绘制世卫组织基本药物的治疗多功能性:对非标签性指示进行系统分析
Ramya Kateel1, Shreya Hegde1, Sadhana Holla2
1Department of Pharmacology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.
Therapeutic advances in drug safety
|November 27, 2025
概括
非标签的基本药物的处方是常见的,60%的世界卫生组织EML药物用于未经批准的适用症. 大多数用途的证据有限,尽管许多都包含在临床指南中.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床药房 临床药房
- 基于证据的医学 基于证据的医学
背景情况:
- 非标签处方是一种全球性的临床实践.
- 世界卫生组织基本药物清单 (WHO EML) 药物的非标签使用数据有限.
- 世卫组织EML对医疗保健系统至关重要,特别是在低收入和中等收入国家.
研究的目的:
- 系统地分析非标签药物使用的流行情况.
- 检查这些用途的证据基础和指南支持.
- 评估2023年世卫组织EML上药物的非标签性适用性.
主要方法:
- 描述性的横截面观测研究.
- 对世卫组织EML药物的UpToDate Lexidrug数据库的分析.
- 提取了FDA批准的指示,非标签用途,证据水平 (A,B,C,G) 和指导方针的包含.
主要成果:
- 60%的世卫组织EML药物有非标签用途.
- 传染病 (30.5%) 和瘤病 (25.2%) 的非标签流行率最高.
- 大多数非标签用途具有C级 (32%) 或B级 (30%) 证据;只有11%具有A级证据.
- 64%的非标签用途在临床指南中,通常没有指定的证据水平.
结论:
- 这项研究提供了第一个对世卫组织EML药物的非标签用途的全面分析.
- 基本药物被广泛重新使用,但支持证据的质量不同.
- 这些发现强调需要评估支持非标签使用基本药物的证据.
相关概念视频
Bioequivalence of Drugs: Drugs with Multiple Indications
141
The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
141
Therapeutic Drug Monitoring: Overview and Classification
275
Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
275
Drug Classes and Categories
2.8K
Drugs can be classified according to their chemical composition or their intended therapeutic application. For instance, anti-infective agents that possess the ability to eliminate pathogens or suppress their growth and reproduction can be grouped based on the organisms they target or their chemical structure. Furthermore, drugs can be divided into prescription, nonprescription, or controlled substances. Prescription medications, such as antibiotics, require oversight from a licensed healthcare...
2.8K
Therapeutic Drug Monitoring: Drug Analysis Methods
164
Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood or body tissues to tailor drug therapy effectively. This monitoring is critical for managing drugs with narrow therapeutic indices like digoxin and phenytoin, ensuring they are both safe and effective. For instance, monitoring theophylline levels in asthma patients involves precision and sensitivity to adjust doses according to individual responses to therapy, ensuring efficacy and...
164
Therapeutic Index
6.4K
The therapeutic index of a drug is a key parameter in pharmacology that quantifies the relative safety of a drug by calculating the ratio between the dose that causes toxicity in half the population (50%) to the dose that proves to be effective for half the population (50%). It provides a spectrum of doses for a particular drug ranging from effective to potentially toxic. To illustrate, consider an anticoagulant agent like warfarin. It possesses a narrow window within its therapeutic index to...
6.4K
Therapeutic Drug Monitoring: Affecting Factors
182
Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
182


