美国FDA已经批准Trelstar 22.5mg（供注射用混悬液羟萘酸曲普瑞林，从沃森对晚期前列腺癌的姑息性治疗）。Trelstar
22.5mg是GnRH类似物的半年一度的政府当局打算。这个批准是基于数据从第三阶段，12个月的研究表明Trelstar 22.5mg产生了平均12.8ng/dL血清睾酮水平2-12个月。白天29，达到97.5％的患者阉割的水平，和“> 98％的病人均低于阉割在6月份和12月份的水平。中位数前列腺特异性抗原（PSA）也减少了96.4％，在研究结束。
【关键词】Watson 缓释 Debiopharm公司 促黄体素释放激素 前列腺癌患者 注射混悬剂 睾丸切除术 Ipsen 医药公司 曲普瑞林
姑息治疗 肌肉注射 激动剂 雌激素 产品 泌尿学 商品名 美国
【文　摘】Watson医药公司已在美国推出其缓释促黄体素释放激素(LHRH)激动剂Trelstar Depot和Trelstar L(triptorelin
pamoate，曲普瑞林双羟萘酸盐注射混悬剂)，用于对睾丸切除术或雌激素给药不适合或不能接受的晚期前列腺癌患者的姑息治疗。1个月(3．75mg)和3个月(11．25mg)的缓释肌肉注射产品已在美国获批准几年了，但未积极促销。Watson公司是依据一项帮助其扩展泌尿学市场的协议于去年9月从Debiopharm公司转让上述产品的。在欧洲，这两种产品由BeaufourIpsen公司销售，商品名为Decapeptyl。

The FDA has approved Trelstar 22.5mg(triptorelinpamoateforinjectablesuspension, from Watson) for the palliative treatment of advanced prostate cancer. Trelstar 22.5mg is a GnRH analogue intended for twice-yearly administration. This approval was based on data from a Phase 3, 12-month study demonstrating that Trelstar 22.5mg produced a mean testosterone serum level of 12.8ng/dL from month 2–12. By day 29, 97.5% of patients achieved castrate level, and >98% of all patients were below castrate level at month six and month 12. Median prostate specific antigen (PSA) was also reduced by 96.4% at the end of the study.

About TRELSTAR® 
       
What is TRELSTAR?
TRELSTAR is a luteinizing hormone releasing hormone (LHRH) agonist and is indicated in the palliative treatment of advanced prostate cancer. It offers an alternative treatment forprostatecancerwhenorchiectomyorestrogenadministration are either not indicated or unacceptable to the patient.
TRELSTAR reduces serum testosterone concentrations to below castrate levels within 1 month of therapy and maintains serum testosterone concentrations below castrate levels during continued therapy.
TRELSTAR is available in a 4 week depot formulation, TRELSTAR Depot, and a 12 week long acting formulation, TRELSTAR LA.
      
TRELSTAR DEPOT is a sterile, lyophilized biodegradable microgranule formulation supplied as a single-dose vial containing triptorelin pamoate (3.75 mg as the peptide base), 170 mg poly-d, l-lactide-co-glycolide, 85 mg mannitol, USP, 30 mg carboxymethylcellulose sodium, USP, 2 mg polysorbate 80, NF. When 2 mLsterile water for injection is added to the vial containing TRELSTAR DEPOT and mixed, a suspension is formed which is intended as a monthly intramuscular injection.
       
TRELSTAR LA is a sterile, lyophilized biodegradable microgranule formulation supplied as a single-dose vial containing triptorelin pamoate (11.25 mg as the peptide base), 145 mg poly-d, l-lactide-coglycolide, 85 mg mannitol, USP, 30 mg carboxymethylcellulose sodium, USP, 2 mg polysorbate 80, NF. When 2 mLsterile water for injection is added to the vial containing TRELSTAR LA and mixed, a suspension is formed which isintendedasanintramuscularinjectiontobeadministered every 84 days (ie, every 12 weeks).
       
TRELSTAR Highlights  
      
Indications andUsageTRELSTAR®DepotandTRELSTAR® LA are indicated in the palliative treatmentofadvanced prostate cancer. TRELSTAR Depot and TRELSTAR LA offer an alternative treatment for prostate cancer when orchiectomy or estrogen administration are either not indicated or unacceptable to the patient.
        
Safety Information 
The most commonly reported adverse events associated with the use of TRELSTAR Depot/TRELSTAR LA included hot flushes (58.6%/73.0%), skeletal pain(12.1%/13.2%), impotence (7.1%/2.3%), headache (5.0%/6.9%), leg pain
(2.1%/5.2%), and edema in legs (0.0%/6.3%) . TRELSTAR is contraindicated in women who areormaybecomepregnant as well as patients whoarehypersensitivetotriptorelin, other LHRH agonists, or LHRH . Infrequentpostmarketing reports of anaphylactic shock and angioedema have been
received since 1986 (global experience) . As with all LHRH agonists, triptorelin causes an initial transient increase in testosterone levels.
Patients may experience the onset or exacerbation of symptoms during this period, including bone pain, neuropathy, hematuria, spinal cord compression, or urethral or bladder outlet obstruction. Patients with
metastatic 
      
关于TRELSTAR ®
        

什么是TRELSTAR？
TRELSTAR是一个促黄体激素释放激素（LHRH）激动剂，是晚期前列腺癌的姑息性治疗说明。它提供了一个替代性治疗前列腺癌根治切除术或雌激素时，政府不是没有说明或者不能接受的病人。

TRELSTAR降低血清睾酮浓度低于阉割内一个月的治疗水平和维护血清睾酮浓度低于阉割水平在继续治疗。

TRELSTAR可在4周仓库制定，TRELSTAR厂及12周长效配方，TRELSTAR洛杉矶。
       
TRELSTAR
Depot是无菌，冻干生物降解microgranule制定作为单剂量的含有肽基羟萘酸曲普瑞林（3.75毫克小瓶提供），170毫克聚D，L -乳酸，羟基乙酸，85毫克甘露醇，美国药典，30毫克羧甲基纤维素钠，美国药典，2毫克吐温80，核因子。当2毫升注射用无菌水将被添加到小瓶含TRELSTAR工场和混合，形成暂停这是作为每月肌肉注射打算。

TRELSTAR
      LA是一个无菌，冻干生物降解microgranule制定作为单剂量的含有肽基羟萘酸曲普瑞林（11.25毫克小瓶提供），145毫克聚D，L -乳酸- coglycolide，甘露醇85毫克，美国药典，30毫克羧甲基纤维素钠，美国药典，2毫克吐温80，核因子。当2毫升注射用无菌水将被添加到小瓶含TRELSTAR洛杉矶和混合，形成暂停这是作为肌肉注射拟管理的每84天（即每12周）。
TRELSTAR亮点
适应症和用法
TRELSTAR ®车厂及TRELSTAR ®洛杉矶是表示晚期前列腺癌的姑息治疗。
TRELSTAR车厂及TRELSTAR洛杉矶提供一个替代性治疗前列腺癌根治切除术或雌激素时，政府不是没有说明或者不能接受的病人。
         
安全信息
最常见的副作用同TRELSTAR车厂使用相关/ TRELSTAR洛杉矶包括潮热（58.6％/ 73.0％），骨骼疼痛（12.1％/ 13.2％），阳萎（7.1％/ 2.3％），头痛（5.0％ / 6.9％），腿部疼痛（2.1％/ 5.2％）和下肢水肿（0.0％/ 6.3％）。
TRELSTAR是禁忌的妇女谁是或可能怀孕的病人，以及谁是敏感，曲普瑞林，其他释放激素激动剂，或释放激素。过敏性休克和血管性水肿的疏落，上市后收到的报告自1986年（国际经验）。正如所有释放激素激动剂，曲普瑞林导致睾酮水平在最初的短暂上升。患者可能会在这一期间发生或症状加重，包括骨骼疼痛，神经病变，血尿，脊髓压迫，或尿道或膀胱出口梗阻与病人转移.