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Elan公司推出新型非阿片类鞘内止痛剂

【 2005-01-14 发布 】 美迪医讯
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Elan公司推出的新型鞘内止痛剂是Conus magus海洋蜗牛体内天然存在的conopeptide合成类似物。这种止痛剂已经获得了美国食品药品管理局的许可。

这种止痛剂叫做Prialt,属于N-型钙通道阻滞剂的非阿片疼痛缓解剂。研究发现药物的作用机制是针对并阻断位于神经纤维上传递疼痛信号的N-型钙通道。Prialt可以长期应用而无需增加剂量。这种止痛剂在三次III期临床试验中涉及了1200多例患者,这些临床试验评估了药物对不能被其它药物或者方法控制的严重慢性疼痛患者的药物效能与安全性。在一项癌症患者的临床试验中,Prialt将疼痛减少了53%。

加利福尼亚州圣地亚哥大学麻醉学教授Mark Wallace医生指出:“总而言之Prialt临床试验结果是无可置疑的其它药物不能缓解的疼痛患者提供了了治疗选择。而且Prialt不会导致药物滥用。”

Prialt是爱尔兰都柏林Elan公司产品,该药是近二十多年来第一个获得批准的新型鞘内止痛剂。

Non-opioid Analgesic for Severe Pain
 
A new intrathecal (IT) analgesic is the synthetic equivalent of a naturally occurring conopeptide
found in a marine snail known as Conus magus. The analgesic has been cleared by the U.S. Food and Drug Administration (FDA).

Called Prialt (ziconotide intrathecal infusion), the analgesic is in a class of non-opioid pain relievers known as N-type calcium channel blockers. Research suggests that its echanism of action works by targeting and blocking N-type calcium channels on nerves that ordinarily transmit pain signals. Prialt can be used long-term without needing the dosage to be increased. The analgesic was tested in three phase III clinical trials involving more than 1,200 patients, which evaluated its efficacy and safety in patients with severe chronic pain not managed by other drugs or systems. In one trial involving cancer patients, Prialt was shown to improve pain reduction by 53%.

“Taken together, the findings from the Prialt clinical trials are conclusive evidence that this therapy represents a significant treatment option for patients who do not have adequate in relief from other therapies,” noted Mark Wallace, M.D., professor of clinical nesthesiology, University of California San Diego (CA, USA; www.ucsd.edu). “Furthermore, Prialt is not associated with the risk of addiction.”

Prialt is the product of Elan Corp. (Dublin, Ireland), which notes that it is the first new IT analgesic approved in more than two decades.

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