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.Sequence polymorphism and evolutionary analysis of HLA-A, -B, and -C loci in the northern Han Chinese population
Wenqian SONG ; Wanzhen YU ; Suning BAI ; Liying WANG ; Linnan SHAO ; Shihang ZHOU ; Xiaohua LIANG
Chinese Journal of Blood Transfusion 2026;39(6):743-749
Objective: To characterize the sequence polymorphism of HLA-A, -B, and -C loci in the northern Han Chinese population and to evaluate their selection signals and phylogenetic patterns based on long-read sequencing data. Methods: A total of 408 unrelated healthy blood donors were enrolled. Long-read sequencing of HLA-A, -B, and -C loci was performed using the PacBio Sequel II platform. The Ewens-Watterson neutrality test, sliding-window nucleotide diversity (π) and Tajima′s D analyses were conducted, together with genetic distance heatmaps, principal coordinates analysis (PCoA), and maximum likelihood phylogenetic analysis to assess polymorphism distribution, selection signals, and phylogenetic structure across the three loci. Results: The analyzed sequence lengths for the HLA-A, -B, and -C loci were 3 257 bp, 3 794 bp, and 3 831 bp, respectively; the numbers of locus-specific sequence types were 44, 82, and 56, with corresponding locus-specific sequence type diversities of 0.905 2, 0.964 9, and 0.939 8, respectively. The Ewens-Watterson test showed no significant deviation from neutrality (P>0.05). Sliding-window analysis revealed elevated π and Tajima′s D values in exons 2 and 3 as well as in certain intronic regions of HLA-A and HLA-B, whereas HLA-C exhibited relatively lower overall diversity. Genetic distance heatmaps, PCoA, and phylogenetic analysis consistently showed clear clustering in HLA-A and HLA-C, while HLA-B displayed the highest phylogenetic heterogeneity. Conclusion: HLA-A, -B, and -C gene sequences in the northern Chinese Han population exhibit high levels of polymorphism and marked regional heterogeneity. HLA-B shows greater diversity, stronger signals of selection, and more complex phylogenetic structure compared with HLA-A and HLA-C.
4.Predictive value of patient-reported outcomes combined with hematological indicators for moderate-to-severe endoscopic activity in patients with ulcerative colitis
Caimin LI ; Wenqian LI ; Sicong HOU ; Weiming XIAO ; Jie CHEN ; Mei WANG
Journal of Clinical Medicine in Practice 2025;29(13):55-60,65
Objective To analyze the predictive value of patient-reported outcomes(PRO)com-bined with hematological indicators for moderate-to-severe endoscopic activity in patients with ulcera-tive colitis(UC).Methods Clinical data of UC patients were retrospectively collected,including PRO,hematological parameters and endoscopic findings.Based on the Mayo endoscopic score,pa-tients were divided into remission and mild activity group(<2 points)and moderate-to-severe activity group(≥ 2 points).Independent influencing factors for moderate-to-severe endoscopic activity were screened through multivariate Logistic regression analysis,and a binary Logistic regression model was constructed.The receiver operating characteristic(ROC)curve was used to evaluate the discriminato-ry ability of the predictive model.The calibration of the model was assessed using calibration curves and the Spiegelhalter Z-test,and the model's performance was further validated in an external valida-tion cohort.Results Rectal bleeding(RB),C-reactive protein/albumin(CAR)and erythrocyte sed-imentation rate(ESR)were independent influencing factors for moderate-to-severe endoscopic activity(P<0.05).The area under the curve(AUC)of the nomogram predictive model constructed based on the logistic regression analysis results was 0.848(95%CI,0.798 to 0.900),with sensitivity of 76.6%and specificity of 79.6%.In the external validation cohort,the model's AUC was 0.778(95%CI,0.699 to 0.857),and there was no statistically significant difference compared with the AUC of the training cohort model(P>0.05).In both the training and validation cohorts,the Spiegelhalter Z-test results indicated that the model had good goodness-of-fit(P>0.05).Conclu-sion RB,CAR and ESR are independent influencing factors for moderate-to-severe endoscopic ac-tivity in UC patients.The combination of RB,CAR and ESR has high predictive value for moderate-to-severe endoscopic activity in UC patients,with good discriminatory and calibration abilities.
5.Immunomodulatory effect of short-chain fatty acids in hepatic encephalopathy and its potential diagnostic value
Weiyu CHEN ; Dewen MAO ; Han WANG ; Yang DU ; Wenqian FENG ; Lei FU ; Chun YAO
Journal of Clinical Hepatology 2025;42(5):954-962
Hepatic encephalopathy(HE)is a common complication of severe liver disease in the end stage,and it is urgently needed to improve the rate of effective treatment and clarify the pathogenesis of HE.The liver is a crucial hub for immune regulation,and disruption of immune homeostasis is a key factor in the pathological mechanisms of HE.As the main metabolites of intestinal flora,short-chain fatty acids(SCFAs)play a vital role in the biological processes of both innate and adaptive immunity and can regulate the proliferation and differentiation of immune cells maintain the homeostasis of intestinal microenvironment and the integrity of barrier function.Studies have shown that SCFAs participate in bidirectional and dynamic interactions with the liver-gut-brain axis through immunomodulatory pathways,thereby playing an important role in the diagnosis,treatment,and prognostic evaluation of HE.Starting from the immunoregulatory effect of SCFAs,this article summarizes and analyzes the crosstalk relationship between SCFAs and the liver-gut-brain axis and the significance of SCFAs in the diagnosis and treatment of HE,in order to provide new ideas for optimizing clinical prevention and treatment strategies.
6.Aerobic exercise activates SLC7A11/GPx4 pathway to inhibit mitochondrial ferroptosis and prevent sarco-penia in aging mice
Haitao WANG ; Wenqian YANG ; Yuqian LIU
Chinese Journal of Rehabilitation Medicine 2025;40(4):501-507
Objective:To elucidate the role of solute carrier protein 7,family member 11(SLC7A11)/Glutathione peroxi-dase 4(glutathione peroxidase 4,GPx4)regulated ferroptosis pathway in the improvement of sarcopenia through aerobic exercise,and to identify a new target for the prevention and treatment of sarcopenia with exercise.Method:Twenty 52-week-old Specific pathogen Free(SPF)C57BL/6 male mice were randomly divided into the old control group(OC)and the old exercise group(OE).There were 10 mice in each group.Following one week of adaptive exercise,moderate-intensity exercise with incremental load was implemented as follows:14 m/min at 1-2 weeks,15 m/min at 3-4 weeks,16m/min at 5-10weeks,17m/min at 11-16weeks,60min/d,all with a slope of 0°.Gastrocnemius was harvested for ultrathin electron microscope sections.The levels of Glutathione(GSH),muscle glycogen and non-heme iron(non-heme iron)were measured by spectro-photometer.The serum ferritin(SF),mitochondrial 8-hydroxy-2 deoxyguanosine(8-OHdG)and 4-Hydroxynone-na(4-HNE)were measured by enzyme-linked immunosorbent assay(ELISA).Western blot was used to detect the expression of iron metabolism-related proteins,such as GPx4,SLC7A11,ferroportin 1(FPN1)and ferri-tin heavy chain 1(FTH1)in gastrocnemius muscle.Result:①Compared with OC,the wet weights of quadriceps femoris and gastrocnemius in OE were signifi-cantly increased(P<0.01).In the exercise group,mitochondrial cristae arranged neatly and densely,and the light and dark bands of myofilaments were clear.In the aged control group,the mitochondrial cristae of gas-trocnemius muscle were disrupted,vacuolated or pyknotic,showing typical features of ferroptosis.② The SF and the iron content of gastrocnemius muscle were decreased in OE(P<0.01).③ The levels of 4-HNE and 8-OHdG in gastrocnemius muscle of OE were significantly lower than those of OC(P<0.01).The GSH content in gastrocnemius of OE was significantly higher than that of OC(P<0.01).④ The expressions of SLC7A11,GPx4,FPN1 and FTH1 in gastrocnemius muscle of OE were significantly higher than those of OC(P<0.01).Conclusion:Moderate aerobic exercise can prevent age-related sarcopenia by activating the SLC7A11/GPx4 pathway and inhibiting mitochondrial ferroptosis.
7.Advances in research on host factors for pathogenesis of non-tuberculous mycobacterial disease
Wenqian ZENG ; Yifan HE ; Li WANG ; Wei SHA
Chinese Journal of Clinical Infectious Diseases 2025;18(1):30-36
In recent years,the incidence and prevalence of non-tuberculous mycobacterial(NTM)infections have been on the rise,posing a serious threat to public health and presenting significant challenges for disease management. Currently,the treatment outcomes for NTM disease are poor,one of the main reasons being the high resistance of NTM pathogens to various anti-mycobacterial drugs. Novel therapeutic strategies targeting the host rather than the NTM pathogens themselves may help improve cure rates and reduce mortality. This article summarizes the latest research findings on host factors related to the incidence of NTM disease,including age,pulmonary diseases,immune function,genetic factors and lifestyle,which aids in the early identification of high-risk populations and provides a theoretical basis for developing targeted prevention and treatment strategies and optimizing treatment plans.
8.Effect of paeoniflorin on myocardial injury in rats with coronary atherosclerotic heart disease by regulating SDF-1/CXCR4 signaling pathway
Chinese Journal of Immunology 2025;41(6):1455-1460
Objective:To investigate the effect of paeoniflorin(PF)on myocardial injury in rats with coronary atherosclerotic heart disease(CHD)by regulating stromal cell-derived factor-1(SDF-1)/CXC chemokine receptor 4(CXCR4)signaling pathway.Methods:A CHD rat model was established using a high-fat diet combined with intraperitoneal injection of pituitrin.The successfully established model rats were randomly separated into PF low,medium,and high doses groups,activator group and Model group,according to the random number table method.Another 18 rats were randomly selected as control group.Corresponding drugs were administered by gavage or intraperitoneal injection once a day for 4 consecutive weeks.HE and TUNEL staining were applied to observe myocardial pathological damage and apoptosis of rats;ELISA was applied to detect levels of serum myocardial injury indicators,includ-ing myoglobin(Mb),creatine kinase isoenzyme(CK-MB),creatine kinase(CK),TNF-α,IL-1β and IL-6;automatic biochemical analyzer was applied to measure serum triglyceride(TG),total cholesterol(TC),low-density lipoprotein cholesterol(LDL-C),high-density lipoprotein cholesterol(HDL-C)of rats;kits were applied to detect levels of malondialdehyde(MDA),reactive oxygen spe-cies(ROS)and Glutathione peroxidase(GSH-Px)in rats myocardial tissues;Western blot was applied to detect expressions of cleaved-cysteinyl aspartate specific proteinase 3(cleaved-caspase-3)and SDF-1/CXCR4 pathway proteins in myocardial tissue.Results:Compared with control group,myocardial cell apoptosis rate,Mb,CK-MB,CK,TNF-α,IL-1β,IL-6,TC,TG,LDL-C,MDA,ROS,cleaved-caspase-3,SDF-1,CXCR4 protein levels in Model group were obviously increased,while levels of HDL-C and GSH-Px were obviously reduced(P<0.05);compared with Model group,apoptosis rate of myocardial cells,Mb,CK-MB,CK,TNF-α,IL-1β,IL-6,TC,TG,LDL-C,MDA,ROS,cleaved-caspase-3,SDF-1,CXCR4 protein levels in low,medium and high doses PF groups were obviously reduced,while levels of HDL-C and GSH-Px were obviously increased(P<0.05);compared with high-dose PF group,changes in the above indicators in activator group of rats were obviously reversed(P<0.05).Conclusion:PF may alleviate myo-cardial injury in CHD rats by inhibiting the SDF-1/CXCR4 signaling pathway,inhibiting inflammation,oxidative stress and cell apop-tosis.
9.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.
10.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.

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