Oral squamous cell carcinoma (OSCC) is a common head and neck malignancy. Approximately 50% to 60% of patients with OSCC are diagnosed at a locally advanced stage (clinical staging III-IVa). Even with comprehensive and sequential treatment primarily based on surgery, the 5-year overall survival rate remains below 50%, and patients often suffer from postoperative functional impairments such as difficulties with speaking and swallowing. Programmed death receptor-1 (PD-1) inhibitors are increasingly used in the neoadjuvant treatment of locally advanced OSCC and have shown encouraging efficacy. However, clinical practice still faces key challenges, including the definition of indications, optimization of combination regimens, and standards for efficacy evaluation. Based on the latest research advances worldwide and the clinical experience of the expert group, this expert consensus systematically evaluates the application of PD-1 inhibitors in the neoadjuvant treatment of locally advanced OSCC, covering combination strategies, treatment cycles and surgical timing, efficacy assessment, use of biomarkers, management of special populations and immune related adverse events, principles for immunotherapy rechallenge, and function preservation strategies. After multiple rounds of panel discussion and through anonymous voting using the Delphi method, the following consensus statements have been formulated: 1) Neoadjuvant therapy with PD-1 inhibitors can be used preoperatively in patients with locally advanced OSCC. The preferred regimen is a PD-1 inhibitor combined with platinum based chemotherapy, administered for 2-3 cycles. 2) During the efficacy evaluation of neoadjuvant therapy, radiographic assessment should follow the dual criteria of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune RECIST (iRECIST). After surgery, systematic pathological evaluation of both the primary lesion and regional lymph nodes is required. For combination chemotherapy regimens, PD-L1 expression and combined positive score need not be used as mandatory inclusion or exclusion criteria. 3) For special populations such as the elderly (≥ 70 years), individuals with stable HIV viral load, and carriers of chronic HBV/HCV, PD-1 inhibitors may be used cautiously under the guidance of a multidisciplinary team (MDT), with close monitoring for adverse events. 4) For patients with a poor response to neoadjuvant therapy, continuation of the original treatment regimen is not recommended; the subsequent treatment plan should be adjusted promptly after MDT assessment. Organ transplant recipients and patients with active autoimmune diseases are not recommended to receive neoadjuvant PD-1 inhibitor therapy due to the high risk of immune related activation. Rechallenge is generally not advised for patients who have experienced high risk immune related adverse events such as immune mediated myocarditis, neurotoxicity, or pneumonitis. 5) For patients with a good pathological response, individualized de escalation surgery and function preservation strategies can be explored. This consensus aims to promote the standardized, safe, and precise application of neoadjuvant PD-1 inhibitor strategies in the management of locally advanced OSCC patients.

Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.

Objective To assess renal oxygen metabolism and iron deposition in type 2 diabetes mellitus(T2DM)patients using a combination of blood oxygen level-dependent(BOLD)and mDixon Quant techniques.Methods Clinical data of 58 T2DM patients from Tianjin First Central Hospital(September 2022-December 2023)were prospectively collected.According to urinary albumin-to-creation ratio(ACR),patients were divided into the normal albuminuria(NAU,ACR＜30 mg/g,n=35)group and the microalbuminuria(MAU,30 mg/g≤ACR＜300 mg/g,n=23)group.Thirty-three healthy volunteers were included as the control group during the same period.All participants underwent renal BOLD and mDixon Quant MRI to obtain cortical and medullary apparent relaxation rate(R2*)values.The differences of general data and image parameter values were compared between groups.Receiver operating characteristic(ROC)curves were used to analyze the diagnostic efficacy of relevant parameters for early renal function changes.Results There were significant differences in body weight,estimated glomerular filtration rate(eGFR)and ACR between the control group,the NAU group and the MAU group(P＜0.01).The R2* value in renal cortex was lower than that in renal medulla(P＜0.01)in the same group.Apart from R2* value of BOLD renal cortex,which showed no significant difference between the three groups(P＜0.05),and the differences in the other parameters were statistically significant(P<0.05).When distinguishing between the control group and the NAU group,the NAU group and the MAU group,as well as between the control group and the early-stage T2DM(NAU+MAU)group,the combined two-sequence approach demonstrated higher area under the curve(AUCs)than any single sequence alone,with AUC value of 0.892(95%CI:0.809-0.975),0.785(95%CI:0.666-0.904)and 0.841(95%CI:0.756-0.926),respectively.Conclusion The combination of BOLD imaging with mDixon Quant enables noninvasive and quantitative assessment of alterations in renal oxygen metabolism and iron content in early-stage T2DM patients.The diagnostic performance of this combined approach surpasses that of individual methods.

Inflammatory bowel disease(IBD)is a chronic inflammatory bowel disease with a complex etiology,mainly including two types:ulcerative colitis(UC)and Crohn's disease(CD),whose risk factors for its development are still incompletely understood.In recent years,Mendelian randomization(MR)has gained increasing attention in IBD research.MR mainly uses genetic variation as an instrumental variable to infer causality between exposure and outcome,effectively avoiding confounding and reverse causality in observational studies and randomised controlled trials.This review summarises currently published MR studies related to IBD,focusing on causal relationships between different risk factors and IBD development.Current findings support a causal relation-ship between IBD and selected oral diseases,skin diseases,psychiatric disorders,autoimmune diseases,bone diseases,gut diseases,gut microbiota,cytokines and nutrients,but not between IBD and lifestyle,cardiovascular diseases and neurodegenerative diseases.Despite its limitations,MR studies are of great significance in improving understanding of etiology of IBD and in identifying potential therapeutic interventions.

Objective:To explore the predictive value of human cartilage glycoprotein 39 (YKL-40) and growth differentiation factor 15 (GDF-15) for clinical outcomes of patients with Parkinson disease (PD).Methods:A total of 109 patients with PD admitted to Xinxiang Central Hospital from February 2021 to February 2023 were selected and treated with regular anti-PD medications for 4 weeks, with dosage appropriately adjusted according to clinical status and individual response.Clinical outcomes were evaluated after 2 months of treatment, and the predictive value of serum YKL-40 and GDF-15 at admission for clinical outcomes was analyzed.Data were analyzed by independent sample t-test, χ2 test and Logistic regression using SPSS 26.0. Results:PD patients with poor outcomes exhibited higher serum levels of YKL-40((3.18±0.67)mg/L, (2.34±0.41)mg/L) and GDF-15((457.82±142.83)pg/mL, (282.95±105.96)pg/mL) than those with good outcomes, and the differences were statistically significant ( t=8.082, 7.349, both P<0.05).Logistic regression analysis showed that elevated serum levels of YKL-40( B=0.664, OR=1.943, 95% CI=1.237-3.052) and GDF-15( B=0.185, OR=1.787, 95% CI=1.145-2.789) both influenced the clinical outcomes of PD patients(both P<0.05).Serum YKL-40 combined with GDF-15 demonstrated a predictive sensitivity of 87.23%, specificity of 90.32%, and AUC of 0.927(95% CI=0.861-0.968) for clinical outcomes in PD patients.The AUC was significantly higher than that achieved by either indicator alone (YKL-40: AUC (95% CI)=0.722 (0.628-0.804); GDF-15: AUC (95% CI)=0.797 (0.709-0.868)). Conclusion:The elevated levels of YKL-40 and GDF-15 in PD patients are associated with clinical outcomes, which may be the potential markers for predicting clinical outcomes of patients with PD.

OBJECTIVE To explore the distribution of pathogens isolated from the cervical cancer(CC)patients with postoperative urinary catheter-associated urinary tract infection(UTI)and analyze the predictive values of se-rum high mobility group protein B1(HMGB1),Toll-like receptor 4(TLR4)and nuclear factor kappa B(NF-κB).METHODS Totally 116 patients with CC who underwent radical resection in the First Affiliated Hospital of Henan University of Science and Technology from Jan.2021 to Jan.2024 were enrolled in the study and were divided into the infection group with 31 cases and the non-infection group with 85 cases according to the status of complication with UTI after urinary catheterization.The midstream urine specimens were collected by aseptic method,the pathogens were isolated and identified.The serum HMGB1 level was detected by means of enzyme-linked immu-nosorbent assay,the relative expression levels of peripheral blood TLR4 and NF-κB proteins were detected by Western blot.The efficiencies of serum HMGB1,TLR4 and NF-κB in prediction of postoperative urinary catheter-associated UTI in the CC patients were analyzed by means of receiver operating characteristic(ROC)curves.RESULTS Totally 49 strains of pathogens were isolated from 31 CC patients with postoperative urinary catheter-associated UTI,and the patients who had infection of single species were dominant.Gram-negative bacteria were the most common pathogens,accounting for 61.22％.There were significant differences in the age,complication with diabetes mellitus,duration of urinary catheter indwelling,postoperative uroschesis and previous history of UTI between the infection group and the non-infection group(P＜0.05);there were significant differences in the levels of serum HMGB1,TLR4 and NF-κB between the two groups(P＜0.05).The area under the curve(AUC)of the joint detection of serum HMGB1,TLR4 and NF-κB was 0.906 in prediction of the postoperative urinary catheter-associated UTI in the CC patients,with the sensitivity 83.87％;the predictive efficiencies of the joint de-tection of the indexes were better than those of the single detection(P＜0.05).CONCLUSIONS The gram-negative bacteria are dominant among the pathogens isolated from the CC patients with postoperative urinary catheter-asso-ciated UTI.The joint detection of the serum HMGB1,TLR4 and NF-κB has the highest value in prediction of postoperative urinary catheter-associated UTI in the CC patients.

Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.

Objective To assess renal oxygen metabolism and iron deposition in type 2 diabetes mellitus(T2DM)patients using a combination of blood oxygen level-dependent(BOLD)and mDixon Quant techniques.Methods Clinical data of 58 T2DM patients from Tianjin First Central Hospital(September 2022-December 2023)were prospectively collected.According to urinary albumin-to-creation ratio(ACR),patients were divided into the normal albuminuria(NAU,ACR＜30 mg/g,n=35)group and the microalbuminuria(MAU,30 mg/g≤ACR＜300 mg/g,n=23)group.Thirty-three healthy volunteers were included as the control group during the same period.All participants underwent renal BOLD and mDixon Quant MRI to obtain cortical and medullary apparent relaxation rate(R2*)values.The differences of general data and image parameter values were compared between groups.Receiver operating characteristic(ROC)curves were used to analyze the diagnostic efficacy of relevant parameters for early renal function changes.Results There were significant differences in body weight,estimated glomerular filtration rate(eGFR)and ACR between the control group,the NAU group and the MAU group(P＜0.01).The R2* value in renal cortex was lower than that in renal medulla(P＜0.01)in the same group.Apart from R2* value of BOLD renal cortex,which showed no significant difference between the three groups(P＜0.05),and the differences in the other parameters were statistically significant(P<0.05).When distinguishing between the control group and the NAU group,the NAU group and the MAU group,as well as between the control group and the early-stage T2DM(NAU+MAU)group,the combined two-sequence approach demonstrated higher area under the curve(AUCs)than any single sequence alone,with AUC value of 0.892(95%CI:0.809-0.975),0.785(95%CI:0.666-0.904)and 0.841(95%CI:0.756-0.926),respectively.Conclusion The combination of BOLD imaging with mDixon Quant enables noninvasive and quantitative assessment of alterations in renal oxygen metabolism and iron content in early-stage T2DM patients.The diagnostic performance of this combined approach surpasses that of individual methods.

Inflammatory bowel disease(IBD)is a chronic inflammatory bowel disease with a complex etiology,mainly including two types:ulcerative colitis(UC)and Crohn's disease(CD),whose risk factors for its development are still incompletely understood.In recent years,Mendelian randomization(MR)has gained increasing attention in IBD research.MR mainly uses genetic variation as an instrumental variable to infer causality between exposure and outcome,effectively avoiding confounding and reverse causality in observational studies and randomised controlled trials.This review summarises currently published MR studies related to IBD,focusing on causal relationships between different risk factors and IBD development.Current findings support a causal relation-ship between IBD and selected oral diseases,skin diseases,psychiatric disorders,autoimmune diseases,bone diseases,gut diseases,gut microbiota,cytokines and nutrients,but not between IBD and lifestyle,cardiovascular diseases and neurodegenerative diseases.Despite its limitations,MR studies are of great significance in improving understanding of etiology of IBD and in identifying potential therapeutic interventions.

Objective:To explore the diagnostic value of shear wave elastography(SWE)for clinically significant prostate cancer(csPCa).Methods:We retrospectively analyzed the clinical data of 359 cases with suspected prostate cancer(PCa)in Baoji Central Hospital from June 2017 to July 2023.All the patients underwent the following examinations in the order of serum prostate-spe-cific antigen(PSA)testing,transrectal ultrasonography(TRUS),measurement of the stiffness of the entire prostate gland by SWE,and TRUS-guided prostate puncture biopsy.The stiffness of the entire prostate gland was defined as the average of Young's modulus at both sides of the base,middle,and apex of the prostate,including the maximum Young's modulus(Emax),mean Young's modulus(Emean),and minimum Young's modulus(Emin).We analyzed the correlation of the parameters of the stiffness of the entire prostate gland with the pathological results,focusing on their diagnostic performance for csPCa.Results:Of the 359 cases,189 were diag-nosed by pathological puncture biopsy as BPH,26 as non-csPCa,and 144 as csPCa.The PSA level,Emax,Emean and Emin were significantly higher in the csPCa than those in the BPH and non-csPCa groups(all P＜0.01),but showed no statistically significant difference between the BPH and non-csPCa groups(all P＞0.05).The area under the receiver operating characteristic curve(AUC),optimal cut-off value,sensitivity,specificity,positive predictive value(PPV),negative predictive value(NPV)and accura-cy of Emax in the diagnosis of csPCa were 0.852,143.92 kPa,72.22％,84.65％,75.91％,81.98％and 79.67％;those of Emean were 0.868,82.42 kPa,67.36％,91.16％,83.62％,80.66％and 81.62％;and those of Emin were 0.682,32.73 kPa,47.22％,89.30％,73.91％,71.54％and 72.14％,respectively.In the non-csPCa group,Emax,Emean and Emin were found be-low the optimal cut-off value in 73.08％(19/26),92.31％(24/26)and 88.46％(23/26),respectively.Conclusion:The stiff-ness of the entire prostate gland measured by SWE contributes to the diagnosis of csPCa,reduces unnecessary detection of non-csPCa,and provides some reference for its active surveillance.