英文药名: Avodart(Dutasteride Tablets) 中文药名: 度他雄胺（胶囊） 生产厂家: Glaxo Smith Kline 药品介绍； AVODART 的成份为Dutasteride(度他雄胺)，是一种的双重5α-还原酶阻挡剂, 可阻断两种催化睾酮转化产生DHT的5α-还原酶。 度他雄胺是首个也是唯一用于治疗前列腺增生的双重5α还原酶抑制剂，能够改善泌尿系统症状、降低急性尿潴留发作与进行有关前列腺手术的风险。坦索罗辛为α受体阻断剂，能改善前列腺增生的症状。 美国FDA的此次批准基于1项为期2年的多中心随机双盲对照的临床研究――首个长期评价度他雄胺与α受体阻断剂联用的临床研究。纳入的患者为中度至重度前列腺增生男性患者(年龄大于或等于50岁，前列腺体积(PV)≥30cc，血清前列腺特异性抗原(PSA)水平为1.5～10ng/mL，5mL/秒＜最大尿流率(Qmax)≤15mL/秒，最小排尿量≥125mL，国际前列腺症状评分(IPSS)≥12)。患者先服用安慰剂4个星期，再随机服用度他雄胺0.5mg/天与坦索罗辛0.4mg/天，单用度他雄胺0.5mg/天或坦索罗辛0.4mg/天。   此项临床研究表明：12～24个月后，联用度他雄胺与坦索罗辛，其治疗效果优于单方治疗。本品最常见的不良反应有阳痿、性欲减退、乳腺疾病(包括乳房增大、肿胀)、射精障碍和眩晕。 药物作用 Dutasteride为一种「控制前列腺肿大」的药物。通常年龄超过50岁的男性，由於前列腺逐渐肿大会压迫到尿道，最後导致尿道内的小便不易流出，渐并产生尿意及频尿的感觉。前列腺的成长、主要受到血液中化学酵素Dihydrotestosterone二氢睾固酮(简称DHT) 所影响。此药主要的作用就是能抑制血液中(DHT)的含量，使位於尿道旁边的前列腺不致於过量增长，使尿道受到挤压，而达到帮助排尿的目的。此药对於尿道感染或其他尿道或膀恍病症所引起的小便困难，无治疗的效果。也有部分病患使用此药促进头发的增生。 用法 此药只用於男性病患、通常是一天服用一次、空腹或与食物一起服用均可。使用胶囊时应该整粒的吞服以免胶囊内药物导致口咽内黏膜的刺激。不论是早上成晚上，最好养成每天在固定时间服药的习惯，以减少忘记服药的可能。 注意事项 此药必须经过3至6个月以上的时间，才能完全达到药物的作用。临床报告显示、连续使用此药物两年以上、可以免除尿道完全阻塞及使用外科手术疏导的必要。病患应该持续使用此药物、不可一时觉得无效而放弃服用。另外，此药只能控制前列腺肿大，并不能根治，必须持续服用此药，甚至可能需要服用一辈子，才能适当控制前列腺肿大。经过一阵子服药後，也不可因为一时觉得症状已经改善而停止服用。 由於此药物可能会导致胎儿出生後畸形效应、怀孕妇女不应该用手触摸此一药物。以免微量药物通过皮肤吸收进入母体、导致胎儿的先天缺陷。男性在使用药物期间或在停药後的六个月内、不应该捐赠血液以免受血者为孕妇、导致胎儿的危险。 在服药期间，如果配偶怀孕的话，当从事性行为时，应该使用保险套，以免药物经精液传送到对方体内，造成肚内男性胎儿生殖器的成长及发展受到不良的影响。另外，也应该避免让妇女接触到药品，尤其是已经破碎或断裂的药片，以免药物粉末吸入母体内，而影响到胎儿的安全。 造成排尿困难的因素有很多，此药主要是治疗男性荷尔蒙引起前列腺肿大而造成的排尿困难，对於其他因素所造成的排尿困难，应该用其他的方法治疗。在用药之前，医师应该会彻底检查身体以排除尿道感染、前列腺癌、膀恍张力不足、尿道狭窄，以及神经系统疾病等所引起的排尿不足。在服用药物後的第一年，病患应该每半年依照医师指示、定期作超音波前列腺扫描或尿流速检查，通常药物需在前列腺有缩小或尿流速增加的情况下，方得继续使用。 许多治疗过敏、感冒、气喘，及咳嗽的成药中，通常含有使血管或尿道收缩的成分，可能会导致或者恶化尿道阻塞的情况，以及降低此药防止前列腺肿大的效力，因此在使用此类药物前，应该先徵求医师或药师的意见，并且尽可能避免服用。同时，也应该避免在晚上饮用咖啡成茶，以免造成夜间尿急必须起床的困扰。 副作用 Dutasteride常见的副作用为: 阳痿（1％至5％）、性欲降低（3.1％)、性欲降低（≤3％）、男性乳房增大胀痛（≤1％）、射精困难（0.1％至1.4％）、精液数量减少等。。如果这些副作用强到困扰你的程度，或者经过一段时间後，这些症状还不能完全消除，就应该通知医师。 此药较严重的副作用为: 困难呼吸; 喉头紧缩、嘴唇、舌头或者面孔的膨胀、皮肤起红疹等等。通常这些副作用发生的机率较低，但是如果发生时，此可能是药物造成的不良反应，或者是剂量需要调整，应该尽快通知医师。 怀孕及哺乳 美国药管局(FDA)将此药归类为X级：X级表示动物或人类实验已证实药物会导致胎儿先天性缺陷且用药的风险明显大於其益处、服用此类药物对孕妇是绝对禁忌。 此药为一种专治男性前列腺肿大的药物，妇女及小孩不能使用。孕妇接触到此药的话，可能会对男性胎儿的生殖器造成不良的影响。 忘记用药 如果忘记服药，应该在记得时，立即服用。但是，如果距离下次服药的时间太近，就应该舍弃此次药物，恢复到正常服药的时间，千万不可一次服用双倍的剂量。如果忘记服药超过两天以上，就应该通知医师。 Avodart Information: What is Avodart? Avodart prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. DHT is involved in the development of benign prostatic hyperplasia (BPH). Avodart is used to treat benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Avodart may also be used for purposes other than those listed in this medication guide What should I discuss with my healthcare provider before taking Avodart? Before taking Avodart, tell your doctor if you have liver disease. You may not be able to take Avodart, or you may need a dosage adjustment or special monitoring during therapy. Do not donate blood while taking Avodart and for at least 6 months after the last dose to prevent pregnant women from receiving Avodart through blood transfusion. Avodart is intended for use by men only. Avodart is not intended for use by women. Do not handle this medication if you are pregnant or could become pregnant. Avodart is in the FDA pregnancy category X. This means that it is known to cause birth defects in an unborn baby. Women who are or who may become pregnant must not take Avodart and must not handle Avodart capsules. The medication can be absorbed through the skin and may cause birth defects in the unborn baby. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water. Avodart is not intended for use by women. It is not known whether Avodart passes into breast milk. Do not take this medication if you are breast-feeding a baby.   Avodart Side Effects: What are the possible side effects of Avodart? Stop taking Avodart and seek emergency medical attention if you experience a rare allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives). Other, less serious side effects have been reported but may resolve with continued treatment. Continue to take Avodart and notify your doctor if you experience Decreased Libido (sex drive); Decreased amount of semen released during sex; Impotence (trouble getting or keeping an erection); Breast tenderness or enlargement Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. What other drugs will affect Avodart? Many drugs may affect the way that Avodart is metabolized ("broken down") in the body, leading to higher or lower than expected levels of the medication in the blood. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, during treatment with Avodart. Hair Loss Issues - It is believed that Phase III trials for hair loss are underway by GSK.- There Supplemental New Drug Application for Hair Loss is thought to have been submitted to FDA sometime in 2001. The excitement around Avodart stems from the fact that it has a much greater and longer inhibition of DHT than Propecia (Finasteride) in early testing. A larger question ultimately will be is it better than Propecia and whether side effects will be greater or more serious. It's currently approved a 0.5 mg softgel form. The drug is expected to be on the market for hair loss in 2006 if approved. Avodart, a second-generation 5 alpha-reductase inhibitor, is the first and only medicine to inhibit both the type 1 and type 2 enzymes responsible for the conversion of testosterone to DHT (dihydrotestosterone), the primary cause of prostate growth. Avodart's dual inhibition decreases levels of DHT by 90 percent at two weeks and 93 percent at two years. By reducing DHT levels, Avodart reduces the size of an enlarged prostate. This reduction in prostate volume was seen as early as one month with reductions continuing through treatment. Shrinking the enlarged prostate relieves urinary obstruction and improves urinary flow. Avodart also improves urinary symptoms and reduces the risk of AUR (the sudden complete inability to urinate) and BPH-related surgery, two potential long-term serious consequences of BPH. The pivotal phase III study data were published in this month's edition of the journal Urology.1 "With avodart, we now have a medicine that reduces the production of DHT by more than 90 percent, helping to shrink the prostate," said Claus Roehrborn, MD, a principal trial investigator and professor and chairman of the Department of Urology at the University of Texas Southwestern Medical Center in Dallas, Texas. "By taking Avodart, patients can improve urinary symptoms and reduce their risk of suffering from acute urinary retention - where you suddenly can't urinate at all - or needing BPH-related prostate surgery." Avodart Directions: How should I take Avodart? Take Avodart exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you. Avodart is intended for use by men only. Take each dose with a full glass of water. Swallow the capsules whole. Do not chew, crush or break the capsules. Avodart can be taken with or without food. It is important to take Avodart regularly to get the most benefit. Do not stop taking Avodart without first talking to your doctor. While some men have fewer problems and symptoms after 3 months of treatment with Avodart, a treatment period of at least 6 months is usually necessary to see if treatment with Avodart will be beneficial. Your doctor may perform blood tests or other forms of monitoring during treatment with Avodart. One of the tests that may be performed is called PSA (prostate-specific antigen). This test is used to help detect prostate cancer. Avodart will reduce the amount of PSA measured in the blood. Your doctor is aware of this effect and can still use PSA to help detect prostate cancer. Store Avodart at room temperature (77 degrees Fahrenheit/ 25 degrees Celsius) or lower, away from moisture and heat. Avodart is supplied in soft gelatin capsules that may become soft and leak or may stick to other capsules if kept at high temperatures. If the capsules are cracked or leaking, do not use them and contact your pharmacist. What happens if I miss a dose? Take the missed dose as soon as you remember during the same day. However, if you don't remember until the next day, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of the medication. What happens if I overdose? Seek emergency medical attention. Symptoms of a Avodart overdose are not known. What should I avoid while taking Avodart? Do not donate blood while taking Avodart and for at least 6 months after the last dose to prevent pregnant women from receiving Avodart through blood transfusion. The generic alternative is not manufactured by the company that makes the brand product.