尼古丁替代治疗戒烟的不良反应：对177390人参与的120个研究进行的系统综述和荟萃分析
2010/09/14
摘要
背景：尼古丁替代治疗（NRT）是最为常见的戒烟药物治疗形式，已有研究证实了其在治疗烟草依赖方面的有效性。虽然轻度的不良反应是吸烟者采用NRT戒烟动机减弱的一个独立预测因子，但对与NRT有关的不良反应尚未进行准确定量。
目的：本文对包含NRT与对照组的临床随机试验进行系统性综述和荟萃分析，寻找报道NRT不良反应程度的观察性研究。
方法：在10个电子数据库中寻找2009年11月前进行的相关研究。试验入选和数据提取分2次独立完成。采用随机效应法对RCT进行集中分析，优势比（OR）作为效果指标。对观察性研究中的比例进行集中分析。荟萃回归分析用于检测尼古丁贴剂的不良反应是否与其他的NRT治疗（如口服）有所不同。
结果：92项RCT入选，共计有32185名参与者；28项观察性研究入选，包括145205名参与者。RCT研究集中分析显示，不同的NRT治疗都会增加心悸、胸痛 (OR：2.06；95% CI：1.51-2.82, P<0.001)、恶心和呕吐(OR：1.67；95% CI：1.37-2.04, P=<0.001)、 消化道症状 (OR：1.54； 95% CI：1.25-1.89, P<0.001)和失眠(OR：1.42；95% CI：1.21-1.66, P=<0.001)的风险。有证据显示，NRT贴剂能增加皮肤刺激(OR：2.80；95% CI：2.28-3.24, P=<0.001)。口服给予NRT与口腔和咽喉疼痛(OR：1.87；95% CI：1.36-2.57, P=<0.001)、口腔溃疡(OR：1.49；95% CI：1.05-2.20, P=<0.001)、打嗝(OR：7.68；95% CI：4.59-12.85, P=<0.001)和咳嗽(OR：2.89；95% CI：1.92-4.33, P=<0.001)有关。NRT使用与焦虑和抑郁症状无关。非比较性观察研究显示，这些事件在较广范的人群中均有出现。
结论：使用NRT存在一些不良反应。除了进行咨询和医学监测外，临床医生应该告知患者使用NRT治疗烟草依赖的潜在不良反应。
（林江涛 审校）
Tob Induc Dis. 2010 Jul 13;8(1):8. [Epub ahead of print]
Adverse events associated with nicotine replacement therapy (NRT) for smoking cessation. A systematic review and meta-analysis of one hundred and twenty studies involving 177,390 individuals
Mills EJ, Wu P, Lockhart I, Wilson K, Ebbert JO.
Abstract
BACKGROUND: Nicotine replacement therapy (NRT) is the most common form of smoking cessation pharmacotherapy and has proven efficacy for the treatment of tobacco dependence. Although expectations of mild adverse effects have been observed to be independent predictors of reduced motivation to use NRT, adverse effects associated with NRT have not been precisely quantified.
OBJECTIVE: A systematic review and meta-analysis aimed to identify all randomized clinical trials (RCTs) of NRT versus inert controls and all observational studies to determine the magnitude of reported adverse effects with NRT.
METHODS: Searches of 10 electronic databases from inception to November 2009 were conducted. Study selection and data extraction were carried out independently in duplicate. RCTs were pooled using a random effects method with Odds Ratio [OR] as the effect measure, while proportions were pooled from observational studies. A meta-regression analysis was applied to examine whether the nicotine patch is associated with different adverse effects from those common to orally administered NRT.
RESULTS: Ninety-two RCTs involving 32,185 participants and 28 observational studies involving 145,205 participants were identified. Pooled RCT evidence of varying NRT formulations found an increased risk of heart palpitations and chest pains (OR 2.06, 95% Confidence Interval [CI] 1.51-2.82, P<0.001); nausea and vomiting (OR 1.67, 95% CI 1.37-2.04, P=<0.001); gastrointestinal complaints (OR 1.54, 95% CI, 1.25-1.89, P<0.001); and insomnia (OR 1.42, 95% CI, 1.21-1.66, P=<0.001). Pooled evidence specific to the NRT patch found an increase in skin irritations (OR 2.80, 95% CO, 2.28-3.24, P=<0.001). Orally administered NRT was associated with mouth and throat soreness (OR 1.87, 95% CI, 1.36-2.57, P=<0.001); mouth ulcers (OR 1.49, 95% CI, 1.05-2.20, P=<0.001); hiccoughs (OR 7.68, 95% CI, 4.59-12.85, P=<0.001) and coughing (OR 2.89, 95% CI, 1.92-4.33, P=<0.001). There was no statistically significant increase in anxiety or depressive symptoms associated with NRT use. Non-comparative observational studies demonstrated the prevalence of these events in a broad population.
CONCLUSION: The use of NRT is associated with a variety of side effects. In addition to counseling and medical monitoring, clinicians should inform patients of potential side effects which are associated with the use of NRT for the treatment of tobacco dependence.
Tob Induc Dis. 2010 Jul 13;8(1):8. [Epub ahead of print]
背景：尼古丁替代治疗（NRT）是最为常见的戒烟药物治疗形式，已有研究证实了其在治疗烟草依赖方面的有效性。虽然轻度的不良反应是吸烟者采用NRT戒烟动机减弱的一个独立预测因子，但对与NRT有关的不良反应尚未进行准确定量。
目的：本文对包含NRT与对照组的临床随机试验进行系统性综述和荟萃分析，寻找报道NRT不良反应程度的观察性研究。
方法：在10个电子数据库中寻找2009年11月前进行的相关研究。试验入选和数据提取分2次独立完成。采用随机效应法对RCT进行集中分析，优势比（OR）作为效果指标。对观察性研究中的比例进行集中分析。荟萃回归分析用于检测尼古丁贴剂的不良反应是否与其他的NRT治疗（如口服）有所不同。
结果：92项RCT入选，共计有32185名参与者；28项观察性研究入选，包括145205名参与者。RCT研究集中分析显示，不同的NRT治疗都会增加心悸、胸痛 (OR：2.06；95% CI：1.51-2.82, P<0.001)、恶心和呕吐(OR：1.67；95% CI：1.37-2.04, P=<0.001)、 消化道症状 (OR：1.54； 95% CI：1.25-1.89, P<0.001)和失眠(OR：1.42；95% CI：1.21-1.66, P=<0.001)的风险。有证据显示，NRT贴剂能增加皮肤刺激(OR：2.80；95% CI：2.28-3.24, P=<0.001)。口服给予NRT与口腔和咽喉疼痛(OR：1.87；95% CI：1.36-2.57, P=<0.001)、口腔溃疡(OR：1.49；95% CI：1.05-2.20, P=<0.001)、打嗝(OR：7.68；95% CI：4.59-12.85, P=<0.001)和咳嗽(OR：2.89；95% CI：1.92-4.33, P=<0.001)有关。NRT使用与焦虑和抑郁症状无关。非比较性观察研究显示，这些事件在较广范的人群中均有出现。
结论：使用NRT存在一些不良反应。除了进行咨询和医学监测外，临床医生应该告知患者使用NRT治疗烟草依赖的潜在不良反应。
（林江涛 审校）
Tob Induc Dis. 2010 Jul 13;8(1):8. [Epub ahead of print]
Adverse events associated with nicotine replacement therapy (NRT) for smoking cessation. A systematic review and meta-analysis of one hundred and twenty studies involving 177,390 individuals
Mills EJ, Wu P, Lockhart I, Wilson K, Ebbert JO.
Abstract
BACKGROUND: Nicotine replacement therapy (NRT) is the most common form of smoking cessation pharmacotherapy and has proven efficacy for the treatment of tobacco dependence. Although expectations of mild adverse effects have been observed to be independent predictors of reduced motivation to use NRT, adverse effects associated with NRT have not been precisely quantified.
OBJECTIVE: A systematic review and meta-analysis aimed to identify all randomized clinical trials (RCTs) of NRT versus inert controls and all observational studies to determine the magnitude of reported adverse effects with NRT.
METHODS: Searches of 10 electronic databases from inception to November 2009 were conducted. Study selection and data extraction were carried out independently in duplicate. RCTs were pooled using a random effects method with Odds Ratio [OR] as the effect measure, while proportions were pooled from observational studies. A meta-regression analysis was applied to examine whether the nicotine patch is associated with different adverse effects from those common to orally administered NRT.
RESULTS: Ninety-two RCTs involving 32,185 participants and 28 observational studies involving 145,205 participants were identified. Pooled RCT evidence of varying NRT formulations found an increased risk of heart palpitations and chest pains (OR 2.06, 95% Confidence Interval [CI] 1.51-2.82, P<0.001); nausea and vomiting (OR 1.67, 95% CI 1.37-2.04, P=<0.001); gastrointestinal complaints (OR 1.54, 95% CI, 1.25-1.89, P<0.001); and insomnia (OR 1.42, 95% CI, 1.21-1.66, P=<0.001). Pooled evidence specific to the NRT patch found an increase in skin irritations (OR 2.80, 95% CO, 2.28-3.24, P=<0.001). Orally administered NRT was associated with mouth and throat soreness (OR 1.87, 95% CI, 1.36-2.57, P=<0.001); mouth ulcers (OR 1.49, 95% CI, 1.05-2.20, P=<0.001); hiccoughs (OR 7.68, 95% CI, 4.59-12.85, P=<0.001) and coughing (OR 2.89, 95% CI, 1.92-4.33, P=<0.001). There was no statistically significant increase in anxiety or depressive symptoms associated with NRT use. Non-comparative observational studies demonstrated the prevalence of these events in a broad population.
CONCLUSION: The use of NRT is associated with a variety of side effects. In addition to counseling and medical monitoring, clinicians should inform patients of potential side effects which are associated with the use of NRT for the treatment of tobacco dependence.
Tob Induc Dis. 2010 Jul 13;8(1):8. [Epub ahead of print]
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