英文药名: Androcur(Cyproterone Acetate Tablets)

中文药名: 醋酸环丙孕酮片

品牌药生产厂家: Schering

药品名称和成分

商品名：色普龙

通用名：醋酸环丙孕酮片

成分: 醋酸环丙孕酮 　　
　　
药理毒理

本药为一抗雄激素抑制剂，能抑制男性性激素（雄激素）的作用，雄激素也可由女性器官少量产生，并且也起一定的孕激素及抗促性腺激素作用。对于男性，用本药治疗可降低性欲及性功能，并抑制性腺功能，这些变化在停止治疗后是可逆的。本药可保护雄激素依赖性靶器官，如前列腺，使之不受来源于性腺及/或肾上腺皮质的雄激素的影响。对于妇女，本药可减轻多毛症，及雄激素依赖性脱发及增高的皮脂腺功能，治疗期间卵巢功能受到抑制。
适应症 　　

降低男性性欲倒错的性欲；不能手术的前列腺癌；女性重度雄性化体征：如非常严重的多毛症，雄激素依赖性严重脱发，最终导致秃顶（重度雄激素性脱发），常伴有重度痤疮及/或皮脂溢。
用法用量

一般治疗从1片 bid开始，需要时可增加到2片 bid，或甚至短期内 2片 tid。药物应在饭后用少量液体吞服。当达到满意效果时，应试用最低可能剂量维持疗效，常常每日2次，每次半片即已足够。建立维持量或停止用药时，不应突然而应逐渐减量，间隔数周将每日剂量减少1片或最好半片。为了稳定治疗作用，必须延长使用本药一段时间，如果可能，同时采用心理治疗方法。　　
不能手术的前列腺癌
睾丸切除术后为消除肾上腺皮质雄激素的作用：每次2片，每日1-2次（即100-200 mg）。
未行睾丸切除术：每次2片，每日2-3次（即200-300 mg）。症状改变或减轻后，不应改变或中断治疗剂量。
用促性腺激素释放激素激动剂（LH-Rha）治疗时，为减少男性性激素的初始增加：开始时单用本药，每次2片，每日2次（即200 mg）5-7天，继之用本药每次2片，每日2次（共200 mg），与一种LH-Rha同时使用，共3-4周。
为消除在LH-Rha治疗时肾上腺皮质雄激素的作用：连续抗雄激素治疗，服用本药每次2片，每日1-2次（即100-200 mg）。　　
女性重度雄性化体征： 如非常严重的多毛症，雄激素依赖性严重脱发，最终导致秃顶（重度雄激素性脱发），常伴有重度痤疮及/或皮脂溢。育龄妇女治疗宜在月经周期第1天开始（即出血的第1天），只有闭经妇女可以立即开始药物治疗。这种情况下治疗的第1天被视作周期的第1天，按下列推荐用法常规观察。在周期的第1-10天，每天餐后用水吞服2片本药，此外，这些妇女还服用含有雌、孕激素的制剂，如从月经周期的第1-21天，每天服用1片口服避孕药，以提供必要的避孕保护作用并稳定月经周期。接受周期性联合治疗的妇女，应于每天的固定时间服药。若超过固定服药时间12小时，则本周期的避孕效果可能降低，但是本药与口服避孕药仍应按说明继续服完，以避免本周期提早出血。遗漏的药片可忽略，但在周期的余下时间内应加用非激素的避孕方法（安全期法及测量体温法除外）。服药21天后有停药7天的观察期，在此期间会发生撤退性出血，在第一疗程开始的整4个星期后，亦即同一个星期几，开始下一周期的联合治疗而不论出血是否停止。如果在停药期间未发生出血，应进行必要的诊断检查。临床症状改善以后，可以在联合治疗的头10天内将本药的每天剂量减少至1片或半片，可能单独使用口服避孕药已足够。绝经后或行子宫切除术的患者可以单独使用本药。根据症状的严重程度，该药的平均用量应为每日1次，每次1至半片，共21天，继之停药7天。
任何疑问，请遵医嘱！
不良反应 　　

用药几周后，该药逐渐限制了男性的生育能力。停止治疗后数月，这种能力可以恢复。对于男性，偶可引起乳房肿大（有时伴有乳头触痛），停药后通常可以消退。对于女性，联合治疗可抑制排卵，因此可能发生不孕、乳房胀感。个别病例，用高剂量本药治疗时，有发生肝功能受损，某些为严重受损的报告。可以发生疲乏，精力减退，偶有暂时性的烦躁或情绪抑郁，也可能发生体重改变。可偶尔引起气短的感觉。在极罕见情况下，有报告发生血栓栓塞与使用本药有关。然而，因果关系似乎不能肯定。
相互作用 　　

本药的降低性欲作用可在酒精的抗抑制作用影响下减弱。口服抗糖尿病药物或胰岛素的需要量可发生变化。
注意事项 　　

1、妊娠，哺乳，肝脏疾病，曾有妊娠期黄疸或持续瘙痒史，妊娠期疱疹史，Dubin-Johnson综合征，Rotor综合征，曾有或现有肝脏肿瘤（并非由于转移的前列腺癌），消耗性疾病（不能手术的前列腺癌除外），重度慢性抑郁症，曾有或现有血栓栓塞性情况，伴有血管变化的严重糖尿病，镰状细胞性贫血禁用。
2、前列腺癌患者有血栓栓塞史、镰状细胞性贫血或伴有血管变化的重度糖尿病，在应用本药前，必须对每一病例认真权衡利弊。 　　
3、对于职业要求注意力高度集中的患者（如驾驶员，机器操作者）应慎用，本药可引起疲乏，精力减退，也可能影响注意力集中的能力。　
4、本药的降低性欲作用，可在酒精的抗抑制作用影响下减弱。　　
5、在青春期结束前不应给予该药，因为不能排除它对体格生长，以及尚不稳定的内分泌功能轴的不利影响。　　
6、治疗期间，应定期检查肝功、肾上腺皮质功能与红细胞计数。　　
7、糖尿病患者慎用，口服抗糖尿病药物或胰岛素的需要量可发生变化。　　
8、与其他性甾体激素一样，个别病例报告有良性与恶性肝脏变化。在极罕见情况下，肝脏肿瘤可能导致危及生命的腹腔内出血。因此，当发生异常的上腹不适而短期内不能自行消失时，应进行适当的诊治。　　
9、治疗开始前，应进行彻底的全身与妇科检查（包括乳房与宫颈细胞学涂片）。　　
10、育龄妇女必须除外妊娠。如果在联合治疗期间，在服药的3周内发生少量不规则出血，不应停止服药。然而如出血过多时，应进行必要的检查。

Product Information
ANDROCUR 50 mg*50TABLET

ALLEMAGNE
Androcur is an antiandrogenic hormone preparation. It inhibits the influence of androgens which are also produced - to a slight extent- in the female organism, and also exerts a progestational and antigonadotrophic effect.
Cyproterone acetate inhibits competitively the effect of androgens at androgen-dependent target organs, e.g. it shields the prostate from the effect of androgens originating from the gonads and/or the adrenal cortex.
Cyproterone acetate is a drug which is used in the treatment of prostate cancer. It is a type of hormonal therapy. Hormonal therapies interfere with the production or action of particular hormones in the body. Hormones are substances produced naturally in the body, where they act as chemical messengers and help control the activity of cells and organs.
How it works
In order to grow, most prostate cancers rely on supplies of the male hormone testosterone, which is produced by the testes and adrenal glands. On the surface of the prostate cancer cells are proteins called receptors. Cyproterone acetate has a structure similar to testosterone. It works by attaching itself to the receptors on the surface of the prostate cancer cells to block and prevent the attachment of testosterone.
The easiest way to understand the way cyproterone acetate works is to liken the process to that of a lock and key. The receptors are the lock and testosterone is the key. When testosterone comes into contact with the receptors it fits into the lock, activates the cancer cells to divide and the tumour grows. Cyproterone acetate imitates the action of testosterone and fits into the lock but the key does not turn and the cells do not divide. The cyproterone acetate remains in place and prevents the testosterone from reaching the cancer cells so they either grow more slowly or stop growing altogether.
Cyproterone acetate may be given together with injections of another type of hormonal therapy drug (goserelin, buserelin, triptorelin or leuprorelin). These drugs block the production of a hormone produced by the pituitary gland (luteinising hormone) which stimulates the production of testosterone.
Possible Side Effects
Each person's reaction to any medication is unique. Many people have very few side effects with cyproterone acetate, while others may experience more. The side effects described here will not affect everyone and may be different if you are having more than one drug.
We have outlined the most common side effects, so that you can be aware of them if they occur. However, we have not included those that are very rare and therefore extremely unlikely to affect you. If you do notice any effects which you think may be due to the drug, but which are not listed , please discuss these with your doctor or nurse.
You will see your doctor regularly while you have this treatment so that they can monitor the effects. This information should help you to discuss any queries about your treatment and its side effects with your doctor or nurse, as they are in the best position to help and advise you.
Some people may have some of the following side effects:
Breast tenderness or fullness
Some men may notice slight breast swelling and tenderness. Your doctor can prescribe medication to reduce any discomfort
Tiredness and low mood
This is common during the first few weeks of treatment, but reduces with time
Breathlessness
You may have a feeling of mild breathlessness while having cyproterone acetate treatment. This will disappear if the treatment is stopped
Nausea (feelings of sickness)
Vomiting and Diarrhoea
These are uncommon and if they occur they are usually mild and easily controlled. Nausea can sometimes be relieved by taking the tablet with food.
Let your doctor know if you have any of these side effects as medication can be prescribed to help.
Lowering of libido (sex drive), and impotence (a loss of ability to have an erection). This is uncommon. If it occurs sexual function will return to normal after stopping the drug. Your doctor or nurse can discuss this with you. More information is available in the section on Sexuality and cancer.
Effect on liver function
Your doctor will take blood samples to measure how your liver is working, as cyproterone acetate can sometimes cause chemicals produced by the liver to become abnormal. If this happens the drug will be stopped and the liver function will return to normal.
Length of treatment
Your doctor will discuss the length of treatment that they feel is appropriate for your situation. It is often given for several months or years.
WARNING
Androcur is the most powerful of anti-androgen drugs and must not be taken by any patient with a medical condition, or one who is taking / has recently taken other drugs that are contra-indicated.
During treatment, liver function, adrenocortical function and the red blood-cell count should be checked regularly.
Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure, which has been fatal in some cases, has been reported in patients treated with 200 - 300mg cyproterone acetate. Most reported cases are in men with prostatic cancer. Toxicity is dose-related and develops, usually, several months after treatment has begun. Liver function tests should be performed pre-treatment and whenever any symptoms or signs suggestive of hepatotoxicity occur. If hepatotoxicity is confirmed, cyproterone acetate should normally be withdrawn, unless the hepatotoxicity can be explained by another cause, e.g. metastatic disease, in which case cyproterone acetate should be continued only if the perceived benefit outweighs the risk.