1.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
2.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
3.Efficacy of audiovisual training on ameliorating core symptoms in children with autism spectrum disorder
QU Zhiyi, LIU Zhao, LI Yi, HE Yingli, CHE Hong, ZHANG Xin
Chinese Journal of School Health 2026;47(5):646-651
Objective:
To explore the effect of a computer assisted audiovisual combined intervention model on the core symptoms of children with autism spectrum disorder (ASD), in order to provide references for enriching intervention and treatment methods for ASD children.
Methods:
From December 2023 to March 2024, 36 ASD children aged 4-8 years were recruited from Tianjin Disabled Persons Rehabilitation Center and Xinxinyu Children s Rehabilitation Center, and were divided into a training group (22 cases) and a control group (14 cases). The training group completed a 12 week audiovisual training course (visual sessions:twice a week, for 50-60 minutes each session; auditory sessions:three times a week, for 15 minutes each time), while the control group received only conventional treatment interventions. Before and after the intervention, the core symptoms of ASD children were assessed using the Short Sensory Profile (SSP), Social Responsiveness Scale (SRS), and Repetitive Behavior Questionnaire-2 ( RBQ- 2). Eye tracking experiments were used to test preferences for social attention.
Results:
Before the intervention, there were no statistically significant differences in the total scores and factor scores of the SSP and RBQ-2 scales between the two groups ( t =-1.63, 0.38, both P >0.05). The SRS total score, social communication, and restricted interests and repetitive behavior factor scores of the training group (90.68±25.83, 33.36±11.80, 15.64±7.00) were significantly higher than those of the control group (72.29±19.84, 24.93±7.85, 10.21±5.67) ( t =2.27, 2.36, 2.43, all P <0.05). Children in the training group with higher social communication factor scores before the intervention scored lower than the control group at the post intervention test (simple slope=-14.17, t =-2.48, P = 0.02), while there was no statistically significant difference in post intervention scores between children with lower social communication factor scores before the intervention and the control group (simple slope=2.31, t =0.57, P >0.05). Eye tracking experiments showed that the total fixation time on geometric images decreased significantly more in the training group [ -4.56 (-11.42, 1.21)] compared to the control group [6.55 (-0.32, 16.53)] after the intervention ( Z=2.48, P <0.05).
Conclusions
The computer assisted audiovisual intervention model can effectively improve the core symptoms of ASD children with poorer social communication levels. The promotion of the intervention model needs to consider individual differences in ASD.
4.Mechanism of action of remifentanil in alleviating lung ischemia-reperfusion injury in rats by modulating HIF-1α/NLRP3 pathway to inhibit cell pyroptosis
Lifang ZHAO ; Jiangong YANG ; Mingyong LI ; Kun SHAO ; Changli SHEN ; Jiajie LI ; Hong ZHU ; Liangchao QU
Acta Universitatis Medicinalis Anhui 2026;61(3):395-401
ObjectiveTo investigate the mechanism of action of remifentanil (RMZL) in alleviating lung ischemia-reperfusion injury (LIRI) in rats by inhibiting pyroptosis through modulating hypoxia inducible factor-1α (HIF-1α)/NOD-like receptor thermal protein domain associated protein 3 (NLRP3) pathway. MethodsRats were stochastically assigned into Control group, LIRI group, RMZL low-dose group, RMZL medium-dose group, RMZL high-dose group, and RMZL high-dose+HIF-1α activator dimethyloxallyl glycine (DMOG) group, with 18 rats in each group. Rats in Control group only had their left pulmonary hilum free and did not undergo ischemia-reperfusion treatment. Except for the Control group, LIRI models were constructed in all other groups. Rats in LIRI group were intraperitoneally injected with an equal amount of physiological saline 15 minutes before constructing LIRI model; rats in Control group were intraperitoneally injected with an equal amount of physiological saline 15 minutes before freeing left pulmonary hilum; rats in other groups were intraperitoneally injected with corresponding dose of drug 15 minutes before constructing LIRI model. The wet/dry weight ratio of lungs was calculated. HE staining was used to study lung tissue pathology. Immunofluorescence staining was used to detect the relative fluorescence intensity of gasdermin D (GSDMD) and NLRP3 double positive cells in lung tissue. ELISA was used to detect interleukin-1β and IL-18 in lung tissue. Western blot was used to detect HIF-1α, NLRP3, cysteine-aspartic protease-1 (Cleaved caspase-1), and gasdermin D-N (GSDMD-N) proteins in lung tissue. ResultsCompared to the Control group, the LIRI group showed disordered alveolar structure, thickened alveolar septa, and abundant inflammatory cell infiltration in rats. The lung wet/dry weight ratio, relative fluorescence intensity of GSDMD and NLRP3 double positive cells in lung tissue, IL-1β, IL-18 levels, and HIF-1α, NLRP3, Cleaved caspase-1, and GSDMD-N proteins increased (P0.05). For the LIRI group, rats in the RMZL low, medium, and high-dose groups displayed attenuated alveolar septal thickening and reduced inflammatory cell infiltration. The lung wet/dry weight ratio, relative fluorescence intensity of GSDMD and NLRP3 double positive cells in lung tissue, IL-1β, IL-18 levels, and HIF-1α, NLRP3, Cleaved caspase-1, and GSDMD-N proteins declined, and the RMZL high-dose group showed the most prominent trend (P0.05). Compared with the RMZL high-dose group, rats in the RMZL high-dose+DMOG group exhibited thickened alveolar septa and more inflammatory cell infiltration, along with increased lung wet/dry weight ratio, relative fluorescence intensity of GSDMD and NLRP3 double positive cells in lung tissue, levels of IL-1β and IL-18, and protein expression of HIF-1α, NLRP3, Cleaved caspase-1, and GSDMD-N (P0.05). ConclusionRMZL may inhibit pyroptosis in LIRI rats by suppressing HIF-1α/NLRP3 pathway.
5.Tasquinimod promotes the sensitivity of ovarian cancer cells to cisplatin by down-regulating the HDAC4/p21 pathway
Zhao LI ; Ya-Hong WU ; Ye-Qing GUO ; Xiao-Jia MIN ; Ying LIN
The Korean Journal of Physiology and Pharmacology 2025;29(2):191-204
To investigate whether Tasquinimod can influence cisplatin resistance in drug-resistant ovarian cancer (OC) cell lines by regulating histone deacetylase 4 (HDAC4) or p21, we explored its effects on the cell cycle, and associated mechanisms.RT-PCR and Western blot analyses, flow cytometry, CCK8 assay, and immunofluorescence were utilized to investigate the effects of Tasquinimod on gene expression, cell cycle, apoptosis, viability, and protein levels in OC cells. The results showed that Tasquinimod inhibited cell viability and promoted apoptosis in SKOV3/DDP (cisplatin) and A2780/DDP cells more effectively than DDP alone. In combination with cisplatin, Tasquinimod further enhanced cell apoptosis and reduced cell viability in these cell lines, an effect that could be reversed following HDAC4 overexpression. Tasquinimod treatment down-regulated HDAC4, Bcl-2, and cyclin D1, and CDK4 expression and up-regulated the cleaved-Caspase-3, and p21 expression in SKOV3/DDP and A2780/ DDP cells. Additionally, Tasquinimod inhibited DDP resistance in OC/DDP cells. These effects were similarly observed in OC mouse models treated with Tasquinimod. In conclusion, Tasquinimod can improve OC cells' sensitivity to DDP by down-regulating the HDAC4/p21 axis, offering insights into potential strategies for overcoming cisplatin resistance in OC.
6.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
7.Overview of the Research on Mechanisms and Application of Essential Oil of Aromatic Chinese Medicinals in Prevention of Respiratory Infectious Disease
Wan Ling LI ; Xinxin WU ; Xiaolei LI ; Mingzhao HAO ; Fang ZHANG ; Yue ZHANG ; Haoyue LI ; Jing ZHAO
Journal of Traditional Chinese Medicine 2025;66(6):638-644
Aromatic Chinese medicinal essential oils are volatile oils extracted from aromatic Chinese herbs, which can prevent and treat respiratory infectious diseases through multiple synergistic mechanisms including pathogen inhibition, immune regulation, and inflammatory response regulation. Essential oils are primarily used externally on the body to prevent infections and alleviate symptoms through methods like inhalation, smearing, topical application, bathing, gargling or as a suppository. They can also be utilized in the environment for disinfection and air purification, through methods like diffusion, vaporization, or spraying. The external application of essential oils extracted from Chinese aromatic herbs has the advantages of convenience, quick absorption, and simultaneous influence on both the body and mind. However, there are still challenges and deficiencies in aspects such as the positioning of functions, indications, safety, and the research on the mechanism of action. It has been proposed to combine the theory of aromatic Chinese medicinals with the characteristics of essential oils, and formulate prescriptions of Chinese medicinal essential oils under the principles of traditional Chinese medicine syndrome differentiation, and prevent and treat respiratory infectious diseases efficiently, accurately, and safely, thereby expanding the clinical application of aromatic Chinese medicinals and the preventive theory of traditional Chinese medicine.
8.Internal tension relieving technique assisted anterior cruciate ligament reconstruction to promote ligamentization of Achilles tendon grafts in small ear pigs in southern Yunnan province
Bohan XIONG ; Guoliang WANG ; Yang YU ; Wenqiang XUE ; Hong YU ; Jinrui LIU ; Zhaohui RUAN ; Yajuan LI ; Haolong LIU ; Kaiyan DONG ; Dan LONG ; Zhao CHEN
Chinese Journal of Tissue Engineering Research 2025;29(4):713-720
BACKGROUND:We have successfully established an animal model of small ear pig in southern Yunnan province with internal tension relieving technique combined with autologous Achilles tendon for anterior cruciate ligament reconstruction,and verified the stability and reliability of the model.However,whether internal tension relieving technique can promote the ligamentalization process of autologous Achilles tendon graft has not been studied. OBJECTIVE:To investigate the differences in the process of ligamentalization between conventional reconstruction and internal reduction reconstruction of the anterior cruciate ligament by gross view,histology and electron microscopy. METHODS:Thirty adult female small ear pigs in southern Yunnan province were selected.Anterior cruciate ligament reconstruction was performed on the left knee joint with the ipsilateral knee Achilles tendon(n=30 in the normal group),and anterior cruciate ligament reconstruction was performed on the right knee joint with the ipsilateral knee Achilles tendon combined with the internal relaxation and enhancement system(n=30 in the relaxation group).The autogenous right forelimb was used as the control group;the anterior cruciate ligament was exposed but not severed or surgically treated.At 12,24,and 48 weeks after surgery,10 animals were sacrificed,respectively.The left and right knee joint specimens were taken for gross morphological observation to evaluate the graft morphology.MAS score was used to evaluate the excellent and good rate of the ligament at each time point.Hematoxylin-eosin staining was used to evaluate the degree of ligament graft vascularization.Collagen fibers and nuclear morphology were observed,and nuclear morphology was scored.Ultrastructural remodeling was evaluated by scanning electron microscopy and transmission electron microscopy. RESULTS AND CONCLUSION:(1)The ligament healing shape of the relaxation group was better at various time points after surgery,and the excellent and good rate of MAS score was higher(P<0.05).Moreover,the relaxation group could obtain higher ligament vascularization score(P<0.05).(2)The arrangement of collagen bundles and fiber bundles in the two groups gradually tended to be orderly,and the transverse fiber connections between collagen gradually increased and thickened,suggesting that the strength and shape degree of the grafts were gradually improved,but the ligament remodeling in the relaxation group was always faster than that in the normal group at various time points after surgery.(3)The diameter,distribution density,and arrangement degree of collagen fibers in the relaxation group were better than those in the normal group at all time points,especially in the comparison of collagen fiber diameter between and within the relaxation group(P<0.05).
9.Genetic screening and typing study of Thalassemia among ethnic Miao Group in Qianxinan area of China.
Xiuxiu ZHANG ; Yan HE ; Yonghui LIAO ; Panpan LI ; Dachun TANG ; Hong ZHAO ; Hongmei MURONG
Chinese Journal of Medical Genetics 2025;42(11):1316-1321
OBJECTIVE:
To determine the carrier rate for thalassemia mutations in the ethnic Miao population of Qianxinan Prefecture.
METHODS:
Ethnic Miao people suspected for thalassemia trait at the People's Hospital of Qianxinan Prefecture, Guizhou Province between November 2020 to September 2024 were selected as the study subjects. Gap-PCR technology combined with high-throughput sequencing was used to screen a total of 666 individuals. ArcMap v10.8.2 was used to create a spatial distribution map of thalassemia based on the screening results. This study was approved by the Medical Ethics Committee of the hospital (Ethics No.: 2016-01).
RESULTS:
In total 254 positive cases were detected, with an overall positive rate of 38.14%. Among these, 173 cases were α-thalassemia (25.98%), 77 cases were β-thalassemia (11.56%), and 4 cases were αβ compound thalassemia (0.60%). The most common genotypes for α-thalassemia were αα/--SEA (positive rate = 10.06%, accounting for 38.73%), αα/-α3.7 (positive rate = 8.86%, accounting for 34.10%), and αCSα/αα (positive rate = 4.95%, accounting for 19.08%). The most common genotypes for β-thalassemia were β41/42(-TTCT)/βA (positive rate = 5.11%, accounting for 44.16%) and β17 (A>T)/βA(positive rate = 4.20%, accounting for 36.36%), with these two genotypes accounting for as much as 80.52%. The spatial distribution map indicated that the highest overall detection rate of thalassemia and α-thalassemia in the Miao population of Qianxinan Prefecture was in Xingyi City. The highest detection rate of β-thalassemia was in Zhenfeng County, and the highest detection rate of αβ compound thalassemia was in Wangmo County.
CONCLUSION
The detection rate of thalassemia among the ethnic Miaos from Qianxinan Prefecture is relatively high, which primarily consisted of α-thalassemia. Regular monitoring and educational outreach should be conducted.
Humans
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China/ethnology*
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Female
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Male
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Genetic Testing
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Adult
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alpha-Thalassemia/genetics*
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Thalassemia/ethnology*
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Ethnicity/genetics*
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Genotype
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beta-Thalassemia/ethnology*
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Adolescent
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Mutation
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Middle Aged
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Child
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Asian People/genetics*
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Young Adult
10.Interpretation of the group standard for measurement technique of central venous pressure
Mingxi ZHAO ; Xin GUAN ; Hong SUN ; Hongming MA ; Yueying FENG ; Meng YU ; Dengxiu ZOU ; Hongbo LUO ; Zunzhu LI ; Jie JING ; Xinjuan WU
Chinese Journal of Nursing 2025;60(1):47-51
Central venous pressure(CVP)is a commonly used hemodynamic index in clinical practice,and the accuracy of its measurement results is influenced by the measurement technical specifications.Based on research evidence and clinical practice,this article interprets the main content of the group standard of CVP measurement technology,and proposes suggestions for its use.It aims to guide clinical nursing staff to correctly understand the principles and methods of CVP measurement,and promote the standardization of nursing practice and the accuracy of measurement results.


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