Mann R D, Pearce G L, Dunn N, Shakir S
Southampton University, Southampton.
BMJ. 2000 Apr 29;320(7243):1184-6. doi: 10.1136/bmj.320.7243.1184.
To investigate the frequency with which sedation was reported in post-marketing surveillance studies of four second generation antihistamines: loratadine, cetirizine, fexofenadine, and acrivastine.
Prescription-event monitoring studies.
Prescriptions were obtained for each cohort in the immediate post-marketing period.
Event data were obtained for a total of 43 363 patients.
Reporting of sedation or drowsiness.
The odds ratios (adjusted for age and sex) for the incidence of sedation were 0.63 (95% confidence interval 0.36 to 1.11; P=0.1) for fexofenadine; 2.79 (1.69 to 4.58; P<0.0001) for acrivastine, and 3.53 (2.07 to 5.42; P<0.0001) for cetirizine compared with loratadine. No increased risk of accident or injury was evident with any of the four drugs.
Although the risk of sedation was low with all four drugs, fexofenadine and loratadine may be more appropriate for people working in safety critical jobs.
调查在四种第二代抗组胺药（氯雷他定、西替利嗪、非索非那定和阿伐斯汀）的上市后监测研究中报告的镇静发生率。
处方事件监测研究。
在上市后即刻为每个队列获取处方。
共获得43363名患者的事件数据。
镇静或嗜睡的报告情况。
与氯雷他定相比，非索非那定镇静发生率的比值比（校正年龄和性别后）为0.63（95%置信区间0.36至1.11；P=0.1）；阿伐斯汀为2.79（1.69至4.58；P<0.0001），西替利嗪为3.53（2.07至5.42；P<0.0001）。四种药物中任何一种均未显示出事故或伤害风险增加。
虽然四种药物的镇静风险都较低，但非索非那定和氯雷他定可能更适合从事安全关键工作的人群。
