缓释安非他酮用于中国吸烟者戒烟：双盲、安慰剂对照、随机临床试验
2012/07/05
摘要
简介：安非他酮是辅助戒烟的一线药物，但尚未有研究在中国人群中采用安非他酮进行戒烟治疗。
方法：本试验为在北京4个门诊中心进行的以医院为基础的、戒烟随机临床试验，入选248名吸烟者。123名参与者接受为期8周的缓释安非他酮（Bup-SR）治疗，125名参与者接受为期8周的安慰剂治疗。所有参与者均接受有关戒烟的简短宣教和咨询。8周和12周时，对基于化学和自我主诉检测的戒断率和吸烟下降进行评价。
结果：治疗结束（8周）和试验结束（12周）时，Bup-SR组的戒断率分别为29.3%和39.8%，安慰剂组分别为10.4%和8.0%（均P<0.001）。在减少每日吸烟量和尿可替宁水平上，Bup-SR优于安慰剂。
结论：对于中国健康吸烟者，门诊采用Bup-SR能有效戒烟，且吸烟者能较好耐受，副作用少。
（陈欣 审校）
Nicotine Tob Res. 2012 May 21. [Epub ahead of print]
Sustained-Release Bupropion for Smoking Cessation in a Chinese Sample: A Double-Blind, Placebo-Controlled Randomized Trial.
Sheng LX, Tang YL, Jiang ZN, Yao CH, Gao JY, Xu GZ, Tong XY
.
Source
Corresponding Author: Li-Xia Sheng, M.D., Department of Medical Affairs, Beijing Anding Hospital, Capital Medical University, Beijing, China, 5 Ankang Lane De Sheng Men Wai, Beijing, China 100088. Telephone: +86-10-5830-3134; Fax: +86-10-5830-3197; E-mail: shenglixia32@126.com.
Abstract
INTRODUCTION: Bupropion is a first-line pharmacological aid for smoking cessation; however, no clinical trials have been conducted in a Chinese population.
METHODS: We enrolled 248 smokers in a hospital-based, randomized, smoking cessation trial conducted at four outpatient centers in Beijing. A total of 123 participants received an 8-week course of sustained-release bupropion (Bup-SR) and 125 participants received 8 weeks of placebo. All participants received brief education and counseling on smoking cessation. We determined rates of abstinence and smoking reduction based on chemical verification and self-report at 8 and 12 weeks.
RESULTS: At the end of the medication treatment (8 weeks) and at the end of the trial (12 weeks), the abstinence rates for Bup-SR were 29.3% and 39.8%, respectively, and 10.4% and 8.0% for placebo, respectively (both p < .001). Bup-SR was also superior to placebo in reducing cigarettes per day and urinary cotinine levels.
CONCLUSION: Bup-SR is efficacious for smoking cessation in healthy Chinese patients treated in the outpatient setting. It is well tolerated with a few mild side effects.
Nicotine Tob Res. 2012 May 21. [Epub ahead of print]
简介：安非他酮是辅助戒烟的一线药物，但尚未有研究在中国人群中采用安非他酮进行戒烟治疗。
方法：本试验为在北京4个门诊中心进行的以医院为基础的、戒烟随机临床试验，入选248名吸烟者。123名参与者接受为期8周的缓释安非他酮（Bup-SR）治疗，125名参与者接受为期8周的安慰剂治疗。所有参与者均接受有关戒烟的简短宣教和咨询。8周和12周时，对基于化学和自我主诉检测的戒断率和吸烟下降进行评价。
结果：治疗结束（8周）和试验结束（12周）时，Bup-SR组的戒断率分别为29.3%和39.8%，安慰剂组分别为10.4%和8.0%（均P<0.001）。在减少每日吸烟量和尿可替宁水平上，Bup-SR优于安慰剂。
结论：对于中国健康吸烟者，门诊采用Bup-SR能有效戒烟，且吸烟者能较好耐受，副作用少。
（陈欣 审校）
Nicotine Tob Res. 2012 May 21. [Epub ahead of print]
Sustained-Release Bupropion for Smoking Cessation in a Chinese Sample: A Double-Blind, Placebo-Controlled Randomized Trial.
Sheng LX, Tang YL, Jiang ZN, Yao CH, Gao JY, Xu GZ, Tong XY
.
Source
Corresponding Author: Li-Xia Sheng, M.D., Department of Medical Affairs, Beijing Anding Hospital, Capital Medical University, Beijing, China, 5 Ankang Lane De Sheng Men Wai, Beijing, China 100088. Telephone: +86-10-5830-3134; Fax: +86-10-5830-3197; E-mail: shenglixia32@126.com.
Abstract
INTRODUCTION: Bupropion is a first-line pharmacological aid for smoking cessation; however, no clinical trials have been conducted in a Chinese population.
METHODS: We enrolled 248 smokers in a hospital-based, randomized, smoking cessation trial conducted at four outpatient centers in Beijing. A total of 123 participants received an 8-week course of sustained-release bupropion (Bup-SR) and 125 participants received 8 weeks of placebo. All participants received brief education and counseling on smoking cessation. We determined rates of abstinence and smoking reduction based on chemical verification and self-report at 8 and 12 weeks.
RESULTS: At the end of the medication treatment (8 weeks) and at the end of the trial (12 weeks), the abstinence rates for Bup-SR were 29.3% and 39.8%, respectively, and 10.4% and 8.0% for placebo, respectively (both p < .001). Bup-SR was also superior to placebo in reducing cigarettes per day and urinary cotinine levels.
CONCLUSION: Bup-SR is efficacious for smoking cessation in healthy Chinese patients treated in the outpatient setting. It is well tolerated with a few mild side effects.
Nicotine Tob Res. 2012 May 21. [Epub ahead of print]
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乙酰胆碱酯酶抑制剂多奈哌齐对未进行戒烟治疗吸烟者认知的影响：初步可行性研究
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