背景:丙戊酸钠(VPA)是一种广泛使用的抗惊厥药,这是治疗成人和儿童癫痫的有效药物,以及偏头痛等疾病,双相情感障碍,躁狂症,和三叉神经痛.镇静,眩晕,共济失调,剂量依赖性震颤,头痛,胃肠道副作用是最常见的与VPA相关的不良反应。VPA报告的潜在危及生命的事件是高氨血症(HA),其定义为血清氨水平的增加。在VigiAccess数据库中仅发现587例报告的HA病例,仅占95,000例报告的与VPA相关的不良事件的0.6%。因此,本病例系列研究的重点是监测VPA患者的血清氨水平升高,无论有无肝酶升高.
目的:评估VPA给药后血清氨水平升高,并确定服用VPA并随后血清氨水平升高的肝酶增加的个体的百分比。
方法:本研究是在印度药物警戒计划(PvPI)和精神病学系的药物不良反应(ADR)监测中心(AMC)进行的。基督教医学院和医院(CMC&H),卢迪亚娜.该研究由12名患者组成,这些患者仅接受VPA治疗,并表现出与血清氨升高有关的症状。在获取患者的个人详细信息之前,向患者提供了知情同意书(ICF)。进行实验室调查以建立诊断和肝功能测试(LFTs),还主要进行ALT(丙氨酸转移酶)和AST(天冬氨酸转氨酶)。这是一项为期六个月的描述性研究。结果:本研究包括12例经实验室检查证实患有HA的患者。在这12名患者中,两名患者(17%)的LFT相应增加.截至患者的平均值为53.08年,平均血清氨水平为219.15。出现HA的患者均未发展为高氨血症性脑病(HAE)。
结论:这个关于丙戊酸诱导的HA的病例系列应该是精神科医生感兴趣的,医师,内科医生,家庭医生,住院医生,以及将患者进行VPA的外科医生。HA识别的延迟可导致潜在危及生命的并发症的发展。快速诊断和管理将有助于减少进展为高度致命的脑病的病例数。
BACKGROUND: Sodium valproate (VPA) is an extensively used anti-convulsant, which is an effective drug for treatment of epilepsy in adults and children, as well as for conditions like migraine, bipolar disorder, mania, and trigeminal neuralgia. Sedation, vertigo, ataxia, dose-dependent tremors, headaches, and gastrointestinal side effects are the most often reported adverse effects associated with VPA. A potential life-threatening event reported with VPA is hyperammonemia (HA), which is defined as an increase in serum level of ammonia. Only 587 reported cases of HA were found in the VigiAccess database, representing a mere 0.6% of the 95,000 reported adverse events linked to VPA. Hence, this case series was conducted with emphasis on monitoring of increased serum ammonia levels with or without hepatic enzymes increase for patients who are on VPA.
OBJECTIVE: To assess elevated serum ammonia levels following VPA administration, and to ascertain the percentage of individuals with hepatic enzymes increased who took VPA and subsequently had elevated serum ammonia levels.
METHODS: This study was conducted at the adverse drug reaction (ADR) monitoring centre (AMC) of the Pharmacovigilance Programme of India (PvPI) and Department of Psychiatry, Christian Medical College and Hospital (CMC&H), Ludhiana. The study comprised of 12 patients who were exclusively on VPA and exhibited symptoms related to elevated serum ammonia. An informed consent form (ICF) was provided to the patient prior to taking their personal details. Laboratory investigations were done to establish the diagnosis and liver function tests (LFTs), chiefly ALT (alanine transferase) and AST (aspartate aminotransferase) were also performed. It is a descriptive study which was for a time period of six months. Results: This study includes 12 patients who had HA confirmed by laboratory investigation. Out of these 12 patients, two patients (17%) had a corresponding increase in LFT. The average as of the patients was 53.08 years and average serum ammonia levels were 219.15. None of the patients who presented with HA progressed to hyperammonemic encephalopathy (HAE).
CONCLUSIONS: This case series on valproate-induced HA should be of interest to psychiatrists, physicians, internists, family medicine physicians, hospitalists, and surgeons who will have patients on VPA. Delay in recognition of HA can result in the development of potentially life-threatening complications. Rapid diagnosis and management will help in reducing the number of cases which progress to encephalopathy which is highly fatal.