Bhattacharya Prasanta Kumar, Barman Bhupen, Roy Aakash, Jamil Md, Lyngdoh Monaliza, Mishra Jaya
Department of General Medicine, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) Mawdiangdiang, Shillong, 793018 Meghalaya India.
Department of Pathology, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) Mawdiangdiang, Shillong, 793018 Meghalaya India.
Springerplus. 2015 Jun 30;4:302. doi: 10.1186/s40064-015-1081-9. eCollection 2015.
Nimesulide is a non-steroidal anti-inflammatory drug with antipyretic and analgesic properties, which is still used in many countries despite its known hepatotoxicity. Along with hepatotoxicity it has also been associated with several other Adverse Drug Reactions (ADRs) including leukocytoclastic vasculitis (LCV).
A 38 year-old female presented with history of acute onset fever for which she took tablet nimesulide and paracetamol combination (100 mg Nimesulide + 500 mg paracetamol tablet), 1 tab three times daily for 4 days, following which she developed rash all over the body. She also had clinical and biochemical evidence of acute hepatitis. Histopathological examination of the skin rash documented the presence of LCV. She was managed symptomatically with anti-inflammatory and supportive therapy and was not further exposed to nimesulide.
Our case demonstrates occurrence of acute hepatitis and LCV associated with nimesulide intake. The case meets the defining criteria for the diagnosis of LCV preceded by history of nimesulide intake. There was also clinical and biochemical evidence of hepato-cellular damage which supports the concurrent development of hepatitis along with the development of LCV following nimesulide use. To the best of our knowledge there is no previous published report of LCV and hepatitis occurring concurrently in the same patient following nimesulide intake. Nimesulide should be added to the list of agents associated with these serious adverse drug reactions.
Nimesulide has been a contentious drug over many years. Under such evidence of serious ADRs the scientific community should consider ensuring strict pharmacovigilance with respect to its use especially in the developing countries where such monitoring systems are inadequate.
尼美舒利是一种具有解热和镇痛特性的非甾体抗炎药,尽管已知其具有肝毒性,但仍在许多国家使用。除肝毒性外,它还与包括白细胞破碎性血管炎(LCV)在内的其他几种药物不良反应(ADR)有关。
一名38岁女性,有急性发热病史,她服用了尼美舒利和对乙酰氨基酚的复方片剂(100毫克尼美舒利 + 500毫克对乙酰氨基酚片),每日3次,每次1片,共服用4天,之后全身出现皮疹。她还有急性肝炎的临床和生化证据。皮疹的组织病理学检查证实存在LCV。对她进行了抗炎和支持性对症治疗,并且不再接触尼美舒利。
我们的病例显示了与服用尼美舒利相关的急性肝炎和LCV的发生。该病例符合在服用尼美舒利病史之后诊断LCV的定义标准。也有肝细胞损伤的临床和生化证据,这支持了在使用尼美舒利后肝炎与LCV同时发生。据我们所知,此前没有关于同一患者在服用尼美舒利后同时发生LCV和肝炎的报道。尼美舒利应被列入与这些严重药物不良反应相关的药物名单中。
多年来,尼美舒利一直是一种有争议的药物。在有这些严重ADR证据的情况下,科学界应考虑确保对其使用进行严格的药物警戒,尤其是在那些此类监测系统不完善的发展中国家。