摘要
目的:通过尼古丁舌下含片用于戒烟的随机双盲安慰剂对照的临床验证,评价尼古丁舌下含片用于戒烟的有效性及安全性。方法:①纳入对象240例来源于和平里医院所属社区卫生服务站(为2006-04/12广告招募所收集),均为尿可的宁检测呈阳性的吸烟患者240例,其中安慰剂组120例、尼古丁舌下含片组120例;年龄18～65岁。纳入者均有1年以上吸烟史,每日吸烟10支以上(含10支),并至少有过一次戒烟失败史,且均对试验目的知情同意。②尼古丁舌下含片组采用尼古丁舌下含片(北京泽生生物技术研究所研制,活性成分是尼古丁)进行干预。给药方法为替代递减给药方案,剂量根据FTND(Fagerstrom烟碱依赖量表)分值确定(FTND≥7分者为重度依赖),治疗范围为0～20片/d;安慰剂组:给予口服淀粉制备的安慰剂。两组均干预8周,指标观察至停药后4周。③以戒烟成功率、吸烟量减少情况、CO呼出量评估疗效。安全性评价依据不良事件、心电图、实验室检查、生命体征和体格检查等。④疗效比较采用配对t检验、组间t检验或秩和检验。副反应频度和严重程度比较采用χ2检验。结果:两组各115例进行疗效和安全性评价。疗效:①戒烟成功率与有效率:安慰剂组于治疗结束时戒烟成功率和戒烟总有效率分别为19.1%和57.4%,低于尼古丁舌下含片组(52.2%,85.2%)。②CO呼出量:两组在治疗开始时和治疗第4天比较,差异无显著性意义,以后至实验结束时比较,差异均有显著性意义(P<0.05)。服药安全性:尼古丁舌下含片不良反应轻,局部和全身的不良反应随药物使用时间的延长而逐渐减轻,适于长期服用。结论:①尼古丁舌下含片用于戒烟的疗效明显优。②尼古丁舌下含片的不良反应轻,耐受性好,是有效、安全的戒烟药物。
AIM： Through a double-blind randomized placebo-controlled clinical trial to evaluate the efficacy and safety of nicotine sublingual tablet for smoking cessation. METHODS： （1）A total of 240 smokers, aged 18 to 65 years old, from the community medical service station of He Pingli Hospital were recruited for recruiting in the advertisement from April to December 2006. All the participants with positive urinary cotinine excretion were randomized into two groups, placebo-controlled group （n =120） and nicotine sublingual tablet group （n =120）. The included patients were with at least one-year smoking history, smoking 10 or more cigarettes per day, at least one quit attempt failure. They all knew and agreed to participate in the experiment. （2）The patients in the nicotine sublingual tablet group received nicotine sublingual tablet that was produced by Beijing Zesheng Biotechnology Institute and the active component was nicotine. According to scores on the Fagerstrom Test for Nicotine Dependence （FTND, high nicotine dependence with the scores of FTND at least 7 points）, nicotine replacement therapy was offered, 0 to 20 tablets per day with doses decreased progressively. The patients in the placebo-controlled group received starch-prepared placebo orally. The intervention was performed for 8 weeks, whereas indexes were observed until 4 weeks after treatment. （3）The therapeutic effect was mainly evaluated by the successful rate of smoking cessation, decreasing rate of smoking and exhaled carbon monoxide concentration. The safety of this therapy was also evaluated by side event, electrocardiogram, laboratory examination, vital sign and physical inspection. （4）Paired t test, interclass t test or rank-sum test were used to assess curative effect. Х^2 test was applied to determine side reaction frequency and severity. RESULTS： 115 cases in each group received curative effect and safety evaluation.（1）Successful rate and effective rate of smoking cessation in the placebo-controlled group （19.1%, 57.4%） were lower than those in the nicotine sublingual tablet group （52.2%, 85.2%）at the end of treatment. （2）Exhaled carbon monoxide concentration did not show significant difference at the beginning and at day 4 between the two groups, but showed significant differences at the end of the treatment （P 〈 0.05）. All the abnormal symptoms in local or the whole body due to nicotine sublingual tablet diminished with time and the dose tapered, so it was fit for long-term administration. CONCLUSION： （1）Curative effect of nicotine sublingual tablet for smoking cessation is clearly effective. （2） Nicotine sublingual tablet with mild side-effects is effective, safe and well tolerated for smoking cessation.
出处
《中国组织工程研究与临床康复》
CAS
CSCD
北大核心
2007年第52期10443-10446,共4页
Journal of Clinical Rehabilitative Tissue Engineering Research
