Debois H, Loupi E, Saliou P, Blangy H, Loeuille D, Gillet P
Aventis Pasteur, Département Affaires Médicales, 2, avenue Pont Pasteur, 69367 Lyon.
Prog Urol. 2001 Jun;11(3):458-65.
Intravesical BCG therapy remains the first-line prophylactic treatment for recurrences of superficial bladder tumours. However, necessary the safety of this medicinal product, for which a potential risk of complications was demonstrated during development, needs to be evaluated.
Based on spontaneous notifications of adverse events reported according to good pharmacovigilance practice and in the context of a survey conducted jointly with Health Authorities, the authors present an analysis of adverse event notifications received by the manufacturer over a three-year period. A summary of serious adverse events (SAE) was established and hypotheses concerning factors predisposing to these adverse events were discussed. Finally, practice guidelines were formulated.
During this period, 97 SAEs were reported spontaneously, including 12 local SAEs, 12 regional SAEs and 73 systemic SAEs. 46 of the 73 systemic SAEs were suspected to be due to BCG infection, 18 were related to immune disorders and the cause of 9 SAEs could not be determined. Several hypotheses are formulated concerning the circumstances leading to the onset of these SAEs and practice guidelines are proposed.
Pharmacovigilance has allowed a better understanding of the qualitative and quantitative safety of BCG-IT in France. Hypotheses concerning factors predisposing to adverse effects were formulated and practice guidelines were proposed. It is essential to continue this collaboration between practitioners, Health Authorities and the manufacturer to ensure optimal use of this medicinal product.
膀胱内卡介苗治疗仍是浅表性膀胱肿瘤复发的一线预防性治疗方法。然而，尽管该药品安全性有必要，但在其研发过程中已证实存在潜在的并发症风险，因此需要对其进行评估。
基于按照良好药物警戒规范报告的不良事件自发通知，并在与卫生当局联合开展的一项调查背景下，作者对制造商在三年期间收到的不良事件通知进行了分析。总结了严重不良事件（SAE），并讨论了与这些不良事件易患因素相关的假设。最后制定了实践指南。
在此期间，自发报告了97例SAE，其中包括12例局部SAE、12例区域SAE和73例全身SAE。73例全身SAE中有46例怀疑是卡介苗感染所致，18例与免疫紊乱有关，9例SAE的病因无法确定。针对导致这些SAE发生的情况提出了几种假设，并提出了实践指南。
药物警戒有助于更好地了解法国卡介苗膀胱内灌注治疗（BCG-IT）的定性和定量安全性。提出了与不良反应易患因素相关的假设，并制定了实践指南。从业者、卫生当局和制造商之间必须继续这种合作，以确保该药品的最佳使用。
