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  药店国别: 美国药房
产地国家: 美国
所属类别: 心血管系统药物->治疗心衰药物
处方药:处方药
包装规格: 1.5毫克/毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
SCIOS
生产厂家英文名:
SCIOS
该药品相关信息网址1:
http://www.drugs.com/natrecor.html
该药品相关信息网址2:
http://www.rxlist.com/natrecor-drug.htm
该药品相关信息网址3:
http://www.medilexicon.com/drugs/natrecor.php
原产地英文商品名:
NATRECOR 1.5mg/ml/Vial
原产地英文药品名:
NESIRITIDE
中文参考商品译名:
NATRECOR 1.5毫克/毫升/瓶
中文参考药品译名:
奈西立肽重组
原产地国家批准上市年份:
2001/08/10
英文适应病症1:
Acute congestive heart failure
英文适应病症2:
Difficulty in breathing
临床试验期:
完成
中文适应病症参考翻译1:
急性充血性心力衰竭
中文适应病症参考翻译2:
呼吸困难
药品信息:

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 详细处方信息以本药内容附件PDF文件(201242223205323.PDF,200952505155210.pdf)的“原文Priscribing Information”为准
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部分中文Natrecor处方资料(仅供参考)

美国食品药物管理局(FDA) 2001年8月批准上市   
    Scios公司生产, 用于急性充血性心力衰竭。
    Nesiritide是基因工程重组人B型促尿钠排泄肽(hBNP)。BNP和血管平滑肌细胞及上皮细胞上的鸟甘酸环化酶受体结合, 使细胞内的第二信使环磷酸鸟甘(cGMP)的浓度增加, 而环磷酸鸟甘具有舒張平滑肌細胞,扩张动静脉血管的作用。
    充血性心力衰竭是心脏功能減退,引起左室排血量減少,进而不能滿足机体的需要。心功能不全的患者攝入钠过多或者漏服药物可以引起急性充血性心力衰竭,此时患者的循患功能进一步下降,通常需要入院治疗。
    10项的临床试验共有941名充血性心力衰竭患者参与, 靜息时均有時气短症状。在基础治疗上,试验比较了Natrecor、安慰剂和静脉用硝酸甘油的效果。观察的指标为用药后3小时, 肺毛细血管压的改变和患者呼吸困难的改善情况, 结果显示, 和安慰剂组相比, Natrecor組患者呼吸困难好转的程度更大;与硝酸甘油組相比,Natrecor組患者的肺毛細血管压明显降低。在另一項双盲试验中, 分別接受兩种种不同剂量的Natrecor的患者用药后6小时呼吸困难症状的改善程度都好于安慰剂組。
    副作用有:高血压, 室性心动过速, 心絞痛、心搏过缓、头痛、腹痛、背痛、失眠、头昏、焦虑、恶心、呕吐等。

分类名称
一级分类:循环系统药物 二级分类:抗心功能不全药物 三级分类:其他 
 
药品英文名
Nesiritide
 
药品别名
利钠肽、脑促尿钠排泄肽、Natrecor
 
药物剂型
注射剂:1.5mg(含奈西立肽1.58mg,枸橼酸2.1mg,枸橼酸钠二水合物294mg)。
 
药理作用
本品为人工合成的基因重组人B型利钠肽(recombined human B-type natriuretic peptide,rhBNP),与心室肌分泌的天然利钠肽具有相同的32个氨基酸序列。本品能与血管平滑肌和内皮细胞上的鸟苷酸环化酶受体结合,增加细胞内的cGMP的含量,cGMP作为第二信使使动静脉扩张。研究显示,本品能使内皮素Ⅰ或α-肾上腺素受体激动剂处理的离体人动脉和静脉舒张。在人体,本品能剂量依赖性降低心衰患者肺毛细血管嵌楔压(pulmonary capillarywedge pressure,PCWP)和动脉压力。
 
药动学
充血性心衰患者静滴或静注本品后,血浆中呈双相分布,平均终末消除半衰期为18min,平均起始消除相约为2min,中央室分布容积为0.073L/kg,平均稳态分布容积(Vss)为0.19L/kg,平均清除率(CL)为9.2ml/(kg·min)。静注本品0.01~0.03mg/(kg·min)达稳态后,血浆奈西立肽水平比基础水平提高3~6倍。本品代谢途径主要有三条:与细胞表面的消除受体结合,被细胞溶酶体酶分解;被肽类内肽酶(如血管表面的中性肽链内切酶)溶蛋白性分解;经肾脏滤过。
 
适应证
本品用于急性代偿失调性充血性心力衰竭伴休息时或轻微活动时呼吸困难的患者,降低肺毛细血管嵌楔压,改善呼吸困难症状。
 
禁忌证
1.对本品及其中任何成分过敏的患者禁用。收缩压≤90mmHg的患者禁用。3.心源性休克的患者禁用。4.本品不适宜心脏瓣膜狭窄、限制或阻塞性心肌病、缩窄性心包炎、心包填塞等患者。5.已知或怀疑心脏充盈压低的患者避免使用。
 
注意事项
1.本品可引起低血压,舒张压低于100mmHg的患者慎用。孕妇用药安全性尚未确立,孕妇慎用。本品是否通过乳汁分泌尚不清楚,哺乳期妇女慎用。2.尚无儿童应用本品安全性和有效性的研究资料。3.肾功能不足的患者不需调整剂量。4.本品对肺毛细血管嵌楔压、心排血指数、收缩压的影响与肾功能不足(基线血清肌酐的范围2~4.3mg/dl)及正常肾功能的患者没有明显差异。5.本品的清除与患者的体重成正比,应根据患者的千克体重调整剂量。6.本品应新鲜配制,配制的药液2~8℃可保存24h。7.室温保存。
 
不良反应
本品不良反应为低血压、心动过速、房颤、窦房结传导阻滞、注射部位反应、发热、感觉异常、嗜睡、咳嗽、咯血、出汗、腿痛性痉挛、皮疹、皮肤瘙痒、弱视、贫血等。
 
用法用量
静脉给药:初始剂量为2mg/kg静注,然后以0.01mg/(kg·min)静滴。初始剂量不能超过推荐剂量。将本品1.5mg用5%葡萄糖注射液或0.9%氯化钠注射液或5%葡萄糖氯化钠注射液5ml溶解后,加入到250ml上述液体中静滴。
 
药物相应作用
1.本品与肝素、胰岛素、利尿酸钠、布美他尼、依那普利、肼屈嗪、呋塞米等混合可产生理化反应,静滴时不能用同一输液管。2.本品可与肝素钠结合,使用含肝素的注射器可降低本品的作用。3.本品与血管紧张素转化酶抑制剂合用,易导致症状性低血压。4.本品与亚硫酸钠存在配伍禁忌,含亚硫酸钠作为防腐剂的注射剂不能与本品同时输注。
 
Natrecor (nesiritide)
Company: Scios
Approval Status: Approved August 2001
Treatment for: Acutely decompensated congestive heart failure
Areas: Cardiovascular / Cardiology; Diabetes / Endocrinology

General Information
Natrecor has been approved by the FDA for the intravenous treatment of subjects with acutely decompensated congestive heart failure (CHF) who have shortness of breath at rest or with minimal activity.

Natrecor is a recombinant form of human B-type natriuretic peptide (hBNP), a naturally occurring hormone secreted by the ventricles. It is the first of this drug class to be made available as a therapeutic for human disease in the United States. Scios anticipates launching the drug in US hospitals by the end of August.

Congestive heart failure is caused by a reduction in the heart's pumping strength, producing a reduced outflow of blood from the left side of the heart. During acutely decompensated CHF, the heart's already compromised ability to circulate blood throughout the body worsens, causing symptoms to become severe enough to require hospital treatment to stabilize the subject's condition. Events that can precipitate acutely decompensated CHF include a sudden increase in dietary sodium and failure to take chronic oral medications.

Clinical Results
Natrecor has been evaluated in 10 trials that included 941 subjects with congestive heart failure.

The randomized, double-blind VMAC (Vasodilation in the Management of Acute Congestive Heart Failure) trial included 489 subjects who required hospitalization for management of shortness of breath at rest due to acutely decompensated CHF. The trial compared the effects of Natrecor, placebo and intravenous nitroglycerin when added to background therapy. Among other measures, the trial was designed to evaluate the change from baseline in pulmonary capillary wedge pressure (PCWP) and the change from baseline in subjects' dyspnea (abnormal breathing), evaluated after three hours.

Results demonstrated that subjects receiving Natrecor reported greater improvement in their dyspnea at three hours than subjects receiving placebo. Additionally, there was a greater reduction in mean PCWP for the Natrecor-treated group compared to placebo- and nitroglycerin-treated subjects.

In a second double-blind trial, 127 subjects requiring hospitalization for symptomatic CHF were randomized to receive placebo or one of two doses of Natrecor. Results demonstrated that subjects receiving both doses of Natrecor reported greater improvement in dyspnea at six hours compared to subjects receiving placebo.

Side Effects
Adverse events that occurred during the first 24 hours of Natrecor infusion in clinical trials include (but are not limited to) the following:
Hypotension
Ventricular tachycardia (abnormally fast heart rate)
Angina pectoris (chest pain)
Bradycardia (abnormally slow heart rate)
Headache
Abdominal pain
Back pain
Insomnia
Dizziness
Anxiety
Nausea
Vomiting

Mechanism of Action
Human BNP binds to the particulate guanylate cyclase receptor of vascular smooth muscle and endothelial cells, leading to increased intracellular concentrations of guanosine 3'5'-cyclic monophosphate (cGMP) and smooth muscle cell relaxation. Cyclic GMP serves as a second messenger to dilate veins and arteries. Nesiritide has been shown to relax isolated human arterial and venous tissue preparations that were precontracted with either endothelin-1 or the alpha-adrenergic agonist, phenylephrine.

In human studies, nesiritide produced dose-dependent reductions in pulmonary capillary wedge pressure (PCWP) and systemic arterial pressure in subjects with heart failure.

In animals, nesiritide had no effects on cardiac contractility or on measures of cardiac electrophysiology such as atrial and ventricular effective refractory times or atrioventricular node conduction.

Naturally occurring atrial natriuretic peptide (ANP), a related peptide, increases vascular permeability in animals and humans and may reduce intravascular volume. The effect of nesiritide on vascular permeability has not been studied. (from Natrecor Prescribing Information)

Additional Information
For additional information on Natrecor, please visit the Scios web site.

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 详细处方信息以本药内容附件PDF文件(201242223205323.PDF,200952505155210.pdf)的“原文Priscribing Information”为准
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更新日期: 2015-03-24
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