Murray R P, Bailey W C, Daniels K, Bjornson W M, Kurnow K, Connett J E, Nides M A, Kiley J P
University of Manitoba, Winnipeg.
Chest. 1996 Feb;109(2):438-45. doi: 10.1378/chest.109.2.438.
To assess cardiovascular conditions and other side effects associated with the use of nicotine polacrilex (NP), 2 mg.
A multicentered randomized control trial of early intervention for the prevention of COPD.
Ten university medical centers in the United States and Canada.
Adult smoking volunteers with evidence of early COPD; 3,923 in intervention and 1,964 controls.
Smoking cessation program, including NP.
Data on hospitalizations were collected annually. Data on reported NP side effects were collected at 4-month intervals for intervention participants.
The rates of hospitalization for cardiovascular conditions and cardiovascular deaths during the 5 years of the study were not related to use of NP, to dose of NP, or to concomitant use of NP and cigarettes. About 25% of NP users reported at least one side effect, but most were very minor and transient. Side effects associated with discontinuance of NP in 5% or more of users included headache, indigestion, mouth irritation, mouth ulcers, and nausea. There was no evidence that concomitant use of NP and cigarettes was associated with elevated rates of reported side effects. Participants in the smoking cessation intervention who received intensive levels of instruction and monitoring of NP use (initially at 12 meetings during 3 months) appeared to report significantly lower rates of side effects (dizziness, headache, and throat irritation) than control participants, presumed to have less instruction and monitoring.
NP, as used in the Lung Health Study, appears to be safe and unrelated to any cardiovascular illnesses or other serous side effects.
评估使用2毫克尼古丁聚半乳糖醛酸酯（NP）相关的心血管状况及其他副作用。
一项预防慢性阻塞性肺疾病（COPD）早期干预的多中心随机对照试验。
美国和加拿大的十所大学医学中心。
有早期COPD证据的成年吸烟志愿者；干预组3923人，对照组1964人。
戒烟项目，包括使用NP。
每年收集住院数据。对干预组参与者每隔4个月收集关于NP报告副作用的数据。
在研究的5年中，心血管疾病的住院率和心血管死亡与NP的使用、NP剂量或NP与香烟的同时使用无关。约25%的NP使用者报告至少有1种副作用，但大多数非常轻微且短暂。5%或更多使用者中与停用NP相关的副作用包括头痛、消化不良、口腔刺激、口腔溃疡和恶心。没有证据表明NP与香烟同时使用会使报告的副作用发生率升高。接受NP使用强化指导和监测（最初在3个月内参加12次会议）的戒烟干预参与者报告的副作用（头晕、头痛和喉咙刺激）发生率似乎明显低于对照组参与者，推测对照组的指导和监测较少。
在肺部健康研究中使用的NP似乎是安全的，与任何心血管疾病或其他严重副作用无关。
