Greenland S, Satterfield M H, Lanes S F
Department of Epidemiology, University of California, Los Angeles, USA.
Drug Saf. 1998 Apr;18(4):297-308. doi: 10.2165/00002018-199818040-00005.
To estimate the frequency of adverse effects associated with the use of the transdermal nicotine patch, we abstracted and analysed data from 47 reports of 35 clinical trials. The meta-analysis presented here represents a synthesis of data from 41 groups of nicotine patch recipients totalling 5501 patients, and 33 groups of placebo recipients totalling 3752 patients. Smoking abstinence was the primary outcome in 32 of the trials, and relief of colitis symptoms was the primary outcome in 2 of the trials; 1 study of contact sensitisation was included in the skin irritation analysis. The patch was clearly effective as an aid to smoking abstinence. Despite the large number of patients in the analysis, few adverse cardiovascular outcomes (myocardial infarction, stroke, tachycardia, arrhythmia, angina) were reported, and no excess of these outcomes was detected among patients assigned to nicotine-patch use. The incidences of several minor adverse effects were clearly elevated among the nicotine-patch groups, especially sleep disturbances, nausea or vomiting, localised skin irritation and respiratory symptoms, but the background rates and risk ratios varied considerably across studies. The incidence of nausea or vomiting appeared to be lowest when the patch dose was tapered. The results of this meta-analysis indicate that very large studies would be needed to assess the effect of the patch, if any, on serious, rare outcomes. These results also suggest that the rate of minor adverse effects might be lowered by modifying patch-use protocols.
为评估使用经皮尼古丁贴片相关不良反应的发生频率，我们从35项临床试验的47份报告中提取并分析了数据。此处呈现的荟萃分析综合了来自41组共5501例尼古丁贴片使用者以及33组共3752例安慰剂使用者的数据。32项试验的主要结局为戒烟，2项试验的主要结局为结肠炎症状缓解；皮肤刺激性分析纳入了1项接触性致敏研究。该贴片作为戒烟辅助手段显然有效。尽管分析中有大量患者，但报告的不良心血管结局（心肌梗死、中风、心动过速、心律失常、心绞痛）很少，且在使用尼古丁贴片的患者中未检测到这些结局的过量发生。尼古丁贴片组中几种轻微不良反应的发生率明显升高，尤其是睡眠障碍、恶心或呕吐、局部皮肤刺激和呼吸道症状，但不同研究中的背景发生率和风险比差异很大。当贴片剂量逐渐减小时，恶心或呕吐的发生率似乎最低。这项荟萃分析的结果表明，需要非常大规模的研究来评估该贴片对严重罕见结局（如果有影响的话）的作用。这些结果还表明，通过修改贴片使用方案可能会降低轻微不良反应的发生率。
