1.Pregnancy outcomes in dichorionic twins: comparing assisted reproductive technology and spontaneous conception
Jiancai YIN ; Ziyan ZHAO ; Baojing ZHAO ; Zhen YU ; Yuanyuan YANG
Acta Universitatis Medicinalis Anhui 2026;61(5):908-913
ObjectiveTo investigate the differences in pregnancy outcomes between dichorionic diamniotic (DCDA) twin pregnancies conceived via assisted reproductive technology (ART) and those from spontaneous conception, in order to provide evidence for the perinatal management of ART-conceived DCDA twins. MethodsA retrospective analysis was conducted on the clinical data of 549 DCDA twin parturients. Based on the mode of conception, they were divided into ART group (423 cases) and spontaneous conception group (126 cases). The baseline characteristics, pregnancy complications and neonatal outcomes were compared between the two groups. ResultsRegarding baseline characteristics, the ART group had higher maternal age, number of previous abortions, proportions of primiparas, proportions of advanced maternal age and greater 24-hour postpartum blood loss, but lower parity and proportion of scarred uterus compared to the spontaneous conception group (P<0.05). For pregnancy complications, the ART group exhibited higher incidences of hypertensive disorders of pregnancy, placental adhesion, postpartum hemorrhage and a higher application rate of uterine artery ascending branch ligation (P<0.05). There were no statistically significant differences in neonatal-related indicators between the two groups. After adjusting for confounding factors such as age, number of abortions and parities, ART remained an independent risk factor for hypertensive disorders of pregnancy, placental adhesion and postpartum hemorrhage (P<0.05), while it did not increase the risk of adverse neonatal outcomes. Further subgroup analysis by gestational age showed that in the late preterm subgroup, the risk of ART-related pregnancy complications remained elevated (P<0.05). Additionally, neonatal outcomes showed no significant difference between the two groups in both the late preterm and term subgroups. ConclusionART increases the risk of hypertensive disorders of pregnancy, placental adhesion and postpartum hemorrhage in DCDA twin parturients. Clinically, enhanced monitoring of blood pressure during pregnancy and blood loss during delivery and postpartum, along with targeted prevention and management of these complications, are crucial for improving pregnancy outcomes.
2.An exploratory study on the identification of early esophageal cancer and non-cancerous lesions based on Lab color space
Yongxin ZHANG ; Hanwen CHEN ; Renyu FAN ; Yang LI ; Yalei WANG ; Yuanyuan ZHAO
Acta Universitatis Medicinalis Anhui 2026;61(4):729-735
ObjectiveTo explore the clinical application value of CIE 1976 L*a*b*(Lab) color space in the differential diagnosis of early esophageal cancer and non-cancerous lesions. MethodsWe selected the endoscopic images of patients with esophageal lesions confirmed by pathology who underwent white light imaging endoscopy (WLI) and narrow band imaging endoscopy (NBI). Five regions of interest (ROI) were selected respectively from the mucosa of the lesion area and the mucosa of the surrounding normal area for labeling. The Lab color space parameters were extracted and counted, and the color difference values(ΔE*)were calculated. ResultsA total of 213 eligible patients were included for analysis in the study. In WLI and NBI modes, there were differences in mucosal color between the early esophageal cancer group and the non-cancer group (P<0.05). Compared with WLI mode, NBI mode could significantly increase the color difference between early esophageal cancer and non-cancerous lesions (P<0.05). The lightness component value (L* value) of the early esophageal cancer lesion area was lower than that of the non-cancerous lesion area, and this color difference was more significant in the NBI mode (P<0.05). In WLI mode, there was no significant difference in yellow-blue component value (b* value) between the mucosa of early esophageal cancer and non-cancerous lesions. However, in the NBI mode, the b* value of the mucosa in the non-cancerous lesion area was higher than that in the early esophageal cancer lesion area (P<0.05). On the red-green axis, the mucosa of the early esophageal cancer and non-cancerous lesions was red in WLI mode and green in NBI mode. There was no significant difference in red-green component value (a* value) between the two groups. ConclusionThere are color differences between early esophageal cancer and non-cancerous lesions under WLI and NBI. The color of early esophageal cancer is darker under WLI, and the color of non-cancerous lesions is yellower under non-magnified NBI mode. Lab color space is helpful to identify early esophageal cancer and non-cancerous lesions.
3.Metabolic dysfunction-associated fatty liver disease with different clinical phenotypes: Pathogenesis and strategies for integrated traditional Chinese and Western medicine treatment
Wenxia ZHAO ; Lei GAO ; Xinju CHEN ; Yuanyuan ZHENG ; Sutong LIU ; Lihui ZHANG ; Qing ZHAO ; Chenlu ZHAO
Journal of Clinical Hepatology 2026;42(4):930-937
Metabolic dysfunction-associated fatty liver disease (MAFLD) is a chronic metabolic liver disorder with complex etiologies. Different clinical phenotypes of MAFLD (such as obesity, hyperlipidemia, type 2 diabetes mellitus, the postmenopausal state, and chronic hepatitis B) have different mechanisms of action in the development and progression of MAFLD, leading to high heterogeneity in its clinical progression and prognosis. This article systematically reviews the pathogeneses and clinical features of the above five clinical phenotypes of MAFLD and elaborates on the corresponding individualized diagnosis and treatment regimens integrating traditional Chinese medicine and Western medicine, in order to provide a reference for clinical practice and improve clinical diagnosis and treatment.
4.Mechanism of action of organelle interactions in the progression of liver fibrosis and traditional Chinese medicine prevention and treatment strategies
Yuanyuan ZHENG ; Chenlu ZHAO ; Lihui ZHANG ; Sutong LIU ; Wenxia ZHAO
Journal of Clinical Hepatology 2026;42(3):711-717
Liver fibrosis is the core pathological stage of the progression of various chronic liver diseases to liver cirrhosis, and hepatic stellate cell (HSC) activation and the abnormal accumulation of collagen fibers are important processes for the development and progression of liver fibrosis. In recent years, studies have shown that HSC activation is regulated by the complex interactions between various organelles (including mitochondria, endoplasmic reticulum, Golgi apparatus, lysosome, and peroxisomes), and such interactions affect the key cellular processes such as energy metabolism, protein synthesis and folding, reactive oxygen species balance, and autophagy, thereby participating in the progression of liver fibrosis. Meanwhile, traditional Chinese medicine and its active ingredients with multi-target synergistic effects have attracted wide attention. From the perspective of the interaction between organelles, this article systematically elaborates on the specific mechanism of such interactions in the progression of liver fibrosis and reviews how traditional Chinese medicine inhibits HSC activation and collagen production by regulating the function of these organelle and their interaction networks, thereby exerting an anti-liver fibrosis effect, in order to provide a theoretical basis for in-depth understanding of the pathological mechanism of liver fibrosis and the development of new traditional Chinese medicine intervention strategies.
5.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
6.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.
7.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.
8.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
9.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.
10.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.

Result Analysis
Print
Save
E-mail