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当前位置:药品说明书与价格首页 >> 综合药讯 >> 睾酮贴片Intrinsa(英特丽莎)-治疗女性性功能障碍新药

睾酮贴片Intrinsa(英特丽莎)-治疗女性性功能障碍新药

2010-03-16 16:23:36  作者:新特药房  来源:互联网  浏览次数:390  文字大小:【】【】【
简介: 使用睾酮贴片的女性性满意度上升辛辛那提的制造商称这种睾酮贴片为“Intrinsa(英特丽莎)”,被允许在欧洲发售但暂不允许在美国发售。超过800名在报告中称自己有性冷淡方面的私人困扰的女性参加了这次研 ...

使用睾酮贴片的女性性满意度上升
辛辛那提的制造商称这种睾酮贴片为“Intrinsa(英特丽莎)”,被允许在欧洲发售但暂不允许在美国发售。超过800名在报告中称自己有性冷淡方面的私人困扰的女性参加了这次研究。
根据更早先的研究显示,更多的服用睾酮与雌激素结合疗法的性冷谈女性,报告说性满意程度增加。但是由于研究显示,这种疗法更易导致癌症,心血管疾病等的发生,不少女性不得不停止治疗,所以新的研究目标在于单独使用睾酮,而不再结合雌性激素的疗法。
“问题在于,睾酮治疗法如果要达到同样的效果,是否必须使用雌性激素”罗宾·克罗尔,美国西雅图女性临床研究中心以及女性更年期研究中心负责人,在今天的采访中如是说,“我们发现即便女生不使用雌性激素,而单独使用睾酮治疗的方法是可行的”
根据一篇将在明天发表在《新英格兰医学杂志》的新的调查研究报告,记录中显示,使用这种贴片的绝经期女性,在使用期间感受到了相较使用安慰剂类别而言的,“适度但是具有意义的”性满意度提升体验。参加这项调查中,有四位使用睾酮贴片的女性,被诊断出患有乳腺癌。与不服用此治疗贴片的女性所比较,另一位持不同意见的作者称“这也许是一个契机”的说法,仍待商榷。
满意度案例
调查员根据分为每天使用150微克或者300微克剂量的睾酮,或者使用同类型安慰剂,或者模拟治疗三个组的814位女性所提供的治疗数据进行分析。研究显示,使用贴片的两个小组均显示性欲提高的报告,而使用高剂量的小组,则统计显示有显著的性快感提高。
使用300微克的小组报告称,每个月增加2.1个性满意案例,比使用安慰剂的小组四星期平均增长少一个案例。研究发现,在300微克小组,其组员身体内游离睾酮含量水平与18-24岁女性通常含量非常接近。
参加这项研究的女性来自美国,加拿大,澳大利亚和英国,年龄从20-70岁之间,已经绝经至少一年以上。所有参加研究的女性包括自然绝经的女性以及卵巢切除后进入绝经期的女性。
关于癌症案例
在这四个使用睾酮贴片,而被确诊患有乳腺癌的女性中,有一位在使用贴片之前已经出现了癌症先兆。而第二个案例则在停止使用贴片后的三月被发现。
2004年12月, P&G(宝洁公司)向食品和药物管理局撤回了药品销售的申请,在FDA(食品和药物管理局)职员说,必须经过更多的研究,使贴片能够不会导致心血管和癌症的发生之后。
P&G(宝洁公司)发言人,汤姆·姆里奇在今天的电话采访中说道:“我们会继续与FDA商讨一种可行的这个产品的上市方式”一些医生已经开始对性欲低下的绝经期女性实施睾酮疗法了,性欲低下是大多数女性存在的性问题,克罗尔说。因为他们不是美国人—允许对女性使用睾酮疗法,一般医生比较代表性的方式是,给女性患者远远低于药品管理对于男性的水平的睾酮产品,比如说苏威制药公司的睾酮凝胶。一些医生建议病人去药房购买一些含有睾酮的凝胶或者涂剂。
新的研究创办人,洛杉矶西德斯西奈医学中心内分泌学家格列·布朗斯丁说,这种方式最大的缺点是,复合物会被不同的患者的身体所吸收,而睾酮的剂量的配比就变得非常的复杂。

 Intrinsa Testosterone Patches

Pack of 8 x 8.4mg Transdermal Testosterone Patches

What is Intrinsa used for?

Intrinsa is used in cases of low sex drive (hypoactive sexual desire disorder) in women who have had their womb and both ovaries surgically removed, resulting in a surgically-induced menopause. Women should also be taking oestrogen replacement therapy (HRT).

How does Intrinsa work?

Intrinsa patches contain the active ingredient testosterone, which is the same as the sex hormone that is produced naturally in both men and women.

Testosterone is known as an androgen. In women it is produced in small amounts by the ovaries. The ovaries also produce large amounts of the female sex hormone oestrogen.

Women who have had their ovaries removed produce less testosterone and oestrogen. This reduced level of testosterone in women can cause decreased sexual desire, and reduce sexual thoughts and arousal. This lack of libido can lead to personal distress and result in relationship difficulties. Medically, this condition can be known as hypoactive sexual desire disorder, referred to as HSDD.

Testosterone replacement therapy for women allows natural testosterone levels to return to normal, thus helping to restore libido.

Intrinsa patches are designed to be applied twice a week on a continuous basis. The testosterone is absorbed through the skin from the patch and into the bloodstream.

Who can use the Intrinsa patch?

Intrinsa patch has been developed for the treatment of low sexual desire in women up to the age of 60, who have had both their ovaries and their womb removed (surgically induced menopause) and who are taking oestrogen hormone replacement therapy (HRT).

How do I use the Intrinsa patches?

When using your patches follow the instructions in the leaflet provided with your patches carefully. Only one patch should be applied at a time. The patch should be applied to clean, dry, hairless, healthy skin on the lower abdomen below the waist. The patch must not be applied to the breasts or bottom. Don’t apply lotions, creams or powders to the skin before applying the patch, as they will prevent it sticking properly.

The patch must be changed every three to four days, which means you will use two patches a week. This means that one patch stays on the skin for three days and the other one stays on for four days. You need to decide which two days each week are going to be your patch change days. For example, if you start your treatment on Sunday, then you must change your patch on the following Wednesday. It may help if you write your patch change days on the medication box.

When changing the patch the old patch should be removed and disposed of safely; the new patch should be applied to a different area of the skin on the lower abdomen so as to avoid irritating the same area of the skin. If an oestrogen patch is being used at the same time as the Intrinsa patch, make sure that they do not overlap.

The Intrinsa patch has been designed to remain in place during showering, bathing and exercising, but it should be covered by clothing when sunbathing. If for any reason a patch does come off, re-apply by pressing it firmly or replace it with a new one. However, the regular patch day change routine should be continued as normal.

What do I do if I forget to change my patch?

If you forget to change your patch on the day it is due, then change it as soon as you remember and then continue with your regular routine of patch change days. This may mean you have to remove a patch after only having worn it for less than three or four days. By returning to your regular routine in this way it may help you remember your patch change day.

Special Warning about Intrinsa

Women using Intrinsa patches must see their doctor regularly. It is recommended that women see their doctor within three to six months of starting the treatment and every six months thereafter. It may take over a month to notice any changes in libido.

It is important for women to be aware of possible side effects of this treatment, such as increased facial hair growth, acne, increase in the size of the clitoris, hair loss and changes in their voice. Tell your doctor if you experience any of these or have severe skin irritation due to the patches.

Women with heart disease or high blood pressure should have their weight and blood pressure checked regularly by the doctor while using the patches.

Use Intrinsa with caution in

  • Heart disease.
  • High blood pressure (hypertension).
  • Diabetes.
  • Liver disease.
  • Kidney disease.
  • History of adult acne .
  • History of excessive body or facial hair growth.
  • History of hair loss, enlargement of the clitoris, voice deepening or hoarseness.

Do not use Intrinsa in

  • Women with known, suspected or past history of breast cancer.
  • Women with any form of cancer that is caused or stimulated by the female hormone oestrogen.
  • Pregnancy.
  • Breastfeeding.
  • Naturally menopausal women (women who still have their ovaries and uterus intact).
  • Women taking conjugated equine oestrogens, eg Premarin.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Intrinsa in Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine must not be used during pregnancy or breastfeeding. Seek medical advice from your doctor.

Intrinsa Side effects

Medicines and their possible side effects can affect individual people in different ways. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect. The following are some of the side effects that are known to be associated with this medicine:

  • irritation of skin at patch application site
  • acne
  • excessive facial hair growth
  • migraine
  • voice deepening
  • breast pain
  • weight gain
  • hair loss
  • difficulty sleeping (insomnia)
  • increased sweating
  • anxiety
  • nasal congestion
  • dry mouth
  • increased appetite
  • double vision
  • vaginal burning or itching
  • enlargement of the clitoris
  • palpitations.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can Intrinsa affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before starting treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while on this treatment, to ensure that the combination is safe.

Testosterone may increase the anti-blood-clotting effects of anticoagulants such as warfarin, nicoumalone and phenindione. If you are taking any of these your blood clotting time (INR) may need to be monitored more frequently; in particular it should be measured after you start or stop testosterone treatment.

If you have diabetes, your dose of insulin or antidiabetic tablets may need to be reduced after you start treatment with this medicine.

责任编辑:admin


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