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.Application of minimally invasive osteotomy with preservation of blood supply to transversely transported bone segment in tibial transverse bone transport.
Bin WANG ; Guizu GAO ; Zhenxing TU ; Huanyou YANG ; Ruizheng HAO ; Wenqian BU
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(3):320-325
OBJECTIVE:
To investigate the efficacy of minimally invasive osteotomy with preservation of blood supply to the transversely transported bone segment in the treatment of chronic ischemic lower limb diseases using tibial transverse bone transport.
METHODS:
A retrospective analysis was conducted on the clinical data of 12 patients with chronic ischemic lower limb diseases who met the selection criteria and were treated between June 2016 and December 2023. The cohort included 7 males and 5 females, aged 26-87 years (mean, 61.2 years). Among them, 7 patients had diabetic foot (DF), including 2 cases complicated by arteriosclerosis obliterans (ASO), with a DF duration ranging from 1.7 to 23.0 months (mean, 9.6 months) and ulcer sizes ranging from 3.2 cm×2.4 cm to 10.0 cm×6.6 cm. Three patients had ASO with a disease duration of 1.7-23.0 months (mean, 10.4 months) and ulcer or post-amputation wound sizes ranging from 2.2 cm×2.1 cm to 12.0 cm×7.7 cm. Additionally, 2 patients with thromboangiitis obliterans (TAO) had a disease duration of 7 and 12 months, respectively. Preoperatively, the mean foot skin temperature was (27.63±0.34)℃, and the visual analogue scale (VAS) score was 8.5±0.7. All patients underwent tibial transverse bone transport using minimally invasive osteotomy while preserving the blood supply to the transported bone segment. Postoperative complications and foot ulcer healing were observed. The effectiveness of tibial transverse bone transport was evaluated by comparing preoperative and postoperative foot skin temperature, VAS scores, as well as through CT angiography (CTA).
RESULTS:
One DF patient with ASO was lost to follow-up, while the remaining 11 patients were followed up 10-29 months (mean, 20.5 months). One DF patient had a displaced fracture at the site of tibial transport due to trauma, which healed after plaster immobilization; 1 DF patient had a small amount of pigmentation in the skin of the donor site, but the blood circulation was good; no complication such as pin tract infection, skin necrosis, or osteomyelitis occurred in the donor site of all patients. At 2-3 weeks postoperatively, the foot skin temperature was (34.21±0.65)℃, and the VAS score was 0.3±0.1, both significantly improved compared to preoperative ones ( t=-31.578, P<0.001; t=49.000, P<0.001). Two TAO patients experienced recurrent, persistent, intolerable pain at 7-10 days postoperatively, with no reduction in ulcer size or necrotic areas; 1 underwent toe amputation, and the other required a mid-leg amputation. The remaining patients achieved complete ulcer healing, with healing time ranging from 5.1 to 9.2 weeks (mean, 6.8 weeks). CTA showed no new vascular occlusions or embolisms. X-ray films at 4 months postoperatively demonstrated proper repositioning and good healing of the transported tibial bone segment.
CONCLUSION
The application of minimally invasive osteotomy with preserved blood supply to the transversely transported bone segment in tibial transverse bone transport for the treatment of chronic ischemic lower limb diseases effectively minimizes extensive soft tissue dissection, reduces surgical soft tissue damage, and better maintains local blood supply. This approach lowers the risk of postoperative infection and skin necrosis while accelerating postoperative recovery.
Humans
;
Osteotomy/methods*
;
Middle Aged
;
Male
;
Female
;
Aged
;
Tibia/surgery*
;
Minimally Invasive Surgical Procedures/methods*
;
Retrospective Studies
;
Adult
;
Bone Transplantation/methods*
;
Aged, 80 and over
;
Diabetic Foot/surgery*
;
Treatment Outcome
;
Arteriosclerosis Obliterans/surgery*
;
Ischemia/surgery*
;
Lower Extremity/blood supply*
4.Application of index finger proximal dorsal island flap supplied by nutrient vessels of superficial branch of radial nerve for thumb skin and soft tissue defect.
Huanyou YANG ; Huiwen ZHANG ; Wenqian BU ; Wei WANG ; Jian ZHANG ; Bin WANG
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(7):869-872
OBJECTIVE:
To explore the method and effectiveness of index finger proximal dorsal island flap supplied by the nutrient vessels of superficial branch of radial nerve for treatment of thumb skin and soft tissue defect.
METHODS:
Between August 2019 and December 2024, 12 patients with thumb skin and soft tissue defects caused by trauma accompanied by variation of the first dorsal metacarpal artery were treated. There were 8 males and 4 females, aged 19-55 years, with an average age of 32 years. The wound area ranged from 2.2 cm×2.0 cm to 5.5 cm×3.5 cm. The time from injury to operation ranged from 1.5 to 6.0 hours, with an average of 4.5 hours. After thorough debridement, the wound was repaired with a index finger proximal dorsal island flap supplied by the nutrient vessels of the superficial branch of the radial nerve. The flap area ranged from 2.4 cm×2.2 cm to 6.0 cm×4.0 cm. The donor site was repaired with free skin grafting. Regular follow-up was conducted postoperatively to observe the appearance, texture, sensory recovery of the flap, and the condition of the donor site.
RESULTS:
The operation time ranged from 30 to 72 minutes, with an average of 47 minutes; intraoperative blood loss ranged from 30 to 70 mL, with an average of 46 mL. After operation, partial necrosis occurred at the skin edge of the radial incision on the dorsum of the hand in 1 case, which healed after dressing changes; all other flaps survived uneventfully, with primary wound healing. The skin grafts at the donor sites all survived. All 12 patients were followed up 5-36 months, with an average of 14 months. The appearance and texture of the flaps were good. At last follow-up, the two-point discrimination of the flaps ranged from 4 to 9 mm, with an average of 5.2 mm. According to the functional evaluation criteria for upper limb issued by the Hand Surgery Society of Chinese Medical Association, the results were excellent in 11 cases and good in 1 case. No scar contracture, pain, or joint movement limitation was observed at the donor sites.
CONCLUSION
For patients with skin and soft tissue defects of the thumb accompanied by variation of the first dorsal metacarpal artery, the index finger proximal dorsal island flap supplied by the nutrient vessels of the superficial branch of the radial nerve can be selected. This method has advantages such as shorter operation time, less intraoperative bleeding, and good postoperative appearance and sensation of the flap.
Humans
;
Male
;
Adult
;
Female
;
Thumb/surgery*
;
Soft Tissue Injuries/surgery*
;
Radial Nerve/surgery*
;
Middle Aged
;
Surgical Flaps/innervation*
;
Plastic Surgery Procedures/methods*
;
Skin Transplantation/methods*
;
Young Adult
;
Treatment Outcome
;
Fingers/surgery*
;
Skin/injuries*
5.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.
6.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.
7.Preconditioning strategies for adipose-derived mesenchymal stem cells
Wenqian YANG ; Lin KANG ; Xiao LONG
Chinese Journal of Plastic Surgery 2025;41(8):865-874
Adipose-derived mesenchymal stem cells (ADSCs) are prominent candidates for regenerative medicine owing to their accessibility and multilineage differentiation potential. Nonetheless, clinical translation is limited by poor survival, differentiation, and migration after transplantation. To overcome these challenges, various pretreatment strategies have been developed to enhance their therapeutic efficacy. This review summarizes recent advances in ADSC pretreatment, focusing on methods that improve their survival, integration, and function in therapeutic applications. Physical, chemical, and biological pretreatments are discussed, including hypoxic conditioning, pharmacological interventions, and cytokine pre-incubation, all of which serve to precondition ADSCs for enhanced regenerative performance. These developments hold promise for enhancing the therapeutic potential of ADSCs and offer new opportunities for their future clinical application.
8.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.
9.Field-driven medical micro-robots:application prospect of continuously optimizing material preparation process
Wenqian XIAO ; Hongjuan HAN ; Haocheng YANG ; Bo LI ; Binyan HE
Chinese Journal of Tissue Engineering Research 2025;29(10):2097-2104
BACKGROUND:Micro-robots have the characteristics of small size,flexibility,and strong targeting,and can complete complex tasks in a single or clustered manner in a narrow environment.With the continuous optimization of materials,preparation processes,and driving approaches,they have shown increasingly important application value in the field of biomedicine. OBJECTIVE:To analyze the application of field-driven micro-robots in medical field and to look forward to their application prospect. METHODS:Using"microrobots,nanorobots,drivers,biomedical,medical"as Chinese keywords and"microrobots,micro-robots,nanorobots,micromachine,microswimmer,medical"as English keywords,WanFang Data and PubMed databases were searched,respectively.The search time range was from January 2010 to January 2024,and a small number of long-term articles were included.Through reading the titles and preliminarily screening the abstracts,the repetitive studies,low-quality journals,and irrelevant literature were excluded.After reading the entire text,66 papers were finally included for review. RESULTS AND CONCLUSION:Field-driven medical micro-robots mainly include magnetic,optical,thermal,ultrasonic,and multi-mixed factor-driven robots.Field-driven robots have been used in intestinal diagnosis,drug targeting therapy,and stem cell therapy.Medical micro-robots are currently only used in a small number of clinical applications,but most of which are still in the theoretical and experimental stages.Medical micro-robots will face many challenges in future,such as large-scale preparation,precise control of micro-robots,recycling or degradation in vivo,whether the materials used will cause adverse reactions to the human body,and the related minimally invasive medical procedures.
10.Incidence of pulmonary tuberculosis and its influencing factors in Hubei Province based on the geographically weighted regression model
Xingxing LU ; Xun LIU ; Fan WANG ; Jianjun YE ; Yu ZHANG ; Chengfeng YANG ; Liping ZHOU ; Hongxing WANG ; Wenqian ZHOU
Journal of Public Health and Preventive Medicine 2025;36(5):28-31
Objective To study the spatial distribution of the incidence of pulmonary tuberculosis in Hubei Province and its influencing factors, so as to improve the theoretical basis for scientific development of tuberculosis prevention and control measures in the future. Methods The data of reported incidence of tuberculosis and related influencing factors in various counties and districts of Hubei Province in 2020 were collected. Global Moran's I index, hotspot analysis and geographically weighted regression (GWR) model analysis were used to calculate the spatial autocorrelation of the incidence of tuberculosis, and to analyze the influencing factors affecting the incidence rate of tuberculosis. Results There were obvious regional differences in the space distribution of the incidence rate of tuberculosis. Hot spot analysis showed positive spatial correlation and obvious clustering. The GWR model (AICc=784.251) in this study had higher AICc value compared to the ordinary least squares regression (OLS) model (AICc=804.2585). The GWR model showed that the increase in the proportion of the population aged 65 and above and the proportion of the ethnic minority population had a significant promoting effect on the increase of the incidence rate of tuberculosis, and there was significant spatial heterogeneity. The effect of PM2.5 concentration on the incidence rate of pulmonary tuberculosis varied in different regions, and the degree of effect was also different. Conclusion The proportion of people aged 65 and above and the proportion of ethnic minorities may significantly influence the incidence of pulmonary tuberculosis. The effect of PM2.5 concentration varies in different regions, so targeted measures should be formulated according to the situation in different regions.


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