Durrieu G, Olivier P, Montastruc J L
Faculté de Médecine de Toulouse, Unité de Pharmacoépidémiologie UA 3696, IFR INSERM 126, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmaco épidémiologie et d'Informations sur le Médicament, Toulouse, France.
Eur J Clin Pharmacol. 2005 Sep;61(8):611-4. doi: 10.1007/s00228-005-0964-z. Epub 2005 Aug 24.
To evaluate the main characteristics of case reports of arterial hypertension (AH) related to COX-2 inhibitor (coxib) use in real-life practice.
This study was based on spontaneous reports of adverse drug reactions (ADRs) submitted to the French Pharmacovigilance system. Associations between AH and the different groups of those using non-steroidal anti-inflammatory drugs (NSAIDs: rofecoxib, celecoxib and non-selective NSAIDs) were compared using calculation of the odds ratio (OR) with 95% confidence intervals (CIs).
In France, between 1 April 2000 and 30 November 2003, 34 AH cases related to coxibs were reported. Case reports include predominantly patients older than 65 years, with a previous story of essential AH. Most AH (60%) occurred during the first 15 days of treatment. The AH was reported significantly more frequently for rofecoxib than celecoxib. The OR for development of AH with rofecoxib versus celecoxib was 3.3 (1.6-6.9). The AH was also reported more frequently with coxib (2.8%) than with non-selective NSAID (0.5%) use, OR = 5.9 (3.8-9.0).
This study shows that coxibs are associated with a risk of AH in real-life practice. More spontaneous reports of AH to the French Pharmacovigilance system concern rofecoxib than celecoxib (and coxibs than non-selective NSAIDs). This ADR is of special epidemiological importance due to both the risks of AH and the large use of coxibs.
评估在实际临床实践中与COX-2抑制剂（昔布类）使用相关的动脉高血压（AH）病例报告的主要特征。
本研究基于提交至法国药物警戒系统的药物不良反应（ADR）自发报告。使用比值比（OR）及95%置信区间（CI）计算，比较AH与使用不同组非甾体抗炎药（NSAIDs：罗非昔布、塞来昔布及非选择性NSAIDs）之间的关联。
在法国，2000年4月1日至2003年11月30日期间，共报告了34例与昔布类相关的AH病例。病例报告主要包括年龄大于65岁、既往有原发性AH病史的患者。大多数AH（60%）发生在治疗的前15天。罗非昔布导致AH的报告显著多于塞来昔布。罗非昔布与塞来昔布相比，发生AH的OR为3.3（1.6 - 6.9）。与使用非选择性NSAIDs（0.5%）相比，昔布类导致AH的报告也更频繁，OR = 5.9（3.8 - 9.0）。
本研究表明，在实际临床实践中昔布类与AH风险相关。提交至法国药物警戒系统的关于AH的自发报告中，涉及罗非昔布的比塞来昔布多（涉及昔布类的比非选择性NSAIDs多）。鉴于AH的风险及昔布类的大量使用，这种ADR具有特殊的流行病学重要性。
