跳至主要内容
临床试验/NCT04967326
NCT04967326已完成4 期

Role of Clinical Pharmacists in Epilepsy Management at a General Hospital in Vietnam: A Before-and-after Study

Gia Dinh People Hospital0 个研究点目标入组 141 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
141
主要终点
Number of patients with two seizures or less

研究概览

简要总结

Clinical pharmacists have an important role in inter-professional healthcare collaboration for epilepsy management. However, the pharmacy practices of managing epilepsy are still limited in Vietnam, deterring pharmacists from routine adjustments of antiepileptic drugs, which could decrease the patients' quality of life. This study aimed to assess the effectiveness of pharmacist interventions in epilepsy treatment at a Vietnamese general hospital.

详细描述

Phenytoin, carbamazepine, and valproic acid, which are among the first-generation AEDs, are prescribed in many countries around the world, including Vietnam. These agents have complicated pharmacokinetics, which may result in alterations in absorption, distribution, and metabolism. This means that, given the same dose, the serum concentration of each drug may vary between patients. The management of epilepsy, as a result, requires inter-professional collaboration to ensure therapeutic optimization. As healthcare professionals, clinical pharmacists play an important role in epilepsy management, which includes establishing a therapeutic drug monitoring (TDM) protocol, adjusting doses, monitoring ADRs, etc.

However, the clinical pharmacy practices in epilepsy management are quite limited in Vietnam. The treatment gap-the proportion of people with epilepsy who are not adequately treated-still remains very high, especially in rural areas (84.7%), which probably results from discontinuing the treatment or refusing to take medications. This shows a need for pharmacist consultations for patients with epilepsy and their family members, as they may be lack information about AEDs or motivation in controlling potential seizures. In addition, the adjustments of antiepileptic drugs by pharmacists are not routine procedures, nor are monitored for effectiveness in many Vietnamese hospitals. This lack of engagement threatens the patients' safety and decreases their quality of life. To address this issue, certain interventions are needed to enable pharmacists to manage patients with epilepsy more systematically. This study was therefore conducted to evaluate the effectiveness of pharmacist interventions in epilepsy treatment at a general hospital in Vietnam.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • were prescribed a monotherapy or polytherapy of phenytoin, carbamazepine, or valproic acid.
  • were treated for more than one month.

排除标准

  • were pregnant or breastfeeding women.
  • had a history of alcoholism.
  • had liver or renal disease.
  • were using drugs known to have an influence on cytochrome P450 enzymes.

研究组 & 干预措施

Patients with epilepsy

Experimental

The therapies of patients with epilepsy were optimized using pharmacists' interventions, including medication consultation, dosage adjustment, medication switching/discontinuation, or combination therapy.

干预措施: Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid) (Drug)

结局指标

主要结局

Number of patients with two seizures or less

时间窗: One year from the start of the study

Patients with two seizures or less in a year were categorized as having good control, whereas those who had more were considered to have poor control.

次要结局

  • Number of patients who maintained an optimized concentration of antiepileptic drugs(One year from the start of the study)

研究者

发起方
Gia Dinh People Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pham Hong Tham

Clinical pharmacist

Gia Dinh People Hospital

相似试验