1.Optimization of drug management model for investigator-initiated trial with benchmarking analysis
Yufei XI ; Tianxiao WANG ; Xue ZHANG ; Yingzhuo DING ; Li YAN ; Feng JIANG ; Xiangui HE ; Jiannan HUANG ; Qin LI
China Pharmacy 2025;36(3):280-284
		                        		
		                        			
		                        			OBJECTIVE To optimize the management model of drugs used in investigator-initiated trial (IIT). METHODS With benchmarking analysis, based on the practical work experience of a tertiary specialized hospital in the field of IIT drug management in Shanghai, a thorough review was conducted, involving relevant laws, regulations, and academic literature to establish benchmark criteria and the evaluation standards. Starting from the initiation of IIT projects, a detailed comparative analysis of key processes was carried out, such as the receipt, storage, distribution, use and recycling of drugs for trial. The deficiencies in the current management of IIT drugs were reviewed in detail and a series of optimization suggestions were put forward. RESULTS It was found that the authorized records of drug management were missing, the training before project implementation was insufficient, and the records of receipt and acceptance of IIT drugs were incomplete. In light of these existing problems, improvement measures were put forward, including strengthening the training of drug administrators and stipulating that only drug administrators with pharmacist qualifications be eligible to inspect and accept drugs, etc. The related systems were improved, and 17 key points of quality control for the management of IIT drugs were developed. CONCLUSIONS A preliminary IIT drug management system for medical institutions has been established, which helps to improve the institutional X2023076) framework of medical institutions in this field.
		                        		
		                        		
		                        		
		                        	
2.Analysis of ancient medical physicians′ spatial theory from the perspective of liver and mingmen visceral manifestation
Chongcheng XI ; Jie ZHANG ; Wenjun WU ; Zhiwen ZHANG ; Shuangqing ZHAI ; Quansheng FENG
Journal of Beijing University of Traditional Chinese Medicine 2025;48(2):187-192
		                        		
		                        			
		                        			Yin-yang, visceral manifestation, and ti-yong theories are the core theories of traditional Chinese medicine (TCM) and play a crucial role in its formation and development. With the continuous evolution of Chinese philosophy, TCM philosophy and theories have undergone significant influence, resulting in differing interpretations of the visceral manifestation of liver and mingmen across various historical periods by different medical practitioners. This paper focuses on the different understandings of the position of liver and mingmen, combining relevant philosophical images and TCM anatomical illustrations to deeply explore ancient medical theorists′ concepts regarding the four spatial directions of left, right, up, and down. The research reveals that ancient medical theorists′ conceptualization of spatial theory transitioned from an initial circular motion to a vertical movement, with the focus shifting from the upper part to the lower part. The primary reasons for these differences and changes could be explained by the varying emphasis on the ti-yong theory and differing focal points within the yin-yang theory. This study systematically examines the evolution of visceral manifestation theories related to liver and mingmen, highlights the shifts in physicians′ perspectives on spatial theory, and analyzes the influence of the ti-yong theory and yin-yang theory on these changes. The findings aim to provide a theoretical guide for advancing research and clinical application of spatial theory in TCM, thereby fostering the integration of TCM philosophy with medical theory.
		                        		
		                        		
		                        		
		                        	
3.Criteria and prognostic models for patients with hepatocellular carcinoma undergoing liver transplantation
Meng SHA ; Jun WANG ; Jie CAO ; Zhi-Hui ZOU ; Xiao-ye QU ; Zhi-feng XI ; Chuan SHEN ; Ying TONG ; Jian-jun ZHANG ; Seogsong JEONG ; Qiang XIA
Clinical and Molecular Hepatology 2025;31(Suppl):S285-S300
		                        		
		                        			
		                        			 Hepatocellular carcinoma (HCC) is a leading cause of cancer-associated death globally. Liver transplantation (LT) has emerged as a key treatment for patients with HCC, and the Milan criteria have been adopted as the cornerstone of the selection policy. To allow more patients to benefit from LT, a number of expanded criteria have been proposed, many of which use radiologic morphological characteristics with larger and more tumors as surrogates to predict outcomes. Other groups developed indices incorporating biological variables and dynamic markers of response to locoregional treatment. These expanded selection criteria achieved satisfactory results with limited liver supplies. In addition, a number of prognostic models have been developed using clinicopathological characteristics, imaging radiomics features, genetic data, and advanced techniques such as artificial intelligence. These models could improve prognostic estimation, establish surveillance strategies, and bolster long-term outcomes in patients with HCC. In this study, we reviewed the latest findings and achievements regarding the selection criteria and post-transplant prognostic models for LT in patients with HCC. 
		                        		
		                        		
		                        		
		                        	
4.Criteria and prognostic models for patients with hepatocellular carcinoma undergoing liver transplantation
Meng SHA ; Jun WANG ; Jie CAO ; Zhi-Hui ZOU ; Xiao-ye QU ; Zhi-feng XI ; Chuan SHEN ; Ying TONG ; Jian-jun ZHANG ; Seogsong JEONG ; Qiang XIA
Clinical and Molecular Hepatology 2025;31(Suppl):S285-S300
		                        		
		                        			
		                        			 Hepatocellular carcinoma (HCC) is a leading cause of cancer-associated death globally. Liver transplantation (LT) has emerged as a key treatment for patients with HCC, and the Milan criteria have been adopted as the cornerstone of the selection policy. To allow more patients to benefit from LT, a number of expanded criteria have been proposed, many of which use radiologic morphological characteristics with larger and more tumors as surrogates to predict outcomes. Other groups developed indices incorporating biological variables and dynamic markers of response to locoregional treatment. These expanded selection criteria achieved satisfactory results with limited liver supplies. In addition, a number of prognostic models have been developed using clinicopathological characteristics, imaging radiomics features, genetic data, and advanced techniques such as artificial intelligence. These models could improve prognostic estimation, establish surveillance strategies, and bolster long-term outcomes in patients with HCC. In this study, we reviewed the latest findings and achievements regarding the selection criteria and post-transplant prognostic models for LT in patients with HCC. 
		                        		
		                        		
		                        		
		                        	
5.Criteria and prognostic models for patients with hepatocellular carcinoma undergoing liver transplantation
Meng SHA ; Jun WANG ; Jie CAO ; Zhi-Hui ZOU ; Xiao-ye QU ; Zhi-feng XI ; Chuan SHEN ; Ying TONG ; Jian-jun ZHANG ; Seogsong JEONG ; Qiang XIA
Clinical and Molecular Hepatology 2025;31(Suppl):S285-S300
		                        		
		                        			
		                        			 Hepatocellular carcinoma (HCC) is a leading cause of cancer-associated death globally. Liver transplantation (LT) has emerged as a key treatment for patients with HCC, and the Milan criteria have been adopted as the cornerstone of the selection policy. To allow more patients to benefit from LT, a number of expanded criteria have been proposed, many of which use radiologic morphological characteristics with larger and more tumors as surrogates to predict outcomes. Other groups developed indices incorporating biological variables and dynamic markers of response to locoregional treatment. These expanded selection criteria achieved satisfactory results with limited liver supplies. In addition, a number of prognostic models have been developed using clinicopathological characteristics, imaging radiomics features, genetic data, and advanced techniques such as artificial intelligence. These models could improve prognostic estimation, establish surveillance strategies, and bolster long-term outcomes in patients with HCC. In this study, we reviewed the latest findings and achievements regarding the selection criteria and post-transplant prognostic models for LT in patients with HCC. 
		                        		
		                        		
		                        		
		                        	
6.Exploration of the "Wisdom-Transmission-Modeling-Linkage" Intelligent Inheritance Model for the Academic Thoughts and Clinical Experience of Famous Chinese Medicine Practitioners
Qiuping CHEN ; Hang ZHOU ; Ju CHEN ; Chongcheng XI ; Baixue LI ; Quansheng FENG
Journal of Traditional Chinese Medicine 2025;66(14):1419-1423
		                        		
		                        			
		                        			As traditional Chinese medicine (TCM) culture evolves, the academic thoughts of these practitioners, being a core component of TCM inheritance, are gradually shifting from traditional models to digital and intelligent approaches. However, this process faces challenges, including insufficient standardization of data collection and processing, low inheritance efficiency, and the risk of inheritance alienation. To address these issues, this paper proposed the construction of an intelligent platform following the "intelligence-transmission-modeling-linkage" path. "Intelligence" involves using smart perception technologies to accurately collect and classify diagnostic and therapeutic information from famous TCM practitioners, laying the foundation for digital inheritance; "transmission" focuses on leveraging artificial intelligence to mine and inherit the clinical experience of famous TCM practitioners, thereby establishing a "regional academic schools+group commonality" dynamic inheritance system; "modeling" integrates the academic thoughts and advantageous diseases of multiple schools to develop intelligent diagnostic and therapeutic models of famous TCM practitioners, resulting in personalized treatment plans; "linkage" involves constructing a clinical decision support system of famous TCM practitioners by integrating blockchain and generative intelligence, creating an AI digital avatar of TCM diagnostic and therapeutic knowledge. The "intelligence-transmission-modeling-linkage" intelligent inheritance model not only provides new ideas for the digital inheritance of TCM academic schools, but also offers strong support for the modernization and internationalization of TCM. 
		                        		
		                        		
		                        		
		                        	
7.Antibody threshold and demographic characteristics of low-titer group O whole blood donors in Jiangsu
Tao FENG ; Rui ZHU ; Wenjia HU ; Ling MA ; Hong LIN ; Xi YU ; Chun ZHOU ; Nizhen JIANG
Chinese Journal of Blood Transfusion 2025;38(9):1225-1229
		                        		
		                        			
		                        			Objective: To investigate the distribution of IgM anti-A/B titers among group O whole blood donors in Jiangsu, establish a low-titer threshold, and analyze the demographic characteristics of low-titer donors, so as to provide data for recruiting low-titer group O whole blood (LTOWB) donors. Methods: Plasma samples from 1 009 group O whole blood donors were tested for IgM anti-A and anti-B titers using the microplate technique. The distribution of antibody titers was analyzed to establish a low-titer threshold. The distribution trends of titers across different demographic groups were also analyzed. Results: The peak titer for anti-A, anti-B were 64 (31.5%), 4 (23.8%), respectively, The proportion of donors with both anti-A and anti-B titers below 64 was 97.3% (982/1 009). The mean anti-A titer was higher than anti-B titer. Anti-A titers were higher in female donors than in male donors (P<0.05). The anti-A titers differed significantly among different age groups (P<0.05). However, no significant difference in titers was observed based on the number of donations (P>0.05). Conclusion: A titer of 64 can be used as the reference threshold of LTOWB in Jiangsu. Male donors of appropriate age are more suitable than female donors for establishing an emergency panel of LTOWB mobile donors.
		                        		
		                        		
		                        		
		                        	
8.Analysis on Formation Mechanism of Self-precipitation in Process of Compound Decoction of Famous Classical Formula Sinitang
Meihui LI ; Xi FENG ; Xinyu LUO ; Juehan ZHOU ; Yunya HUANG ; Shuhan LI ; Yanfen CHENG ; Shu FU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(22):145-152
		                        		
		                        			
		                        			ObjectiveTo explore the main mechanism of self-precipitation formed during the decoction of Sinitang(SNT), and to provide a research basis for exploring the differences in the toxic and effective components of this compound. MethodsThe average precipitation yields of SNT, Glycyrrhizae Radix et Rhizoma(GRR)-Aconiti Lateralis Radix Praeparata(ALRP) decoction(GF), ALRP-Zingiberis Rhizoma(ZR) decoction(FJ), GRR-ZR decoction(GJD), ALRP decoction(FZ), ZR decoction(GJ) and GRR decoction(GC) were determined. The four main self-precipitation samples of SNT, GF, FZ and GC were physically characterized by particle size, scanning electron microscopy(SEM), pH, total dissolved solids(TDS), conductivity, and Fourier transform infrared spectroscopy(FT-IR) analysis. The chemical compositions of SNT decoction and its different phases was identified by ultra-performance liquid chromatography-quadrupole-electrostatic field orbitrap high-resolution mass spectrometry(UPLC-Q-Exactive Orbitrap-MS) for SNT, SNT self-precipitation and SNT supernatant, and the contents of its main toxic and effective components were determined by high performance liquid chromatography(HPLC). ResultsPrecipitation yield results of the 7 samples of SNT decoction and single decoction showed that SNT had the highest self-precipitation yield. The formation of SNT self-precipitation was mainly related to the reaction between ALRP and GRR components to form complexes, and FT-IR showed that GRR had the greatest influence on the formation of self-precipitation. A total of 110 components were identified in the SNT decoction, including 100 components in the SNT self-precipitation and 106 components in the SNT supernatant. And quantitative results of the main toxic and effective components revealed that the reaction between ALRP and GRR components formed complexes, resulting in the following content hierarchy for free components:SNT decoctionsupernatantself-precipitation, these components included free liquiritin, benzoylmesaconine, benzoylaconitine, benzoylhypacoitine, liquiritigenin, aconitine, hypoaconitine, isoliquiritigenin and ammonium glycyrrhizinate. ConclusionSNT exhibits spontaneous precipitation during compound decoction, with GRR exerting the greatest influence on its formation. This suggests GRR plays a significant role in the detoxification of SNT. The differences in the self-precipitated toxic-effective components of SNT compound decoction primarily manifest as changes in component content, reflecting the characteristics of SNT "deposition in vitro and sustained release in vivo" and the importance of "administered at draught" in the clinical application of SNT. 
		                        		
		                        		
		                        		
		                        	
9.Strategic planning for paying attention to anal preservation in low rectal cancer
Medical Journal of Chinese People's Liberation Army 2024;49(1):10-16
		                        		
		                        			
		                        			Based on the background of a multidisciplinary treatment team and the increasing high-quality life aspirations of patients,the preservation of anal function for patients with low rectal cancer has undergone changes in recent years.With the optimization of neoadjuvant therapy,refinement of surgical techniques,and the deepening of the concept of anal preservation after surgery,the concept of anal preservation for low rectal cancer has gradually shifted from traditional simple surgery to comprehensive treatment,and anal preservation surgery tends to be more accurate preservation.The goal of comprehensive treatment is to preserve good anal function and reduce surgical damage.However,comprehensive treatment for anal preservation in low rectal cancer is still in its infancy,and there is no consensus on the strategy planning for anal preservation.Therefore,summarizing various preoperative,intraoperative,and postoperative treatment strategies for low rectal cancer is of great significance for the selection of anal preservation schemes for patients with low rectal cancer.This article focus on exploring the optimization of neoadjuvant therapy models,"watch and wait"plans,the development of anal preservation techniques,and postoperative and preservation strategies,aiming to review the current status of anal preservation strategy planning for low rectal cancer.
		                        		
		                        		
		                        		
		                        	
10.Comparison of clinical efficacy of NOSES combined with ERAS and conventional laparoscopic surgery in treatment of rectal cancer
Feng SONG ; Feng GAO ; Ming XU ; Jian GAO ; Zeng-Xi MAO
Medical Journal of Chinese People's Liberation Army 2024;49(1):31-36
		                        		
		                        			
		                        			Objective To compare the clinical efficacy of natural orifice specimen extraction surgery(NOSES)combined with enhanced recovery after surgery(ERAS)and conventional laparoscopic surgery in treatment of rectal cancer patients.Methods A hundred patients with rectal cancer in the Department of Colorectal and Anal Surgery,the 940th Hospital of Joint Logistics Support Force of PLA were selected as the research objects from January 2019 to December 2021,including 49 cases treated with NOSES combined with ERAS were set as the observation group,and 51 cases treated with conventional laparoscopic surgery of rectal cancer were set as the control group.Postoperative C-reactive protein(CRP),procalcitonin(PCT),interleukin-6(IL-6),white blood cell count(WBC),percentage of neutrophil(NEUT),K+ concentration,postoperative peristalsis recovery time,first time out-of-bed activity,first liquid feeding time,removal time of urinary,and drainage tubes,hospital stay and intraoperative blood loss,number of lymph node detection,positive margin rate,incidence of complications,and pain score were compared between the two groups.Results The observation group showed significant lower postoperative CRP,PCT,IL-6 levels when compared with control group(P<0.05),while no significant difference in K+ concentration between the two groups(P>0.05).The recovery time of intestinal peristalsis,the time of the first out-of-bed activity,the first liquid feeding time,the time of removal of the urinary tube and the drainage tube,and the number of days of hospitalization in observation group were all superior to the control group(P<0.05).The observation group with the duration of surgery was longer than the control group,and the difference was statistically significant(P<0.05).There were no significant differences in intraoperative bleeding,number of lymph nodes detected and positive rate of resection margins between the two groups(P>0.05).There was no significant difference in the incidence of complications between the two groups(4.1%vs.7.8%,P>0.05).The observation group showed significant lower pain scores than control group on the 1st,2nd and 3rd day after surgery(P<0.05).Conclusions NOSES combined with ERAS in treatment of rectal cancer patients is safe and feasible,can narrow the surgical incision,alleviate stress response and postoperative pain,improve postoperative efficacy and reduce the occurrence of complications,so is worthy of promotion and application.
		                        		
		                        		
		                        		
		                        	
            

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