1.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.
2.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.
3.Construction of the Diagnosis and Treatment System of "Sinew Prescription Correspondence" under the Guidance of Systematic Dialectical Sphygmology
Feng ZHANG ; Baoqiang DONG ; Xingxing LIN ; Yapeng LIU ; Lujia XIAO ; Bodong XING ; Yiyun CAO ; Wenhui ZHANG ; Wenqian QI
Journal of Traditional Chinese Medicine 2026;67(10):1038-1043
"Sinew prescription correspondence" is the principle of selecting prescriptions for channel sinew diseases. On the basis of the theory of syndrome differentiation and treatment, the pulse manifestation corresponds to the channel sinew syndrome, which can improve the flexibility and standardization of clinical prescriptions. From the perspective of systematic dialectical sphygmology, this paper explains the dialectical relationship between channel sinew theory and pulse body elements, pulse wall elements, pulse elements and blood flow elements, and clarifies the internal relationship between pulse manifestation and prescriptions at the level of channel sinew disease. The prescription is derived from the method, while the method is established with the syndrome, and the prescription is unified by the method. According to the theory of "sinew prescription correspondence", the treatment ideas of channel sinew diseases were analyzed from the perspective of channel sinew distribution, functional characteristics and structural changes. On this basis, the diagnosis of channel sinew disease and the application of prescriptions are expanded, and the research on the internal treatment and diagnosis mode of "pulse manifestation-channel sinew-zang fu (脏腑)" is prospected, so as to expand the differentiation and treatment methods of channel sinew theory.
4.Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults (version 2025)
Bobin MI ; Faqi CAO ; Weixian HU ; Wu ZHOU ; Chenchen YAN ; Hui LI ; Yun SUN ; Yuan XIONG ; Jinmi ZHAO ; Qikai HUA ; Xinbao WU ; Xieyuan JIANG ; Dianying ZHANG ; Zhongguo FU ; Dankai WU ; Guangyao LIU ; Guodong LIU ; Tengbo YU ; Jinhai TAN ; Xi CHEN ; Fengfei LIN ; Zhangyuan LIN ; Dongfa LIAO ; Aiguo WANG ; Shiwu DONG ; Gaoxing LUO ; Zhao XIE ; Dong SUN ; Dehao FU ; Yunfeng CHEN ; Changqing ZHANG ; Kun LIU ; Deye SONG ; Yongjun RUI ; Fei WU ; Ximing LIU ; Junwen WANG ; Meng ZHAO ; Biao CHE ; Bing HU ; Chengjian HE ; Guanglin WANG ; Xiao CHEN ; Guandong DAI ; Shiyuan FANG ; Wenchao SONG ; Ming CHEN ; Guanghua GUO ; Yongqing XU ; Lei YANG ; Wenqian ZHANG ; Kun ZHANG ; Xin TANG ; Hua CHEN ; Weiguo XU ; Shuquan GUO ; Yong LIU ; Xiaodong GUO ; Zhewei YE ; Liming XIONG ; Tian XIA ; Hongbin WU ; Qisheng ZHOU ; Mengfei LIU ; Yiqiang HU ; Yanjiu HAN ; Hang XUE ; Kangkang ZHA ; Wei CHEN ; Zhiyong HOU ; Bin YU ; Jiacan SU ; Peifu TANG ; Baoguo JIANG ; Guohui LIU
Chinese Journal of Trauma 2025;41(5):421-432
Postoperative infection of internal fixation of closed fractures the lower limbs in adults represents a devastating complication, characterized by diagnostic challenges, prolonged treatment duration and high disability rates. Current management of these infections faces multiple challenges, such as difficulties in early accurate diagnosis, and various controversies about the treatment plan, leading to poor overall diagnosis and treatment results. To address these issues, based on evidence-based medicine and principles with emphasis on scientific rigor, clinical applicability and innovation, the Trauma Branch of the Chinese Medical Association, Orthopedic Branch of the Chinese Medical Doctor Association, Orthopedics Branch of the Chinese Medical Association, and Trauma Orthopedics and Polytrauma Group of the Resuscitation and Emergency Committee of the Chinese Medical Doctor Association have collaboratively organized a panel of relevant experts to develop the Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults ( version 2025). The guideline proposed 10 recommendations, aiming to provide a foundation for standardized diagnosis and treatment of postoperative infection in adults with closed lower limb fractures.
5.Association of urinary serine protease Corin with clinical staging in early diabetic kidney disease
Wenqian TIAN ; Jingyi LU ; Danyang CHEN ; Sa LI ; Shiyu LIU ; Xiaoying ZHANG ; Wanjun PANG ; Yahui HU
Chinese Journal of Endocrinology and Metabolism 2025;41(2):120-128
Objective:To investigate the level of urinary serine protease(Corin) in early diabetic kidney disease(DKD) and its correlation with clinical stage.Methods:One hundred and seventy-three patients with type 2 diabetes mellitus(DM) from two tertiary A hospitals in Henan, diagnosed between April 2023 and December 2023 were selected as the research group, and 120 healthy subjects were selected as the control group. Basic clinical information and laboratory data were collected, and urinary Corin level was detected. DM patients were classified into G1-G5 stages based on estimated glomerular filtration rate(eGFR), and those in the early DKD stages(G1-G3) were further divided into A1-A3 subgroups based on urinary albumin/creatinine ratio(ACR). Spearman correlation analysis was performed to assess relationships between urinary Corin and other indicators, linear regression analysis identified factors influencing urinary Corin in early DKD patients, logistic regression analysis evaluated the risk factors for early DKD, and receiver operating characteristic(ROC) curve analysis determined the diagnostic value of urinary Corin in early DKD. Results:Urinary Corin levels were significantly higher in early DKD patients compared to healthy controls, with levels increasing as ACR rose( P<0.05). Urinary Corin was positively associated with serum creatinine( r=0.570), urea( r=0.458), cystatin C( r=0.693), ACR( r=0.616), urinary transferrin( r=0.448), urinary α1 microglobulin( r=0.507), urinary n-acetyl-β-D-glucosaminase( r=0.388) and A subgroup( r=0.692) while was negatively correlated with eGFR( r=-0.647), albumin( r=-0.312)(all P<0.05). eGFR was the only independent factor affecting urinary Corin. After adjusting for confounding factors in logistic regression analysis, urinary Corin was still an independent influencing factor for early DKD. ROC curve analysis indicated that urinary Corin had a diagnostic AUC of 0.842(95% CI 0.791-0.892, P<0.001), with a cut-off value of 2 226.04 pg/mL, sensitivity of 0.712, and specificity of 0.858 for early DKD diagnosis. Conclusions:Urinary Corin was elevated in early DKD patients and correlated with clinical stage. Urinary Corin is an independent factor of early DKD, and a reliable predictor of early DKD diagnosis.
6.Approach to the patient with myxedema coma
Jianxia SHI ; Qiuyu FANG ; Wenqian REN ; Yunqin MA ; Qin ZHEN ; Li ZHAO ; Yufan WANG ; Yongde PENG ; Fang LIU
Chinese Journal of Endocrinology and Metabolism 2025;41(3):233-236
Myxedema coma is a rare condition, typically arising from long-standing, untreated hypothyroidism and triggered by factors such as infection, hypothermia, or severe illness. This report details a successfully treated case of myxedema coma with cardiac attest, accompanied by a literature review, to enhance clinical awareness and improve the diagnosis and management of this critical condition.
7.Advances in the Study of Varenicline Combined with Nicotine Patches for the Treatment of Tobacco Dependence
Qiuqi WEI ; Wenqian ZHAO ; Ling LIU
Journal of Kunming Medical University 2025;46(4):157-162
China has the highest number of smokers in the world with more than 1 million tobacco-related deaths each year.Smoking cessation is a feasible intervention to reduce the prevalence of smoking-related diseases and premature deaths.The smoking cessation therapies approved for use in China are ineffective for some tobacco dependent patients.In order to further improve the rate of smoking cessation,a combination of medications can be chosen,including varenicline combined with nicotine replacement therapy.However,there are conflicting evaluation conclusions on the effectiveness and safety of combination therapy.This article aims to review the mechanism of action,efficacy,and safety of varenicline combined with nicotine replacement therapy in the treatment of tobacco dependence,aiming to provide a basis for this combination therapy.
8.Gadd45b alleviates white matter damage in chronic ischemic rats by modulating astrocyte phenotype
Hui YU ; Yang YANG ; Ting WEI ; Wenli LI ; Wenqian LUO ; Bin LIU
Chinese Journal of Tissue Engineering Research 2025;29(36):7797-7803
BACKGROUND:Previous studies have found that growth arrest and DNA damage-inducible protein 45β(Gadd45b)is beneficial to the repair of acute cerebral ischemia,but the action mechanism is still unclear.OBJECTIVE:To investigate the effect and mechanism of Gadd45b on white matter demyelinating lesions in rats with chronic cerebral ischemia.METHODS:SD rats were randomly divided into four groups:sham operation group,model group,empty vector group,and Gadd45b overexpression group,with 15 rats in each group.Gadd45b-overexpressing lentivirus and no-load lentivirus were injected into the bilateral hippocampus and bilateral ventricles of rats.One week after lentivirus transfection,the rat model of chronic hypoperfusion cerebral ischemia was established by bilateral common carotid artery ligation.Three weeks after the bilateral common carotid artery ligation,the learning and cognitive functions of rats were evaluated by novel object recognition test.Luxol fast blue staining was used to observe the changes of myelin structure in the corpus callosum of rats.Hematoxylin-eosin staining and Nissl staining were used to observe the damage of the rat corpus callosum.Immunofluorescence staining was used to detect the expression of myelin basic protein and neurofilament protein 200 in the corpus callosum of rats.Immunofluorescence double staining was used to detect the expression of astrocyte markers GFAP/C3d and GFAP/S100A10 in rat brain tissue.ELISA was used to detect the levels of tumor necrosis factor-α and interleukin-6 in the supernatant of brain tissue.RESULTS AND CONCLUSION:(1)Gadd45b overexpression could significantly improve the learning and cognitive function of rats with chronic cerebral ischemia,and improve demyelination and pathological damage in the rat corpus callosum.(2)The results of immunofluorescence showed that Gadd45b overexpression significantly increased the expression levels of myelin basic protein and neurofilament protein 200 in the brain tissue of rats with chronic cerebral ischemia.(3)Gadd45b overexpression reduced GFAP/C3d double positive cells and increased GFAP/S100A10 double positive cells in the brain tissue of rats with chronic cerebral ischemia.(4)Gadd45b overexpression reduced the levels of tumor necrosis factor-α and interleukin-6 in the brain tissue of rats with chronic cerebral ischemia.It is concluded that Gadd45b overexpression improves cognitive dysfunction by promoting the A2 phenotype transformation of astrocytes,alleviating white matter myelin structure damage and neuroinflammation in rats with chronic cerebral ischemia.
9.Effects of aerobic exercise on gut microbiota and adult hippocampal neurogenesis related factors in naturally aging mice
Yuqian LIU ; Wenqian YANG ; Haitao WANG
Chinese Journal of Sports Medicine 2025;44(2):119-127
Objective To explore the relationship between gut microbiota and adult hippocampal neu-rogenesis(AHN)in the prevention of age-related neurological decline by aerobic exercise,and to clar-ify the role of microbiota-gut-brain axis in exercise enhancing AHN.Methods Sixteen 52-week-old SPF C57BL/6 male mice were randomly divided into an old control group(OC)and an old aerobic ex-ercise group(OE),each of 8.The OE group underwent 16-week incremental load treadmill exercise,while the control group kept quiet.After the intervention,the contents of 5-Hydroxytryptamine(5-HT),γ-aminobutyric acid(GABA)and Dopamine(DA)in hippocampus were detected using ELISA,while those of glutamic amino acid(Glu)in hippocampus,as well as Acetylcholine(Ach)in hippocam-pus and serum was determined by using the ultraviolet colorimetric method.Moreover,hippocampal in-sulin-like growth factors 1(IGF1)and vascular epithelial growth factor(VEGF)and brain-derived neurotrophic factor(BDNF)proteins expression were measured using Western blotting.Meanwhile,fe-cal samples were collected for microbiota analysis by 16S rDNA sequencing.Results① After 16-week aerobic exercise,compared with the OC group,the contents of 5-HT and Glu(P<0.01),DA and GA-BA(P<0.05)in hippocampus increased in the OE group.Moreover,the hippocampal and serum Ach levels in the OE group increased significantly,compared to the OC group(P<0.01).②Compared with the OC group,the expression of BDNF,VEGF and IGF1 in the OE group increased significantly(P<0.01)after 16-week aerobic exercise.③Compared with the OC group,the diversity of microbiota in the OE group increased significantly(P<0.01)after the intervention.Moreover,the relative abundance of bacteroidetes and tenericutes increased,while that of proteobacteria decreased significantly in the OE group(P<0.01).Conclusions The composition of gut microbiota and the expression of central neu-rotransmitters in aged mice were significantly improved after 16-week incremental load aerobic exer-cise.Moreover,the expression of hippocampal neurogenesis related factors and the content of central neurotransmitters in adult individuals were promoted.The microbiota-gut-brain axis plays an important role in exercise improving AHN in aged mice.
10.Influence of recombinant human collagen dressing combined with promestriene ointment on symptoms and vaginal microecology in patients with atrophic vaginitis
Hongmei LIU ; Caiying HOU ; Hongmei LI ; Binyan GUO ; Wenqian HU ; Guijun WEN ; Xia ZHANG
Chinese Journal of Pharmacoepidemiology 2025;34(10):1140-1146
Objective To explore the influence of combination of recombinant human collagen dressing and promestriene ointment on symptoms and vaginal microecology in patients with atrophic vaginitis.Methods The data of patients with atrophic vaginitis admitted to the General Hospital of the People's Liberation Army were retrospectively collected from April 2017 to April 2024.According to treatment methods,the enrolled patients were divided into a study group(recombinant human collagen dressing combined with promestriene ointment for 7 days)and a control group(promestriene ointment for 7 days).The efficacy,symptom disappearance time,vaginal microecology and adverse reactions were compared between groups,and recurrence rate of atrophic vaginitis within 1 month was observed.Results A total of 150 patients were screened and included,77 in the study group and 73 in the control group.After treatment,the total therapeutic efficacy in the study group was higher than that in the control group(89.61%vs.76.71%,P<0.05).The disappearance durations of abnormal leucorrhea,vulva pruritus and vulva burning pain in the study group were significantly shorter compared with those in the control group(all P<0.05).The vaginal pH value in the study group was lower,while the positive rate of Lactobacillus and proportions of vaginal flora density grade Ⅱ-Ⅲ and diversity grade Ⅱ-Ⅲ were higher compared to the control group(all P<0.05).During treatment,no significant difference was exhibited in the total incidence rate of adverse reactions between the two groups(P>0.05).The recurrence rate was lower in the study group than that in the control group within 1 month of follow-up(P<0.05).Conclusion Recombinant human collagen dressing combined with promestriene ointment is more effective than promestriene ointment alone in improving the efficacy of patients with atrophic vaginitis,and can better shorten the disappearance durations of symptoms such as abnormal leucorrhea,vulva pruritus and vulva burning pain,correct the disorder of vaginal microecology,and reduce the short-term recurrence rate of vaginitis,and offer good safety.

Result Analysis
Print
Save
E-mail