1.Spinal cord stimulation for spinal cord injury from 1999 to 2025: a bibliometric analysis
Yuanyuan QI ; Haifeng GAO ; Lina LIU ; Yujie XIE ; Jing XU ; Feng GAO ; Liang CHEN ; Degang YANG ; Jun LI
Chinese Journal of Rehabilitation Theory and Practice 2026;32(4):373-386
ObjectiveTo analyze the research hotspots and development trends in the field of spinal cord stimulation (SCS) for spinal cord injury (SCI). MethodsLiterature about SCS for SCI was retrieve from the Web of Science (WOS) Core Collection database, with a time range from January, 1999 to July, 2025. VOSviewer 1.6.20 and CiteSpace 6.4.R2 were used to analyze the annual publication volume, countries, authors, institutions, journals and keywords. ResultsA total of 636 literatures were included. From 1999 to 2025, the overall publication trend in this field showed an upward trajectory, with recent years fluctuating but tending to stabilize. The country with the most publications was the United States (429 papers), followed by Russia (98 papers) and China (70 papers). The institution with the highest number of publications was the University of California, Los Angeles (76 papers), the author with the most publications was V. Reggie Edgerton (70 papers), and the journal with the most publications was Journal of Clinical Medicine (31 papers). The most frequently cited study focused on exploring the combination of epidural spinal cord stimulation with task-specific training to restore motor function in patients with complete SCI. Keyword analysis showed that the research hotspots in this field were mainly focused on neuroregulation mechanisms, recovery of motor and autonomic nervous dysfunction, artificial intelligence, closed-loop stimulation and brain-computer interface technology innovations. In recent years, the research focus gradually shifted from basic mechanisms to personalized and precise multifunctional rehabilitation strategies. ConclusionThe field of SCS for SCI has undergone phases of basic mechanism exploration and clinical application expansion. Current research hotspots and future trends focus primarily on the development of new stimulation paradigms and combined innovative technologies.
2.Prognostic Significance of Pretreatment 18FALF-NOTA-FAPI-04 PET/CT in Patients With Recurrent Gastric Cancer Undergoing Combined PD-1 Inhibitor and Chemotherapy
Haifeng HE ; Yongzhi XIE ; Chengzhi JIANG ; Wanjing ZHOU ; Hui YE
Korean Journal of Radiology 2026;27(3):264-275
Objective:
This study aimed to evaluate the prognostic value of [ 18F]ALF-NOTA-FAPI-04 PET/CT-derived parameters, including the maximum standardized uptake value (SUVmax), FAPI-avid tumor volume (FTV), and total lesion FAP expression (TLF), in patients with recurrent gastric cancer undergoing combined chemoimmunotherapy. We sought to establish a noninvasive imaging biomarker framework to optimize patient stratification and therapeutic decision-making.
Materials and Methods:
This retrospective cohort study analyzed 51 patients with recurrent gastric cancer who received programmed cell death protein 1 (PD-1) inhibitors combined with chemotherapy after gastrectomy. All patients underwent [ 18F]ALF-NOTA-FAPI-04 PET/CT within 14 days of chemoimmunotherapy. Semi-quantitative parameters (SUVmax, FTV, and TLF) were derived using semi-automated tumor segmentation. The primary endpoint of this study was the assessment of the clinical efficacy of chemoimmunotherapy, categorized as a durable or nondurable clinical benefit. The secondary endpoints included progression-free survival (PFS) and overall survival (OS). In a subgroup of 16 patients who underwent sequential [ 18F]FDG PET/CT within seven days of [ 18F]ALF-NOTA-FAPI-04 PET/CT, tracer uptake values were compared between the two PET/CT examinations.
Results:
51 patients were included. The median PFS and OS were 7 and 10 months, respectively. Durable clinical benefit (DCB) was observed in 30 patients and showed significantly lower SUVmax, FTV, and TLF values than non-DCB. TLF demonstrated the highest diagnostic accuracy for DCB (area under the receiver operating characteristic curve [AUC] = 0.80). Multivariable analysis identified TLF ≥ 188.88 SUVbw·cm 3 as an independent factor associated with PFS (hazard ratio [HR] = 7.29, P = 0.001) and FTV ≥ 44.17 cm 3 as an independent factor associated with OS (HR = 5.16, P = 0.010). In the subgroup analysis of 16 patients, semi-quantitative analysis demonstrated consistently higher values of [ 18F]ALF-NOTA-FAPI-04-derived parameters than [ 18F]FDG-derived parameters (all P < 0.001).
Conclusion
[ 18F]ALF-NOTA-FAPI-04 PET/CT may be a useful imaging tool for predicting clinical outcomes in patients with recurrent gastric cancer undergoing treatment with PD-1 inhibitors and chemotherapy.
3.Effect of Heat-Sensitive Moxibustion on Apoptosis of Gastric Mucosal Tissue in Chronic Atrophic Gastritis Model Rats:Based on PI3K/Akt Signaling Pathway
Qi ZHANG ; Yanping ZHOU ; Qide WANG ; Shujuan CHEN ; Yu SUN ; Fang LI ; Hongbin GONG ; Mingjun XIE ; Hui LIU ; Haifeng ZHANG
Journal of Traditional Chinese Medicine 2026;67(15):1650-1658
ObjectiveTo investigate the potential mechanism of heat-sensitive moxibustion on chronic atrophic gastritis (CAG) through the phosphoinositide 3-kinase/protein kinase B (PI3K/Akt) signaling pathway. MethodsFifty-eight SD rats were randomly divided into blank group (n=14) and modeling group (n=44). Rats in the blank group were fed routinely, while the rats in the modeling group received drinking water containing 1-methyl-3-nitro-1-nitrosoguanidine (MNNG) at a concentration of 140 μg/ml, combined with irregular fasting and feeding for 12 weeks to establish CAG model. After successful modeling, the rats were randomly divided into model group (n=10), inhibitor group (n=10) and moxibustion group (n=20). After 40 minutes of suspended moxibustion at "Zhongwan" (CV 12) daily, the rats in the moxibustion group were divided into heat-sensitive moxibustion group (n=10) and non-heat-sensitive moxibustion group (n=9) according to the change of tail temperature during moxibustion. The inhibitor group was bound for 40 minutes daily, and then administered with PI3K/Akt signaling pathway inhibitor, rapamycin solution, by gavage at a dose of 1 mg/kg. The model group received intragastric administration of 1 ml/kg normal saline after 40 minutes of restraint stress each day. All interventions were administered once daily for 28 consecutive days, while the blank group received no intervention. After the intervention finished, the body weight of rats in each group was compared. HE staining was used to observe the histopathological changes of gastric mucosa. The apoptosis-positive rate of gastric mucosal cells was detected by TUNEL assay. Immunohistochemistry was performed to determine the protein levels of matric metalloproteinase-7 (MMP7), vascular endothelial growth factor A (VEGFA) and epidermal growth factor receptor (EGFR) in gastric mucosa. The mRNA expression levels of PI3K, Akt and mammalian target of rapamycin (mTOR) in gastric mucosal tissues were detected by qPCR. The protein levels of phosphorylated Akt (p-Akt) and phosphorylated mTOR (p-mTOR) in rat gastric mucosal tissues were measured by Western Blotting. ResultsCompared to the blank group, rats in all other groups exhibited decreased body weight, significantly increased gastric mucosal cell apoptosis-positive rates, elevated protein levels of MMP7, VEGFA and EGFR in gastric mucosa, increased mRNA expression levels of PI3K, Akt and mTOR, and enhanced protein expression levels of p-Akt and p-mTOR (P<0.05 or P<0.01). Histopathological examination revealed thinning of the gastric mucosa, glandular disorganization and atrophy, accompanied by intestinal metaplasia.Compared to the model group, the heat-sensitive moxibustion group, the non-heat-sensitive moxibustion group and the inhibitor group all showed significant improvements in the above-mentioned indicators (P<0.05 or P<0.01). Compared to the heat-sensitive moxibustion group, the non-heat-sensitive moxibustion group and the inhibitor group exhibited increased positive rates of gastric mucosal cell apoptosis; the non-heat-sensitive moxibustion group showed increased protein levels of MMP7, VEGFA and EGFR, as well as mRNA expression levels of PI3K, Akt and mTOR, and protein expressions of p-Akt and p-mTOR; the inhibitor group exhibited elevated protein expression level of EGFR (P<0.05 or P<0.01). Histopathological examination showed that the gastric mucosal glands in the heat-sensitive moxibustion group were arranged more regularly, with an approximately normal structural appearance. ConclusionHeat-sensitive moxibustion can improve the body weight of CAG rats and repair gastric mucosal injury. Its therapeutic effects may be mediated by inhibiting excessive activation of gastric mucosal PI3K/Akt signaling pathway, thereby reducing gastric mucosal cell apoptosis.
4.Effect of Heat-Sensitive Moxibustion on Apoptosis of Gastric Mucosal Tissue in Chronic Atrophic Gastritis Model Rats:Based on PI3K/Akt Signaling Pathway
Qi ZHANG ; Yanping ZHOU ; Qide WANG ; Shujuan CHEN ; Yu SUN ; Fang LI ; Hongbin GONG ; Mingjun XIE ; Hui LIU ; Haifeng ZHANG
Journal of Traditional Chinese Medicine 2026;67(15):1650-1658
ObjectiveTo investigate the potential mechanism of heat-sensitive moxibustion on chronic atrophic gastritis (CAG) through the phosphoinositide 3-kinase/protein kinase B (PI3K/Akt) signaling pathway. MethodsFifty-eight SD rats were randomly divided into blank group (n=14) and modeling group (n=44). Rats in the blank group were fed routinely, while the rats in the modeling group received drinking water containing 1-methyl-3-nitro-1-nitrosoguanidine (MNNG) at a concentration of 140 μg/ml, combined with irregular fasting and feeding for 12 weeks to establish CAG model. After successful modeling, the rats were randomly divided into model group (n=10), inhibitor group (n=10) and moxibustion group (n=20). After 40 minutes of suspended moxibustion at "Zhongwan" (CV 12) daily, the rats in the moxibustion group were divided into heat-sensitive moxibustion group (n=10) and non-heat-sensitive moxibustion group (n=9) according to the change of tail temperature during moxibustion. The inhibitor group was bound for 40 minutes daily, and then administered with PI3K/Akt signaling pathway inhibitor, rapamycin solution, by gavage at a dose of 1 mg/kg. The model group received intragastric administration of 1 ml/kg normal saline after 40 minutes of restraint stress each day. All interventions were administered once daily for 28 consecutive days, while the blank group received no intervention. After the intervention finished, the body weight of rats in each group was compared. HE staining was used to observe the histopathological changes of gastric mucosa. The apoptosis-positive rate of gastric mucosal cells was detected by TUNEL assay. Immunohistochemistry was performed to determine the protein levels of matric metalloproteinase-7 (MMP7), vascular endothelial growth factor A (VEGFA) and epidermal growth factor receptor (EGFR) in gastric mucosa. The mRNA expression levels of PI3K, Akt and mammalian target of rapamycin (mTOR) in gastric mucosal tissues were detected by qPCR. The protein levels of phosphorylated Akt (p-Akt) and phosphorylated mTOR (p-mTOR) in rat gastric mucosal tissues were measured by Western Blotting. ResultsCompared to the blank group, rats in all other groups exhibited decreased body weight, significantly increased gastric mucosal cell apoptosis-positive rates, elevated protein levels of MMP7, VEGFA and EGFR in gastric mucosa, increased mRNA expression levels of PI3K, Akt and mTOR, and enhanced protein expression levels of p-Akt and p-mTOR (P<0.05 or P<0.01). Histopathological examination revealed thinning of the gastric mucosa, glandular disorganization and atrophy, accompanied by intestinal metaplasia.Compared to the model group, the heat-sensitive moxibustion group, the non-heat-sensitive moxibustion group and the inhibitor group all showed significant improvements in the above-mentioned indicators (P<0.05 or P<0.01). Compared to the heat-sensitive moxibustion group, the non-heat-sensitive moxibustion group and the inhibitor group exhibited increased positive rates of gastric mucosal cell apoptosis; the non-heat-sensitive moxibustion group showed increased protein levels of MMP7, VEGFA and EGFR, as well as mRNA expression levels of PI3K, Akt and mTOR, and protein expressions of p-Akt and p-mTOR; the inhibitor group exhibited elevated protein expression level of EGFR (P<0.05 or P<0.01). Histopathological examination showed that the gastric mucosal glands in the heat-sensitive moxibustion group were arranged more regularly, with an approximately normal structural appearance. ConclusionHeat-sensitive moxibustion can improve the body weight of CAG rats and repair gastric mucosal injury. Its therapeutic effects may be mediated by inhibiting excessive activation of gastric mucosal PI3K/Akt signaling pathway, thereby reducing gastric mucosal cell apoptosis.
5.Ultrasound-guided sacral canal injection of Neurotropin and comprehensive rehabilitation for the aftermath of se-vere sacral plexus injury:a case report
Haifeng ZHU ; Guifeng QIAN ; Yuqin DAN ; Jingchun GAO ; Tingting TANG ; Ming HUO ; Shaodong XIE
Chinese Journal of Rehabilitation Theory and Practice 2025;31(4):476-483
Objective To observe the effect of ultrasound-guided sacral canal injection of Neurotropin combined with comprehen-sive rehabilitation on severe sacral plexus injury after sacral fracture.Methods A case with severe sacral plexus injury ten months after sacral fracture was reviewed.He accepted ultrasound-guided sacral canal injection of Neurotropin along with comprehensive rehabilitation,and was assessed with American Spinal Injury Association Impairment Scale(AIS)impairment scale,manual muscle testing,Visual An-alog Scale(VAS),modified Barthel Index(MBI),Short-form of Health Survey(SF-36)and Functional Gait As-sessment(FGA),and measured the nerve conduction velocity and the structural organization of the sacrococcy-geal ligament using nerve conduction velocity tests,electromyography(EMG)and ultrasound examination be-fore and after treatment.Results After four weeks and ten weeks of treatment,the muscle strength,and scores of MBI,FGA and SF-36 increased,while the ASIA score improved from grade D to grade E,and VAS score decreased.During follow-up,the VAS score and physical pain and general health status scores of the SF-36 increased.After ten weeks of treatment,nerve conduction velocity increased,latency shortened,and the amplitude of evoked action potentials increased.The presence of spontaneous sharp waves decreased,and the peak of active potentials increased.The peak of ac-tive potentials in the right gluteus maximus,vastus lateralis and gastrocnemius muscles increased.The structural organization of the sacrococcygeal ligament appeared clearer and more orderly.No adverse reaction was ob-served.Conclusion Ultrasound-guided sacral canal injection of Neurotropin combined with comprehensive rehabilitation is ef-fective on pain,activities of daily living and quality of life for patients with severe sacral plexus injury during the sequelae period.
6.Effect of Qingfei-Jiedu-Huatan Formula on severe pneumonia in rats via mTOR-regulated alveolar macrophage autophagy
Mingyan JIA ; Yingjin LIANG ; Kang ZHANG ; Ya LI ; Wenshuai JI ; Chen DU ; Xinxin KONG ; Kai XIE ; Pengzhen JING ; Haifeng WANG
Chinese Journal of Pathophysiology 2025;41(7):1383-1391
AIM:This study aims to investigate the mechanism by which Qingfei-Jiedu-Huatan Formula(QJHF)regulates autophagy in alveolar macrophages through mTOR in the treatment of severe pneumonia(SP)in rats.METHODS:Sixty SPF-grade male rats were randomly assigned to six groups:control,model,QJHF,moxifloxacin(MOX),rapamycin(RAPA),and QJHF+RAPA,with ten rats in each group.An SP rat model was established using Klebsiella pneumoniae.After seven days of treatment,changes in IL-33 and IFN-γ levels in bronchoalveolar lavage fluid(BALF)were measured using ELISA.Histopathological alterations in lung tissue were assessed via HE staining,and the autophagy of alveolar macrophages was detected using immunofluorescence co-localization methods.The expression levels of mTOR,beclin-1,and LC3 mRNA in lung tissue were analyzed using qPCR,while Western blot was employed to assess the protein levels of p-mTOR/mTOR,beclin-1,and LC3-II/LC3-I.RESULTS:Compared to the control group,the model group exhibited a deteriorated condition,characterized by alveolar wall rupture and thickening,significant inflammatory cell infiltration in the alveolar cavity,and extensive lung tissue damage(P<0.01).Elevated levels of IL-33 and IFN-γ in BALF were also observed(P<0.01),along with increased colocalization of CD68 and LC3 in immunofluorescence analy-sis.The mTOR mRNA expression in lung tissue decreased(P<0.01),while LC3 and beclin-1 mRNA expressions in-creased(P<0.01).Additionally,the protein expression ratio of p-mTOR/mTOR decreased(P<0.01),whereas LC3-II/LC3-I and beclin-1 protein levels increased(P<0.01).In comparison to the model group,significant improvements were noted after treatment with QJHF and MOX(P<0.01),while RAPA treatment led to a worsening of these indicators(P<0.05).A slight improvement was observed with the QJHF combined with RAPA intervention,though this was not statisti-cally significant.No significant differences were found between the MOX and QJHF groups.However,the QJHF+RAPA group displayed notable improvements in various indicators compared to the RAPA group(P<0.05).CONCLUSION:The QJHF can mitigate the inflammatory response associated with severe pneumonia,potentially by activating mTOR phos-phorylation activity,which in turn inhibits excessive autophagy in alveolar macrophages.
7.Regularity of prescriptions for epidemic disease in Taiping Huimin Heji Ju Fang based on latent structure combined with association rules
Wenjing YIN ; Kai XIE ; Xinyu MIAO ; Xiaoxuan HE ; Haifeng WANG
Chinese Journal of Pharmacoepidemiology 2025;34(6):666-675
Objective To explore the regularity of prescriptions for epidemic disease in Taiping Huimin Heji Ju Fang based on the latent structure model and association rules analysis,and to provide references for modern epidemic treatment.Methods Prescriptions for epidemic diseases were extracted from Taiping Huimin Heji Ju Fang.A high-frequency herb matrix(frequency≥10)was constructed,and high-frequency herbs were analyzed using MicrosoftExcel 2016,Lantern 5.0,and IBM SPSS Modeler 18.0 for efficacy classification,property/flavor/channel tropism statistics,latent structure modeling,and association rule analysis.Results Among the 200 collected herbal prescriptions,46 high-frequency medicinal materials were identified,such as licorice,fresh ginger,dried ginger,poriae,and ginseng.The top 3 drugs efficacy were tonifying deficiency,relieving surface and warming inner.The medicinal properties were mainly warm,and the medicinal flavors were pungent,bitter,and sweet.The meridian tropisms mainly included the spleen meridian,lung meridian and stomach meridian.The analysis of latent structure model suggested that there were 8 types of common symptoms of epidemic disease,such as wind evil attack exterior,wind-cold-dampness,wind-heat,excess-heat in triple energizer,dampness inhibits qi stagnation,yang deficiency,blockage and spleen-qi deficiency.Theanalysis of association rules obtained licorice-ephedra and licorice-atractylodes,which with a core of licorice medicine,and the 16 association rules such as dried ginger-cinnamon,pericarpium citri reticulatae-mangnolia officinalis and poriae-ginseng-atractylodes macrocephala after eliminating ginger,jujube and licorice.Conclusion Most of the medicines used in the treatment of epidemic diseases in Taiping Huimin Heji Ju Fang are pungent,bitter and dispelling evil,the treatment should follow the principle of dispelling evil,warming yang to dissipate cold,dispelling dampness,clearing heat and expelling fire,inducing resuscitation,supporting the right and supplementing deficiency,which embodies the treatment principle of dispelling evil and supporting right,and provides reference and ideas for the treatment of clinical diseases based on syndrome differentiation.
8.Effect of Qingfei-Jiedu-Huatan Formula on severe pneumonia in rats via mTOR-regulated alveolar macrophage autophagy
Mingyan JIA ; Yingjin LIANG ; Kang ZHANG ; Ya LI ; Wenshuai JI ; Chen DU ; Xinxin KONG ; Kai XIE ; Pengzhen JING ; Haifeng WANG
Chinese Journal of Pathophysiology 2025;41(7):1383-1391
AIM:This study aims to investigate the mechanism by which Qingfei-Jiedu-Huatan Formula(QJHF)regulates autophagy in alveolar macrophages through mTOR in the treatment of severe pneumonia(SP)in rats.METHODS:Sixty SPF-grade male rats were randomly assigned to six groups:control,model,QJHF,moxifloxacin(MOX),rapamycin(RAPA),and QJHF+RAPA,with ten rats in each group.An SP rat model was established using Klebsiella pneumoniae.After seven days of treatment,changes in IL-33 and IFN-γ levels in bronchoalveolar lavage fluid(BALF)were measured using ELISA.Histopathological alterations in lung tissue were assessed via HE staining,and the autophagy of alveolar macrophages was detected using immunofluorescence co-localization methods.The expression levels of mTOR,beclin-1,and LC3 mRNA in lung tissue were analyzed using qPCR,while Western blot was employed to assess the protein levels of p-mTOR/mTOR,beclin-1,and LC3-II/LC3-I.RESULTS:Compared to the control group,the model group exhibited a deteriorated condition,characterized by alveolar wall rupture and thickening,significant inflammatory cell infiltration in the alveolar cavity,and extensive lung tissue damage(P<0.01).Elevated levels of IL-33 and IFN-γ in BALF were also observed(P<0.01),along with increased colocalization of CD68 and LC3 in immunofluorescence analy-sis.The mTOR mRNA expression in lung tissue decreased(P<0.01),while LC3 and beclin-1 mRNA expressions in-creased(P<0.01).Additionally,the protein expression ratio of p-mTOR/mTOR decreased(P<0.01),whereas LC3-II/LC3-I and beclin-1 protein levels increased(P<0.01).In comparison to the model group,significant improvements were noted after treatment with QJHF and MOX(P<0.01),while RAPA treatment led to a worsening of these indicators(P<0.05).A slight improvement was observed with the QJHF combined with RAPA intervention,though this was not statisti-cally significant.No significant differences were found between the MOX and QJHF groups.However,the QJHF+RAPA group displayed notable improvements in various indicators compared to the RAPA group(P<0.05).CONCLUSION:The QJHF can mitigate the inflammatory response associated with severe pneumonia,potentially by activating mTOR phos-phorylation activity,which in turn inhibits excessive autophagy in alveolar macrophages.
9.Platelet rich plasma versus hyaluronic acid in treatment of knee osteoarthritis:an overview of systematic reviews
Yunyi ZHANG ; Songtao LIU ; Shaodong XIE ; Haifeng ZHU ; Guifeng QIAN ; Ming HUO ; Jie ZHOU ; Zixuan DENG
Chinese Journal of Tissue Engineering Research 2025;29(28):6138-6145
OBJECTIVE:The quality of systematic reviews/meta-analyses directly affects the reliability of clinical decision-making basis.Currently,there is no literature quality research on the systematic reviews/meta-analyses of platelet rich plasma versus hyaluronic acid in the treatment of knee osteoarthritis both domestically and internationally.This article will comprehensively evaluate the methodological quality,reporting quality,and evidence quality of the systematic reviews/meta-analyses of platelet rich plasma versus hyaluronic acid in the treatment of knee osteoarthritis.METHODS:Computer searches were conducted on CNKI,WanFang Data,VIP,CBM,PubMed,Embase,and The Cochrane Library.From the establishment of the database until January 24,2024,all systematic reviews/meta-analyses treated with platelet rich plasma versus hyaluronic acid for knee osteoarthritis were collected.Two evaluators independently conducted literature screening and data extraction,and used the AMSTAR 2,PRISMA 2020,and GRADE systems to evaluate and summarize the methodological,reporting,and evidence quality of the included systematic reviews/meta-analyses.RESULTS:A total of 18 qualified systematic reviews/meta-analyses were included,and the results showed that the efficacy and safety of platelet rich plasma might be better than that of hyaluronic acid.The methodological quality of all 18 studies was extremely low;4 reports had poor quality and relatively serious information defects,while 14 reports had moderate quality and some information defects.Among the 275 outcome measures of 16 systematic reviews/meta-analyses,there were 9 medium quality evidence,90 low-quality evidence,and 176 extremely low-quality evidence,with no high-quality evidence.CONCLUSION:At present,the quality of systematic reviews/meta-analyses literature on the treatment of knee osteoarthritis with platelet rich plasma versus hyaluronic acid is relatively low.In the future,the authors of the systematic reviews need to strictly follow the entries of quality evaluation tools such as AMSTAR 2 and PRISMA 2020 in terms of plan registration,research type explanation,retrieval strategy,exclusion list,research site and funding source,bias risk analysis,publication bias evaluation,and public information acquisition,and conduct evidence quality evaluation on the combined results of the systematic reviews/meta-analyses to provide more reliable and rigorous evidence-based basis for clinical practice.
10.Analysis on Registration Status of TCM Clinical Trials of Sepsis Based on WHO ICTRP and ChiCTR
Wenjing YIN ; Kai XIE ; Xinyu MIAO ; Xiaoxuan HE ; Haifeng WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(9):48-53
Objective To investigate the current status and characteristics of registered clinical trials on TCM interventions for sepsis;To provide references for relevant clinical trial registrations.Methods Clinical trials on TCM interventions for sepsis registered in the World Health Organization International Clinical Trials Registry Platform(WHO ICTRP)and the Chinese Clinical Trial Registry(ChiCTR)from inception to June 2024 were retrieved.Data on registration time,registry centers,regions,institutions,participating centers,funding sources,trial design,phase,sample size,randomization methods,blinding,interventions,disease types,and outcome measures were analyzed using Excel 16.0.Results A total of 118 TCM intervention trials for sepsis were included,registered regions involving Guangdong,Jiangsu,and Shanghai,with institutions including Guangdong Provincial Hospital of Chinese Medicine,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,and Jiangsu Provincial Hospital of Traditional Chinese Medicine.Most trials were single-center studies(94,79.66%),funded primarily by hospitals(38)and local governments(36).The majority were interventional studies(105,88.98%),with phases concentrated in pilot/exploratory studies and Phase Ⅳ trials(52).Sample sizes were mostly 60-99 cases(51).Randomized controlled trials predominantly used simple randomization(65)and double-blinding(22).Interventions mainly included empirical formulas,Chinese patent medicines,and classical prescriptions,targeting conditions such as gastrointestinal dysfunction and lung injury,with primary outcomes including SOFA,APACHE Ⅱ,and mortality rate.Conclusion The number of TCM registered clinical trials for sepsis has generally increased.There are some problems,such as uneven distribution of test areas,poor standardization and integrity of registration information,and the advantages and characteristics of TCM need to be further highlighted.

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