艾塞那肽注射液产品分析

艾塞那肽注射液产品分析 【药物名称】 中文通用名称:艾塞那肽 英文通用名称:Exenatide 其他名称:Byetta。 【临床应用】 作为辅助用药，用于单服二甲双胍或磺酰脲类药或联用二甲双胍和磺酰脲类药后均未达到充分血糖控制的2型糖尿病患者的血糖控制的改善。 【药理】 1.药效学 本药是一种合成的肠降血糖素类似物(有抗高血糖作用的肽)，其53%的氨基酸顺序与哺乳动物胰高血糖素样多肽-1(GLP-1)的氨基酸顺序相同，但不是GLP-1的类似物。GLP-1是一种肠道激素，是肠道L细胞响应营养摄入而分泌的激素，可通过其受体产生降血糖和抗糖尿病作用(如刺激葡萄糖依赖性胰岛素的释放，抑制胰高血糖素的分泌)，但半衰期较短[低于2分钟，主要经蛋白水解酶?(二肽酰胺酶?)快速降解]。本药可激动GLP-1受体，产生与GLP-1类似的作用[其许多(或所有)抗糖尿病作用似与GLP-1受体结合有关，但观察到的所有药效学作用与GLP-1的作用并不一致，有研究人员认为，这可能是本药通过功能不同的其他受体而产生的]。其作用包括:增强葡萄糖依赖性的胰岛素的分泌和抑制葡萄糖依赖性的异常增高的胰高血糖素的分泌、减慢胃排空、减少食物摄入、促进β-细胞增殖和再生、减少脂肪堆积及胰岛素增敏作用(动物模型)。由于本药相对较能抵抗蛋白水解酶?(二肽酰胺酶?)的降解(因GLP-1的2位存在一个丙氨酸基团，可被蛋白水解酶?识别，而本药2位则为甘氨酸基团)，故有较长的半衰期，体内活性较GLP-1增强。 一项安慰剂对照研究提示，本药可显著降低禁食状态的血浆葡萄糖水平，降低餐后葡萄糖相对于基础值的峰变化;用药后观察到胃排空延迟、热量摄入减少。资料 表 关于同志近三年现实表现材料材料类招标技术评分表图表与交易pdf视力表打印pdf用图表说话 pdf 明，本药在非糖尿病受试者及2型糖尿病患者中均是一种强效促胰岛素分泌药。 2.药动学 予2型糖尿病患者皮下注射本药，可见餐后葡萄糖水平降低持续达5小时，注射后约3小时达最低点。2型糖尿病患者皮下注射10μg后2.1小时达峰浓度(C)211pg/ml，曲线下面积(AUC)为1.036(ng?h)/ml。动物研究中，经max 皮下注射给药的生物利用度为65%-75%，尚无人类的生物利用度资料。皮下注射和静脉给药的分布容积分别为28.3L(与剂量、年龄、性别、种族和患者的体型无关)和64ml/kg(健康受试者)。药物在人体内的代谢尚不明确，但动物研究表明本药较GLP-1更能抵抗蛋白水解酶?的降解。本药主要经肾小球过滤清除，随后经蛋白水解降解，平均肾清除率为9.1L/h，终末半衰期为2.4小时，轻至中度肾损害者(肌酐清除率30-80ml/min)的平均肾清除率减至0.9L/h。肾清除率和半衰期均与剂量、年龄、性别、种族和患者的体型无关。 3.遗传与生殖毒性 动物研究表明本药对胎仔有不良效应(致畸、致死胎或其他)。 【注意事项】 1.特别警示 本药可能导致胰腺炎。 reading professional language literature, assist clinical teaching (theory class and internship class) participation clinical research activities. (Six) emergency ICU 1. Rotary purpose master: shock, and acute organ function failure, and more organ function obstacles integrated levy, and heart sudden stopped, and breathing sudden stopped, and serious humoral within environment disorder, critical illness of causes, and pathology physiological, and clinical performance, and diagnosis, and identification diagnosis and treatment common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; Various monitoring equipment and rescue equipment (such as defibrillators, ventilators) operation and applications; Common monitoring techniques (such as body temperature, SpO2, end-expiratory carbon dioxide partial pressure, ECG, blood pressure, blood gas analysis, and so on) operation and application. Familiar: blood purification techniques, such as blood flow, CRRT, Swan-Ganz catheter indications, how and cardiac output monitoring; Artificial low temperature indication and implementation. About: Intra-Aortic Balloon counterpulsation (IABP) indications and methods of operation. 2. basic requirements: (1) learning disease species and the cases number requirements: disease on contract number (?) various organ function not full 10 acute breathing distress integrated levy (ARDS) more than 2 more organ function obstacles integrated levy (MODS) 5 shock 5 heart sudden stopped, and breathing sudden stopped 2 (2) clinical operation technology requirements: clinical operation technology name contract times (?) guardianship instrument using 30 by skin Center vein reset tube operation 5 by skin outside week artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electricweek artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electric except fibrillation and complex law 2 3. high requirements ( 1) disease and number of contracts number of disease syndrome after cardiopulmonary resuscitation in multiple organ dysfunction syndrome more than 2 2 (2) clinical knowledge, skills required: clinical operations technical contract blood purification technique 2 people ... ... (1) the number of species and number of cases (?) gallstone 2 peptic ulcer .... 2. basic requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number (?) local infiltration anesthesia of management 2 vertebral tube anesthesia of management 10 body anesthesia of management 10 (2) clinical operation technology requirements: clinical operation technology name contract times (?) around neural block operation 2 supporting jaw method (open gas road) 10 technique artificial ventilation (using anesthesia machine) 5 ball SAC-mask breathing device 5 fast tracheal within intubation operation 10 artery puncture reset tube operation 5 heart electric monitoring 10 pulse oxygen monitoring 10 has create blood pressure monitoring 10 3. high requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number vertebral tube anesthesia of implementation 2 body anesthesia of implementation 2 arm bundle neural block 2 (2) clinical knowledge, and skills requirements: clinical operation technology name contract times mechanical ventilation (anesthesia breathing machine) 10 control sex low blood pressure 2 by skin Center vein puncture reset tube 2 (3) language, and teaching, and research, capacity of requirements: 2.禁忌症 (1)对本药过敏者。(2)1型糖尿病患者。(3)糖尿病性酮症酸中毒患者。(4)晚期肾疾病或严重肾损害(肌酐清除率低于30ml/min)患者不推荐使用本药。(5)严重胃肠道疾病(如胃轻瘫)患者不推荐使用本药。(以上均选自国外资料) 3.慎用 低血糖者(与磺酰脲类同用则风险增加)(国外资料)。 4.药物对儿童的影响 儿童用药的安全性和疗效尚未确立。 5.药物对妊娠的影响 尚无孕妇用药的安全性数据，孕妇用药应权衡利弊。美国食品药品管理局(FDA)对本药的妊娠安全性分级为C级。 6.药物对哺乳的影响 本药可分泌入哺乳小鼠的乳汁中，尚无哺乳妇女用药的安全性数据，哺乳期用药应权衡利弊。 【不良反应】 [国外不良反应参考] 1.心血管系统 未见对心率、血压或ECG等参数的影响。 2.代谢/内分泌系统 (1)可见低血糖(5%-36%)。和联用磺酰脲类后出现轻至中度低血糖，且呈剂量依赖性，口服碳水化合物后症状消除。和联用二甲双胍时罕见低血糖发生。(2)据报道，本药治疗第1日，皮质醇水平轻度升高，第28日后恢复正常。 3.免疫系统 有资料显示，可见本药抗体产生，但似乎对降低糖基化血红蛋白水平无影响。 4.神经 可见头晕(9%)、头痛(9%)、神经质(9%)。 5.胃肠道 可见腹泻(13%)、消化不良(6%)、恶心(44%)、呕吐(13%)。此外，本药可能导致胰腺炎。 【药物相互作用】 ?药物-药物相互作用 1.与对乙酰氨基酚合用，可致对乙酰氨基酚的AUC、峰浓度及生物利用度降低，达峰时间延长。其机制可能与胃排空减慢引起对乙酰氨基酚吸收减少有关。两药联用时，应至少在使用本药前1小时给予对乙酰氨基酚。 2.与洛伐他汀合用，可致洛伐他汀的AUC、峰浓度及生物利用度降低。其机制可能与胃排空减慢引起洛伐他汀吸收减少有关。合用时可能需增加洛伐他汀剂量以弥补其生物利用度的降低，并有必要监测血脂。 【给药 说明 关于失联党员情况说明岗位说明总经理岗位说明书会计岗位说明书行政主管岗位说明书 】 1.对需用胰岛素的患者，本药不能取代胰岛素。 2.使用胰岛素、噻唑烷二酮、右旋苯丙氨衍生物、瑞格列奈类或α-葡萄糖苷酶抑制药的患者应慎用本药。 3.用药后若怀疑出现胰腺炎，应停药。若确诊胰腺炎由本药引起，应永久性停用本药。 【用法与用量】 [国外用法用量参考] 成人 ?常规剂量 ?皮下注射 初始剂量，一次5μg，一日2次;维持剂量，一次10μg，一日2次。 ?肾功能不全时剂量 reading professional language literature, assist clinical teaching (theory class and internship class) participation clinical research activities. (Six) emergency ICU 1. Rotary purpose master: shock, and acute organ function failure, and more organ function obstacles integrated levy, and heart sudden stopped, and breathing sudden stopped, and serious humoral within environment disorder, critical illness of causes, and pathology physiological, and clinical performance, and diagnosis, and identification diagnosis and treatment common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; Various monitoring equipment and rescue equipment (such as defibrillators, ventilators) operation and applications; Common monitoring techniques (such as body temperature, SpO2, end-expiratory carbon dioxide partial pressure, ECG, blood pressure, blood gas analysis, and so on) operation and application. Familiar: blood purification techniques, such as blood flow, CRRT, Swan-Ganz catheter indications, how and cardiac output monitoring; Artificial low temperature indication and implementation. About: Intra-Aortic Balloon counterpulsation (IABP) indications and methods of operation. 2. basic requirements: (1) learning disease species and the cases number requirements: disease on contract number (?) various organ function not full 10 acute breathing distress integrated levy (ARDS) more than 2 more organ function obstacles integrated levy (MODS) 5 shock 5 heart sudden stopped, and breathing sudden stopped 2 (2) clinical operation technology requirements: clinical operation technology name contract times (?) guardianship instrument using 30 by skin Center vein reset tube operation 5 by skin outside week artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electricweek artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electric except fibrillation and complex law 2 3. high requirements ( 1) disease and number of contracts number of disease syndrome after cardiopulmonary resuscitation in multiple organ dysfunction syndrome more than 2 2 (2) clinical knowledge, skills required: clinical operations technical contract blood purification technique 2 people ... ... (1) the number of species and number of cases (?) gallstone 2 peptic ulcer .... 2. basic requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number (?) local infiltration anesthesia of management 2 vertebral tube anesthesia of management 10 body anesthesia of management 10 (2) clinical operation technology requirements: clinical operation technology name contract times (?) around neural block operation 2 supporting jaw method (open gas road) 10 technique artificial ventilation (using anesthesia machine) 5 ball SAC-mask breathing device 5 fast tracheal within intubation operation 10 artery puncture reset tube operation 5 heart electric monitoring 10 pulse oxygen monitoring 10 has create blood pressure monitoring 10 3. high requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number vertebral tube anesthesia of implementation 2 body anesthesia of implementation 2 arm bundle neural block 2 (2) clinical knowledge, and skills requirements: clinical operation technology name contract times mechanical ventilation (anesthesia breathing machine) 10 control sex low blood pressure 2 by skin Center vein puncture reset tube 2 (3) language, and teaching, and research, capacity of requirements: 不推荐晚期肾脏疾病或严重肾损害者(肌酐清除率低于30ml/min)使用本药。 【制剂与规格】 艾塞那肽注射液 1ml:250μg。 贮法:2-8?冷藏、避光保存，严禁冷冻。 降糖药分类 reading professional language literature, assist clinical teaching (theory class and internship class) participation clinical research activities. (Six) emergency ICU 1. Rotary purpose master: shock, and acute organ function failure, and more organ function obstacles integrated levy, and heart sudden stopped, and breathing sudden stopped, and serious humoral within environment disorder, critical illness of causes, and pathology physiological, and clinical performance, and diagnosis, and identification diagnosis and treatment common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; Various monitoring equipment and rescue equipment (such as defibrillators, ventilators) operation and applications; Common monitoring techniques (such as body temperature, SpO2, end-expiratory carbon dioxide partial pressure, ECG, blood pressure, blood gas analysis, and so on) operation and application. Familiar: blood purification techniques, such as blood flow, CRRT, Swan-Ganz catheter indications, how and cardiac output monitoring; Artificial low temperature indication and implementation. About: Intra-Aortic Balloon counterpulsation (IABP) indications and methods of operation. 2. basic requirements: (1) learning disease species and the cases number requirements: disease on contract number (?) various organ function not full 10 acute breathing distress integrated levy (ARDS) more than 2 more organ function obstacles integrated levy (MODS) 5 shock 5 heart sudden stopped, and breathing sudden stopped 2 (2) clinical operation technology requirements: clinical operation technology name contract times (?) guardianship instrument using 30 by skin Center vein reset tube operation 5 by skin outside week artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electricweek artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electric except fibrillation and complex law 2 3. high requirements ( 1) disease and number of contracts number of disease syndrome after cardiopulmonary resuscitation in multiple organ dysfunction syndrome more than 2 2 (2) clinical knowledge, skills required: clinical operations technical contract blood purification technique 2 people ... ... (1) the number of species and number of cases (?) gallstone 2 peptic ulcer .... 2. basic requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number (?) local infiltration anesthesia of management 2 vertebral tube anesthesia of management 10 body anesthesia of management 10 (2) clinical operation technology requirements: clinical operation technology name contract times (?) around neural block operation 2 supporting jaw method (open gas road) 10 technique artificial ventilation (using anesthesia machine) 5 ball SAC-mask breathing device 5 fast tracheal within intubation operation 10 artery puncture reset tube operation 5 heart electric monitoring 10 pulse oxygen monitoring 10 has create blood pressure monitoring 10 3. high requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number vertebral tube anesthesia of implementation 2 body anesthesia of implementation 2 arm bundle neural block 2 (2) clinical knowledge, and skills requirements: clinical operation technology name contract times mechanical ventilation (anesthesia breathing machine) 10 control sex low blood pressure 2 by skin Center vein puncture reset tube 2 (3) language, and teaching, and research, capacity of requirements: 糖尿病领域重点厂家与新产品 reading professional language literature, assist clinical teaching (theory class and internship class) participation clinical research activities. (Six) emergency ICU 1. Rotary purpose master: shock, and acute organ function failure, and more organ function obstacles integrated levy, and heart sudden stopped, and breathing sudden stopped, and serious humoral within environment disorder, critical illness of causes, and pathology physiological, and clinical performance, and diagnosis, and identification diagnosis and treatment common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; Various monitoring equipment and rescue equipment (such as defibrillators, ventilators) operation and applications; Common monitoring techniques (such as body temperature, SpO2, end-expiratory carbon dioxide partial pressure, ECG, blood pressure, blood gas analysis, and so on) operation and application. Familiar: blood purification techniques, such as blood flow, CRRT, Swan-Ganz catheter indications, how and cardiac output monitoring; Artificial low temperature indication and implementation. About: Intra-Aortic Balloon counterpulsation (IABP) indications and methods of operation. 2. basic requirements: (1) learning disease species and the cases number requirements: disease on contract number (?) various organ function not full 10 acute breathing distress integrated levy (ARDS) more than 2 more organ function obstacles integrated levy (MODS) 5 shock 5 heart sudden stopped, and breathing sudden stopped 2 (2) clinical operation technology requirements: clinical operation technology name contract times (?) guardianship instrument using 30 by skin Center vein reset tube operation 5 by skin outside week artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electricweek artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electric except fibrillation and complex law 2 3. high requirements ( 1) disease and number of contracts number of disease syndrome after cardiopulmonary resuscitation in multiple organ dysfunction syndrome more than 2 2 (2) clinical knowledge, skills required: clinical operations technical contract blood purification technique 2 people ... ... (1) the number of species and number of cases (?) gallstone 2 peptic ulcer .... 2. basic requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number (?) local infiltration anesthesia of management 2 vertebral tube anesthesia of management 10 body anesthesia of management 10 (2) clinical operation technology requirements: clinical operation technology name contract times (?) around neural block operation 2 supporting jaw method (open gas road) 10 technique artificial ventilation (using anesthesia machine) 5 ball SAC-mask breathing device 5 fast tracheal within intubation operation 10 artery puncture reset tube operation 5 heart electric monitoring 10 pulse oxygen monitoring 10 has create blood pressure monitoring 10 3. high requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number vertebral tube anesthesia of implementation 2 body anesthesia of implementation 2 arm bundle neural block 2 (2) clinical knowledge, and skills requirements: clinical operation technology name contract times mechanical ventilation (anesthesia breathing machine) 10 control sex low blood pressure 2 by skin Center vein puncture reset tube 2 (3) language, and teaching, and research, capacity of requirements: 原研企业 原研中标价与零售价 reading professional language literature, assist clinical teaching (theory class and internship class) participation clinical research activities. (Six) emergency ICU 1. Rotary purpose master: shock, and acute organ function failure, and more organ function obstacles integrated levy, and heart sudden stopped, and breathing sudden stopped, and serious humoral within environment disorder, critical illness of causes, and pathology physiological, and clinical performance, and diagnosis, and identification diagnosis and treatment common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; Various monitoring equipment and rescue equipment (such as defibrillators, ventilators) operation and applications; Common monitoring techniques (such as body temperature, SpO2, end-expiratory carbon dioxide partial pressure, ECG, blood pressure, blood gas analysis, and so on) operation and application. Familiar: blood purification techniques, such as blood flow, CRRT, Swan-Ganz catheter indications, how and cardiac output monitoring; Artificial low temperature indication and implementation. About: Intra-Aortic Balloon counterpulsation (IABP) indications and methods of operation. 2. basic requirements: (1) learning disease species and the cases number requirements: disease on contract number (?) various organ function not full 10 acute breathing distress integrated levy (ARDS) more than 2 more organ function obstacles integrated levy (MODS) 5 shock 5 heart sudden stopped, and breathing sudden stopped 2 (2) clinical operation technology requirements: clinical operation technology name contract times (?) guardianship instrument using 30 by skin Center vein reset tube operation 5 by skin outside week artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electricweek artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electric except fibrillation and complex law 2 3. high requirements ( 1) disease and number of contracts number of disease syndrome after cardiopulmonary resuscitation in multiple organ dysfunction syndrome more than 2 2 (2) clinical knowledge, skills required: clinical operations technical contract blood purification technique 2 people ... ... (1) the number of species and number of cases (?) gallstone 2 peptic ulcer .... 2. basic requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number (?) local infiltration anesthesia of management 2 vertebral tube anesthesia of management 10 body anesthesia of management 10 (2) clinical operation technology requirements: clinical operation technology name contract times (?) around neural block operation 2 supporting jaw method (open gas road) 10 technique artificial ventilation (using anesthesia machine) 5 ball SAC-mask breathing device 5 fast tracheal within intubation operation 10 artery puncture reset tube operation 5 heart electric monitoring 10 pulse oxygen monitoring 10 has create blood pressure monitoring 10 3. high requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number vertebral tube anesthesia of implementation 2 body anesthesia of implementation 2 arm bundle neural block 2 (2) clinical knowledge, and skills requirements: clinical operation technology name contract times mechanical ventilation (anesthesia breathing machine) 10 control sex low blood pressure 2 by skin Center vein puncture reset tube 2 (3) language, and teaching, and research, capacity of requirements: reading professional language literature, assist clinical teaching (theory class and internship class) participation clinical research activities. (Six) emergency ICU 1. Rotary purpose master: shock, and acute organ function failure, and more organ function obstacles integrated levy, and heart sudden stopped, and breathing sudden stopped, and serious humoral within environment disorder, critical illness of causes, and pathology physiological, and clinical performance, and diagnosis, and identification diagnosis and treatment common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; Various monitoring equipment and rescue equipment (such as defibrillators, ventilators) operation and applications; Common monitoring techniques (such as body temperature, SpO2, end-expiratory carbon dioxide partial pressure, ECG, blood pressure, blood gas analysis, and so on) operation and application. Familiar: blood purification techniques, such as blood flow, CRRT, Swan-Ganz catheter indications, how and cardiac output monitoring; Artificial low temperature indication and implementation. About: Intra-Aortic Balloon counterpulsation (IABP) indications and methods of operation. 2. basic requirements: (1) learning disease species and the cases number requirements: disease on contract number (?) various organ function not full 10 acute breathing distress integrated levy (ARDS) more than 2 more organ function obstacles integrated levy (MODS) 5 shock 5 heart sudden stopped, and breathing sudden stopped 2 (2) clinical operation technology requirements: clinical operation technology name contract times (?) guardianship instrument using 30 by skin Center vein reset tube operation 5 by skin outside week artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electricweek artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electric except fibrillation and complex law 2 3. high requirements ( 1) disease and number of contracts number of disease syndrome after cardiopulmonary resuscitation in multiple organ dysfunction syndrome more than 2 2 (2) clinical knowledge, skills required: clinical operations technical contract blood purification technique 2 people ... ... (1) the number of species and number of cases (?) gallstone 2 peptic ulcer .... 2. basic requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number (?) local infiltration anesthesia of management 2 vertebral tube anesthesia of management 10 body anesthesia of management 10 (2) clinical operation technology requirements: clinical operation technology name contract times (?) around neural block operation 2 supporting jaw method (open gas road) 10 technique artificial ventilation (using anesthesia machine) 5 ball SAC-mask breathing device 5 fast tracheal within intubation operation 10 artery puncture reset tube operation 5 heart electric monitoring 10 pulse oxygen monitoring 10 has create blood pressure monitoring 10 3. high requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number vertebral tube anesthesia of implementation 2 body anesthesia of implementation 2 arm bundle neural block 2 (2) clinical knowledge, and skills requirements: clinical operation technology name contract times mechanical ventilation (anesthesia breathing machine) 10 control sex low blood pressure 2 by skin Center vein puncture reset tube 2 (3) language, and teaching, and research, capacity of requirements: 仿制药注册情况 趋势 reading professional language literature, assist clinical teaching (theory class and internship class) participation clinical research activities. (Six) emergency ICU 1. Rotary purpose master: shock, and acute organ function failure, and more organ function obstacles integrated levy, and heart sudden stopped, and breathing sudden stopped, and serious humoral within environment disorder, critical illness of causes, and pathology physiological, and clinical performance, and diagnosis, and identification diagnosis and treatment common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; Various monitoring equipment and rescue equipment (such as defibrillators, ventilators) operation and applications; Common monitoring techniques (such as body temperature, SpO2, end-expiratory carbon dioxide partial pressure, ECG, blood pressure, blood gas analysis, and so on) operation and application. Familiar: blood purification techniques, such as blood flow, CRRT, Swan-Ganz catheter indications, how and cardiac output monitoring; Artificial low temperature indication and implementation. About: Intra-Aortic Balloon counterpulsation (IABP) indications and methods of operation. 2. basic requirements: (1) learning disease species and the cases number requirements: disease on contract number (?) various organ function not full 10 acute breathing distress integrated levy (ARDS) more than 2 more organ function obstacles integrated levy (MODS) 5 shock 5 heart sudden stopped, and breathing sudden stopped 2 (2) clinical operation technology requirements: clinical operation technology name contract times (?) guardianship instrument using 30 by skin Center vein reset tube operation 5 by skin outside week artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electricweek artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electric except fibrillation and complex law 2 3. high requirements ( 1) disease and number of contracts number of disease syndrome after cardiopulmonary resuscitation in multiple organ dysfunction syndrome more than 2 2 (2) clinical knowledge, skills required: clinical operations technical contract blood purification technique 2 people ... ... (1) the number of species and number of cases (?) gallstone 2 peptic ulcer .... 2. basic requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number (?) local infiltration anesthesia of management 2 vertebral tube anesthesia of management 10 body anesthesia of management 10 (2) clinical operation technology requirements: clinical operation technology name contract times (?) around neural block operation 2 supporting jaw method (open gas road) 10 technique artificial ventilation (using anesthesia machine) 5 ball SAC-mask breathing device 5 fast tracheal within intubation operation 10 artery puncture reset tube operation 5 heart electric monitoring 10 pulse oxygen monitoring 10 has create blood pressure monitoring 10 3. high requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number vertebral tube anesthesia of implementation 2 body anesthesia of implementation 2 arm bundle neural block 2 (2) clinical knowledge, and skills requirements: clinical operation technology name contract times mechanical ventilation (anesthesia breathing machine) 10 control sex low blood pressure 2 by skin Center vein puncture reset tube 2 (3) language, and teaching, and research, capacity of requirements: 首仿艾塞那肽的为长春高新百克药物研究有限公司 公司首仿的降糖药艾塞那肽主要用于治疗糖尿病。是人胰高血糖素样肽-1(GLP-1)的类似物。该产品的原研单位是美国礼来公司和amylin制药公司，商品名为“百泌达”，2009年8月在国内上市。该药物是第一个也是唯一一个经美国食品药物管理局(FDa)和中国食品与药物管理局(SFDa)批准的胰高血糖素样肽-1(GLP-1)受体激动剂。百泌达具有全新的降糖机制，用于二甲双胍、磺酰脲类或二甲双胍与磺酰脲类联合应用不能充分控制血糖的?型糖尿病患者。该产品具有6年的临床应用经验，处方量目前已达740多万张，09年销售额达4.5亿美(礼来年报)。该产品是公司首仿，属于3.1类，通常仅需要做一期临床和类似二期临床的验证性实验，不需要做三期临床研究。该产品目前处于三期临床研究阶段。公司已经在建该产品的生产线。 艾塞那肽刚刚进入到世界最畅销降糖药物的前10名，是礼来公司于2004年开发上市的，并于2009年登陆中国市场。该药是模仿美国内华达州沙漠里栖息的一种大毒蜥唾液里具有显着降血糖作用的多肽类物质的化学结构人工合成的、具有39个氨基酸分子的新药。艾塞那肽的上市，打破了长期以来由胰岛素、双胍、磺酰脲和噻唑烷二酮类reading professional language literature, assist clinical teaching (theory class and internship class) participation clinical research activities. (Six) emergency ICU 1. Rotary purpose master: shock, and acute organ function failure, and more organ function obstacles integrated levy, and heart sudden stopped, and breathing sudden stopped, and serious humoral within environment disorder, critical illness of causes, and pathology physiological, and clinical performance, and diagnosis, and identification diagnosis and treatment common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; Various monitoring equipment and rescue equipment (such as defibrillators, ventilators) operation and applications; Common monitoring techniques (such as body temperature, SpO2, end-expiratory carbon dioxide partial pressure, ECG, blood pressure, blood gas analysis, and so on) operation and application. Familiar: blood purification techniques, such as blood flow, CRRT, Swan-Ganz catheter indications, how and cardiac output monitoring; Artificial low temperature indication and implementation. About: Intra-Aortic Balloon counterpulsation (IABP) indications and methods of operation. 2. basic requirements: (1) learning disease species and the cases number requirements: disease on contract number (?) various organ function not full 10 acute breathing distress integrated levy (ARDS) more than 2 more organ function obstacles integrated levy (MODS) 5 shock 5 heart sudden stopped, and breathing sudden stopped 2 (2) clinical operation technology requirements: clinical operation technology name contract times (?) guardianship instrument using 30 by skin Center vein reset tube operation 5 by skin outside week artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electricweek artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electric except fibrillation and complex law 2 3. high requirements ( 1) disease and number of contracts number of disease syndrome after cardiopulmonary resuscitation in multiple organ dysfunction syndrome more than 2 2 (2) clinical knowledge, skills required: clinical operations technical contract blood purification technique 2 people ... ... (1) the number of species and number of cases (?) gallstone 2 peptic ulcer .... 2. basic requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number (?) local infiltration anesthesia of management 2 vertebral tube anesthesia of management 10 body anesthesia of management 10 (2) clinical operation technology requirements: clinical operation technology name contract times (?) around neural block operation 2 supporting jaw method (open gas road) 10 technique artificial ventilation (using anesthesia machine) 5 ball SAC-mask breathing device 5 fast tracheal within intubation operation 10 artery puncture reset tube operation 5 heart electric monitoring 10 pulse oxygen monitoring 10 has create blood pressure monitoring 10 3. high requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number vertebral tube anesthesia of implementation 2 body anesthesia of implementation 2 arm bundle neural block 2 (2) clinical knowledge, and skills requirements: clinical operation technology name contract times mechanical ventilation (anesthesia breathing machine) 10 control sex low blood pressure 2 by skin Center vein puncture reset tube 2 (3) language, and teaching, and research, capacity of requirements: 药物统治世界糖尿病药物市场的旧格局，具有划时代的意义。自2004年上市以来，艾塞那肽的销售额迅速成长，到2009年，已经达到了8亿美元。 我国是糖尿病大国，目前全球已诊断的2型糖尿病达1.3亿人，我国已超过4000万人，糖尿病市场潜力巨大，预计百克的国产艾塞那肽将可能在2012年上市，此后将成为公司新的重磅产品。 长春百克的“注射用艾塞那肽” 注射用艾塞那肽正是长春百克公司的新药产品，已经进入到国家药品监督局的药品注册阶段，受理号为CXHB1000409吉，可以在国家药品监督局网站( )中查询。 艾塞那肽(Exenatide)是全新类型的?型糖尿病治疗药物。皮下注射针剂，每用药2次，用于二甲双胍、磺酰脲类或二甲双胍与磺酰脲类联合应用不能充分控制血糖的?型糖尿病患者。 我公司已经在国内首家研制出了抗?型糖尿病新药 -艾塞那肽，它是由39 个氨基酸组成的多肽，是首个肠降糖素类药物。肠降糖素类药物是针对?型糖尿病的一种新型疗法，它可以模仿人体内天然的胃肠激素的抗糖尿病反应或降低葡萄糖浓度的反应，这些反应包括在血糖升高时刺激体内产生胰岛素，在饭后抑制胰高血糖素的分泌，减慢血液摄取营养的速度和减少食物摄入量。 艾塞那肽的主要生物功能为:?增加胰岛素的生物合成及葡萄糖依赖性促胰岛素分泌;?刺激β细胞增生和再生，抑制β细胞凋亡从而增加β细胞的数量;?抑制胰高血糖素的分泌;?抑制肝糖生成，但不会引起严重低血糖;?抑制餐后胃肠道动力及分泌功能;?降低食欲，减少食物的摄入;?对神经细胞具有保护作用。 艾塞那肽抗糖尿病的临床表现明显优于胰岛素，它可以避免发生低血糖等危险性;刺激胰岛β细胞再生，促进胰岛素分泌;可以减轻患者体重，这些都是吸引患者的关键因素。它是专门为尚未使用胰岛素进行治疗的?型糖尿病人而研制，是近十年来首次出现的?型糖尿病新疗法。 Byetta(艾塞那肽)可促进葡萄糖依赖的胰岛素分泌，抑制不适当的葡萄糖依赖的胰高血糖素的分泌，减慢胃排空，改善外周组织对胰岛素的敏感性，充分控制血糖。与使用胰岛素的病人相比，使用Byetta的糖尿病患者发生低血糖的危险性仅为前者的1/6。糖尿病患者如果使用注射性药物Byetta加二甲双胍，他们发生低血糖的可能性为2.6,。而使用胰岛素加二甲双胍的病人发生低血糖的可能性为17.4,，这是使Byetta病人的大约6倍。低血糖是困扰糖尿病患者的一种危险病症，而作为一种常用的药物，二甲双胍经常被用于联合药物之中。Byetta虽然在美国上市时间不长，但其销售增长迅reading professional language literature, assist clinical teaching (theory class and internship class) participation clinical research activities. (Six) emergency ICU 1. Rotary purpose master: shock, and acute organ function failure, and more organ function obstacles integrated levy, and heart sudden stopped, and breathing sudden stopped, and serious humoral within environment disorder, critical illness of causes, and pathology physiological, and clinical performance, and diagnosis, and identification diagnosis and treatment common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; Various monitoring equipment and rescue equipment (such as defibrillators, ventilators) operation and applications; Common monitoring techniques (such as body temperature, SpO2, end-expiratory carbon dioxide partial pressure, ECG, blood pressure, blood gas analysis, and so on) operation and application. Familiar: blood purification techniques, such as blood flow, CRRT, Swan-Ganz catheter indications, how and cardiac output monitoring; Artificial low temperature indication and implementation. About: Intra-Aortic Balloon counterpulsation (IABP) indications and methods of operation. 2. basic requirements: (1) learning disease species and the cases number requirements: disease on contract number (?) various organ function not full 10 acute breathing distress integrated levy (ARDS) more than 2 more organ function obstacles integrated levy (MODS) 5 shock 5 heart sudden stopped, and breathing sudden stopped 2 (2) clinical operation technology requirements: clinical operation technology name contract times (?) guardianship instrument using 30 by skin Center vein reset tube operation 5 by skin outside week artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electricweek artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electric except fibrillation and complex law 2 3. high requirements ( 1) disease and number of contracts number of disease syndrome after cardiopulmonary resuscitation in multiple organ dysfunction syndrome more than 2 2 (2) clinical knowledge, skills required: clinical operations technical contract blood purification technique 2 people ... ... (1) the number of species and number of cases (?) gallstone 2 peptic ulcer .... 2. basic requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number (?) local infiltration anesthesia of management 2 vertebral tube anesthesia of management 10 body anesthesia of management 10 (2) clinical operation technology requirements: clinical operation technology name contract times (?) around neural block operation 2 supporting jaw method (open gas road) 10 technique artificial ventilation (using anesthesia machine) 5 ball SAC-mask breathing device 5 fast tracheal within intubation operation 10 artery puncture reset tube operation 5 heart electric monitoring 10 pulse oxygen monitoring 10 has create blood pressure monitoring 10 3. high requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number vertebral tube anesthesia of implementation 2 body anesthesia of implementation 2 arm bundle neural block 2 (2) clinical knowledge, and skills requirements: clinical operation technology name contract times mechanical ventilation (anesthesia breathing machine) 10 control sex low blood pressure 2 by skin Center vein puncture reset tube 2 (3) language, and teaching, and research, capacity of requirements: 速。使用Byetta的病人能够像使用胰岛素那样控制血糖水平，而病人平均减去了5.7磅体重，使用胰岛素的糖尿病患者体重增加了1.3磅。 首仿产品评审状态 总结 初级经济法重点总结下载党员个人总结TXt高中句型全总结.doc高中句型全总结.doc理论力学知识点总结pdf 艾赛那肽～需皮下注射～通过激活GLP-1 受体而发挥作用。GLP-1 受体激动剂可以单独使用～也可以与其他口服降糖药联合使用。GLP-1 受体激动剂可以显著降低体重～单独使用不会导致低血糖。主要不良反应为肠胃不适。 该产品潜力较大～04到09年销售量为8亿美元～未来市场容量将继续增大 该产品的风险～价格定位较高～原研销售量不是很理想～注射液不如口服方便～胃肠道不良反应能否控制～如果患者体重较轻～使用该药会继续降低体重～是否威胁患者身体安全。 reading professional language literature, assist clinical teaching (theory class and internship class) participation clinical research activities. (Six) emergency ICU 1. Rotary purpose master: shock, and acute organ function failure, and more organ function obstacles integrated levy, and heart sudden stopped, and breathing sudden stopped, and serious humoral within environment disorder, critical illness of causes, and pathology physiological, and clinical performance, and diagnosis, and identification diagnosis and treatment common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; Various monitoring equipment and rescue equipment (such as defibrillators, ventilators) operation and applications; Common monitoring techniques (such as body temperature, SpO2, end-expiratory carbon dioxide partial pressure, ECG, blood pressure, blood gas analysis, and so on) operation and application. Familiar: blood purification techniques, such as blood flow, CRRT, Swan-Ganz catheter indications, how and cardiac output monitoring; Artificial low temperature indication and implementation. About: Intra-Aortic Balloon counterpulsation (IABP) indications and methods of operation. 2. basic requirements: (1) learning disease species and the cases number requirements: disease on contract number (?) various organ function not full 10 acute breathing distress integrated levy (ARDS) more than 2 more organ function obstacles integrated levy (MODS) 5 shock 5 heart sudden stopped, and breathing sudden stopped 2 (2) clinical operation technology requirements: clinical operation technology name contract times (?) guardianship instrument using 30 by skin Center vein reset tube operation 5 by skin outside week artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electricweek artery puncture reset tube operation 2 artery blood 10 breathing machine using 10 electric except fibrillation and complex law 2 3. high requirements ( 1) disease and number of contracts number of disease syndrome after cardiopulmonary resuscitation in multiple organ dysfunction syndrome more than 2 2 (2) clinical knowledge, skills required: clinical operations technical contract blood purification technique 2 people ... ... (1) the number of species and number of cases (?) gallstone 2 peptic ulcer .... 2. basic requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number (?) local infiltration anesthesia of management 2 vertebral tube anesthesia of management 10 body anesthesia of management 10 (2) clinical operation technology requirements: clinical operation technology name contract times (?) around neural block operation 2 supporting jaw method (open gas road) 10 technique artificial ventilation (using anesthesia machine) 5 ball SAC-mask breathing device 5 fast tracheal within intubation operation 10 artery puncture reset tube operation 5 heart electric monitoring 10 pulse oxygen monitoring 10 has create blood pressure monitoring 10 3. high requirements (1) learning disease species and the cases number requirements: anesthesia implementation and management contract number vertebral tube anesthesia of implementation 2 body anesthesia of implementation 2 arm bundle neural block 2 (2) clinical knowledge, and skills requirements: clinical operation technology name contract times mechanical ventilation (anesthesia breathing machine) 10 control sex low blood pressure 2 by skin Center vein puncture reset tube 2 (3) language, and teaching, and research, capacity of requirements: