Joseph A M, Norman S M, Ferry L H, Prochazka A V, Westman E C, Steele B G, Sherman S E, Cleveland M, Antonuccio D O, Hartman N, McGovern P G
Department of Medicine, Veterans Affairs (VA) Medical Center and University of Minnesota, Minneapolis 55417, USA.
N Engl J Med. 1996 Dec 12;335(24):1792-8. doi: 10.1056/NEJM199612123352402.
Transdermal nicotine therapy is widely used to aid smoking cessation, but there is uncertainty about its safety in patients with cardiac disease.
In a randomized, double-blind, placebo-controlled trial at 10 Veterans Affairs medical centers, we randomly assigned 584 outpatients (of whom 576 were men) with at least one diagnosis of cardiovascular disease to a 10-week course of transdermal nicotine or placebo as an aid to smoking cessation. The subjects were monitored for a total of 14 weeks for the primary end points of the study (death, myocardial infarction, cardiac arrest, and admission to the hospital due to increased severity of angina, arrhythmia, or congestive heart failure); the secondary end points (admission to the hospital for other reasons and outpatient visits necessitated by increased severity of heart disease); any side effects of therapy; and abstinence from smoking.
There were 48 primary and 78 secondary end points noted in a total of 95 subjects. At least one of the primary end points was reached by 5.4 percent of the subjects in the nicotine group and 7.9 percent of the subjects in the placebo group (difference, 2.5 percent; 95 percent confidence interval, -1.6 to 6.5 percent; P=0.23). In the nicotine group, 11.9 percent of the subjects had at least one of the secondary end points, as compared with 9.7 percent in the placebo group (difference, 2.2 percent; 95 percent confidence interval, -2.2 to 7.4 percent; P= 0.37). After 14 weeks the rate of abstinence from smoking was 21 percent in the nicotine group, as compared with 9 percent in the placebo group (P=0.001), but after 24 weeks the abstinence rates were not significantly different (14 percent vs. 11 percent, P= 0.67).
Transdermal nicotine does not cause a significant increase in cardiovascular events in high-risk outpatients with cardiac disease. However, the efficacy of transdermal nicotine as an aid to smoking cessation in such patients is limited and may not be sustained over time.
经皮尼古丁疗法被广泛用于辅助戒烟，但对于患有心脏病的患者而言，其安全性尚存在不确定性。
在10家退伍军人事务医疗中心开展的一项随机、双盲、安慰剂对照试验中，我们将584名至少被诊断患有心血管疾病的门诊患者（其中576名男性）随机分配，接受为期10周的经皮尼古丁治疗或安慰剂治疗，以辅助戒烟。对受试者进行总共14周的监测，观察研究的主要终点（死亡、心肌梗死、心脏骤停以及因心绞痛、心律失常或充血性心力衰竭病情加重而入院）；次要终点（因其他原因入院以及因心脏病病情加重而进行的门诊就诊）；治疗的任何副作用；以及戒烟情况。
总共95名受试者出现了48个主要终点和78个次要终点。尼古丁组中5.4%的受试者达到了至少一个主要终点，安慰剂组中这一比例为7.9%（差异为2.5%；95%置信区间为-1.6至6.5%；P=0.23）。在尼古丁组中，11.9%的受试者出现了至少一个次要终点，而安慰剂组中这一比例为9.7%（差异为2.2%；95%置信区间为-2.2至7.4%；P=0.37）。14周后，尼古丁组的戒烟率为21%，而安慰剂组为9%（P=0.001），但24周后，戒烟率无显著差异（14%对11%，P=0.67）。
经皮尼古丁不会使患有心脏病的高危门诊患者的心血管事件显著增加。然而，经皮尼古丁辅助此类患者戒烟的疗效有限，且可能无法长期维持。
