国内外戒烟临床随机对照试验结局指标报告文献分析

Literature Analysis of the Reporting of Outcome Measurements in Randomized Controlled Trials of Smoking Cessation

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 Through the analysis on outcome measurements in domestic and overseas randomized controlled trials（RCTs） of smoking cessation, this study aimed to provide references for clinical trial design in the future. Methods We searched CNKI, Wan Fang Data, VIP, Pub Med, EMbase, Science Direct and Spring Link databases to collect RCTs regarding smoking cessation from January 1998 to December 2013. Two reviewers screened literature according to the inclusive and exclusive criteria, extracted the data, and analyzed the outcome measurements of included RCTs. Results A total of 68 RCTs regarding smoking cessation were included. As for the baseline measurements, the frequency from high to low were age, sex, daily cigarette, smoking duration, Fagerstrom Test For Nicotine Dependence（FTND）, race and education, etc.; there were significant differences of race, education level, smoking duration, smoking, starting age of smoking, attempts of trying to stop smoking, the presence of other basic disease, FTND and quit date between English and Chinese RCTs（all P〈0.05）. As for efficacy measurements, the continuous abstinence rate（77.8%） was mainly adopted in Chinese RCTs, while point abstinence rate（95.1%） and continuous abstinence rate（82.9%） was selected in English RCTs. As for the follow-up measurements, 22.1% of the included RCTs did not report it, 70.6% of the RCTs reported abstinence rate, and the follow-up time in Chinese RCTs was shorter than that in the English RCTs（P〈0.05）. Conclusion The selection of outcome measurements is significantly different among RCTs regarding smoking cessation, the Chinese RCTs are inferior to English RCTs, and these are needed to be improved in the future clinical trials.