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目的通过分析国内外发表的戒烟临床随机对照试验(RCT)的结局指标,为戒烟RCT的临床试验设计提供参考依据。方法计算机检索CNKI、Wan Fang Data、VIP、Pub Med、Science Direct、EMbase和Spring Link数据库,纳入戒烟相关RCT,检索时限从1998年1月至2013年12月。由两位研究者独立按照纳入与排除标准筛选文献、提取资料,对纳入研究的结局指标进行统计与分析。结果共纳入68个戒烟相关RCT。对于基线指标,纳入RCT选择频次依次为年龄、性别、每日吸烟数、烟龄、尼古丁依赖检验量表(FTND)、种族和教育程度等;中、英文RCT在种族、教育程度、烟龄、吸烟起始年龄、尝试戒烟次数、有无其他基础病、FTND和戒烟日的选择存在明显差异(P<0.05)。对于疗效评价指标,中文RCT多选择持续戒断率(77.8%),而英文RCT除报告最多的为点戒断率(95.1%)和持续戒断率(82.9%)。对于随访指标,22.1%的RCT未报告,70.6%的RCT报告了戒断率,中文RCT随访时间明显短于英文RCT。结论目前戒烟相关RCT结局指标的选择存在差异,中文RCT差于英文RCT,需在今后的临床试验中加以注意和改进。
Objective To provide a reference for clinical trial design of smoking cessation by analyzing the outcome of clinical randomized controlled trials (RCT) of smoking cessation published in China and abroad. Methods The databases of CNKI, Wan Fang Data, VIP, Pub Med, Science Direct, EMbase and Spring Link were searched by computer and included in smoking cessation related RCTs. The search time was from January 1998 to December 2013. Two researchers independently screened the documents according to inclusion and exclusion criteria, extracted data, and counted and analyzed the outcome indicators included in the study. Results A total of 68 smoking cessation-related RCTs were included. For the baseline indicators, the frequency of inclusion in the RCTs was age, sex, number of smokers per day, smoking age, nicotine dependence test scale (FTND), ethnicity and educational attainment. The Chinese and English RCTs had significant differences in terms of race, education level, The starting age of smoking, the number of smoking cessation attempts, and other underlying diseases, there was a significant difference in the choice of FTND and smoking cessation day (P <0.05). For curative effect evaluation, Chinese RCT mostly chose to continue with abstinence rate (77.8%), while English RCT had the highest abstinence rate (95.1%) and continuous abstinence rate (82.9%) except the report. For follow-up, 22.1% of RCTs were unreported, 70.6% of RCTs reported abstinence rates, and Chinese RCTs were significantly shorter than English RCTs. Conclusions There are differences in the choice of RCT outcomes related to smoking cessation. Chinese RCT is worse than English RCT and needs to be noticed and improved in future clinical trials.