Ferry L, Johnston J A
School of Medicine and Public Health, Loma Linda University, Yucaipa, California 92350, USA.
Int J Clin Pract. 2003 Apr;57(3):224-30.
Bupropion SR was introduced for smoking cessation in the US in 1997. This review assesses the efficacy and safety of bupropion SR for treatment of tobacco dependence based on data from clinical trials and five years of postmarketing experience. Through June 2001, there were approximately 32 million patient exposures to bupropion (9 million for smoking cessation) in clinical practice, and more than 8000 patients have been studied in clinical trials for tobacco dependence. In clinical trials, bupropion SR was more effective than placebo at improving initial and long-term abstinence rates and preventing relapse. Bupropion SR is generally well tolerated. The most common adverse event in clinical trials or clinical practice is insomnia, which can also be a symptom of nicotine withdrawal. The two main risks of treatment with bupropion SR are major motor seizure and hypersensitivity reaction. Clinical trials data suggest that the incidence of seizure is approximately 0.1%, and that of serious cases of hypersensitivity approximately 0.12%. Benefit-risk assessment, assuming a 30% one-year quit rate demonstrates that for every 10,000 smokers treated with bupropion SR, 19 lives are saved and 86 cases of smoking-attributed morbidity are averted in a five-year period while the risk of experiencing one of the two potentially serious adverse events during treatment is 0.22%. These data further establish both the efficacy and safety of bupropion SR and its use in preventing the adverse health effects of chronic tobacco use.
安非他酮缓释片于1997年在美国被用于戒烟。本综述基于临床试验数据和五年上市后经验，评估了安非他酮缓释片治疗烟草依赖的疗效和安全性。截至2001年6月，在临床实践中约有3200万患者使用过安非他酮（900万用于戒烟），并且有超过8000名患者参与了烟草依赖的临床试验。在临床试验中，安非他酮缓释片在提高初始和长期戒烟率以及预防复吸方面比安慰剂更有效。安非他酮缓释片一般耐受性良好。临床试验或临床实践中最常见的不良事件是失眠，而失眠也可能是尼古丁戒断的一种症状。使用安非他酮缓释片治疗的两个主要风险是严重运动性癫痫发作和过敏反应。临床试验数据表明，癫痫发作的发生率约为0.1%，严重过敏反应的发生率约为0.12%。效益风险评估假设一年戒烟率为30%，结果显示，每10000名使用安非他酮缓释片治疗的吸烟者中，在五年内可挽救19条生命，避免86例与吸烟相关的发病情况，而治疗期间发生两种潜在严重不良事件之一的风险为0.22%。这些数据进一步证实了安非他酮缓释片的疗效和安全性及其在预防慢性烟草使用对健康造成不良影响方面的作用。
