1.Standards for the Application of Hemodynamic Monitoring Technology in Critical Care
Hua ZHAO ; Hongmin ZHANG ; Xin DING ; Huan CHEN ; Jun DUAN ; Wei DU ; Bo TANG ; Yuankai ZHOU ; Dongkai LI ; Xinchen WANG ; Cui WANG ; Gaosheng ZHOU ; Xiaoting WANG
Medical Journal of Peking Union Medical College Hospital 2026;17(1):73-85
With the rapid advancement of hemodynamic indices and monitoring technologies, their classification methods and application processes have become increasingly complex. Currently, no unified standard hasbeen established, making it difficult to fully meet the clinical requirements for hemodynamic management. To assist in hemodynamic monitoring assessment and therapeutic decision-making in critically ill patients, the Critical Hemodynamic Therapy Collaborative Group, in conjunction with the Critical Ultrasound Study Group, has jointly developed the Standard for the Application of Hemodynamic Monitoring Techniques in Critical Care. The first part of this standard systematically categorizes hemodynamic indicators into flow indicators, pressure and its derivative indicators, and tissue perfusion indicators, while elaborating on the clinical application of each. The second part establishes a standardized clinical implementation pathway for hemodynamic monitoring. It proposes a tiered monitoring strategy-comprising basic, advanced, indication-specific, and special scenario monitoring-tailored to different clinical settings. It emphasizes the central role of critical care ultrasound across all levels of monitoring and establishes hemodynamic assessment standards for organs such as the brain, kidneys, and gastrointestinal tract. This standard aims to provide a unified framework for clinical practice, teaching, training, and research in critical care medicine, thereby promoting standardized development within the discipline.
2.Compilation Instruction and Key Point Interpretation for Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance System in Medical Institutions
Shuoshuo WEI ; Fumei LIU ; Li ZHANG ; Yuanyuan LI ; Zhifei WANG ; Xiaoxiao ZHAO ; Xin CUI ; Ruili WEI ; Shuo YANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):229-237
The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions (T/CACM 1563.2-2024) were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine (TCM). This guideline was jointly developed with 23 authoritative medical and research institutions in China, under the lead of the Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM (including research and development, marketing, and application) and to establish a four-dimensional framework of "organizational structure, institutional system, information platform, and vigilance activities". Key components included the establishment of a TCM Safety Committee, the construction of nine core systems, the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B standards, alongside the risk monitoring, identification, assessment, and control during clinical trials and post-marketing phases. Therefore, this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations, the guideline compilation involved multiple rounds of expert interviews, systematic evidence integration, and broad consensus. This guideline was specified to be applicable to medical institutions at all levels, primarily addressing core issues, including the difficulty in adverse reaction identification, low reporting rates, and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous, ensuring alignment with current national laws and regulations, and was registered internationally. In the future, implementation will be promoted through standardized training, tiered dissemination, as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks, ensure patient medication safety, and promote the high-quality development of TCM.
3.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
4.Compilation Instruction for Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use
Xin CUI ; Dingquan YANG ; Zhennian XIE ; Yuanyuan LI ; Zhifei WANG ; Xu WEI ; Jinghua GAO ; Lianxin WANG ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):252-259
The Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use (T/CACM 1563.5—2024), the first guideline in China specializing for the clinical safety of Chinese patent medicines for external use, was led by the Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,and jointly developed by more than 30 research institutions of medical sciences across the country. Aiming to standardize the pharmacovigilance activities in the clinical application of Chinese patent medicines for external use,the guideline systematically categorizes potential risks and proposes prevention and control measures that cover 11 core sections of risk monitoring and reporting, signal identification,as well as assessment and control, addressing the gap in domestic and international standardization of this field. The compilation of this guideline strictly adhered to international norms and domestic regulations, involving multiple rounds of expert consultations,hybrid interviews, and evidence integration (covering literature,medical insurance,essential medicine,pharmacopoeia data, and regulatory information). With the scope of application defined to include medical institutions, pharmaceutical manufacturers and distribution enterprises,as well as regulatory authorities, the guideline focuses on key issues such as inherent medicine risks,quality risks,off-label use,risks of combination therapy,and the safety in special populations. During the compilation,core discrepancies such as the definition of application scope and quality risk control were addressed to ensure alignment with regulations such as the Drug Administration Law of the People's Republic of China and the Good Pharmacovigilance Practice. The guideline is registered internationally (PREPARE—2022CN463). In the future,the implementation of the guideline will be promoted through hierarchical dissemination,dynamic revision,and post-effectiveness evaluation, contributing to rational clinical use and improved patient safety.
5.Compilation Instruction and Key Point Interpretation for Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance System in Medical Institutions
Shuoshuo WEI ; Fumei LIU ; Li ZHANG ; Yuanyuan LI ; Zhifei WANG ; Xiaoxiao ZHAO ; Xin CUI ; Ruili WEI ; Shuo YANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):229-237
The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions (T/CACM 1563.2-2024) were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine (TCM). This guideline was jointly developed with 23 authoritative medical and research institutions in China, under the lead of the Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM (including research and development, marketing, and application) and to establish a four-dimensional framework of "organizational structure, institutional system, information platform, and vigilance activities". Key components included the establishment of a TCM Safety Committee, the construction of nine core systems, the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2B standards, alongside the risk monitoring, identification, assessment, and control during clinical trials and post-marketing phases. Therefore, this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations, the guideline compilation involved multiple rounds of expert interviews, systematic evidence integration, and broad consensus. This guideline was specified to be applicable to medical institutions at all levels, primarily addressing core issues, including the difficulty in adverse reaction identification, low reporting rates, and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous, ensuring alignment with current national laws and regulations, and was registered internationally. In the future, implementation will be promoted through standardized training, tiered dissemination, as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks, ensure patient medication safety, and promote the high-quality development of TCM.
6.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
7.Compilation Instruction for Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use
Xin CUI ; Dingquan YANG ; Zhennian XIE ; Yuanyuan LI ; Zhifei WANG ; Xu WEI ; Jinghua GAO ; Lianxin WANG ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):252-259
The Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use (T/CACM 1563.5—2024), the first guideline in China specializing for the clinical safety of Chinese patent medicines for external use, was led by the Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,and jointly developed by more than 30 research institutions of medical sciences across the country. Aiming to standardize the pharmacovigilance activities in the clinical application of Chinese patent medicines for external use,the guideline systematically categorizes potential risks and proposes prevention and control measures that cover 11 core sections of risk monitoring and reporting, signal identification,as well as assessment and control, addressing the gap in domestic and international standardization of this field. The compilation of this guideline strictly adhered to international norms and domestic regulations, involving multiple rounds of expert consultations,hybrid interviews, and evidence integration (covering literature,medical insurance,essential medicine,pharmacopoeia data, and regulatory information). With the scope of application defined to include medical institutions, pharmaceutical manufacturers and distribution enterprises,as well as regulatory authorities, the guideline focuses on key issues such as inherent medicine risks,quality risks,off-label use,risks of combination therapy,and the safety in special populations. During the compilation,core discrepancies such as the definition of application scope and quality risk control were addressed to ensure alignment with regulations such as the Drug Administration Law of the People's Republic of China and the Good Pharmacovigilance Practice. The guideline is registered internationally (PREPARE—2022CN463). In the future,the implementation of the guideline will be promoted through hierarchical dissemination,dynamic revision,and post-effectiveness evaluation, contributing to rational clinical use and improved patient safety.
8.Ultrasonographic characteristics of renal artery involvement in acute Stanford type A aortic dissection and its relationship with renal function: A retrospective cohort study
Qiushan QING ; Xin WEI ; Hong ZHENG ; Zheng WANG ; Changxue WU ; Peirui CHEN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(04):527-533
Objective To investigate the ultrasonographic characteristics of acute Stanford type A aortic dissection (ATAAD) involving the renal arteries and their relationship with renal function. Methods Patients with ATAAD admitted to Deyang People's Hospital from February 2013 to May 2023 were selected for the study. Based on whether the renal arteries were involved in the dissection, the patients were divided into two groups: a renal artery involvement group and a renal artery non-involvement group. General data and ultrasound characteristics of the two groups were compared. Logistic regression analysis and model correction were performed to analyze the relationship between ultrasound characteristics and renal function involvement in ATAAD patients. Receiver operating characteristic (ROC) curves were used to evaluate the predictive value of ultrasound characteristics for renal artery involvement in ATAAD patients. Additionally, patients in the renal artery involvement group were divided into normal renal function and abnormal renal function subgroups based on serum blood urea nitrogen (BUN) and serum creatinine (Scr) levels. Clinical data of the two subgroups were compared, and a log-binomial model was used to analyze the risk effects of ultrasound characteristics for abnormal renal function. Pearson correlation analysis was performed to assess the correlation between ultrasound characteristics of renal artery involvement and renal function indicators. Results A total of 163 patients were included, consisting of 106 males and 57 females, with a mean age of (50.06±10.46) years (ranging from 20 to 85 years). Significant differences in gender, Scr, and BUN were observed between the renal artery involvement group and the renal artery non-involvement group (P<0.001). Compared to the renal artery non-involvement group, the renal artery involvement group had an increased ascending aorta diameter, a greater proportion of ascending aortic dilation and poor renal perfusion (P<0.05). Logistic regression analysis indicated that ascending aorta diameter, ascending aortic dilation, and poor renal perfusion were independent factors for renal artery involvement (P<0.05). Ultrasonographic characteristics showed good predictive ability for renal artery involvement in ATAAD patients. Furthermore, the combination of the three characteristics yielded a higher predictive value for renal artery involvement. Compared to the normal renal function group, the abnormal renal function group had higher BUN and Scr levels, increased ascending aortic diameter, a greater proportion of ascending aortic dilation and poor renal perfusion (P<0.05). The log-binomial model analysis revealed that the risk ratios for ascending aortic diameter, ascending aortic dilation, and poor renal perfusion were statistically significant both before and after adjustment (P<0.05). Pearson correlation analysis revealed that ascending aortic diameter, ascending aortic dilation, and poor renal perfusion were strongly correlated with renal function parameters (P<0.05). Conclusion Ultrasound characteristics of ATAAD involving the renal arteries are associated with renal function. Ascending aorta diameter, ascending aortic dilation, and poor renal perfusion are independent risk factors for abnormal renal function.
9.Correlations Between Traditional Chinese Medicine Syndromes and Lipid Metabolism in 341 Children with Wilson Disease
Han WANG ; Wenming YANG ; Daiping HUA ; Lanting SUN ; Qiaoyu XUAN ; Wei DONG ; Xin YIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):140-146
ObjectiveTo study the correlations between traditional Chinese medicine (TCM) syndromes and lipid metabolism in children with Wilson disease (WD). MethodsClinical data and lipid metabolism indicators [total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB), and lipoprotein a (Lpa)] were retrospectively collected from 341 children with WD. The clinical data were compared among WD children with different syndromes, and the correlations between TCM syndromes and lipid metabolism in children with WD were analyzed. Least absolute shrinkage and selection operator (LASSO) regression was used for variable screening, and unordered multinomial Logistic regression was employed to analyze the effects of lipid metabolism indicators on TCM syndromes. ResultsThe 341 children with WD included 121 (35.5%) children with the dampness-heat accumulation syndrome, 103 (30.2%) children with the liver-kidney Yin deficiency syndrome, 68 children with the combined phlegm and stasis syndrome, 29 children with the spleen-kidney Yang deficiency syndrome, and 20 children with the liver qi stagnation syndrome. The liver-kidney Yin deficiency syndrome, combined phlegm and stasis syndrome, and spleen-kidney Yang deficiency syndrome had correlations with the levels of lipid metabolism indicators (P<0.05). Lipid metabolism abnormalities occurred in 232 (68.0%) children, including hypertriglyceridemia (108), hypercholesterolemia (23), mixed hyperlipidemia (67), lipoprotein a-hyperlipoproteinemia (12), and hypo-HDL-cholesterolemia (22). The percentages of hypertriglyceridemia and hypo-HDL-cholesterolemia varied among children with different TCM syndromes (P<0.05). Correlations existed for the liver-kidney Yin deficiency syndrome with TG, TC, and HDL-C, the combined phlegm and stasis syndrome with TG, the spleen-kidney Yang deficiency syndrome with TG, TC, and LDL-C, and the liver Qi stagnation syndrome with TC and LDL-C (P<0.05, P<0.01). ConclusionThe TCM syndromes of children with WD are dominated by the dampness-heat accumulation syndrome and the liver-kidney Yin deficiency syndrome, and dyslipidemia in the children with WD is dominated by hypertriglyceridemia and mixed hyperlipidemia. There are different correlations between TCM syndromes and lipid metabolism indicators, among which TG, TC, LDL-C, and HDL-C could assist in identifying TCM syndromes in children with WD.
10.Research on the chemical compositions and their biological activities of Piper nigrum L.
Xing GAO ; Fengping ZHAO ; Wentao WANG ; Wei TIAN ; Canhui ZHENG ; Xin CHEN
Journal of Pharmaceutical Practice and Service 2025;43(7):313-319
Piper nigrum L. is an evergreen climbing vine, which belongs to the genus Piperia in the Piperaceae family. Piper nigrum L., which known as the “king of spices”, is used as both food and medicine. The main active substances in Piper nigrum L. are alkaloids mainly composed of amides, and essential oil, as well as phenolic compounds. In this paper, the chemical compositions, especially amide alkaloids, and their biological activities of Piper nigrum L. were summarized. These studies showed that Piper nigrum L., as a medicinal and food plant, had a wide range of biological activities and was deserved further research and in-depth utilization.

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