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FDA新药批准最新信息
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Chantix Generic Name: varenicline Date of Approval: May 11, 2006 Company: Pfizer Inc Treatment for: Smoking Cessation -------------------------------------------------------------------------------- The U.S. Food and Drug Administration (FDA) has approved the anti-smoking pill, Chantix (varenicline). Chantix, the first new prescription medication approved for smoking cessation in nearly a decade, received priority review designation by the FDA because of its potential to be a significant therapeutic advance over existing therapies. Addiction to nicotine is a habit that is very difficult for many smokers to quit. When smokers inhale smoke from a cigarette, nicotine reaches the brain within seconds and binds to nicotinic receptors, which activates the reward pathway in brain circuitry. This stimulates the pleasure center in the brain. The initial effects recede quickly and a cycle of craving and withdrawal takes hold. Chantix is unique because it is specifically designed to partially activate the nicotinic receptor and reduce the severity of the smoker's craving and the withdrawal symptoms from nicotine. Moreover, if a person smokes a cigarette while receiving treatment, Chantix has the potential to diminish the sense of satisfaction associated with smoking. This may help to prevent the cycle of nicotine addiction. Chantix's approval was based on a comprehensive clinical trial program including four pivotal trials involving more than 2,000 cigarette smokers. Subjects on average had smoked about 21 cigarettes per day for an average of approximately 25 years. In two identically designed studies, patients receiving a 12-week course of Chantix therapy (1 mg twice daily) nearly quadrupled the likelihood of quitting than those taking placebo and had nearly twice the likelihood of quitting than those patients taking buproprion (150 mg twice daily), after the 12-week course of therapy. Enrolled patients were provided with educational materials. Patients were followed for an additional 40 weeks without treatment. After one year, approximately one-in-five patients who received the 12-week course of Chantix remained smoke-free. For those patients who quit at the end of 12 weeks, an additional course of 12 weeks treatment with Chantix resulted in a greater likelihood of long-term success in quitting smoking. In trials, Chantix was generally well tolerated, with overall discontinuation rates similar to placebo. The most common side effects included nausea, changes in dreaming, constipation, gas and vomiting. Because smokers need considerable support to successfully quit, Chantix will be available to patients with a support program designed to help address behavioral components of smoking dependence. This personalized program will be free and easy to use. |
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目前，全球吸烟人数估计有１２．５亿人，尽管有７０％的吸烟者很想戒烟，但是最后能成功戒烟的不超过５％。辉瑞公司研发的戒烟药Ｖａｒｅｎｉｃｌｉｎｅ可减少戒断症状，将为戒烟药物产业带来一场革命。 烟草中的生物碱尼古丁被认为是致使吸烟成瘾的化合物，它直接作用于中枢神经系统，被吸入后在吸烟者的大脑中扩散，与尼古丁受体发生作用，激活脑细胞释放多巴胺。而多巴胺与人类产生愉快感觉息息相关，一旦吸烟者对吸烟产生的愉悦感觉产生依赖，戒烟就困难了。目前，尼古丁替代疗法基本统领戒烟药市场，一些采用含有尼古丁的贴片、口香糖、鼻喷雾剂和吸入剂帮助吸烟者在戒烟过程中克服因体内缺乏尼古丁引起的各种戒断症状。目前市场上惟一的非尼古丁戒烟药为葛兰素史克公司的安非他酮（ｂｕｐｒｏｐｉｏｎ，Ｚｙｂａｎ）。 Ｖａｒｅｎｉｃｌｉｎｅ是一种非尼古丁产品，可选择性作用于脑中的α４－β２尼古丁受体。该品可以与脑中的尼古丁受体结合，因此戒烟的同时可减少戒断症状。研究显示，Ｖａｒｅｎｉｃｌｉｎｅ疗效优于现有产品。针对不同剂量本品在健康吸烟者中的有效性、安全性和耐受性，两项Ⅱ期临床研究结果显示，半数以上吸烟者每天服用１ｍｇ剂量Ｖａｒｅｎｉｃｌｉｎｅ就停止了吸烟。 有３项研究证明，Ｖａｒｅｎｉｃｌｉｎｅ可使吸烟者成功戒烟的几率提高了１倍。其中２项研究涉及２０００位平均每天吸烟一包的吸烟者。这些吸烟者分别被给予Ｖａｒｅｎｉｃｌｉｎｅ、Ｚｙｂａｎ或安慰剂。治疗１２周后，停药４０周。结果显示，Ｖａｒｅｎｉｃｌｉｎｅ组４４％的吸烟者在１２周内戒烟，Ｚｙｂａｎ组为３０％，安慰剂组为１８％。在停止给药４０周后，一项研究显示，Ｖａｒｅｎｉｃｌｉｎｅ组２２．１％的吸烟者依然戒烟，而Ｚｙｂａｎ组为１６．４％，安慰剂组为８．４％。另一项研究显示了相似的研究结果，Ｖａｒｅｎｉｃｌｉｎｅ组２３％的吸烟者依然戒烟，而Ｚｙｂａｎ组为１５％，安慰剂组为１０％。第３项研究评估了在服用Ｖａｒｅｎｉｃｌｉｎｅ１２周后成功戒烟的１２００位吸烟者将其分为２组，一组再接受Ｖａｒｅｎｉｃｌｉｎｅ１２周的治疗，另一组给予安慰剂。在第２个疗程开始的６个月后，Ｖａｒｅｎｉｃｌｉｎｅ组７０％的吸烟者停止吸烟，安慰剂组为５０％。一年后，Ｖａｒｅｎｉｃｌｉｎｅ组连续戒烟率达４４％，安慰剂组为３７％。 |
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4楼2006-05-13 23:21:22