Abhilasha Pallavi, Bhatti Neena, Joseph Girish, Badyal Dinesh K
Psychiatry, Christian Medical College and Hospital, Ludhiana, IND.
Pharmacology, Christian Medical College and Hospital, Ludhiana, IND.
Cureus. 2024 Jul 25;16(7):e65390. doi: 10.7759/cureus.65390. eCollection 2024 Jul.
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.
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.
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).
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.
丙戊酸钠（VPA）是一种广泛使用的抗惊厥药，是治疗成人和儿童癫痫以及偏头痛、双相情感障碍、躁狂症和三叉神经痛等病症的有效药物。镇静、眩晕、共济失调、剂量依赖性震颤、头痛和胃肠道副作用是与VPA相关的最常报告的不良反应。与VPA相关的一种潜在危及生命的事件是高氨血症（HA），其定义为血清氨水平升高。在VigiAccess数据库中仅发现587例HA报告病例，仅占与VPA相关的95,000例报告不良事件的0.6%。因此，本病例系列重点关注服用VPA的患者血清氨水平升高（无论肝酶是否升高）的监测情况。
评估服用VPA后血清氨水平升高情况，并确定服用VPA后血清氨水平升高的患者中肝酶升高的个体百分比。
本研究在印度药物警戒计划（PvPI）的药物不良反应（ADR）监测中心（AMC）以及卢迪亚纳基督教医学院和医院（CMC&H）的精神科进行。该研究包括12例仅服用VPA且出现与血清氨水平升高相关症状的患者。在获取患者个人详细信息之前，向患者提供了知情同意书（ICF）。进行实验室检查以确诊，并进行了肝功能检查（LFTs），主要检测了谷丙转氨酶（ALT）和谷草转氨酶（AST）。这是一项为期六个月的描述性研究。结果：本研究包括12例经实验室检查确诊为HA的患者。在这12例患者中，2例（17%）的肝功能检查结果相应升高。患者的平均年龄为53.08岁，平均血清氨水平为219.15。出现HA的患者均未进展为高氨血症性脑病（HAE）。结论：本关于丙戊酸盐诱导的HA的病例系列对于治疗服用VPA患者的精神科医生、内科医生、实习医生、家庭医学医生、住院医生和外科医生来说应该具有参考价值。对HA的识别延迟可能导致潜在的危及生命的并发症。快速诊断和处理将有助于减少进展为高度致命性脑病的病例数量。
