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 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.

Thyroid-associated ophthalmopathy (TAO) is related to environmental, genetic and immune factors, mainly involving the autoimmune response of the thyroid and extraocular muscles.However, its specific pathogenesis is unclear.Non-coding RNAs (ncRNAs), the transcription products of RNA, are mainly divided into long non-coding RNAs (lncRNAs), circular RNAs (circRNAs) and microRNAs (miRNAs).ncRNAs regulate molecular functions and biological processes in cells and the body at the transcription and pre-transcription levels.Recent studies have found that ncRNAs, especially miRNAs, play an important biological regulatory role in the pathogenesis of TAO.This article explains how miRNAs, such as miRNA-146a, miRNA-155, miRNA-21, etc., lncRNAs and circRNAs are involved in the pathogenesis of TAO, such as inflammation mediation, adipogenesis and fibrosis, and cell proliferation, in order to provide new ideas for future research on the pathogenesis of TAO and clarify the important inspiration and guiding significance of ncRNAs for the targeted intervention and early treatment of TAO.

Thyroid-associated ophthalmopathy (TAO) is the ocular manifestation of thyroid autoimmune dysfunction.Its clinical feathers mainly include eyelid retraction, proptosis, and ocular movement disorders.TAO is the most common orbital diseases.The pathogenesis of TAO has not been fully elucidated, but researchers generally believe that T cells play an important role in the pathogenesis of TAO.In the early stage of TAO development, a large number of T cells are activated and infiltrated into the retroorbital soft tissue.T cells can be divided into CD4 + T cells and CD8 + T cells.CD4 + T cells play a more central role in TAO.CD4 + T cells include Th1, Th2, Treg and recently discovered Th17, Th22 and Tfh cells.In target tissues, the complete activation and later function of T cells largely rely on the costimulatory pathways, there needs to unravel the mechanism of these costimulatory pathways in TAO.This paper reviews the recent research progress of T cells and costimulatory signals required for their activation in the pathogenesis of TAO.

Thyroid-associated ophthalmopathy (TAO) is related to environmental, genetic and immune factors, mainly involving the autoimmune response of the thyroid and extraocular muscles.However, its specific pathogenesis is unclear.Non-coding RNAs (ncRNAs), the transcription products of RNA, are mainly divided into long non-coding RNAs (lncRNAs), circular RNAs (circRNAs) and microRNAs (miRNAs).ncRNAs regulate molecular functions and biological processes in cells and the body at the transcription and pre-transcription levels.Recent studies have found that ncRNAs, especially miRNAs, play an important biological regulatory role in the pathogenesis of TAO.This article explains how miRNAs, such as miRNA-146a, miRNA-155, miRNA-21, etc., lncRNAs and circRNAs are involved in the pathogenesis of TAO, such as inflammation mediation, adipogenesis and fibrosis, and cell proliferation, in order to provide new ideas for future research on the pathogenesis of TAO and clarify the important inspiration and guiding significance of ncRNAs for the targeted intervention and early treatment of TAO.

Thyroid-associated ophthalmopathy (TAO) is the ocular manifestation of thyroid autoimmune dysfunction.Its clinical feathers mainly include eyelid retraction, proptosis, and ocular movement disorders.TAO is the most common orbital diseases.The pathogenesis of TAO has not been fully elucidated, but researchers generally believe that T cells play an important role in the pathogenesis of TAO.In the early stage of TAO development, a large number of T cells are activated and infiltrated into the retroorbital soft tissue.T cells can be divided into CD4 + T cells and CD8 + T cells.CD4 + T cells play a more central role in TAO.CD4 + T cells include Th1, Th2, Treg and recently discovered Th17, Th22 and Tfh cells.In target tissues, the complete activation and later function of T cells largely rely on the costimulatory pathways, there needs to unravel the mechanism of these costimulatory pathways in TAO.This paper reviews the recent research progress of T cells and costimulatory signals required for their activation in the pathogenesis of TAO.

Purpose To explore the ultrasound features and early diagnostic clues of fetal myocardial non-compaction.Materials and Methods The clinical data and echocardiographic data of four fetuses who underwent fetal echocardiography in Henan Provincial People's Hospital from January 2015 to February 2023 and were confirmed to have myocardial non-compaction by pathological finding or postnatal examination were collected,and analyzed.Results A total of four fetuses diagnosed as myocardial non-compaction by prenatal ultrasound:two involved the left ventricle with isolated lesions,and apical myocardial non-compaction was confirmed by postnatal echocardiography;two involved the biventricles,and both of which were pathologically confirmed after induction of labor.The prenatal ultrasound of fetal myocardial involvement in four cases showed that:(1)the affected myocardium showed a bilayer structure:the outer layer was compacted myocardium,which showed thin and compacted homogeneous hypoechoic;the inner layer was loose and thickened non-compacted myocardium with enhanced echogenicity;(2)color Doppler flow imaging:the non-compacted myocardium showed sieve mesh blood flow with ventricular communication.Some cases were associated with cardiac enlargement and arrhythmia.Conclusion Prenatal echocardiography can diagnose fetal myocardial non-compaction with a characteristic echographic presentation.Localized myocardial thickening and echogenic enhancement,cardiac enlargement and arrhythmia may be important clues to identify fetal myocardial non-compaction.