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.

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.

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.

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.

OBJECTIVE: To investigate the gene carrier rate and genotype distribution characteristics of thalassemia in the population of Kunming, and compare the differences of red blood cell (RBC) parameters between β⁺ heterozygous carriers, β⁰ heterozygous carriers and healthy population, as well as between different sexes of adults aged 18-45 years. METHODS: A retrospective analysis of 3 195 cases of thalassemia gene screened in the First Affiliated Hospital of Kunming Medical University from April 1, 2020 to March 31, 2022 was performed to detect 21 mutations of β-globin genes which was common in Chinese people using fluorescence PCR melting curve method. Patients with single heterozygous carrying β-thalassemia gene were divided into β⁺ heterozygote group and β⁰ heterozygote group, while the control group consisted of 219 healthy individuals. Four indices, including RBC, hemoglobin (Hb), mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH) were collected from all β heterozygous carriers and 219 healthy people, and compared between β⁺ heterozygote group, β⁰ heterozygote group and control group, as well as between β⁺ heterozygous carriers, β⁰ heterozygous carriers and healthy population of different sexes aged 18-45 years. RESULTS: There were 688 cases confirmed thalassemia gene carriers, accounting for 21.53%. Among them, 322 cases were found to have β-globin gene mutations, including 145 cases of β⁺ heterozygote, 151 cases of β⁰ heterozygote, and 14 cases of β⁺ homozygotes as well as β⁺ and β⁰ dual heterozygotes. Additionally, 12 cases were found to have simultaneous mutation or deletion of β-globin and α-globin. The carrier rate of CD26 G>A mutation in β⁺ thalassemia was the highest, accounting for 57.9%, while in β⁰ thalassemia CD17 A>T was the highest, accounting for 46.4%. The erythrocyte parameters of 296 β heterozygous mutation carriers were compared with the normal reference interval, and it was found that 218 cases with RBC value greater than the highest value of reference interval, while 105, 281, and 269 cases with Hb, MCV, and MCH value less than the lowest value of reference interval, respectively. There were significant differences in the 4 erythrocyte parameters between β⁺ heterozygotes, β⁰ heterozygotes and healthy individuals (all P < 0.001), and further comparison between different sexes also showed significant differences (all P < 0.001). CONCLUSIONS The carrier rates of thalassemia gene and β-thalassemia heterozygote are both at high level in Kunming, and there are significant differences in the erythrocyte parameters between β⁺ heterozygous carriers, β⁰ heterozygous carriers and healthy individuals. When genetic counseling, it is necessary to inform and strengthen screening among adults of marriageable age to prevent birth of children with severe thalassemia.
Humans ; beta-Thalassemia/blood* ; Adult ; Heterozygote ; Male ; Female ; beta-Globins/genetics* ; Retrospective Studies ; Middle Aged ; Mutation ; Adolescent ; Genotype ; Erythrocytes ; Erythrocyte Indices ; Young Adult ; China ; Genetic Testing ; Asian People/genetics*

Objective Building a TCM health management and clinical research integration platform for knee osteoarthritis,promoting the integration of traditional Chinese medicine with internet and mobile health technology,driving the digitalization of TCM-enabled knee osteoarthritis health management strategies,and providing a convenient digital platform for the efficient conduct of TCM clinical research on knee osteoarthritis.Methods Using a combination of literature review and market research,a preliminary framework for the platform's functions and services was established.Then,17 patients with knee osteoarthritis were interviewed through a convenient sampling method to identify their needs and preferences,and design the platform's functional modules and service flow.In the development and testing phase,a multidisciplinary team consisting of professional development engineers,data scientists,and clinical experts conducted multiple rounds of discussions to ensure the scientificity,feasibility,and convenience of the platform's function and service development.Results The integrated platform of traditional Chinese medicine health management and clinical research for knee osteoarthritis is built.The traditional Chinese medicine health management module includes features of health education,evaluation and exercise training,etc.The scientific research module includes patient self-report outcome data collection and remote quality control,etc.,which can provide the whole process service integrating health management and remote intelligent clinical trial.Conclusion Building an integrated platform of TCM health management and clinical research will provide more convenient and effective health management solutions for patients with knee osteoarthritis.

OBJECTIVE To investigate the induction of apoptosis in hepatocellular carcinoma cells by polyphyllin 9 （PP9） through the regulation of the Fas/Fas ligand （FasL） signaling pathway， and its inhibitory effect on the growth of transplanted tumor in nude mice. METHODS Based on the screening of cell lines and intervention conditions， HepG2 cells were selected as the experimental subject to investigate the effects of 2 μmol/L and 4 μmol/L PP9 treatment on cell colony formation activity， apoptosis rate， as well as the protein expressions of Fas， FasL， cleaved caspase-8 and cleaved caspase-3. Additionally， Fas inhibitor KR- 33493 was introduced to investigate the underlying mechanism of PP9’s anti-hepatocellular carcinoma activity. Using HepG2 cell tumor-bearing nude mice model as the object， and 5-fluorouracil （20 mg/kg） as the positive control， the effects of 10 mg/kg PP9 on tumor volume， tumor mass， and the protein expressions of the nuclear proliferation-associated antigen Ki-67 and cleaved caspase-3 in tumor-bearing nude mice were investigated. RESULTS Compared with the control group， 2， 4 μmol/L PP9 significantly decreased the number of clones and the clone formation rate of cells， but significantly increased the apoptosis rate， the protein expressions of Fas， FasL， cleaved caspase-8 and cleaved caspase-3 （P＜0.05 or P＜0.01）. However， the combination of Fas inhibitor KR-33493 could significantly reverse the effect of PP9 on the up-regulation of proteins related to the Fas/FasL signaling pathway （P＜0.01）. Compared with the control group， the tumor volume （on day 27）， mass and protein expression of Ki- 67 in nude mice of the PP9 group were significantly decreased， while the protein expression of cleaved caspase-3 was significantly increased （P＜0.01）. CONCLUSIONS PP9 can induce apoptosis of HepG2 cells by activating the Fas/FasL signaling pathway. Meanwhile， PP9 can also effectively inhibit the growth of transplanted tumors in nude mice.

Artificial intelligence technology brings new opportunities for the reform and innovation of medical imaging teaching and training models. We took the lead in building an artificial intelligence neuroimaging education platform. The platform included four modules: imaging case library, intelligent interactive learning, self-test and exercise, and online exam. The platform enables a more flexible and convenient education mode, a precise and individualized training method, which can motivate the enthusiasm and initiative of medical imaging students and resident trainees in learning, promote the rapid integration of theoretical knowledge and clinical practice, and improve the efficiency and quality of residency training.

Objective To observe CT and MRI manifestations of gastritis cystica profunda(GCP).Methods Seventeen patients with GCP confirmed by operation or biopsy pathology were enrolled,and lesions'CT and MRI manifestations were observed.Results Among 17 cases,16 cases(16/17,94.12％)were found with single lesion and 1(1/17,5.88％)with diffuse multiple lesions.The lesion located in the fundus of stomach in 5 cases(5/17,29.41％),in the body of stomach in 4 cases(4/17,23.53％),in the cardia and antrum of stomach each in 3 cases(3/17,17.65％)and in the pylorus in 1 case(1/17,5.88％),while 1 case(1/17,5.88％)was found with diffused multiple lesions within stomach.Non-enhance CT showed local thickening of gastric wall in 10 cases(10/17,58.82％),all were isodensities,and the mucosa uniformly enhanced in contrast enhance CT(CECT).Predominately cystic lesion in 5 cases(5/17,29.41％)presented as submucosal cystic protrusions,and grew into the stomach cavity with circular or oblong low density in non-enhanced CT,while sandwich enhancement of mucosa was observed in CECT.Among these 5 cases(5/17,29.41％),MRI showed lesion confined to the submucosa with low signal on T1WI and high signal on T2WI,while diffusion weighted imaging showed unrestricted diffusion,and the enhancement pattern was consistent with that of CT in 2 cases.In other 2 cases(2/17,11.77％)with cystic-solid lesion,non-enhanced CT showed soft tissue density,while CECT showed lump-like stratified enhancement.Conclusion CT and MRI manifestations of GCP had certain characteristics.

Objective To observe CT and MRI manifestations of gastritis cystica profunda(GCP).Methods Seventeen patients with GCP confirmed by operation or biopsy pathology were enrolled,and lesions'CT and MRI manifestations were observed.Results Among 17 cases,16 cases(16/17,94.12％)were found with single lesion and 1(1/17,5.88％)with diffuse multiple lesions.The lesion located in the fundus of stomach in 5 cases(5/17,29.41％),in the body of stomach in 4 cases(4/17,23.53％),in the cardia and antrum of stomach each in 3 cases(3/17,17.65％)and in the pylorus in 1 case(1/17,5.88％),while 1 case(1/17,5.88％)was found with diffused multiple lesions within stomach.Non-enhance CT showed local thickening of gastric wall in 10 cases(10/17,58.82％),all were isodensities,and the mucosa uniformly enhanced in contrast enhance CT(CECT).Predominately cystic lesion in 5 cases(5/17,29.41％)presented as submucosal cystic protrusions,and grew into the stomach cavity with circular or oblong low density in non-enhanced CT,while sandwich enhancement of mucosa was observed in CECT.Among these 5 cases(5/17,29.41％),MRI showed lesion confined to the submucosa with low signal on T1WI and high signal on T2WI,while diffusion weighted imaging showed unrestricted diffusion,and the enhancement pattern was consistent with that of CT in 2 cases.In other 2 cases(2/17,11.77％)with cystic-solid lesion,non-enhanced CT showed soft tissue density,while CECT showed lump-like stratified enhancement.Conclusion CT and MRI manifestations of GCP had certain characteristics.