英文药名: SecreFlo(secretin injection） 中文药名: 分泌活素注射液(胃泌素肿瘤) 生产厂家: Repligen制药 药品介绍： 近日，美国食品和药物管理局FDA批准了注射用药SecreFlo正式用于辅助性诊断胰腺功能紊乱和可能癌化的胰腺肿瘤。SecreFlo是与猪体内的天然激素类相似的人工合成物。到目前为止,它是第一个获得FDA上市许可的内分泌激素类药物。自1999年以来，不允许给病人使用内分泌激素类药，只允许临床实验时给病人使用。胰腺功能紊乱的病人不能完全消化食物，厚厚的黏液堵在胰腺内致使胰腺酶无法分解食物，如果长期不治疗，病人会严重营养不良甚至脱水。SecreFlo辅助诊断胰腺功能紊乱的原理是：刺激胰腺使其分泌出胰腺黏液，测量其中的重碳酸盐的含量。SecreFlo辅助诊断胰腺癌的原理是：刺激胃部分泌激素，测量胃泌激素的含量。 包装规格：16mcg Vial DS Company: Repligen Approval Status: Approved April 2002 Treatment for: Pancreatic dysfunction and gastrinoma General Information SecreFlo is a synthetic version of the intestinal hormone secretin. This product has been approved by the FDA for use in stimulating pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction. Additionally, SecreFlo is approved for use in stimulating gastrin secretion to aid in the diagnosis of gastrinoma, a tumor usually found in the pancreas. Clinical Results Intravenous administration of SecreFlo stimulates the pancreas to secrete pancreatic juice, which can aid in the diagnosis of exocrine pancreatic dysfunction. Three crossover studies eva luated 21 subjects with a history of chronic pancreatitis. In these trials, SecreFlo was compared to biologically derived porcine secretin (bPS). Results demonstrated that all subjects - treated with either drug - had peak bicarbonate concentrations of less than 80 mEq/L, which is consistent with impaired pancreatic function. Intravenously administered SecreFlo has been shown to stimulate gastrin secretion in patients with gastrinoma; in contrast, secretion is not considerably increased in healthy individuals or those with peptic ulcer disease. Two SecreFlo crossover studies included eight subjects with tissue-confirmed gastrinoma. Subjects received treatment with SecreFlo, and serum gastrin concentrations were compared to those obtained with bPS. Results showed that for both drugs, serum gastrin concentrations exceeded 100 pg/mL from basal levels. Side Effects<br> Adverse events noted in clinical trials of SecreFlo include (but are not limited to) the following: · Abdominal discomfort · Nausea · Mild bradycardia (reduced heart rate) · Decreased blood pressure · Diaphoresis (profuse perspiration) · Endoscopic perforation of pancreatic duct Mechanism of Action SecreFlo (secretin) is a pure sterile, non-pyrogenic, lypholized white cake powder acetate salt of secretin, a peptide hormone. The primary action of SecreFlo is to increase the volume and bicarbonate content of secreted pancreatic juices. -------------------------------------- New Drugs Online Report for secretin Information Generic Name: secretin   Trade Name: SecreFlo  Synonym: RG1068  Entry Type: New molecular entity   Development and Regulatory status UK: Filing withdrawn  EU: Filing withdrawn  US: Not recommended for approval (Negative opinion)  UK launch Plans: Available only to registered users Actual UK launch date:   Comments Sep 12: EU filing withdrawn. RepliGen decided to withdraw the application as major objections raised by the Committee cannot be answered in the available timeframe [8]. 17/09/2012 10:52:54  Jun 12: FDA has issued a Complete Response letter requesting additional efficacy and safety trial data [7]. 23/06/2012 22:15:31  Apr 12: The FDA Advisory Committee meeting scheduled for May 31 has been cancelled and the Company expects to receive a Complete Response letter requesting additional clinical trial data [6] 16/05/2012 15:38:54  May 12: Filed in the EU via the centralised procedure [5]. 15/05/2012 14:28:15  Feb 12: Plans to file in the EU Q1 2012 [4].  22/02/2012 09:45:17  Feb 12: Filed in the US for the improved detection of pancreatic duct abnormalities in patients with pancreatitis and granted priority review, with a decision date of 21 Jun. It had previously been granted fast-track and orphan status [4]. 22/02/2012 09:45:05  Trial or other data In a PIII multi-centre, baseline controlled, single dose study 258 patients were enrolled at 23 clinical sites in the US and Canada. Each patient received an MRI of the pancreas with and without SecreFlo and separately underwent endoscopy (ERCP) as a diagnostic reference. The MRI images were randomized and independently read and reviewed by three central radiologists. The study´s co-primary endpoints were achievement of a statistically significant improvement in sensitivity of detection of abnormalities of the pancreatic ducts with minimal loss in specificity by 2 of the 3 central radiologists reading the MRI images. The study met its primary endpoints; the addition of SecreFlo to MRI resulted in a significant improvement (p<0.0001) in sensitivity of detection of 10 prespecified abnormalities of the pancreatic ducts, with minimal loss in specificity (<7.5%). All 3 secondary endpoints were also met, with improvements (p<0.0001) in image quality, visualization of the main pancreatic duct and diagnostic confidence when compared to MRI alone [4].  22/02/2012 09:45:46 RG 1068, a synthetic human form of secretin, is in development as a diagnostic agent in functional magnetic resonance imaging (MRI) for the detection of pancreatic disorders. Clinical trials are in progress in North America. The agent also has potential in the treatment of obsessive-compulsive disorders. The development of RG 1068 for the treatment of autism and schizophrenia appears to have been discontinued.(3) 22/07/2008 14:11:47 References   Available only to registered users  Category BNF Category: Endocrine system (06) Pharmacology: gastrointestinal peptide   Epidemiology: Company claim that there are approximately 300,000 abdominal MRI procedures conducted in the US and EU each year that may directly benefit from the addition of SecreFlo [4].   Indication: Pancreatic disorders  Additional Details: diagnostic with MRI  Company Information Name: Repligen  US Name: Repligen  Further Information Anticipated commissioning route (England) -  High cost drug list? Awaiting Update Implications Available only to registered users