英文药名：SecreFlo（Secretin） 中文药名：注射用胰泌素 药品简介 药品名称:Secreflo(Secretin) 生产公司:Repligen 批准日期:2002年5月 主要适应症:帮助诊断胰腺功能紊乱和促胃液素瘤 Secreflo是一种人工合成的肠分泌激素,这种产品已经被FDA批准用于促进胰液分泌,包括碳酸氢盐。以帮助诊断胰腺外分泌功能紊乱。另外,Secreflo又被批准用于刺激胃泌素的分泌,以帮助诊断促胃液素瘤—一种经常发现长在胰腺上的肿瘤。主要副作用:腹部不适、恶心、心率减慢、低血压、多汗、可能导致胰腺管穿孔。 分类名称 一级分类：其他用药 二级分类：诊断用药 三级分类：器官功能检查诊断剂  药品英文名 Secretin 药品别名 肠促胰液素、促胰液素、肠促胰液肽、分泌素、SecreFlo．、SEC 药物剂型 注射剂：每支含胰泌素16mg，L-半胱氨酸盐酸盐15mg。 药理作用 本品为含27个氨基酸的多肽类激素，与天然猪胰泌素具有相同的氨基酸序列。本品的主要作用是增加胰液的分泌和胰液中碳酸氢盐的含量。本品的活性标准单位以临床单位(clinicalunits，CU)表示，本品的效能相当于5000CU/mg的肽，等同于3000CU/mg的生物合成猪胰泌素。本品为纯肽类制剂，其含量用mg表示，胰泌素mg与生物活性之间的换算关系为：0.2mg＝1CU。 药动学 12名健康受试者静注本品0.4mg/kg后，大多数志愿者的血浆胰泌素浓度在60～90min内降至正常基线水平，血浆清除速率为(487±136)ml/min，表观分布容积为2L。 适应证 本品主要用于胰泌素刺激试验。 1.刺激胰腺分泌，包括碳酸氢盐的分泌，用来帮助诊断胰腺分泌功能障碍。 2.刺激胃泌素分泌，以诊断胃泌素瘤。 3.刺激胰腺分泌，以在内窥镜逆行性胆管造影术(endoscopic retrograde cholangio pancreatography，ERCP)检查中区别十二指肠乳头胆道口壶腹及副壶腹。 禁忌证 1．急性胰腺炎患者禁用，直到急性发作期结束。 2．妊娠毒性分级为C级，动物试验未发现生殖毒性，尚不知孕妇用药是否影响胎儿或生殖能力，故本品不宜给孕妇使用，除非必需。 3．儿童用药的安全性和疗效尚不清楚，不推荐儿童使用。 注意事项 1．尚不知本品是否经人乳汁分泌，哺乳期妇女慎用。 2．迷走神经切断术患者、正在使用抗胆碱药的患者、炎性肠病患者可对本品的刺激呈低反应性，但该反应并不代表有胰脏疾病。 3．对胰泌素的刺激产生超过正常体积的胰液分泌，有可能掩盖并发的胰脏病，这种情况偶尔会在酒精性肝病或其他肝病患者身上发生。 4．临床研究显示，老年人与成年人使用相同剂量，其安全性、药理作用、诊断效果无差别，但不能排除个别患者敏感性增加。 5．本品溶解后立即注射，剩余的溶解液弃掉。－20℃冷冻保存。 不良反应 偶见轻度不良反应。尽管在临床观察中未发现皮肤试验过敏或用药后过敏，但仍有引起过敏反应的可能，故用药前应先做皮试，皮试剂量为0.2mg(0.1ml)，皮试后1min无过敏反应症状方可用药，尤其有特异性变态反应或哮喘病史的患者，对严重过敏反应应立即采取适当解救措施。尚无长期动物试验研究本品的致癌作用、致畸形作用和致突变作用，小鼠和兔给药20mg/kg无致死。 用法用量 1．胰泌素刺激试验以辅助诊断胰腺分泌功能障碍： 患者禁食12～15h，在透视控制下，将不透过射线的双腔管的近侧管开口经口放入胃窦，远侧管开口置于法特乳头外，双管间断给予20～40mmHg负压，当十二指肠内容物pH＞6.0时收集十二指肠内基础样品10min。静注本品0.2mg(1ml)试验过敏反应，1min后如无过敏反应，1min内静注本品0.2mg/kg，收集十二指肠液共60ml，每15min分段收集共收集4部分，每次收集完后注射空气清洁十二指肠肠道。将每份液体冷却并对其体积及碳酸氢盐浓度进行分析，如果任何一个样品的碳酸氢盐浓度＜80mEq/L，均说明胰腺分泌功能与慢性胰腺炎密切相关。 2．刺激胃泌素分泌以诊断胃泌素瘤： 患者至少禁食12h，抽取2份血浆样品测定血浆胃泌素浓度作为基础水平浓度，然后静注本品0.2mg(0.1ml)皮试，如未发生过敏，则1min内静注0.4mg/kg，分别于给药后1min、2min、5min、10min、30min取血浆样品测定胃泌素浓度，若任何一个给药后血浆中的胃泌素浓度比基础水平浓度增加110pg/ml，则胃泌素瘤可能性很大。 3．刺激胰腺分泌以在内窥镜逆行插管中区别法特壶腹和副乳头： 胰腺分裂患者区别法特壶腹和副乳头时，1min内静注本品0.2mg/kg，看是否有胰液分泌物从乳头流出，有利于区分及套管插入术。将本品16mg溶于8ml生理盐水中，浓度为2mg/ml，强烈振摇使溶解，供注射用。 药物相应作用 合用抗胆碱药可使患者敏感性增强产生假阳性结果。   Drugs Approved by the FDA Drug Name: SecreFlo (secretin) The following information is obtained from various newswires, published medical journal articles, and medical conference presentations. 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 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. (from SecreFlo FDA Label) Additional Information For additional information on SecreFlo, please visit the Repligen company web site. 包装规格：16mcg Vial DS Innovative Therapies for Complex Diseases Repligen's Development Pipeline Repligen is developing a pipeline of innovative products and therapies with the potential to make a significant impact in the lives of patients suffering from diseases with limited treatment options. The company's diverse pipeline includes the following development programs: SecreFlo(TM), synthetic human secretin, positive Phase 3 study completed to improve magnetic resonance imaging of the pancreas SecreFlo(TM), synthetic human secretin, investigator led pilot studies to improve pancreatic cancer detection RG3039, promoters of SMN2 gene expression, entering Phase 1 for spinal muscular atrophy RG2833, HDAC (Class 1) inhibitors, in preclinical development for Friedreich's ataxia SecreFlo(TM): Better Patient Care through Improved Imaging of the Pancreas Repligen is evaluating the use of SecreFlo(TM), synthetic human secretin, to improve visualization of pancreatic duct abnormalities when used in combination with magnetic resonance imaging (MRI). Detailed assessment of the pancreatic ducts is important in the diagnosis and treatment of diseases such as acute and chronic pancreatitis. RG1068 is a synthetic version of human secretin, a natural gastrointestinal hormone involved in the process of digestion. Secretin signals the release of fluids into the ducts of the pancreas which results in increased delineation of the pancreatic ducts and improved MRI imaging. Repligen's Phase 3 Development Program Repligen has completed a positive Phase 3 study to evaluate the safety and efficacy of SecreFlo(TM) to improve MRI imaging of the pancreas in patients with pancreatic disease using endoscopy (ERCP) as a diagnostic reference. The study's co-primary endpoints were achievement of a statistically significant improvement in sensitivity of detection of abnormalities with a loss of specificity of less than 7.5% by two of the three central radiologists reading the MRI images. In this study, all three radiologists achieved a clinically and statistically significant improvement in sensitivity (all radiologists p<0.0001) with minimal loss in specificity (all radiologists <7.5%). In addition, the SecreFlo(TM)-MRI images showed highly significant improvements on image quality (all radiologists p<0.0001), and confidence in the diagnostic findings (all radiologists p<0.0001), when compared to MRI alone. There were no Serious Adverse Events (SAEs) or unscheduled days of hospitalization associated with the RG1068-MRI procedures compared to 55 SAEs and 236 days of unscheduled hospitalization associated with the ERCP procedures. About Diagnosing Pancreatic Disease Endoscopy has been used for many years by gastroenterologists to diagnose and treat diseases of the pancreas. There are risks associated with the use of endoscopy, which have generated interest in the development of safer non-invasive tests to diagnose pancreatic disorders. The use of SecreFlo(TM) in combination with a non-invasive procedure such as MRI can improve the detection of abnormalities and increase the diagnostic quality of the MRI image of the pancreas, leading to increased diagnostic confidence. The FDA has granted RG1068 Orphan Drug status and Fast Track Designation, a process designed to facilitate development and expedite the review of drugs that treat serious diseases and fill unmet medical needs. There are more than 300,000 MRI procedures conducted in the U.S. and Europe each year that could directly benefit by the addition of SecreFlo(TM)