Nicorandil-induced ulcerations: a 10-year observational study of all cases spontaneously reported to the French pharmacovigilance network
Nicorandil-induced ulcerations: a 10-year observational study of all cases spontaneously reported to the French pharmacovigilance network
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DOI：
10.1111/iwj.12845
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发表时间：
2018-08-01
影响因子：
3.1
通讯作者：
Gillet, Pierre
中科院分区：
文献类型：
--
作者：
Babic, Valerie;Petitpain, Nadine;Gillet, Pierre
尼可地尔引起的溃疡通常仍未得到很好的识别，诊断较晚，处理不当。我们的目标是提供2005至2014年间向法国药物警戒网络自发报告的148例尼可地尔诱发溃疡的临床概述，并与同期全球公布的病例相结合。自发报告的尼可地尔诱导的溃疡主要是粘膜(口腔和肛门)溃疡，有23.0%的患者有既往创伤，12.8%的患者出现严重并发症。严重病例尼可地尔的平均累积剂量较高。从开始使用尼可地尔到出现溃疡的中位延迟时间为23.4个月，在溃疡确诊后，尼可地尔入选的中位时间仍为3.3月，粘膜溃疡的中位延迟时间为5.2月，而皮肤溃疡的中位延迟时间为14.0个月，P=0.001。199例已发表病例的解剖分布略有不同，但延迟时间相似。机制的假设变得更加精确，毫无疑问，有必要停止治疗。从业者需要意识到，尼可地尔引起的溃疡可以发生在许多地方，可能是多个和复杂的，应该简单地通过停止治疗而不再重新引入尼可地尔来处理。
Nicorandil-induced ulcers remain often poorly recognised, with a late diagnosis and an inadequate management. We aimed to provide a clinical overview of the 148 spontaneously reported cases of nicorandil-induced ulcers to the French pharmacovigilance network between 2005 and 2014 and to complete this picture with worldwide published cases over the same period.Spontaneously reported nicorandil-induced ulcers were mainly mucosal (oral and anal) with a previous trauma in 23.0% of patients, revealed by a severe complication in 12.8% of cases. The mean cumulative dose of nicorandil was higher in serious cases. The median delay between the start of nicorandil use and the onset of the ulcer was 23.4 months, and after the ulcer was diagnosed, the median time to incriminate nicorandil was still 3.3 months, being shorter for mucosal ulcerations than for cutaneous ulcerations (5.2 versus 14.0 months, P = 0.001). The anatomic distribution in the 199 published cases differed slightly, but delays were similar. The hypothesis of mechanism becomes more precise, leaving no doubt about the necessity to discontinue the treatment. Practitioners need to be aware that nicorandil-induced ulcers can occur in many locations, possibly multiple and complicated, and should be simply managed by discontinuing treatment with no further reintroduction of nicorandil.