基于倾向性评分匹配法的针刺戒烟随机对照研究与队列研究的疗效比较
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摘要
目的:比较针刺戒烟的随机对照研究与队列研究的临床疗效差异,为进一步明确针刺戒烟的疗效提供循证医学证据。方法:分析针刺戒烟的随机对照研究(CATCR)与香港"中医针灸戒烟"队列研究的受试者信息,确定最小数据集,以8周戒烟成功率作为主要结局指标,采用SPSS 24.0软件对两项研究的受试者资料进行倾向性评分匹配(PSM)分析,得到组间协变量均衡的样本,并利用新样本进行疗效比较。结果:共100例CATCR研究的受试者和3 967例香港"中医针灸戒烟"研究的受试者纳入分析,并在性别、年龄、教育程度、吸烟特点等方面均存在统计学差异(P<0.05)。经PSM处理后,99对受试者匹配成功,且各基线变量均无统计学差异;队列研究8周戒烟率为34.34%,与CATCR的35.35%相比差异无统计学意义(OR=0.97,95%CI[0.56,1.68]);20个亚组人群中,仅5个亚组人群在两项研究中的戒烟成功率存在显著差异(P<0.05);队列研究复吸者的开始复吸时间为23.35d,与RCT的25.21d相比差异无统计学意义。结论:针刺戒烟的疗效与有效性相当,故而可以作为临床实际有效的戒烟方法进行推广使用。
Objective: To compare the clinical differences between randomized controlled study and cohort study of acupuncture for smoking cessation, and to provide evidence-based medical evidence for further clarifying the efficacy of acupuncture for smoking cessation. Methods: The information of subjects in the randomized controlled study and cohort study of acupuncture for smoking cessation were analyzed, and the minimum data set was determined. The success rate of smoking cessation in 8 weeks was taken as the main outcome index. PSM was performed by software SPSS 24.0, and the new data was obtained and compared. Results: A total of 100 subjects in RCT and 3 967 subjects in cohort study were included in the analysis, and there were statistical differences in gender, age, education level and smoking characteristics(P<0.05). After PSM, 99 pairs of subjects were successfully matched, and there was no statistical difference among the baseline variables; smoking cessation rate was 34.34% in 8 weeks of cohort study, and there was no significant difference compared with 35.35% of RCT(OR= 0.97, 95%CI[0.56, 1.68]); among 20 subgroups, only 5 subgroups had different quit rates(P<0.05). The time to relapse in cohort study was 23.35 days, and there was no significant difference compared with 25.21 days of RCT. Conclusion: The effectiveness and efficacy of acupuncture for smoking cessation was similar, so it can be used as a practical and effective method for quitting smoking in clinic.
Objective: To compare the clinical differences between randomized controlled study and cohort study of acupuncture for smoking cessation, and to provide evidence-based medical evidence for further clarifying the efficacy of acupuncture for smoking cessation. Methods: The information of subjects in the randomized controlled study and cohort study of acupuncture for smoking cessation were analyzed, and the minimum data set was determined. The success rate of smoking cessation in 8 weeks was taken as the main outcome index. PSM was performed by software SPSS 24.0, and the new data was obtained and compared. Results: A total of 100 subjects in RCT and 3 967 subjects in cohort study were included in the analysis, and there were statistical differences in gender, age, education level and smoking characteristics(P<0.05). After PSM, 99 pairs of subjects were successfully matched, and there was no statistical difference among the baseline variables; smoking cessation rate was 34.34% in 8 weeks of cohort study, and there was no significant difference compared with 35.35% of RCT(OR= 0.97, 95%CI[0.56, 1.68]); among 20 subgroups, only 5 subgroups had different quit rates(P<0.05). The time to relapse in cohort study was 23.35 days, and there was no significant difference compared with 25.21 days of RCT. Conclusion: The effectiveness and efficacy of acupuncture for smoking cessation was similar, so it can be used as a practical and effective method for quitting smoking in clinic.
引文
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[14]Dalby M,Bouzamondo A,Lechat P,et al.Transfer for primary angioplasty versus immediate thrombolysis in acute myocardial infarction:A meta-analysis.Circulation,2003,108:1809-1814
[15]Singal A G,Higgins P D,Waljee A K.A primer on effectiveness and efficacy trials.Clin Transl Gastroenterol,2014(5):e45
[16]Heather N.The efficacy-effectiveness distinction in trials of alcohol brief intervention.Addict Sci Clin Pract,2014(9):13
[17]孙婷,秦国友,武振宇,等.不同混杂结构条件下各倾向性评分方法的模拟比较研究.中国卫生统计,2017,34(3):415-420
[2]Doll R,Peto R,Boreham J,et al.Mortality in relation to smoking:50 years’observations on male British doctors.BMJ,2004,328(7455):1519
[3]Cao Y,Kenfield S,Song Y,et al.Cigarette smoking cessation and total and cause-specific mortality:a 22-year follow-up study among US male physicians.Arch Intern Med,2011,171(21):1956-1959
[4]刘朝,王莹莹,吴远,等.针灸戒烟现状与疗效评价分析.中国针灸,2015,35(8):851-857
[5]方幼安,李其松.耳针戒烟的临床研究.上海针灸杂志,1985,4(2):30
[6]Wang Y Y,Liu Z,Wu Y,et al.Efficacy of acupuncture is noninferior to nicotine replacement therapy for tobacco cessation:Results of a prospective,randomized,active-controlled ipen-label trial.Chest,2018,153(3):680-688
[7]Wang Y Y,Liu Z,Wu Y,et al.Acupuncture for smoking cessation in Hong Kong:A prospective multicenter observational study.Evid Based Complement Alternat Med,2016:2865831
[8]Rosenbaum P R,Rubin D B.The central role of the propensity score in observational studies for causal effects.Biometrika,1983,70(1):41-55
[9]Stuart B L,Grebel L E,Butler C C,et al.Comparison between treatment effects in a randomised controlled trial and an observational study using propensity scores in primary care.Br J Gen Pract,2017,67(662):e643-e649
[10]Bolland M J,Grey A,Gamble G D,et al.Concordance of results from randomized and observational analyses within the same study:Are-analysis of the women’s health initiative limited-access dataset.PLo S One,2015,10(10):e0139975
[11]Chikwe J,Chiang Y P,Egorova N N,et al.Survival and outcomes following bioprosthetic vs mechanical mitral valve replacement in patients aged 50 to 69 years.JAMA,2015,313(14):1435-1442
[12]Selker H P,Oye K A,Eichler H G,et al.A proposal for integrated efficacy-to-effectiveness(E2E)clinical trials.Clin Pharmacol Ther,2014,95(2):147-153
[13]Keeley E C,Boura J A,Grines C L.Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction:Aquantitative review of 23 randomised trials.Lancet,2003,361:13-20
[14]Dalby M,Bouzamondo A,Lechat P,et al.Transfer for primary angioplasty versus immediate thrombolysis in acute myocardial infarction:A meta-analysis.Circulation,2003,108:1809-1814
[15]Singal A G,Higgins P D,Waljee A K.A primer on effectiveness and efficacy trials.Clin Transl Gastroenterol,2014(5):e45
[16]Heather N.The efficacy-effectiveness distinction in trials of alcohol brief intervention.Addict Sci Clin Pract,2014(9):13
[17]孙婷,秦国友,武振宇,等.不同混杂结构条件下各倾向性评分方法的模拟比较研究.中国卫生统计,2017,34(3):415-420