三种二阶梯镇痛药（右丙氧芬、曲马多和可待因[与对乙酰氨基酚合用]）上报法国药物警戒系统的不良反应报告率。
Reporting rate of adverse drug reactions to the French pharmacovigilance system with three step 2 analgesic drugs: dextropropoxyphene, tramadol and codeine (in combination with paracetamol).
机构信息
Laboratoire de Pharmacologie Médicale et Clinique, Unité de Pharmacoépidémiologie, EA3696, Université de Toulouse, Faculté de Médecine, 31000 Toulouse, France.
出版信息
Br J Clin Pharmacol. 2009 Sep;68(3):422-6. doi: 10.1111/j.1365-2125.2009.03472.x.
AIMS
Three 'weak' opioid analgesics in association with paracetamol are marketed in France as step 2 analgesics: dextropropoxyphene, tramadol and codeine. These combinations are involved in several adverse drug reactions (ADRs), but no data are available about their comparative reporting rate. The aim was to compare the reporting rate of ADRs between tramadol/paracetamol (TRM+P), codeine/paracetamol (COD+P) and dextropropoxyphene/paracetamol (DXP+P).
METHODS
All spontaneous reports submitted to the French Pharmacovigilance Database from 1 January 1987 to 31 December 2006 suspected to be induced by one of the three step 2 analgesic combinations (DXP+P, TRM+P, COD+P) were extracted. Their consumption for the same period was obtained from the French Drug Agency. The number of ADRs, serious ADRs and different organ classes of ADRs were compared according to their consumption. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for each variable using DXP+P as reference.
RESULTS
The reporting rate of ADRs was calculated as 24.9/100 000 person-years for DXP+P, 44.5/100 000 person-years for TRM+P and 12.5/100 000 person-years for COD+P. The reporting rate (OR 0.56, 95% CI 0.50, 0.63) and 'seriousness>>' (OR 0.65, 95% CI 0.53, 0.80) of ADRs were significantly higher with TRM+P than with DXP+P. However, hepatobiliary ADRs were significantly more frequent with the DXP+P combination (OR 2.62, 95% CI 1.59, 4.37). In contrast, the reporting rate (OR 1.99, 95% CI 1.82, 2.18) and 'seriousness' (OR 2.64, 95% CI 2.24, 3.11) of ADRs were significantly higher with DXP+P than with COD+P.
CONCLUSIONS
Among the three step 2 analgesic combinations, reporting rate and 'seriousness' of ADRs are the highest with TRM+P and the lowest with COD+P. Our study suggests that the safety profile of DXP+P is worst than that of COD+P.
目的
在法国，三种“弱效”阿片类镇痛药与扑热息痛联合使用被列为第二阶梯镇痛药：右丙氧芬、曲马多和可待因。这些组合涉及到几种药物不良反应（ADR），但没有关于它们相对报告率的数据。本研究旨在比较曲马多/扑热息痛（TRM+P）、可待因/扑热息痛（COD+P）和右丙氧芬/扑热息痛（DXP+P）之间的 ADR 报告率。
方法
从 1987 年 1 月 1 日至 2006 年 12 月 31 日，从法国药物警戒数据库中提取所有怀疑与三种第二阶梯镇痛药组合（DXP+P、TRM+P、COD+P）有关的自发报告。同期从法国药品管理局获得每种药物的使用数据。根据使用情况，比较 ADR 、严重 ADR 和不同器官类别的 ADR 数量。使用 DXP+P 作为参考，计算各变量的调整比值比（OR）和 95%置信区间（CI）。
结果
DXP+P 的 ADR 报告率为 24.9/100000 人年，TRM+P 为 44.5/100000 人年，COD+P 为 12.5/100000 人年。与 DXP+P 相比，TRM+P 的 ADR 报告率（OR 0.56，95%CI 0.50，0.63）和“严重性>>”（OR 0.65，95%CI 0.53，0.80）更高。然而，DXP+P 组合的肝胆 ADR 更为常见（OR 2.62，95%CI 1.59，4.37）。相反，与 COD+P 相比，DXP+P 的 ADR 报告率（OR 1.99，95%CI 1.82，2.18）和“严重性”（OR 2.64，95%CI 2.24，3.11）更高。
结论
在这三种第二阶梯镇痛药组合中，TRM+P 的 ADR 报告率和“严重性”最高，而 COD+P 最低。本研究表明，DXP+P 的安全性不如 COD+P。
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