药物安全性证据生态体系:从发现药物不良反应信号到优化风险管理

Drug safety evidence ecosystem:from detecting adverse drug reaction signals to optimizing risk management

上市前临床试验常由于样本量不足和随访期短等局限性,无法发现罕见或迟发的药物不良反应(ADR),因此在药品批准上市后,持续的药物安全性评价研究尤为必要。证据的产生依赖于不良反应信号的发现和特定风险的验证研究,通过meta分析等方法整合多个来源的证据可进一步提高药物安全性评价的全面性和可靠性。此外,还应重视诊疗实践中的用药风险管理,通过制订规范的临床指南和建立决策支持系统等促进证据的传播与利用,确保其真正用于诊疗实践。构建证据生态体系不仅有助于识别和理解药物使用中的潜在风险,还能提升风险管理的科学性和实用性,最终减少患者因ADR受到的伤害。

Pre-marketing clinical trials may fail to detect rare or delayed adverse drug reactions(ADRs)due to insufficient sample size and short follow-up periods.Therefore,continuous post-marketing safety evaluation is necessary.Evidence generation relies on discovering ADR signals and conducting studies to verify specific risks.Integrating evidence from multiple sources through methods like meta-analy-sis can further enhance the comprehensiveness and reliability of drug safety evaluations.Additionally,risk management in clinical practice should be emphasized by developing standardized clinical guidelines and establishing decision support systems to facilitate the dissemination and application of evidence,ensuring its practical use.Constructing an evidence ecosystem not only helps identify and understand potential medi-cation safety issues,but also enhance the scientific and practical aspects of risk management,ultimately reducing patient harm from ADRs.