近日，美国FDA批准了紧急避孕药Ella（黄体酮受体阻断剂/拮抗剂，其主要作用是抑制或延迟女性排卵，2009年已在欧洲上市，商品名为EllaONe）。

向FDA提交的临床试验数据来自于以下两项试验：
一项在美国40个计划生育诊所中实施的前瞻性、多中心、开放、单臂临床试验，共纳入18-35岁的妇女1242名，这些受试者均在无防护房事或避孕失败后48-120小时内服用Ella，整个试验中共有27人怀孕，占总人数的2.2%。

另一项在美国、英国和爱尔兰进行的随机、多中心、单盲、阳性对照临床试验，844名妇女0-120小时内服用Ella，其中1.9%的受试者怀孕。在本试验中有10%的受试者服用Ella的时间是房事后72小时，这些人中无一人怀孕。

临床试验中观察到Ella最常见的不良反应包括：头痛，恶心，腹痛，疼痛/不适、月经期间痛经，疲劳，头晕，不良反应类似美国FDA已批准的左炔诺孕酮紧急避孕药（Plan B）。
FDA称，作为紧急避孕药，Ella的上市申请提供了令人信服的有效性证据和充分的安全性信息。

根据在欧洲上市的EllaOne的临床研究资料，以无防护房事或避孕失败0-72小时的妇女为研究对象的临床试验，观察到的怀孕率为1.5%，非劣于左炔诺孕酮；另一项事后48-120小时的临床试验，观察到的怀孕率为2.1%，有61%的预期怀孕被阻止。临床研究中观察到的不良反应与上述试验数据一致。

Information on Ellaone
Ellaone is a medicine that contains the active substance ulipristal acetate. It is available as whitetablets (30 mg).
What is Ellaone used for?
Ellaone is a female emergency contraceptive to be taken within five days of unprotected sex orcontraceptive failure (such as a tear in a condom during sex).
The medicine can only be obtained with a prescription.
How is Ellaone used?
Ellaone is taken as one tablet as soon as possible but no later than five days after unprotected sex orcontraceptive failure.
The tablet can be taken with or without food. If the woman vomits within threehours of taking the medicine she should take another tablet. Ellaone can be taken at anytime during themenstrual cycle.
How does Ellaone work?
For pregnancy to occur there has to be ovulation (release of eggs) followed by the fertilisation of theegg (fusion with a sperm) and implantation in the womb.
The sex hormone progesterone stimulates theproduction of the proteins that play a role in the timing of ovulation and in preparing the lining ofwomb to receive the fertilised egg.
The active substance in Ellaone, ulipristal acetate, acts as a progesterone receptor modulator.
Thismeans that it attaches to the receptors that progesterone normally attaches to, preventing the hormonefrom having its effect.
Through its actions on the progesterone receptors, Ellaone prevents pregnanciesby interfering with ovulation and it may also lead to changes in the lining of the womb.

How has Ellaone been studied?
The effects of Ellaone were first tested in experimental models before being studied in humans.
In one main study, Ellaone was given to 1,533 women (aged on average 24 years) who had requestedemergency contraception between two and five days after unprotected sex or contraceptive failure.
The main measure of effectiveness was the number of women who did not become pregnant.
This wasthen compared with the number of women who would have been expected to become pregnant if theyhad not taken any contraceptive, calculated from published rates.

新型5天内有效避孕药“事后丸”EllaOne本周起法国上市

【欧洲时报网】新一代取名为EllaOne“事后丸”，号称在无避孕性交5天之内仍然有效而引起关注。这种紧急避孕药即将在欧洲行销。

这种事后丸的生产厂家HRAPharma制药厂将于本周末在罗马欧洲妇科协会代表大会上介绍这种紧急避孕药。事后丸Norlevo也是这家药厂销售的。此药1999年以来投放市场，在法国自由销售。总部设在法国的HRAPharma总裁盖纳医生说：“EllaOne是用新分子ulipristal制作的，此前从未销售过，必须凭医生处方才能购买。”由于EllaOne是新药，它的售后监督计划还必须获得欧洲药品管理局（EMEA）的同意。欧洲药品管理局应于9月24日对这个问题表态。盖纳医生进而指明：如果到这个日期，药品管理局开绿灯，“我们9月就可以销售EllaOne，而无需等待社会保险局是否同意报销。”药厂“希望2009年底或2010年初能够销售可在法国报销的事后丸EllaOne”，药厂已经在法国和欧洲大多数国家递交了报销申请材料。
EllaOne的价格将比Norlevo高（依国家不同，价格低则为7.5欧元，高则达30欧元），但“低于50欧元”。药厂总裁声称“将在国际范围内寻求统一价”。依据对4000名妇女做的临床研究资料看，EllaOne耐受性好，药效看来高于Norlevo的成分左炔诺孕酮(levonorgestrel)。

【原产地英文商品名】:EllaOne (30mg,1Tablet)
【原产地英文药品名】:Ulipristal acetate
【原产地英文化合物名称】:Ulipristal acetate
【中文参考商品译名】:EllaOne (30毫克,1片)
【中文参考药品译名】:Ulipristal 醋酸
【中文参考化合物名称】:Ulipristal 醋酸
【生产厂家中文参考译名】:HRAPharma
【生产厂家英文名】:HRAPharma