Department of Clinical Decision Support, Health Base Foundation, Houten, The Netherlands.
Department of Pharmacy, Unit of Pharmacotherapy, Epidemiology and Economics, University of Groningen, Groningen, The Netherlands.
Drug Saf. 2018 Jun;41(6):603-613. doi: 10.1007/s40264-017-0635-x.
The presence of liver cirrhosis can have a major impact on pharmacodynamics and pharmacokinetics, but guidance for prescribing is lacking.
The aim of this study is to provide an overview of evidence-based recommendations developed for the safe use of drugs in liver cirrhosis.
Recommendations were based on a systematic literature search combined with expert opinion from a panel of 10 experts. The safety of each drug was classified as safe, no additional risks known, additional risks known, unsafe, unknown or the safety class was dependent on the severity of liver cirrhosis (Child-Pugh classification). If applicable, drug-specific dosing advice was provided. All recommendations were implemented in clinical decision support systems and on a website.
We formulated 218 recommendations for a total of 209 drugs. For nine drugs, two recommendations were formulated for different administration routes or indications. Drugs were classified as 'safe' in 29 recommendations (13.3%), 'no additional risks known' in 60 (27.5%), 'additional risks known' in 3 (1.4%), and 'unsafe' in 30 (13.8%). In 57 (26.1%) of the recommendations, safety depended on the severity of liver cirrhosis and was 'unknown' in 39 (17.9%) recommendations. Large alterations in pharmacodynamics were the main reason for classifying a drug as 'unsafe'. For 67 drugs (31%), a dose adjustment was needed.
Over 200 recommendations were developed for the safe use of drugs in patients with liver cirrhosis. Implementing these recommendations into clinical practice can possibly enhance medication safety in this vulnerable patient group.
肝硬化的存在会对药效动力学和药代动力学产生重大影响，但缺乏指导用药的相关建议。
本研究旨在提供一套循证推荐，以安全使用治疗肝硬化的药物。
推荐意见基于系统文献检索，并结合来自 10 位专家组成的专家组的专家意见。将每种药物的安全性分类为安全、已知无附加风险、已知附加风险、不安全、未知或安全性取决于肝硬化严重程度（Child-Pugh 分级）。如果适用，提供了特定药物的剂量建议。所有建议都被实施在临床决策支持系统和网站上。
我们为总共 209 种药物制定了 218 条建议。对于 9 种药物，为不同的给药途径或适应证制定了 2 条建议。29 条（13.3%）建议药物被分类为“安全”，60 条（27.5%）“已知无附加风险”，3 条（1.4%）“已知有附加风险”，30 条（13.8%）“不安全”。在 57 条（26.1%）建议中，安全性取决于肝硬化的严重程度，39 条（17.9%）建议安全性“未知”。药效动力学的重大变化是将药物分类为“不安全”的主要原因。对于 67 种药物（31%），需要调整剂量。
为治疗肝硬化患者安全使用药物制定了 200 多条建议。将这些建议应用于临床实践中，可能会提高这一脆弱患者群体的用药安全性。
