在受托格利塔治疗的患者中,对肝酶进行监测
D J Graham1, C R Drinkard, D Shatin
1Office of Postmarketing Drug Risk Assessment, US Food and Drug Administration, 5600 Fishers Ln, HFD-400, Room 15B-32, Rockville, MD 20857, USA. grahamd@cder.fda.gov
JAMA
|August 22, 2001
概括
美国食品和药物管理局 (FDA) 对格利塔的风险管理工作并没有显著改善肝酶监测. 尽管采取了监管措施,但对肝脏健康的持续患者测试仍然不足.
科学领域:
- 药物监督 药物监督 药物监督
- 药物安全监测监测 药物安全监测
- 肝毒性评估 肝毒性评估
背景情况:
- 格利塔是第一个 thiazolidinedione,在1997年上市后不久就导致严重的肝衰竭.
- 由于安全问题,该药在2000年3月被撤回.
研究的目的:
- 评估美国食品和药物管理局 (FDA) 风险管理策略的有效性.
- 评估标签变化和专业信件对格利塔使用者的肝酶监测的影响.
主要方法:
- 分析来自大型托管护理组织的索赔数据 (N=7603).
- 在1997年4月至1999年9月期间,根据越来越严格的FDA肝脏监测建议,建立了四组患者队伍.
- 基线,月度和完整 (基线和月度) 肝酶检测的测量率.
主要成果:
- 在FDA干预后,基线肝酶测试从15%增加到44.6% (P<.001).
- 在连续使用的第一个月后,随访测试率显著下降 (33.4%在1个月下降到13%在5个月).
- 不到5%的患者在第三个月完成了所有推的肝酶测试.
结论:
- 美国食品和药物管理局的风险管理行动没有导致患者肝酶监测的实质性或持久改善.
- 需要进一步评估,以确定药物安全监管干预措施的真正影响和充分性.
相关概念视频
Esophageal Varices-II: Clinical Features and Management
Esophageal varices often manifest as gastrointestinal bleeding episodes, presenting symptoms like hematemesis (vomiting of blood), hematochezia (passing fresh blood via the rectum), and melena (black, tarry stools). Other signs can include weight loss, anorexia, abdominal discomfort, jaundice, pruritus, altered mental status, and muscle cramps.
In the initial assessment, a thorough review of the patient's medical history is vital to identify risk factors such as liver disease, alcohol abuse, or...
In the initial assessment, a thorough review of the patient's medical history is vital to identify risk factors such as liver disease, alcohol abuse, or...
Effect of Hepatic Disease on Pharmacokinetics: Drug Dosing and Hepatic Blood Flow
Chronic liver disease significantly impacts drug metabolism due to alterations in hepatic blood flow and enzyme accessibility. This disruption affects the body's pharmacokinetics—the movement and processing of drugs within the system. Key enzymes crucial for metabolizing medications become less accessible, changing how drugs are processed and utilized. Furthermore, liver disease influences the synthesis of plasma proteins, such as albumin and globulins, which play critical roles in drug binding...
Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test
In clinical practice, the direct measurement of hepatic blood flow to evaluate liver function presents significant challenges due to the intricate and specialized nature of the necessary techniques. Consequently, healthcare professionals often rely on empirical estimates derived from thorough patient examinations and liver function tests to gauge liver health. Among the tools at their disposal, the Child–Pugh and MELD scoring systems stand out for their ability to categorize and assess the...
Kidney Transplant III: Nursing Management
Postoperative Nursing Management for Kidney Transplant PatientsPostoperative nursing management care includes monitoring the surgical site, encouraging early movement, and promoting lung health through breathing exercises. Nurses also administer prescribed medications like H2-blockers, such as famotidine, or proton pump inhibitors, like omeprazole, to help prevent gastrointestinal ulcers and bleeding. Fungal infections in the mouth and bladder can result from immunosuppressive and antibiotic...


