伐尼克兰对冠心病吸烟患者的有效性及安全性研究

Efficacy and safety of varenicline for smoking cessation in patients with CAD undergoing PCI

目的探讨冠心病患者服用伐尼克兰药物的戒烟疗效及其对氯吡格雷抗血小板作用的影响。方法连续选取2010年9月至2013年8月在武警总医院住院择期行PCI术的冠心病吸烟患者128例,随机分为伐尼克兰组和常规治疗组。伐尼克兰组:服用伐尼克兰治疗2周,2周后继续提供戒烟方法和咨询随访。常规治疗组:仅提供戒烟方法和咨询随访。其他治疗均按常规冠心病患者治疗。分别于入院时、服用伐尼克兰前、服用伐尼克兰2周检测血小板反应指数(PRI)、尿素氮(BUN)及肌酐(Cr),并记录2周及6个月不良事件及严重不良事件。结果两组患者入院时、服药前及服药2周时PRI比较无统计学差异(P>0.05)。6个月时伐尼克兰组戒烟率高于常规治疗组(P<0.01)。两组不良事件发生率没有统计学差异,6个月严重不良事件再发心绞痛发生率伐尼克兰组发生率低于对照组(P=0.042)。结论伐尼克兰对冠心病吸烟患者戒烟效果明显,对氯吡格雷抗血小板聚集作用没有明显影响,安全性好。

Objective This study focused on the efficacy of varenicline and the safety of the combination of two drugs by investigating the patients who were given clopidogrel and varenicline with CAD undergoing PCI. Methods Eligible smoking patients in hospital, with CAD undergoing PCI were consecutively included. All patients received aspirin （100 mg/day） and clopidogrel （loading dose 300 mg, followed by 75 mg/day） . On 3 day after received clopidogrel 75 rag/day,, patients will be randomized to receive either associated varenicline or without varenicline for 14 days. Blood samples will be collected before rendered clopidogrel, on day 1 before associated varenicline, and on 14 day after associated varenicline. Clopidogrel effect will be tested by measuring platelet phosphorylated-VASP expressed as a platelet reactivity index （PRI）. All patients were followed for 6 months and documented the smoking ceased rates, concomitant medication and adverse events. Results In the conventional therapy group, PRI was （80.08~5.60）%, （55.21~14.87）% and （43.01~13.59）% respectively at the three time. In varenicline group, PRI was （79.94~5.18）%, （53.74~14.47）% and （42.18~11.27）% respectively at the three time. There was no significant difference between the two groups. The smoking cessation rate of the varenicline group （66.03%） was higher than the conventional therapy group （35.18%, P〈0.010） after 6 months. The data of eGFR were similar in the 2 groups. The rate of adverse events were no significant difference between the two groups. However, the serious adverse events rate of the varenicline group in was lower than those the conventional therapy group. Conclusions The rate of smoking cessation of varenicline was significantly improved in patients with CAD in periprocedural of PCI. Clopidogrel can be safely administrated with varenicline.