前言:伐尼克兰联合尼古丁替代治疗的安全性和有效性的相关研究资料较少。
方法:我们对入选社区戒烟计划中两组吸烟人群的临床经历进行回顾研究,这些吸烟者接受伐尼克兰和NRT联合治疗(N = 104)或常规治疗(在伐尼克兰正式上市之前,N = 135)。
结果:两组的人口统计学数据类似。联合治疗组的吸烟者,71%使用尼古丁贴剂,平均剂量为32±14 mg/天,73%使用至少两种类型的NRT。联合治疗组的不良反应发生率为39%(95% CI = 31%-49%),而常规治疗组为59%(95% CI = 51%-67%)。共有5名吸烟者(5%)由于不良反应而中断伐尼克兰治疗,而常规治疗组仅为1人。6个月后,30天戒断率两组无显著差异,联合治疗组和常规治疗组分别为:54%(95% CI = 44%-64%)和59%(95% CI = 50%-66%)。
讨论:我们结果显示,对于社区戒烟计划的参与者,伐尼克兰与NRT联合治疗较为安全,吸烟者能更好耐受。
(刘国梁 审校)
Ebbert JO, et al. Nicotine Tob Res. 2009 May;11(5):572-576. Epub 2009 Apr 7
Combination treatment with varenicline and nicotine replacement therapy
INTRODUCTION: A paucity of data exists regarding the safety and effectiveness of combination treatment with varenicline and nicotine replacement therapy (NRT).
METHODS: We reviewed the clinical experience of two groups of cigarette smokers enrolled in a residential tobacco treatment program: (a) patients receiving combination treatment with varenicline and NRT (N = 104) and (b) usual-care patients receiving treatment before the release of varenicline (N = 135).
RESULTS: Demographic characteristics were similar between the two groups. Among smokers receiving varenicline and NRT, 71% used the nicotine patch with a mean dose of 32 mg/day (SD = 14) and 73% used at least two types of NRT. Adverse events were experienced by 39% (95% CI = 31%-49%) of patients receiving varenicline and NRT and by 59% (95% CI = 51%-67%) of usual-care patients during the residential program. A total of five patients (5%) discontinued varenicline due to adverse events, compared with one patient in the usual-care group. We did not observe a significant difference in the 30-day point prevalence smoking abstinence rate at 6 months between patients treated with varenicline and NRT (54%; 95% CI = 44%-64%) and usual-care patients (59%; 95% CI = 50%-66%).
DISCUSSION: Our findings suggest that combination therapy with varenicline and NRT is safe and well tolerated among patients in a residential tobacco treatment program.