2003年3月13日在西班牙的马德里- GlaxoSmithKline (GSK) 今天庆祝 Avodart (dutaster ide)的国际上市, 一种新的并且有效的减缓严重的良性前列腺症状的配方, 并且减低严重尿路避锁的风险及手术的风险.  对于此药的发行上市, 英国Stevenage的Lister 医院的泌尿外科医师Tom McNicholas说 " 上市对于前列腺肿大的患者是一个好消息,因为此药提供患者一种有效的治疗选择, 它列出除了症状的控制更多的东西. 在超过两年的临床试验以经证明 Avodart不仅是安全的,并且能减低严重尿路避锁达57%,及前列腺手术达48%."  Avodart 是一种新奇的5-alpha 还原酶阻档剂 (5-ARI), 它阻挡了type 1及 type 2 两种5-alpha 还原酶的异酵素（isoenzymes,这种酵素是负责将前列腺中的睪丸激素转化成dihydrotest osterone (DHT), DHT 是一种主要的造成前列腺增长及肥大的荷尔蒙原因. Avodart 显示了它在两周内对DHT压制的能力达90%并且最快在1个月就能缩小前列腺,在此研究持续使用两年以上的实验中还一直持续缩小前列腺的肥大情形.1  欧洲泌尿科协会在马德里的年度会议新发表的资料更加强化了 5-ARIs做为前列腺肥大的一种治疗选择的地位.一个有4,500 病患参与的实验显示有使用 alpha-阻档剂者比起使用5ARI组挡剂者者有约两倍者还是有严重尿路避锁/导尿的经验 2   从此会议新发表的其它的资料显示用alpha-阻挡剂来治疗前列腺肥大并不能改变前列腺持续肥大化等复杂的相关症状的风险 3  前列腺肥大是一种上了年纪的男人最常见的建康问题 .它是一种非应癌症性的前列腺体增大它通常会造成尿道缩小的症状. 前列腺肥大是一种累进性的疾病如果长期放任着不去治疗可能会造成更严重的问题如尿道闭锁或必须动手术.   Avodart 是非常容易被人体所接受. 大体来说, 在临床试验中, 在被认证过的产品总结特征报告中最常见的负面结果是 阳萎 (6%), 性欲减退 (3.7%), 射精失调 (1.8%), 女乳化 (1.3%). 英文药名: Avodart(Dutasteride) 中文药名: 度他雄胺（胶囊） 适尿通 0.5毫克/软胶囊 生产品牌药厂家: Glaxo Smith Kline 药品名称 英文药名: Avodart (Dutasteride Tablets) 中文药名: 度他雄胺 药品说明 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。Dutasteride是2002年10月9日被美国食品药物管理局核准用于治疗前列腺肿大的新药，而针对脱发治疗的临床试验结果还处于等待FDA的核准中。5α-还原酶又分两种类型：第Ⅰ型和第Ⅱ型，5α-Ⅰ型还原酶主要是存在于毛囊基部的外鞘细胞以及基质细胞和毛囊旁边的皮脂腺内；5α-Ⅱ型还原酶主要存在于毛囊基部的内鞘细胞里面。如果只是抑制5α-Ⅱ型还原酶，只能挽救毛囊基部内鞘细胞免于死亡，而Dutasteride (药品名Avodart)则可以同时抑制伤害毛囊细胞组织的5α-Ⅰ型还原酶和5α-Ⅱ型还原酶，同时挽救外鞘细胞以及基质细胞，从而使毛囊得到更加周全的保护，脱发部位也可得到更高程度的恢复,根据国外初步的临床试验，用药六个月后，AVODART新生头发的效果比保法止多三分之一。 美国FDA批准度他雄胺与坦索罗辛联用治疗前列腺增生症:2008年6月19日，葛兰素史克公司宣布美国FDA批准其度他雄胺(dutasteride, Avodart)与坦索罗辛(tamsulosin， Harnal)联用治疗前列腺增生症。 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。 适应症 前列腺肿大、男性型脱发、脂溢性脱发、遗传性脱发 (女性及儿童切忌服用) 注意事项 服药期间及停药后6个月之内,请勿捐血,或让女性怀孕。 任何疑问，请遵医嘱！ 【原产地英文商品名】AVODART 0.5mg/softgel 100softgel/bottle 【原产地英文药品名】DUTASTERIDE 【中文参考商品译名】 注：以下产品不同规格和不规格，购买时请以电话为咨询为准 ·适尿通 0.5毫克/软胶囊 100软胶囊/瓶 ·适尿通 0.5毫克/软胶囊 30软胶囊/盒 【中文参考药品译名】度他雄胺 【生产厂家中文参考译名】葛兰素史克 【生产厂家英文名】GLAXOSMITHKLINE Dutasteride Dutasteride (brand name Avodart) is a 5-alpha-reductase inhibitor that inhibits the conversion of testosterone into dihydrotestosterone (DHT). It is approved for the treatment of benign prostatic hyperplasia (BPH) and is prescribed off-label for the treatment of male pattern baldness (MPB). Avodart is manufactured and marketed by GlaxoSmithKline. Classification and method of action Dutasteride belongs to a class of drugs called 5-alpha-reductase inhibitors, which block the action of the 5-alpha-reductase enzymes that convert testosterone into dihydrotestosterone (DHT). Finasteride, which is also approved for the treatment of benign prostatic hyperplasia (BPH), in addition to the treatment of male pattern baldness (MPB), belongs to this group of drugs. Dutasteride inhibits both isoforms of 5-alpha reductase, Type I and Type II, whereas finasteride only inhibits Type II. There are no long-term randomized trials comparing the effects of dutasteride and finasteride in patients with BPH. The EPICS trial, a 12-month clinical study done by GlaxoSmithKline, demonstrated treatment with dutasteride and finasteride resulted in similar decreases in prostate volume, with numerically but not statistically significantly greater improvements in symptom scores for the dutasteride group. Finasteride is marketed by Merck under the trademark names Proscar (5 mg/day finasteride) for BPH and Propecia (1 mg/day finasteride) for MPB. Published data from controlled clinical trials demonstrated that 5 mg finasteride did not have better results than 1 mg for the treatment of MPB. Uses While dutasteride is only officially approved to treat enlargement of the prostate gland (at a dose of 0.5 mg/day), phase I and II clinical trials for dutasteride as a hair loss drug were also undertaken, but called off in late 2002. The reason the trials were called off is not publicly known. Industry sources speculate that Avodart would have been seen as too similar to Propecia (1 mg/day finasteride) to have proven itself profitable on the market as a hair loss treatment. However, phase II results indicated that dutasteride at both 0.5 mg and 2.5 mg/day generated a superior hair count to finasteride 5 mg at 12 and 24 weeks. In a test area at 24 weeks, results showed: Placebo - Minus 32.3 hairs Finasteride 5 mg - 75.6 hairs Dutasteride 0.1 mg - 78.5 hairs Dutasteride 0.5 mg - 94.6 hairs Dutasteride 2.5 mg - 109.6 hairs In December 2006, GlaxoSmithKline started a new Phase III, six month study in Korea to test the safety, tolerability and effectiveness of a once-daily dose of dutasteride (0.5 mg) for the treatment of MPB in the vertex region of the scalp (types IIIv, IV and V on the Hamilton-Norwood scale). The study has been completed as of January 2009. The future impact that this study will have on the approval or disapproval by the U.S. Food and Drug Administration (FDA) of Avodart for the treatment of MPB in the United States is yet to be determined. The REDUCE trial, a randomized controlled trial of 6,729 men comparing dutasteride to placebo for prevention of prostate cancer, found an overall reduction of 22% in the incidence of prostate cancer over 4 years. However, the reduction was entirely in Gleason grades 5 and 6 cancers, which are less life-threatening and often not treated. In Gleason grade 7-10, which are life-threatening, there was no reduction in cancer. According to an editorial, "Dutasteride and finasteride do not prevent prostate cancer but merely temporarily shrink tumors that have a low potential for being lethal." They may also delay diagnosis until prostate cancer is difficult to cure. Side effects Avodart 500 micrograms soft capsules (AU)Adverse events Year 1 Placebo (n = 2158) Impotence 3% - Decreased libido 2% - Ejaculation disorders <1% - Breast Disorders <1% Avodart (n = 2167) Impotence 6% - Decreased libido 4% - Ejaculation disorders 2% - Breast Disorders 1% Year 2 Placebo (n = 1736 ) Impotence 1% - Decreased libido <1% - Ejaculation disorders <1% - Breast Disorders <1% Avodart (n = 1744) Impotence 2% - Decreased libido <1% - Ejaculation disorders <1% - Breast Disorders 1% Teratogenic effect The teratogenic effect from dutasteride is harmful to male children. Women who are pregnant should not handle the capsules, as inadvertent consumption could cause birth defects of the male fetus. The adverse effects would be similar to 5-alpha-reductase deficiency, where a developing male child is naturally deficient in 5-alpha reductase Type II, and thus unable to synthesize it. As dutasteride blocks the same process, developing males would have a DHT deficiency with its adverse effects as a result of the drug. Men should not donate blood while taking Avodart and for at least 6 months after treatment ends. Avodart can be carried in the blood and could cause birth defects if a pregnant women receives a transfusion with blood that contains dutasteride See also Finasteride Dihydrotestosterone Baldness treatments Male pattern baldness Benign prostatic hyperplasia