Marteau P, Nelet F, Le Lu M, Devaux C
Laboratoire Ferring, SA.
Aliment Pharmacol Ther. 1996 Dec;10(6):949-56. doi: 10.1046/j.1365-2036.1996.92264000.x.
The incidence of the side-effects of 5-aminosalicylic acid (5-ASA) in clinical practice is not known.
To present the safety reports on the use of Pentasa in France.
Pentasa-related adverse events were recorded from 1 January 1993 to 31 December 1994. Spontaneous reports to Ferring S.A. came from physicians or pharmacovigilance regional centres.
In 1993 and 1994, 51 and 79 adverse events were reported; the estimated gross incidence was 6.6 and 9.0 per million days of therapy. Detailed information was obtained 64% of cases in 1993 and 53% in 1994. Adverse events with a high likelihood of causalty included five cases of diarrhoea, 14 cases of pancreatitis, seven cases of liver abnormalities, seven of blood dyscrasias, two cases of renal insufficiency (one of which was in a fetus), and eight of cardiac disorders including three myocarditis.
Pentasa seldom has adverse effects. The majority of the adverse events do not seem to be dose-related. Clinicians should be aware of exceptional but severe adverse events including pancreatitis, cardiac disorders, blood dyscrasias and renal insufficiency.
5-氨基水杨酸（5-ASA）在临床实践中的副作用发生率尚不清楚。
介绍法国使用颇得斯安的安全性报告。
记录1993年1月1日至1994年12月31日期间与颇得斯安相关的不良事件。向辉凌制药有限公司的自发报告来自医生或地区药物警戒中心。
1993年和1994年分别报告了51例和79例不良事件；估计总发生率分别为每百万治疗日6.6例和9.0例。1993年64%的病例和1994年53%的病例获得了详细信息。高度可能因果关系的不良事件包括5例腹泻、14例胰腺炎、7例肝脏异常、7例血液系统疾病、2例肾功能不全（其中1例发生在胎儿）以及8例心脏疾病，包括3例心肌炎。
颇得斯安很少有不良反应。大多数不良事件似乎与剂量无关。临床医生应注意包括胰腺炎、心脏疾病、血液系统疾病和肾功能不全等罕见但严重的不良事件。
