1.Two visual arthroplasty techniques for L5-S1 disc herniation:a half-year follow-up evaluation of clinical outcomes
Qi LU ; Maji SUN ; Xuezhi WANG ; Ting SONG ; Yiming MA ; Feng YUAN ; Hongliang CHEN
Chinese Journal of Tissue Engineering Research 2025;29(9):1841-1847
BACKGROUND:Currently,spinal endoscopic technology has become the mainstream technology in minimally invasive spinal surgery.The specifications of the instruments for different operating systems are different,and the choice of specific surgical protocols needs to be combined with the actual situation of the patient and the choice of the clinical surgeon. OBJECTIVE:To compare the early efficacy of percutaneous endoscopic interlaminar discectomy for L5-S1 disc herniation under the iLESSYS Delta System and Endo-Surgi Plus System. METHODS:Totally 80 patients with L5-S1 disc herniation were treated with percutaneous endoscopic interlaminar discectomy.Patients were divided into two groups based on the endoscopic system used.Among them,37 cases received the iLESSYS Delta System(Delta group)and 43 cases received the Endo-Surgi Plus System(Plus group).Patient demographic characteristics,perioperative indicators,and complications were analyzed between the two groups.Clinical outcomes were quantified using back and leg visual analog scale scores,Oswestry Disability Index,and Japanese Orthopaedic Association scores at 1 day,1,3,and 6 months after surgery.Patient satisfaction was assessed according to modified MacNab criteria at final follow-up. RESULTS AND CONCLUSION:(1)The operative time and number of arthroplasties in the Plus group were less than those in the Delta group,and the differences were statistically significant(P<0.05).(2)Compared with the preoperative period,the visual analog scale scores,Oswestry Disability Index,and Japanese Orthopaedic Association scores of patients in both groups improved at all follow-up time points,and the difference was statistically significant(P<0.001).(3)There was no statistically significant difference in the comparison of pain visual analog scale scores,Oswestry Disability Index,and Japanese Orthopaedic Association scores of patients in the two groups(P>0.05).(4)At 6-month follow-up after surgery,the MacNab standard excellent and good rates in the Delta group and Plus group were 81%and 79%,respectively,with no significant difference(P=0.823).(5)The incidence of complications was 3%in the Delta group and 2%in the Plus group,but there was no significant difference between the two groups(P=0.914).(6)It is concluded that both iLESSYS Delta and Endo-Surgi Plus surgical systems achieved satisfactory early clinical results in the treatment of lumbar disc herniation,with Endo-Surgi Plus surgical moulding being more efficient and safer.
2.Integrated molecular characterization of sarcomatoid hepatocellular carcinoma
Rong-Qi SUN ; Yu-Hang YE ; Ye XU ; Bo WANG ; Si-Yuan PAN ; Ning LI ; Long CHEN ; Jing-Yue PAN ; Zhi-Qiang HU ; Jia FAN ; Zheng-Jun ZHOU ; Jian ZHOU ; Cheng-Li SONG ; Shao-Lai ZHOU
Clinical and Molecular Hepatology 2025;31(2):426-444
Background:
s/Aims: Sarcomatoid hepatocellular carcinoma (HCC) is a rare histological subtype of HCC characterized by extremely poor prognosis; however, its molecular characterization has not been elucidated.
Methods:
In this study, we conducted an integrated multiomics study of whole-exome sequencing, RNA-seq, spatial transcriptome, and immunohistochemical analyses of 28 paired sarcomatoid tumor components and conventional HCC components from 10 patients with sarcomatoid HCC, in order to identify frequently altered genes, infer the tumor subclonal architectures, track the genomic evolution, and delineate the transcriptional characteristics of sarcomatoid HCCs.
Results:
Our results showed that the sarcomatoid HCCs had poor prognosis. The sarcomatoid tumor components and the conventional HCC components were derived from common ancestors, mostly accessing similar mutational processes. Clonal phylogenies demonstrated branched tumor evolution during sarcomatoid HCC development and progression. TP53 mutation commonly occurred at tumor initiation, whereas ARID2 mutation often occurred later. Transcriptome analyses revealed the epithelial–mesenchymal transition (EMT) and hypoxic phenotype in sarcomatoid tumor components, which were confirmed by immunohistochemical staining. Moreover, we identified ARID2 mutations in 70% (7/10) of patients with sarcomatoid HCC but only 1–5% of patients with non-sarcomatoid HCC. Biofunctional investigations revealed that inactivating mutation of ARID2 contributes to HCC growth and metastasis and induces EMT in a hypoxic microenvironment.
Conclusions
We offer a comprehensive description of the molecular basis for sarcomatoid HCC, and identify genomic alteration (ARID2 mutation) together with the tumor microenvironment (hypoxic microenvironment), that may contribute to the formation of the sarcomatoid tumor component through EMT, leading to sarcomatoid HCC development and progression.
3.Ultrasound radiomics combined with machine learning for early diagnosis of seronegative hashimoto’s thyroiditis
Wenjun WU ; Chang LIU ; Shengsheng YAO ; Daming LIU ; Yuan LUO ; Yihan SUN ; Ting RUAN ; Mengyou LIU ; Li SHI ; Mingming XIAO ; Qi ZHANG ; Zhengshuai LIU ; Xingai JU ; Jiahao WANG ; Xiang FEI ; Li LU ; Yang GAO ; Ying ZHANG ; Liying GONG ; Xuanyu CHEN ; Wanli ZHENG ; Xiali NIU ; Xiao YANG ; Huimei CAO ; Shijie CHANG ; Zuoxin MA ; Jianchun CUI
Chinese Journal of Endocrine Surgery 2025;19(3):313-319
Objective:To evaluate the value of ultrasound radiomics combined with machine learning for early diagnosis of seronegative Hashimoto’s thyroiditis (SN-HT) .Methods:This retrospective study included 164 patients from Liaoning Provincial People’s Hospital , Lixin County People’s Hospital, Linghai Dalinghe Hospital, Fengcheng Phoenix Hospital, who underwent thyroidectomy for solitary nodules with normal thyroid function between Nov. 2016 and Jan. 2024. Postoperative pathology confirmed Hashimoto’s thyroiditis (HT) in some cases, who were further categorized into antibody-positive and antibody-negative groups based on serum antibody status. Patients without Hashimoto’s thyroiditis served as the control group. A total of 298 ultrasound images were analyzed. Radiomics features were extracted from hypoechoic non-nodular areas within 0.5 cm surrounding the tumor. Two senior pathologists and two senior ultrasound physicians independently assessed lymphocytic infiltration, eosinophilic changes of follicular epithelium, and the proportion of hypoechoic areas in pathology and ultrasound images, respectively. A machine learning model, CCH-NET, was developed using linear regression and t-distributed stochastic neighbor embedding (t-SNE) techniques. The dataset was divided into a training set (80%) and a validation set (20%) to compare the diagnostic accuracy of CCH-NET with that of senior ultrasound physicians. Results:In internal validation, CCH-NET achieved a diagnostic accuracy of 88.89% for both antibody-positive and antibody-negative groups, significantly higher than the 66.67% accuracy of senior ultrasound physicians ( P<0.01). In external validation, CCH-NET achieved 75.00% and 66.67% accuracy for the two groups, compared to 50.00% by senior ultrasound physicians. For the control group, both methods achieved 93.33% accuracy. The AUC of CCH-NET was 0.848, outperforming senior ultrasound physicians (0.681) ,demonstrating superior diagnostic performance. Conclusion:The radiomics-based CCH-NET model, using non-nodular hypoechoic areas as a specific indicator, can accurately identify early SN-HT in euthyroid patients. It significantly outperforms senior ultrasound physicians, improving diagnostic accuracy and reducing missed diagnoses.
4.Preliminary examination of the genetic characteristics and antimicrobial resistance genes of Salmonella Alachua
Yue LIU ; Xue-bin XU ; Yi HU ; Qi-fang GU ; Cheng LIU ; Zhen-an YUAN ; Min CHEN
Chinese Journal of Zoonoses 2025;41(2):164-170
This study was aimed at preliminarily investigating the genetic and antimicrobial resistance characteristics of Salmonella Alachua isolates through whole-genome analyses.Five Salmonella Alachua isolates from various sources(both hu-man and non-human)were collected and identified.Phenotype and serotype verification,antimicrobial susceptibility testing,and whole-genome sequencing were performed.Virulence genes,antimicrobial resistance genes,and plasmid replicons were predicted according to globally available Salmonella Alachua genomic data.A phylogenetic tree was constructed to explore the genetic background.The first report of Salmonella Alachua in China emerged in Shanghai in 2015,and patients presented pri-marily with diarrhea.The isolates have been found predominantly in the eastern and southern coastal regions.Among the five i-solates analyzed,four belonged to sequence type(ST)2061,and one belonged to ST1298.All isolates were susceptible to most commonly used clinical antibiotics.Whole-genome analyses revealed that two ST2061 strains carried the blaKPC-2 gene,and one ST1298 strain carried the fosA7 gene.Phylogenetic analysis of global Salmonella Alachua populations indicated that the ST2061 clone belonged to the C1 clade,which was closely related to strains from the UK,whereas the ST1298 clone was found in the C4 clade,a globally disseminated fosA 7-positive lineage.This study provides initial insights into the genetic and antimi-crobial resistance characteristics of Salmonella Alachua in China,highlighting the presence of strains carrying blaKPC-2 and fo-sA7 genes.These findings may provide a reference for future large-scale molecular epidemiological surveillance and source-trac-ing efforts,and they underscore the importance of enhanced resistance monitoring for Salmonella Alachua.
5.Clinical effects of Supplemented Gegen Qinlian Decoction combined with acupuncture on patients with ulcerative colitis of Large Intestinnal Dampness-heat Pattern
Tian CHEN ; Ze-hui WANG ; Yun-hua PENG ; Qing-yuan WANG ; Yan-ni PEI ; Qi-qi YANG ; Wei YANG
Chinese Traditional Patent Medicine 2025;47(2):453-457
AIM To investigate the clinical effects of Supplemented Gegen Qinlian Decoction combined with acupuncture on patients with ulcerative colitis of Large Intestinal Dampness-heat Pattern.METHODS One hundred and twenty patients were randomly assigned into control group(60 cases)for 1-month administration of Pefikang Capsules and Mesalazine Sustained Release Granules,and observation group(60 cases)for 1-month administration of Supplemented Gegen Qinlian Decoction,acupuncture,Pefikang Capsules and Mesalazine Sustained Release Granules.The changes in clinical effects,symptom remission time,TCM syndrome scores,Geboes index,lesion activity index,Baron score,inflammatory factors(IL-6,IL-8,TNF-α),immune function indices(IgA,IgG,IgM),IBDQ score and recurrence rate were detected.RESULTS The observation group demonstrated higher total effective rate than the control group(P<0.05),along with shorter symptom remission time(P<0.05)and lower recurrence rate(P<0.05).After the treatment,the two groups displayed decreased TCM syndrome scores,Geboes index,lesion activity index,Baron score,inflammatory factors,IgG,IgM(P<0.05),and increased IBDQ score(P<0.05),especially for the observation group(P<0.05).CONCLUSION For the patients with ulcerative colitis of Large Intestinal Dampness-heat Pattern,Gegen Qinlian Decoction combined with acupuncture can improve clinical symptoms,promote disease recovery,enhance immune functions and life quality,and reduce recurrence rate.
6.Chinese experts' consensus on principles of preoperative hair removal
Yiping MAO ; Jun ZHENG ; Lei LI ; Deyan YANG ; Bing ZHANG ; Lei YANG ; Wang JIA ; Peng KANG ; Hui JIAO ; Yun YANG ; Qi QI ; Shiqing FENG ; Xiao LONG ; Yuewei ZHANG ; Xiaohui WANG ; Lize WANG ; Yuan WEI ; Jichao ZHOU ; Minghui MAO ; Pengju XIN ; Hongyu TAN ; Dahong ZHANG ; Lianxin LIU ; Lei TAO ; Xietong WANG ; Xiaoning YUAN ; Mang CAI ; Li MU ; Fang DU ; Rongzhu CHEN ; Fengmao ZHAO ; Jiuzuo HUANG ; Mingzi ZHANG ; Jie ZHANG ; Baoguo WANG ; Kun WANG ; Fang LUO ; Jinhua ZHANG ; Nong HE ; Ling LYU ; Zhiyong ZONG
Chinese Journal of Nosocomiology 2025;35(10):1441-1449
To formulate an expert consensus on the principles of preoperative hair removal and provide scientific guidance for standardized removal of hair before surgical procedures so as to reduce the incidence of surgical site infections.METHODS Led by the Hospital Management Institute of National Health Commission of the People's Republic of China,this consensus was reached with the joint efforts from the expects of relevant fields such as surgeries,interventional therapies,nursing,and infection prevention and control.The consensus facilitates the classification and evaluation of literatures by following the evidence grade formulated by Oxford Evidence-based Medicine Center and focuses on the association of preoperative hair removal with surgical site infection,it reaches the evidence grade of expert consensus and recommendation intensity by integrating with discussions on meetings and clinical experience of the expects from relevant fields.RESULTS A total of 6 items of consensus were reached by summarizing the latest evidence on the aspects including the indications for preoperative hair removal,tools,range,timing and places.CONCLUSION The consensus,to some extent,make supplements to and complete the exiting regulations and standards.It provides guidance for the medical institutions to carry out the preoperative hair removal.
7.Effect of butylphthalide on the risk of post-stroke epilepsy in patients with cerebral infarction
Qi YU ; Junfeng YUAN ; Kai CHEN ; Xiuyun LI ; Zhanyong LI
Chinese Journal of Pharmacoepidemiology 2025;34(5):532-538
Objective To explore the effect of sequential therapy with butylphthalide on the risk of post-stroke epilepsy(PSE)in patients with cerebral infarction.Methods The clinical data of patients with cerebral infarction hospitalized in Langfang People's Hospital from October,2016 to October,2022 were selected and analyzed.Patients receiving butylphthalide sequential treatment were included in the butylphthalide group,patients who were hospitalized at the same time with matching gender,age(±5 years),basic disease,clinical drug treatment scheme and follow-up period but did not receive butylphthalide treatment were included in the control group.The general clinical data,laboratory examination results on admission,and incidence of PSE in the two groups were compared,and multivariate Logistic regression was used to analyze the correlation between sequential therapy with butylphthalide and PSE occurrence in patients with cerebral infarction.Results A total of 1,200 patients were included,with 600 patients in each group.There was no significant difference in general clinical data such as sex,age,complications and living habits between the two groups(P>0.05).There were no significant differences between the two groups in the patients distribution of TOAST classification,NIHSS score(P>0.05).The incidence of PSE in butylphthalide group was significantly lower than that in control group(4.17%vs.7.83%,P<0.05).The application of sequential treatment with butylphthalide was a protective factor for PSE occurrence in patients with cerebral infarction[OR=0.352,95%CI(0.151,0.821),P=0.016].Conclusion Sequential treatment with butylphthalide can reduce the risk of post-stroke epilepsy in patients with cerebral infarction.
8.D-dimer/Alb ratio,IL-6 and FDP jointly predict poor outcomes post type A dissection
Yunfang ZHANG ; Zheng LI ; Xiaogai NIE ; Yun GUAN ; Qi CHEN ; Yong YUAN
The Journal of Practical Medicine 2025;41(17):2755-2760
Objective To analyze and evaluate the early warning efficacy of D-dimer/albumin ratio(DAR)combined with interleukin-6(IL-6)and fibrin degradation products(FDP)in the postoperative treatment of acute Stanford type A aortic dissection(ATAAD).Methods A retrospective cohort study was conducted on 284 ATAAD patients who underwent the Sun's procedure at our hospital from July 2024 to March 2025.Patients were divided into a non-adverse outcome group(n=196)and an adverse outcome group(n=88)based on the occurrence of postop-erative complications within 30 days,including acute renal failure requiring dialysis,secondary thoracotomy for hemostasis,severe neurological complications,multiple organ failure,or all-cause mortality.Preoperative baseline data,perioperative parameters,and laboratory indicators were collected via the electronic medical record system.The Mann-Whitney U test was used to compare the differences between groups for continuous variables that did not conform to the normal distribution,and Chi-square test or Fisher's exact test was selected for statistical difference analysis according to the frequency distribution characteristics of categorical variables.On the basis of univariate analysis,multivariate logistic regression analysis was used to screen independent risk factors.Results Statistically significant differences were observed between the non-adverse and adverse outcome group in age,cardiopulmonary bypass time,lactate dehydrogenase(LDH),IL-6,D-dimer(D-D),FDP,and DAR levels(P<0.05).Multivariate analysis revealed that DAR,IL-6,D-D,FDP,and prolonged cardiopulmonary bypass time were independent risk factors for adverse postoperative outcomes(P<0.05).Combined detection analysis demonstrated that the combination of DAR,IL-6,FDP,and cardiopulmonary bypass time yielded the highest predictive efficacy,with an area under the ROC curve of 0.886(95%CI:0.846~0.927).Conclusion The combination of DAR,IL-6,FDP,and cardio-pulmonary bypass time effectively predicts adverse postoperative outcomes in ATAAD patients.This biomarker panel may serve as a robust predictive tool for postoperative risk stratification.
9.Bioequivalence study of desloratadine tablets in healthy Chinese subjects
Peng-fei XIE ; Yuan-lu CHEN ; Hong-di CUI ; Hui LONG ; Yong-gang ZHAO ; Qi-shan HUANG ; Peng YANG ; Yan ZHOU ; Yong-dong ZHANG
The Chinese Journal of Clinical Pharmacology 2025;41(2):220-224
Objective To explore the pharmacokinetic(PK)characteristics of desloratadine tablets and reference drugs in healthy subjects,and evaluate their bioequivalence and safety.Methods The random,open,two-period,cross-over pharmacokinetic study method was adopted,each subject received a single oral dose of desloratadine tablets test drug(T)or reference drug(R)for 5 mg.The concentrations of desloratadine and 3-hydroxy desloratadine in plasma were determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS);and the PK parameters were calculated by WinNonlin 8.1 software to evaluate the bioequivalence.Results The main PK parameters of T and R of desloratadine were as follows:the fasting condition Cmax were respectively(3 809.82±1 016.54)and(3 642.36±777.07)pg·mL-1;AUC0-120h were respectively(5.75 ×104±5.03 ×104)and(5.51 × 104±4.00 × 104)pg·h·mL-1;AUC0-∞ were respectively(6.85× 104±1.03× 104)and(6.37 × 104±7.92 × 104)pg·h·mL-1.The fed condition Cmax were respectively(4 398.98±1 191.22)and(4 744.4±1 511.97)pg·mL-1;AUC0-120h were respectively(5.25 × 104±1.82 × 104)and(5.55 × 104±1.98 × 104)pg·h·mL-1;AUC0-∞ were respectively(5.37 × 104±1.86 × 104)and(5.68 × 104±2.04 × 104)pg·h·mL-1.The 90%confidence interval of Cmax,AUC0-t and AUC0-∞ of desloratadine were all within 80.00%~125.00%.Conclusion There was no significant difference in the main PK parameters between T tablets and R under fasting or high-fat postprandial conditions,and desloratadine tablets were bioequivalent,safe and well tolerated.
10.Feasibility study of using clinical trial individual-level data sample bank as external control to support drug and device development:taking transcatheter aortic valve replacement device as an example
Xiao-ying LIN ; Chi-lie DANZENG ; Duo-er WANG ; Ying-xuan ZHU ; Ye LU ; Fan GAO ; Yuan-xin LI ; Meng-zhu SU ; Zi-long ZHANG ; Min CHEN ; Qi-ze LI ; Ru JIANG ; Yan-yan ZHAO ; Yang WANG
Chinese Journal of Interventional Cardiology 2025;33(8):459-466
Objective To explore the feasibility and corresponding implementation methods of constructing a sample resource bank based on individual-level data of completed clinical trials and using it to construct external controls for drug/device clinical trials.Methods Taking the pre-marketing clinical trial of transcatheter active valve replacement(TAVR)for the treatment of aortic valve stenosis as an example,the individual-level databases of multiple trials were standardized to form a sample bank.The original data of any trial in the sample bank were selected as the experimental group,and the remaining samples were selected as the control group.The potential confounding was handled by using the propensity score matching and stratification methods to clarify the process of constructing external controls based on the sample bank of individual-level data of clinical trials.Results This study included individual-level data of single-group trials of 4 TAVR devices,with a total of 569 subjects(59.2%male).The number of subjects in Trials 1 to 4 was 120,120,163,and 166,respectively.Propensity score matching enabled the matching of 113,117,125,and 147 subjects with comparable or similar characteristics from individual-level data from other trials,respectively,demonstrating a high matching success rate.The PS score distribution plot after stratification showed that the proportions of subjects in the experimental and control groups in strata 1 to 5 in scheme 1 were 4/103,11/103,22/92,32/87,and 51/64,respectively.For all constructed external controlled trials,a certain number of control samples with similar baseline characteristics to the experimental groups were distributed within each propensity score stratum.The results of the simulation test also reflected the potential differences between different devices in the 12-month all-cause mortality rate.Conclusions The sample bank constructed with individual-level data from clinical trials,as a high-quality data source,can serve as a source of external control for single-arm trials in the same field,and as a useful supplement to the external control scenario of real-world evidence to support drug and device development.At the same time,targeted research on research methods and bias control measures in related fields is also needed.

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