1.Interpretation of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Wenxi PENG ; Meng QIAO ; Lianxin WANG ; Yuanyuan LI ; Xiuhui LI ; Xin CUI ; Zijia CHEN ; Xinyi CHEN ; Yi DENG ; Yanming XIE ; Zhifei WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):152-160
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.
2.Research of the construction of comprehensive material management system based on multi-campus development model of public hospital
Heng XU ; Tu TU ; Huaiying ZHANG ; Guo ZHAO ; Pan ZHAO ; Zhifei DENG ; Yuxin LI
China Medical Equipment 2024;21(8):127-131
Objective:To construct a comprehensive material management system for public hospitals to meet the needs of material homogeneity and refined management under the hospital's multi-campus development model.Methods:By systematically sorting out the process and each link of the whole life cycle of hospital material management,using Java programming language,browser and server(B/S)architecture,setting up the integrated management platform module of medical equipment,the process module of each link of the material management system and the authority management module,the comprehensive material management system of public hospitals was constructed.The information call,mutual connection and restriction mechanism between the component modules were determined,and the dynamic real-time usage data and status of hospital materials were uniformly supervised.The homogeneity and fine management effects of hospital materials in Beijing Children's Hospital Capital Medical University before and after the application of the system were compared.Results:The integrated material management system of public hospitals realized full lifecycle coverage of hospital materials,the collaboration between various business modules and the smooth operation of the system,and realized the coordination of basic information,business and resources of hospital materials,as well as the homogeneity,refinement and integrated management of cross-campus materials.After the application of the system,seamless real-time data docking between different hospital campuses was realized,the average time of receiving materials in clinical departments was shortened by 2 hours compared with that before the application of the system,the review efficiency of material warehousing data,consumption data and inventory data was increased by 30%,and the backtracking error rate of the whole process of materials was reduced to 0.2%.Conclusion:The comprehensive material management system of public hospitals can improve the efficiency of material management in the operation of multiple hospital campuses,reduce management costs,and realize the homogeneity,refinement and scientificization of hospital material management.
3.Effects of dexmedetomidine on acute lung injury induced by hind limb ischemia-reperfusion in rats
Zilin WU ; Zhifei ZHOU ; Xiangyu LIU ; Ruihua DENG ; Ning DING
The Journal of Practical Medicine 2015;(13):2084-2087
Objective To investigate the effects of dexmedetomidine on acute lung injury induced by hind limb ischemia-reperfusion in rats. Methods Sixty healthy male Wistar rats were randomly allocated into 4 groups: group C(control), group I-R(ischemia-reperfusion), group Pre-Dex(dexmedetomidine)and group Post-Dex. The morphological changes of the lung tissues were observed under light microscope , and polymorphonuclear neutrophils (PMN) in alveolar septum were counted. Meanwhile, lung coefficient, arterial partial PaO2, lung levels of tumor necrosis factor (TNF)-α, interleukin (IL)-6, interleukin (IL)-10, and malondialdehyde (MDA) were measured. Results Rats in the I-R group were resulted in the damage of the lung tissues. The rats in group Pre-Dex and group Post-Dex were featured with obvious mild lung injury. TNF-α、IL-6、IL-10 and MDA in lung levels were significantly increased in group I-R , Pre-Dex and Post-Dex. TNF-α, IL-6 and MDA in the lung were significantly decreased in group Pre-Pex and group Post-Dex. IL-10 was increased in group Pre-Dex and group Post-Dex. Conclusions Inflammatory response and oxidative stress are involved in the pathogenesis of acute lung injury induced by hind limb ischemia-reperfusion in rats. Dexmedetomidine attenuated the lung injury through anti-inflammation and anti-oxidation.

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