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Campral DSPK Release Tablets 333mg(阿坎酸钙缓释片)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 333毫克/片 180片/盒 
包装规格 333毫克/片 180片/盒 
计价单位: 盒 
生产厂家中文参考译名:
FOREST LABS
生产厂家英文名:
FOREST LABS
该药品相关信息网址1:
http://www.campral.com
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
CAMPRAL DSPK 333mg/tab 180tabs/box
原产地英文药品名:
ACAMPROSATE CALCIUM
中文参考商品译名:
坎普劳板装 333毫克/片 180片/盒
中文参考药品译名:
阿坎酸钙
曾用名:
简介:

 

FDA批准治疗酒精中毒的新药.(通用名:阿坎酸[acamprosate])
7月29日,FDA宣布批准新药Campral(商品名:坎普劳;通用名:阿坎酸[acamprosate])用于治疗已经停止饮酒后寻求继续戒酒的酒精依赖者(alcohol dependent individuals)。Campral对于在治疗开始时仍频繁饮酒,或滥用除酒精之外的其它物质的患者,可能不具疗效。
Campral是十年来获准的第一个用于治疗酒精滥用(alcohol abuse)的新药。
酒精中毒(alcoholism),又称酒精依赖(alcohol dependence),是一种疾病。酒精滥用(alcohol misuse)将造成严重后果,在很多情况下,甚至是威胁生命的。大量饮酒增加患某些癌症的风险,特别是肝脏、食管、咽和喉头等部位的癌症。大量饮酒也会引起肝硬化(liver
cirrhosis)、免疫系统疾病、脑损害;如果在怀孕期,将对胎儿造成伤害。慢性酒精中毒(chronic alcoholism)一直以来都是一个普遍存在的消耗性疾病,在医疗保健费用(healthcare costs)、工资损失和个人身心痛苦等方面对社会造成巨大负担。
Campral的作用机制尚未完全明了,目前认为它是通过作用于与酒精滥用有关的脑通路。通过包括已放弃酒精摄入的酒精依赖患者(即,已戒酒者[detoxified])的多重安慰剂对照临床试验,Campral被证明是安全和有效的。鉴于接受阿坎酸治疗的受试者中较大比例被评定为在整个治疗中达到持续性戒酒,证明Campral在维持戒酒(abstinence)(保持使患者不消费酒)中优于安慰剂。Campral没有成瘾性,并且在临床试验中普遍有良好的耐受性。所报告的患者最常见不良事件,包括头痛、腹泻、胃气胀和恶心。
Campral治疗应作为包括心理社会支持在内的综合治疗项目的一部分。
Campral的申报者是位于法国里昂的Lipha Pharmaceuticals, Inc.(利伐制药公司)。
Campral®
contains the active ingredient acamprosate calcium
CONSUMER MEDICINE INFORMATION
General Information
Campral (acamprosate) is a structural analogue of the amino acid homotaurine and the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). While it's specific mechanism of action is not entirely understood, neurotransmossion systems involving GABA and it's excitatory counterpart glutamate are observed to be thrown out of equilibrium when chronically exposed to alcohol; Campral, by mimicing GABA's actions and interacting with these systems directly, is thought to help restore this equilibrium.
It is specifically indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. It has not been established as effective for initiating abstinence in patients who have not done so on their own prior to taking the drug, and it was designed to be a portion of a full behavioral and pharmacological treatment program. Campral has also not been shown to be effective in patients with multiple subtance dependencies including alcohol.
Campral is administered as an oral tablet, with a recommended dosage of two tablets (each containing 333 mg of Campral) thrice daily.
Clinical Results
FDA approval of Campral was based on three double-blind, placebo-controlled clinical studies enrolling a combined total of 998 subjects. The trials ranged from 90 to 360 days, with all subjects receiving at least one dose of Campral or placebo. All subjects had a history of alcohol abuse and dependence, and all had undergone inpatient detoxification and were abstinent from alcohol on the day of randomization. All subjects received their treatment in combination with standard psychosocial couselling. In all three studies, treatment with Campral yielded a greater portion of subjects maintaining abstinence than with placebo.
A fourth clinical study invesigated the efficacy of Campral in subjects with multiple substance dependencies, and in patients who had not established abstinence prior to dosing. In these studies, Campral was not shown to be superior to placebo.
Side Effects
Adverse events associated with the use of Campral may include, but are not limited to, the following:
•Diarrhea
•Nausea
•Flatulence
•Pruritus
In addition to these events, acute kidney failure was observed in 3 subjects during the trials. A causal role of Campral has not been found, and it has not been determined if these events were relevant to clinical treatment.
Mechanism of Action
Campral (acamprosate) is a structural analogue of the amino acid homotaurine, the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), and the neuromodulatory amino acid taurine. The drug's specific mechanism of action is not entirely understood, but it is thought to help restore GABA-glutamate equilibrium by acting specifically on sites of alcohol dependence. It has been shown to have little to no additional CNS activity, and did not demonstrate significant behavioral effects (depression, anxiety, dizziness, etc.) significantly more often than placebo. 

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