AP-HP, Department of Internal Medicine, Pitié-Salpêtrière Hospital, 83 Boulevard de l'hopital, 75013 Paris, France.
Osteoporos Int. 2013 May;24(5):1751-7. doi: 10.1007/s00198-013-2265-1. Epub 2013 Jan 30.
We have reviewed 47 drug rash with eosinophilia and systemic symptoms (DRESS) cases associated to strontium ranelate reported up to March 2011 to the Marketing Holder. The main signs were skin rash, fever, face oedema hypereosinophilia and liver involvement. For ten patients, persistence of DRESS symptoms was reported at the latest news obtained, and DRESS was identified as the direct cause of death in one case. The maximum incidence of DRESS associated with strontium ranelate was 1/24,112 [95 % CI (1/14,859; 1/42,194)] newly treated patients in France. Because DRESS is a severe drug reaction, the occurrence of a rash in a patient treated with strontium ranelate should lead to prompt and permanent treatment discontinuation.
This study aims to describe cases of DRESS reported to the Marketing Authorisation Holder worldwide for patients receiving strontium ranelate by practitioner or by regulatory authorities.
Spontaneously reported hypersensitivity events from the strontium ranelate pharmacovigilance database since marketing authorisation (2004) to March 2011 were reviewed by an expert committee. Cases of DRESS were classified as established, probable, possible or no DRESS according to expert judgement. National incidences of DRESS were estimated in relation to the number of newly treated patients.
Up to March 2011, 325 cases of strontium ranelate-induced hypersensitivity events were assessed from which 47 DRESS cases were confirmed. Mean age was 68.7 years and besides skin rash, the main signs and symptoms were hypereosinophilia, liver involvement, fever and face oedema. Median time to skin reaction was 33.5 days after treatment start. Most patients (62 %) recovered at the time of reporting or were recovering. For ten patients, persistence of DRESS symptoms was reported at the latest news obtained. Relapses were observed in a single case. The mortality rate was 8.5 %. The maximum incidence of DRESS associated with strontium ranelate was 1/24,112 [95 % CI (1/14,859; 1/42,194)] newly treated patients in France.
DRESS is a well-identified and characterised adverse reaction to strontium ranelate. This risk should be integrated in the risk-benefit balance evaluation of patient treatment, and the occurrence of a rash should lead to prompt and permanent treatment discontinuation with careful follow-up.
描述在全球范围内，接受雷奈酸锶治疗的患者，由从业者或监管机构向药品上市许可持有人报告的药物性皮疹伴嗜酸性粒细胞增多和全身症状（DRESS）病例。
通过专家委员会对自药品上市许可（2004 年）以来至 2011 年 3 月的雷奈酸锶药物警戒数据库中自发报告的超敏反应事件进行回顾。根据专家判断，将 DRESS 病例分为确定、可能、很可能或无 DRESS。根据新治疗患者的数量，估算 DRESS 的国家发生率。
截至 2011 年 3 月，对 325 例雷奈酸锶引起的超敏反应事件进行了评估，其中 47 例被确认为 DRESS 病例。患者的平均年龄为 68.7 岁，除皮疹外，主要体征和症状为嗜酸性粒细胞增多、肝损伤、发热和面部水肿。皮肤反应发生在治疗开始后 33.5 天的中位数时间。大多数患者（62%）在报告时或正在康复中痊愈。在最新获得的消息中，有 10 例患者报告称 DRESS 症状持续存在。在 1 例患者中观察到复发。死亡率为 8.5%。与雷奈酸锶相关的 DRESS 最大发生率为 1/24112（95%CI：1/14000-1/42194），在法国新治疗患者中。
DRESS 是雷奈酸锶明确且特征性的不良反应。该风险应纳入患者治疗的风险-效益平衡评估中，一旦出现皮疹，应立即永久停药，并密切随访。
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