying to make it seem as 'real' as possible and cause as little change as possible in a woman's life," Davtyan said.

But times have changed, and newer contraceptive products such as Seasonale -- a contraceptive pill that cuts the number of periods to just four a year -- have already been readily embraced by some American women over the past decade.

Davtyan said she has recently noticed a big shift in her patients' attitudes toward their period.

"They want convenience, and they tell me that they'd just rather not have the bleeding altogether so that they don't have any limitations with sports, with having to use pads, tampons," she said. "And the younger the woman, the more likely that she will want her periods stopped. It's very possible that this will be the wave of the future."

But Petriella said many women still feel a strong psychological attachment to their period and do not want to give it up, however inconvenient it may be.

"Sometimes [ending periods] is just emotionally uncomfortable for women," he said. "They don't feel right about not having their period. For those women, obviously Lybrel and other such products are not good products for them."

Petriella believes that, at least in the short-term, Lybrel will appeal to only a minority of women. They include those with menstruation-linked conditions such as endometriosis and menstrual migraine, or those who have already tried -- and liked -- period-limiting products such as Seasonale, he said.

As with any pharmaceutical contraceptives, women who decide to go on Lybrel may experience random breakthrough bleeding, Davtyan said.

So, for the 59 percent of women who have no bleeding or spotting after one year, "I think Lybrel is a great deal," Davtyan said. "For the remainder, if they have the patience to hang in there for a few months, the spotting might abate. There will be an occasional patient that will continue to spot, and then, clearly, it's a better deal to have a scheduled period than to start spotting at an unknown time and maybe in an uncomfortable circumstance."

Women who decide to resume their monthly cycle -- for example, those who wish to become pregnant -- can typically expect to resume their normal cycle within days of stopping Lybrel, Shames said. He said that short timespan to resumption of ovulation could leave women who skip or miss pills open to unplanned pregnancy, so the FDA is advising that women consider a second form of birth control while on Lybrel, as a safeguard.

Both Davtyan and Petriella stressed that young women who are considering a pharmaceutical end to their period should not be concerned that doing so will harm their health.

"Remember, there's no real physiological value to hold on to the period that a woman has while she is taking the Pill, unless it is a psychological value, which I respect," Davtyan said.

[U]http://www.nlm.nih.gov/medlineplus/news/fullstory_49556.html[/U]




'No-Period' Contraceptive Pill Gains FDA Approval

Lybrel may become popular with younger women, expert says

HealthDay
Tuesday, May 22, 2007

“无月经期”的避孕药获得FDA批准
专家预测Lybrel将赢得年轻女性青睐
每日健康
2007年5月22日，星期二

TUESDAY, May 22 (HealthDay News) -- Lybrel, a birth-control pill that does away with a woman's monthly period, was approved Tuesday by the U.S. Food and Drug Administration.
5月22日星期二，每日健康新闻报道—一种让妇女和月经说再见的避孕药丸Lybrel周二获得美国食品药品监督管理局批准。
The estrogen-progestin hormonal pill differs from traditional birth-control pills in that it does not include the "week off" of placebo pills that leads to a cessation of artificial hormones and bleeding.
这种含有雌激素和孕酮的激素药丸与传统避孕药区别在于：它没有安慰药丸所具有的“烦心周”效应，并可停止月经出血和人工激素合成。
Lybrel is described as "continual contraception" but it "works the same way as the 21-days on, seven-days off [pill] cycle -- it stops the body's monthly preparation for pregnancy by lowering the production of hormones that make pregnancy possible," Dr. Daniel Shames, deputy director of the FDA's Office of Drug Evaluation III, at the Center for Drug Evaluation and Research, explained at a press conference late Tuesday.
人们把Lybrel描绘成“不间断避孕药物”，“但它工作的方式仍与21天吃药，7天停药的药丸工作方式并无二异。Lybrel通过降低可引发妊娠激素的分泌从而停止人体每月一度为怀孕而作的准备工作。”药物评估和研究中心的FDA III 期药物评估所主任Daniel Shames博士在周二晚些时候举行的新闻发布会上如是解释说。
A majority of women who decide to take Lybrel will encounter unscheduled bleeding, or spotting, that in most cases tapers off over the first year of use, Shames said. In the primary clinical trial leading up to approval, 59 percent of women who took Lybrel for one year reported no bleeding or spotting during the last month of the trial.
Shames说，打算服用Labrel的大多数妇女将面临不规律出血，但多数情况下它将在服药首年内逐步减弱。首次临床试验为Lybrel争取到了FDA的批准。这项试验中，服用Lybrel为期一年的妇女在试验的最后一个月内未见有出血事件报道。
In terms of safety, two one-year clinical trials involving more than 2,400 18-to-49-year-old women showed no increased risk of endometrial cancer among those taking Lybrel. The risks of other side effects linked to the birth-control pill -- primarily blood clots -- were similar to those seen in other contraception regimens, Shames said.
Shames说道，从安全性的角度而言，为期一年涉及超过2400名，年龄介于18至49岁之间妇女的两项临床试验表明，服用Lybrel没有增加妇女罹患子宫内膜癌的风险。该避孕药带来的其他副作用风险与其他避孕药大体类似，主要为血凝块风险。
"We don't expect any surprises in terms of long-term use of this product," he added, although he noted that the FDA has requested that the drug's maker, Wyeth Pharmaceuticals, conduct post-marketing studies to keep tabs on Lybrel's long-term safety.
他补充道，“我们对长期使用该药物一点也不感到吃惊。”但他同时强调FDA已责成Lybrel生产产商惠氏制药公司开展营销后的研究，密切关注Lybrel长期服用的安全性问题。
Despite some women's reticence to do away completely with their monthly period, gynecologic experts agreed that there was no physiological "downside" to a period-free life. In fact, one expert noted that, for decades, many American women have been pharmaceutically ending their periods with more traditional birth-control pills with no resulting problems.
尽管有些妇女对彻底告别经期的做法不愿表态，妇科专家还是认为没有月经的生活不见得会有生理上的负面效应。事实上，一名专家指出，过去数十年来许多美国妇女已经采用更为传统的避孕药物来终止其经期，并没有出现不良后果。
"There were other products, such as the long-acting progestin, Depo-Provera, that was given by injection," said Dr. Michael Petriella, vice chairman of obstetrics and gynecology at Hackensack University Medical Center, in Hackensack, N.J. "Women who were using that for contraception wouldn't get their period at all while on that product."
新泽西州汉肯萨克大学医疗中心妇产科副主任的Michael Petriella博士说，“市场上还有其他避孕药物可通过注射方式给药，比如含长效孕酮的Depo-Provera药物。使用该药物避孕的妇女经期会彻底消失。”
And for years, "some physicians have been allowing some women to take the Pill off-label -- allowing them to take two packages continuously, for example," Petriella said.
Petriella说，“多年以来，一些内科医生允许部分妇女不按药嘱服药。打个比方说，允许妇女连续服用两个包装的药物。”
Another expert noted that the "period" women get while on conventional birth-control pills isn't connected to a natural cycle of egg production, anyway.
另外一名专家则指出，服用常规避孕药物妇女所得到的经期其实与卵细胞自然生成周期没有联系。
"It's not a natural period. It's an artificially induced period that happens because she stops taking the hormones for seven days. So, she gets some vaginal bleeding," explained Dr. Camelia Davtyan, a gynecologist and associate professor of medicine at the University of California, Los Angeles.
“这并不是自然的经期，而是她连续七天停止服用激素避孕药物人工诱导出来的。这样她的阴道还会流一些血，”洛杉矶加州分校医学副教授和妇产学家Camelia Davtyan解释说。
In fact, a no-period pill like Lybrel could have been a contraceptive norm for women from the get-go, Davtyan said. However, the doctors and pharmaceutical companies who developed the birth-control pill back in the 1960s assumed that women would want a regimen that mimicked the monthly cycle.
Davtyan说道，实际上从初潮开始，诸如Lybrel等无经期的药物就理应成为妇女避孕首选。但是早在1960年代就开发出这种避孕药的制药公司和医生却以为妇女们想要的就是能模拟其经期的避孕药物。
"I guess they were trying to make it seem as 'real' as possible and cause as little change as possible in a woman's life," Davtyan said.
Davtyan说，“照我看来，他们曾努力想把这种药物做的就如同真的似的，从而把对妇女生活的影响降低到最低程度。”
But times have changed, and newer contraceptive products such as Seasonale -- a contraceptive pill that cuts the number of periods to just four a year -- have already been readily embraced by some American women over the past decade.
但是时过境迁，新型避孕药过去十年来已经赢得了不少美国女性的青睐。可将月经次数降低到每年才四次的避孕药物Seasonable就是其中之一。
Davtyan said she has recently noticed a big shift in her patients' attitudes toward their period.
Davtyan说她最近注意到她母亲那代人对于月经，态度有了很大转变
"They want convenience, and they tell me that they'd just rather not have the bleeding altogether so that they don't have any limitations with sports, with having to use pads, tampons," she said. "And the younger the woman, the more likely that she will want her periods stopped. It's very possible that this will be the wave of the future."
“方便快捷正是她们所期待的。她们告诉我与其不得不戴上卫生棉或卫生巾，还不如索性不要月经，这样她们运动时就可以毫无顾忌了。”她说道，“妇女年纪越轻，她们就越想同月经说再见。这在未来很可能成为一种流行趋势。”
But Petriella said many women still feel a strong psychological attachment to their period and do not want to give it up, however inconvenient it may be.
但Petriella同时也说虽然经期给妇女带来诸多不便，许多妇女心理上对月经还怀有依依不舍之感，并不愿意失去月经。
"Sometimes [ending periods] is just emotionally uncomfortable for women," he said. "They don't feel right about not having their period. For those women, obviously Lybrel and other such products are not good products for them."
“有时候（结束经期）对妇女而言，情感上难以接受，”他说，“没有月经，她们总觉得少了点什么似的。在这些女性眼里，Lybrel和其他此类药物显然没法打动她们。”
Petriella believes that, at least in the short-term, Lybrel will appeal to only a minority of women. They include those with menstruation-linked conditions such as endometriosis and menstrual migraine, or those who have already tried -- and liked -- period-limiting products such as Seasonale, he said.
Petriella相信，至少在短期内只有少数女性会对Lybre情有独钟，这些妇女或是患有月经相关疾病如子宫内膜异位和经痛，或是曾尝试并喜欢上限制经期的药物如Seasonable，他说到。
As with any pharmaceutical contraceptives, women who decide to go on Lybrel may experience random breakthrough bleeding, Davtyan said.
Davtyan说，正如与其他避孕药物一样，决定尝试Lybrel的妇女可能也会发生随机突破性出血。
So, for the 59 percent of women who have no bleeding or spotting after one year, "I think Lybrel is a great deal," Davtyan said. "For the remainder, if they have the patience to hang in there for a few months, the spotting might abate. There will be an occasional patient that will continue to spot, and then, clearly, it's a better deal to have a scheduled period than to start spotting at an unknown time and maybe in an uncomfortable circumstance."
因此，对于一年后没有发生出血的59%的妇女而言，“我认为Lybrel非常了不起。”Davtyan说。“至于其他人，要是她们有足够的耐心坚持上几个月，出血可能也会减弱。或许偶尔会有一两个病人还会继续出血。那么很显然，与其不知何时会在某个尴尬的场合下出血倒不如选择规律的经期。

Women who decide to resume their monthly cycle -- for example, those who wish to become pregnant -- can typically expect to resume their normal cycle within days of stopping Lybrel, Shames said. He said that short timespan to resumption of ovulation could leave women who skip or miss pills open to unplanned pregnancy, so the FDA is advising that women consider a second form of birth control while on Lybrel, as a safeguard.
Shames说，决定重新开始经期的妇女—比如说打算怀孕的女性---一般来说停用Lybrel数日内就有望恢复正常的月经周期。他同时还说短期内就恢复排卵可能使得偶尔忘记服药的妇女面临意外怀孕的风险。因此FDA建议妇女服用Lybrel时考虑辅助避孕措施，以防万一。
Both Davtyan and Petriella stressed that young women who are considering a pharmaceutical end to their period should not be concerned that doing so will harm their health.
Davtyan和Petriella都再三强调，考虑停止经期的年轻女性无需担心这样做会损害健康。
"Remember, there's no real physiological value to hold on to the period that a woman has while she is taking the Pill, unless it is a psychological value, which I respect," Davtyan said.
“记住：服用避孕药时，坚守经期对于妇女而言实际上没有什么生理上的意义。除非有生理意义我们才保住经期，真是这样的话，我还是很敬佩的。”Davtyan最后说道。

编译：1734字

“无月经期”的避孕药获得FDA批准

专家预测Lybrel将赢得年轻女性青睐

5月22日星期二，每日健康新闻报道—一种让妇女和月经说再见的避孕药丸Lybrel周二获得美国食品药品监督管理局批准。这种含有雌激素和孕酮的激素药丸与传统避孕药区别在于：它没有安慰药丸所具有的“烦心周”效应，并可停止月经出血和人工激素合成。
人们把Lybrel描绘成“不间断避孕药物”，“但它工作的方式仍与21天吃药，7天停药的药丸工作方式并无二异。Lybrel通过降低可引发妊娠激素的分泌从而停止人体每月一度为怀孕而作的准备工作。”药物评估和研究中心的FDA III 期药物评估所主任Daniel Shames博士在周二晚些时候举行的新闻发布会上如是解释说。
Shames说，打算服用Labrel的大多数妇女将面临不规律出血，但多数情况下它将在服药首年内逐步减弱。首次临床试验为Lybrel争取到了FDA的批准。这项试验中，服用Lybrel为期一年的妇女在试验的最后一个月内未见有出血事件报道。
Shames说道，从安全性的角度而言，为期一年涉及超过2400名，年龄介于18至49岁之间妇女的两项临床试验表明，服用Lybrel没有增加妇女罹患子宫内膜癌的风险。该避孕药带来的其他副作用风险与其他避孕药大体类似，主要为血凝块风险。
他补充道，“我们对长期使用该药物一点也不感到吃惊。”但他同时强调FDA已责成Lybrel生产产商惠氏制药公司开展营销后的研究，密切关注Lybrel长期服用的安全性问题。
尽管有些妇女对彻底告别经期的做法不愿表态，妇科专家还是认为没有月经的生活不见得会有生理上的负面效应。事实上，一名专家指出，过去数十年来许多美国妇女已经采用更为传统的避孕药物来终止其经期，并没有出现不良后果。
新泽西州汉肯萨克大学医疗中心妇产科副主任的Michael Petriella博士说，“市场上还有其他避孕药物可通过注射方式给药，比如含长效孕酮的Depo-Provera药物。使用该药物避孕的妇女经期会彻底消失。”
Petriella说，“多年以来，一些内科医生允许部分妇女不按药嘱服药。打个比方说，允许妇女连续服用两个包装的药物。”另外一名专家则指出，服用常规避孕药物妇女所得到的经期其实与卵细胞自然生成周期没有联系。
“这并不是自然的经期，而是她连续七天停止服用激素避孕药物人工诱导出来的。这样她的阴道还会流一些血，”洛杉矶加州分校医学副教授和妇产学家Camelia Davtyan解释说。
Davtyan说道，实际上从初潮开始，诸如Lybrel等无经期的药物就理应成为妇女避孕首选。但是早在1960年代就开发出这种避孕药的制药公司和医生却以为妇女们想要的就是能模拟其经期的避孕药物。Davtyan还说，“照我看来，他们曾努力想把这种药物做的就如同真的似的，从而把对妇女生活的影响降低到最低程度。”
但是时过境迁，新型避孕药过去十年来已经赢得了不少美国女性的青睐。可将月经次数降低到每年才四次的避孕药物Seasonable就是其中之一。
Davtyan说她最近注意到她母亲那代人对于月经，态度有了很大转变。
“方便快捷正是她们所期待的。她们告诉我与其不得不戴上卫生棉或卫生巾，还不如索性不要月经，这样她们运动时就可以毫无顾忌了。”她说道，“妇女年纪越轻，她们就越想同月经说再见。这在未来很可能成为一种流行趋势。”但Petriella同时也说虽然经期给妇女带来诸多不便，许多妇女心理上对月经还怀有依依不舍之感，并不愿意失去月经。
“有时候（结束经期）对妇女而言，情感上难以接受，”他说，“没有月经，她们总觉得少了点什么似的。在这些女性眼里，Lybrel和其他此类药物显然没法打动她们。”
Petriella相信，至少在短期内只有少数女性会对Lybre情有独钟，这些妇女或是患有月经相关疾病如子宫内膜异位和经痛，或是曾尝试并喜欢上限制经期的药物如Seasonable，他说到。
Davtyan说，正如与其他避孕药物一样，决定尝试Lybrel的妇女可能也会发生随机突破性出血。
因此，对于一年后没有发生出血的59%的妇女而言，“我认为Lybrel非常了不起。”Davtyan说。“至于其他人，要是她们有足够的耐心坚持上几个月，出血可能也会减弱。或许偶尔会有一两个病人还会继续出血。那么很显然，与其不知何时会在某个尴尬的场合下出血倒不如选择规律的经期。
Shames说，决定重新开始经期的妇女—比如说打算怀孕的女性---一般来说停用Lybrel数日内就有望恢复正常的月经周期。他同时还说短期内就恢复排卵可能使得偶尔忘记服药的妇女面临意外怀孕的风险。因此FDA建议妇女服用Lybrel时考虑辅助避孕措施，以防万一。
Davtyan和Petriella都再三强调，考虑停止经期的年轻女性无需担心这样做会损害健康。
“记住：服用避孕药时，坚守经期对于妇女而言实际上没有什么生理上的意义。除非有生理意义我们才保住经期，真是这样的话，我还是很敬佩的。”Davtyan最后说道。

请教几个翻译
1The estrogen-progestin hormonal pill differs from traditional birth-control pills in that it does not include the "week off" of placebo pills that leads to a cessation of artificial hormones and bleeding.
这句中的week off如何翻译比较好
2."Remember, there's no real physiological value to hold on to the period that a woman has while she is taking the Pill, unless it is a psychological value, which I respect," Davtyan said.
which i respect如何翻译比较好？
谢谢

vaios

违背自然规律的东西一般都有副作用的

飞扬的火

小雨衣是无敌的！

S-momo

能不吃还是不吃.

竹寒寒

那样不就相当于绝经了?!

ShiyuTang

违背生理规律的事，真的没有害么？

木木炎

逆天為之必將亡矣

Beauty@love

这种东西还是不太放心啊
毕竟总会有副作用的

双一姐姐

可以美肌么?一般BY药都会有点这个效果的说!!