The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines （hereinafter referred to as the Guidelines） is first specialized in the field of drug safety for oral Chinese patent medicines （OCPMs） in China. Rooted in China's healthcare context， the Guidelines address the unique usage patterns and risk characteristics of OCPMs， filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines， and to promote the standardized development of pharmacovigilance practices for OCPMs， this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting， the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment， the Guidelines were examined from three dimensions of formulation components， medication behaviors， and population to address complex safety issues arising from medicinal constituents， irrational use， and individual susceptibility. In the area of risk control， the analysis focused on context-based interventions and dynamic closed-loop management strategies， exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore， this paper evaluated the applied value of the Guidelines and identified implementation challenges， such as insufficient capacity at the primary-care level and limited digital infrastructure. In response， the study proposed optimization strategies including establishing a dynamic updating mechanism， strengthening training at the grassroots level， and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders （including manufacturers）， pharmaceutical distributors， healthcare institutions， and research organizations， ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.

Objective To detect the plasma amino-terminal pro-B-type natriuretic peptide (NT-ProBNP) of children with congenital heart disease(CHD) prior to heart surgery,to analysize its sensitivity,specificity and Youden index by receiver operating characteristic(ROC) curve,to explore the cut-off values of plasma NTProBNP for the diagnosis of congestive heart failure(CHF) in children under 5 years old before and after age stratification.Method The plasma NT-proBNP was detected for 100 children with CHD prior to heart surgery (experimental group) and 100 normal children(control group) between January 2011 to January 2013.Age stratification(0 ～ 1 year group,～3 years group and ～ 5 year group) was conducted in children with CHF younger than 5 years old to explore the cut-off values of plasma NT-ProBNP for the diagnosis of CHF.Results The NT-proBNP of 34 patients with CHF(n =100) was in accordance to Ross criteria The cut-off values were 502 ng/ L before age stratification,and they were 552 ng/L,449 ng/L,349 ng/L after age stratification for 0 ～ 1 year group,～ 3 years group and ～ 5 group.Conclusion The cut-off values of plasma NT-ProBNP for CHF were 552 ng/L、449 ng/L、349 ng/L for 0 ～ 1 year group,～ 3 years group and ～ 5 year group.