中村M,大岛渚,藤本Y, Maruyama N, Ishibashi T,李维斯KR
伐伦克林的疗效和耐受性就是alpha4beta2烟碱乙酰胆碱受体部分激动剂,在12周,随机、安慰剂对照、剂量反应和40周的随访研究在日本吸烟者戒烟。
其他。2007年6月,29 (6):1040 - 56。
背景:伐伦克林,选择性就是alpha4beta2烟碱乙酰胆碱受体部分激动剂,专为戒烟了。在日本,39.3%的男性吸烟,这是一个重大的公共卫生问题。摘要目的:本研究的主要目的是评估的有效性和剂量反应关系伐伦克林在日本吸烟者。方法:在这个双盲,安慰剂对照、随机、与这些相应平行的组织研究中,受试者被随机分配接受伐伦克林在0.25毫克出价,出价0.5毫克,1毫克,为12周,后跟一个40周或安慰剂,:后续阶段。主要疗效变量是连续禁欲率(汽车),定义为没有报道吸烟(甚至一口)或其他使用尼古丁和呼气末证实了一氧化碳的水平
或在烟草依赖过滤网= 5),构成了主要的分析。其中,385例(74.8%)受试者男性,平均年龄是39.0至40.2的范围内。在治疗组中,受试者声称吸烟平均每天23.1到24.9香烟的前30天,和Fagerstrom测试尼古丁依赖的平均评分从5.4到5.7范围内。周9 - 12的车是明显高于所有剂量的伐伦克林与安慰剂相比(39.5% [51/129])。车最高的65.4%(85/130),伐伦克林实现了1毫克报价(优势比[或][95%可信区间]= 2.98 (1.78 - -4.99);P < 0.001)。车数周伐伦克林1毫克竞标9-52明显大于安慰剂(34.6%(45/130)和23.3% (30/129);或(95%置信区间)= 1.81 (1.04 - -3.17);P = 0.036)。周9-24汽车的0.25、0.5和1毫克报价分别为33.6%(43/128),35.2%(45/128),37.7%(49/130),在0.25和0.5毫克数周9-52出价有27.3%(35/128)和28.9%(37/128),但未能达到意义和安慰剂(29.5%[38/129]数周9-24为周9-52)和23.3% (30/129)。 Treatment-emergent adverse events (AEs) were more prevalent among varenicline-treated subjects (79.1% [121/153] at 0.25 mg BID, 80.6% [125/155] at 0.5 mg BID, and 80.1% [125/156] at 1 mg BID) than placebo subjects (71.4% [110/154]). The 3 most prevalent AEs at varenicline 1 mg BID were nasopharyngitis (35.9% [56/156]), nausea (24.4% [38/156]), and headache (10.3% [16/156]), all of which were of mild or moderate intensity. Nausea was the only AE that appeared dose related (7.2% [11/153] at 0.25 mg BID, 9.7% [15/155] at 0.5 mg BID, and 24.4% [38/156] at 1 mg BID) versus placebo (7.8% [12/154]). CONCLUSIONS: Varenicline was associated with dose-dependent improvement in smoking abstinence rates during the last 4 weeks of treatment and in the longer term over 40 weeks of nontreatment follow-up. The dose associated with the highest efficacy was varenicline 1 mg BID.