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.

Cervical spine health issues not only seriously affect patients' quality of life but also impose a heavy burden on the social healthcare system. Existing guidelines lack sufficient clinical guidance on lifestyle and work habits, such as exercise, posture, daily routine, and diet, making it difficult to meet practical needs. To address this, relying on the China Association of Chinese Medicine, Wangjing Hospital of China Academy of Chinese Medical Sciences took the lead and joined hands with more than ten institutions to form a multidisciplinary guideline development group. For the first time, the group developed the Guidelines for Cervical Spine Health Intervention based on evidence-based medicine methods, strictly following the standardized procedures outlined in the World Health Organization Handbook for Guideline Development and the Guiding Principles for the Formulation/Revision of Clinical Practice Guidelines in China (2022 Edition). This proposal systematically explains the methods and steps for developing the guideline, aiming to make the guideline development process scientific, standardized, and transparent.
Humans ; Practice Guidelines as Topic/standards* ; Cervical Vertebrae ; China

Ischemic stroke (IS) is a globally life-threatening disease. Presently, few therapeutic medicines are available for treating IS, and rt-PA is the only drug approved by the US Food and Drug Administration (FDA) in the US. In fact, many agents showing excellent neuroprotection but no blood flow-improving activity in animals have not achieved ideal clinical efficacy, while thrombolytic drugs only improving blood flow without neuroprotection have limited their wider application. To address these challenges and meet the huge unmet clinical need, we have designed and identified a novel compound AAPB with dual effects of neuroprotection and cerebral blood flow improvement. AAPB significantly reduced cerebral infarction and neural function deficit in tMCAO rats, pMCAO rats, and IS rhesus monkeys, as well as displayed exceptional safety profiles and excellent pharmacokinetic properties in rats and dogs. AAPB has now entered phase I of clinical trials fighting IS in China.

BACKGROUND: The use of inserted sham acupuncture as a placebo in randomized controlled trials (RCTs) is controversial, because it may produce specific effects that cause an underestimation of the effect of acupuncture treatment. OBJECTIVE: This systematic survey investigates the magnitude of insert-specific effects of sham acupuncture and whether they affect the estimation of acupuncture treatment effects. SEARCH STRATEGY: PubMed, Embase and Cochrane Central Register of Controlled Trials were searched to identify acupuncture RCTs from their inception until December 2022. INCLUSION CRITERIA: RCTs that evaluated the effects of acupuncture compared to sham acupuncture and no treatment. DATA EXTRACTION AND ANALYSIS: The total effect measured for an acupuncture treatment group in RCTs were divided into three components, including the natural history and/or regression to the mean effect (controlled for no-treatment group), the placebo effect, and the specific effect of acupuncture. The first two constituted the contextual effect of acupuncture, which is mimicked by a sham acupuncture treatment group. The proportion of acupuncture total effect size was considered to be 1. The proportion of natural history and/or regression to the mean effect (PNE) and proportional contextual effect (PCE) of included RCTs were pooled using meta-analyses with a random-effect model. The proportion of acupuncture placebo effect was the difference between PCE and PNE in RCTs with non-inserted sham acupuncture. The proportion of insert-specific effect of sham acupuncture (PIES) was obtained by subtracting the proportion of acupuncture placebo effect and PNE from PCE in RCTs with inserted sham acupuncture. The impact of PIES on the estimation of acupuncture's treatment effect was evaluated by quantifying the percentage of RCTs that the effect of outcome changed from no statistical difference to statistical difference after removing PIES in the included studies, and the impact of PIES was externally validated in other acupuncture RCTs with an inserted sham acupuncture group that were not used to calculate PIES. RESULTS: This analysis included 32 studies with 5492 patients. The overall PNE was 0.335 (95% confidence interval [CI], 0.255-0.415) and the PCE of acupuncture was 0.639 (95% CI, 0.567-0.710) of acupuncture's total effect. The proportional contribution of the placebo effect to acupuncture's total effect was 0.191, and the PIES was 0.189. When we modeled the exclusion of the insert-specific effect of sham acupuncture, the acupuncture treatment effect changed from no difference to a significant difference in 45.45% of the included RCTs, and in 40.91% of the external validated RCTs. CONCLUSION The insert-specific effect of sham acupuncture in RCTs represents 18.90% of acupuncture's total effect and significantly affects the evaluation of the acupuncture treatment effect. More than 40% of RCTs that used inserted sham acupuncture would draw different conclusions if the PIES had been controlled for. Considering the impact of the insert-specific effect of sham acupuncture, caution should be taken when using inserted sham acupuncture placebos in RCTs. Please cite this article as: Luo XC, Liu JL, Yao MH, Chen YM, Fan AY, Liang FR, Zhao JP, Zhao L, Zhou X, Zhong XY, Yang JH, Li B, Zhang Y, Sun X, Li L. Specific effect of inserted sham acupuncture and its impact on the estimation of acupuncture treatment effect in randomized controlled trials: A systematic survey. J Integr Med. 2025; 23(6):630-640.
Acupuncture Therapy/methods* ; Humans ; Randomized Controlled Trials as Topic ; Placebo Effect ; Placebos ; Treatment Outcome

Objective:To investigate the value of the five-sectional screening method of the central nervous system（CNS）in early detection of fetal CNS abnormalities during the first trimester.Methods:The data of pregnant women who underwent nuchal translucency（NT）screening at the Affiliated Suzhou Hospital of Nanjing Medical University from September 2018 to September 2023 were retrospectively analyzed. And a five-sectional screening method of CNS was performed in all fetuses at the meantime. The five-sectional screening protocol in the first trimester consists of the mid-sagittal plane of the fetal head，trans-ventricular plane，trans-thalamus plane，axial plane of the fetal head at the posterior fossa level，and the sagittal plane of the fetal spine. All fetuses underwent ultrasound screening during the second trimester and the third trimester sequentially after NT screening. All the ultrasound findings were tracked，and all fetuses were followed up until delivery or after induction. Fetuses with CNS abnormalities found or suspected in the first trimester were reviewed by at least one senior physician，and follow-up examinations were routinely performed after 2 weeks to further confirm the diagnosis or find other abnormalities that may be present.Results:A total of 13 679 fetuses were screened，included 11 415 singleton pregnancies and 1 132 twin pregnancies. Among them，there were 289 cases of missed follow-up and unexplained fetal death，included 263 singleton pregnancies and 13 twin pregnancies. A total of 13 390 fetuses were finally included，among which，35 cases developed CNS abnormalities with 34 cases detected by prenatal ultrasound and 1 case of closed spina bifida missed in prenatal diagnosis，and the detection rate of CNS malformation by prenatal ultrasound was 97.14%（34/35）. Of the 35 fetuses with CNS abnormalities，24 were detected by the CNS five-sectional screening method in the first trimester，with a sensitivity of 68.57%，a specificity of 100%，a positive predictive value of 100%，and a negative predictive value of 99.92%. Among them，there were 2 cases of anencephaly，3 cases of exencephaly and 6 cases of encephalocele were all detected in the first trimester. In addition，6 cases of holoprosencephaly，3 cases of severe ventriculomegaly，2 cases of open spina bifida，and 2 cases of Dandy-Walker malformation were detected in the first trimester. In this study，1 case of agenesis of corpus callosum（ACC），1 case of arachnoid cyst，1 case of lissencephaly，1 case of schizencephaly，and 1 case of mega cisterna magna were not detected in early pregnancy.Conclusions:The fetal five-sectional screening method of CNS in the first trimester has high specificity，positive predictive value and negative predictive value for the detection of fetal CNS abnormalities，but the sensitivity is moderate. The five-sectional screening method for CNS in early pregnancy may be an effective method for early detection of fetal CNS abnormalities.

Objective:To investigate the diagnostic value of fetal cardiac ultrasound view visualization in the first trimester for congenital heart disease（CHD）.Methods:A retrospective analysis was performed on 13 323 singleton fetuses who underwent first-trimester（11-13 +6 weeks）ultrasound screening at the Ultrasound Medicine Center，the Affiliated Suzhou Hospital of Nanjing Medical University from January 2018 to June 2024. Cardiac views including the four-chamber view（4CV），left ventricular outflow tract view（LVOT），and Results:The study group showed significantly higher rates of "poorly visualized" 4CV，LVOT，and 3VT than the control group（2.70% vs. 0.14%， P=0.005；36.49% vs. 4.76%， P<0.001；36.49% vs.2.46%， P<0.001）. The efficacies of combination 1（any view abnormal）and combination 2（any view "poorly visualized" or "abnormal"）were comparable，with AUCs of 0.86 and 0.85（ P=0.424）. The AUCs of combination 3（3VT "poorly visualized" or any view "abnormal"）and combination 4（4CV "poorly visualized" or any view "abnormal"）were 0.88 and 0.86（ P=0.424），all significantly higher than combination 5（LVOT "poorly visualized" or any view "abnormal"，AUC=0.84，all P<0.05）. Conclusions:"Poorly visualized" cardiac views in the first trimester demonstrate good diagnostic efficacy for CHD，particularly when 3VT or 4CV are affected，warranting heightened clinical vigilance for fetal cardiac anomalies.

Objective To investigate the mechanism of action of Guizhi Fuling pill in treating chro-nic prostatitis(CP)using network pharmacology and molecular docking techniques.Methods Compo-nents of Guizhi Fuling pill were collected from the Traditional Chinese Medicines Systems Pharmacolo-gy Platform(TCMSP),and target information was obtained from the SwissTarget database.Targets for chronic prostatitis were screened from the GeneCards,OMIM,CTD,and DisGeNET disease data-bases.A protein-protein interaction(PPI)network was established and analyzed.Gene ontology(GO)functional annotation and Kyoto Encyclopedia of Genes and Genomes(KEGG)pathway en-richment analysis were performed using the DAVID database.The Cytoscape software was employed to construct an association network linking the components of Guizhi Fuling Pill,their targets,and the targets of chronic prostatitis.Molecular docking was conducted using AutoDock Vina software to verify the binding stability between the components of Guizhi Fuling pill and their targets.Results After screening and deduplication in the TCMSP database,76 components of Guizhi Fuling Pill were iden-tified,and 655 component targets were retrieved from the SwissTarget database.There were 190 intersecting targets between GuizhiFuling Pill and chronic prostatitis.GO analysis indicated that Guizhi Fuling Pill may treat chronic prostatitis by participating in processes such asapoptosis,ATP binding,and signal transduction.KEGG analysis suggested that Guizhi Fuling Pill can regulate pathways such as phosphatidylinositol 3-kinase(PI3K)/protein kinase B(AKT)and mitogen-acti-vated protein kinase(MAPK)to intervene in chronic prostatitis.Molecular docking data demonstra-ted that the components of Guizhi Fuling pill exhibited stable conformations with their targets.Con-clusion The components of Guizhi Fuling Pill can stably bind to their targets and exert therapeutic effects on chronic prostatitis through multiple targets and pathways.

Objective:To explore the impact of the two-way referral model on compliance and prognosis in patients with heart failure.Methods:This bidirectional cohort study enrolled chronic heart failure (CHF) patients treated at Qilu Hospital of Shandong University or designated primary hospitals between March 2018 and March 2022. Patients were categorized into two groups based on referral status: two-way referral group (participating in the referral model with≥1 follow-up visit at primary hospitals) and the core hospital group (receiving treatment and follow-up exclusively at Qilu Hospital). Baseline clinical characteristics were collected and compared between groups. Patients underwent followed-up, with primary endpoints including follow-up rate, drug (β-blockers, angiotension converting enzyme inhibitor (ACEI)/angiotensin Ⅱ receptor blockers (ARB)/angiotensin receptor-neprilysin inhibitor (ARNI), sodium-glucose cotransporter 2 inhibitors and mineralocorticoid receptor antagonists) utilization rate and target dose achievement rate. Secondary endpoints encompassed changes from baseline in left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDd), and N-terminal pro-brain natriuretic peptide (NT-proBNP), plus cardiovascular mortality and heart failure rehospitalization. Generalized linear mixed models analyzed longitudinal trends in LVEF, LVEDd, and NT-proBNP levels. Kaplan-Meier curves and Cox regression evaluated LVEF recovery rates, supplemented by subgroup analyses. Multivariate logistic regression was used to identify factors influencing target dose achievement rate for β-blockers and ACEI/ARB/ARNI therapies in CHF patients.Results:A total of 357 patients were enrolled, aged 53 (41, 63) years, including 256 males (71.7%). 157 patients were in the two-way referral group and 200 patients in the core hospital-treated group. Compared with the core hospital-treated group, the two-way referral group had lower baseline LVEF (28 (22, 34)% vs. 31 (23, 36)%, P=0.021) and systolic blood pressure (116 (104, 125) mmHg vs. 121 (109, 134) mmHg (1 mmHg=0.133 kPa), P=0.010). The 12-month follow-up rate of the two-way referral group was higher than the core hospital-treated group (73.8% vs. 56.0%, P=0.004). No significant between-group differences were observed in drug utilization rate of β-blockers, ACEI/ARB/ARNI, or sodium-glucose cotransporter 2 inhibitors during follow-up (all P>0.05), while mineralocorticoid receptor antagonists use showed a declining trend in both groups. Although the core hospital-treated group had higher target dose achievement rates for β-blockers (65.4% vs. 49.3%, P=0.042) and ACEI/ARB/ARNI (79.8% vs. 65.8%, P=0.046) than the two-way referral group, multivariate logistic regression indicated that the two-way referral model was not a negative predictor for these outcomes (all P>0.05). Both groups showed improved NT-proBNP, LVEDd, and LVEF from baseline (all P<0.001) with no significant difference in trends between groups (all P>0.05). There was no significant difference in the composite incidence (7.6% vs. 6.5%, P=0.674) and cumulative incidence (log-rank P=0.684) of cardiovascular death and heart failure rehospitalization at 12 months between two groups. Conclusion:The two-way referral model demonstrates advantages in improving medication adherence, drug utilization rates, and targetdoseachievement rates among CHF patients. This model not only promotes cardiac functional recovery but also reduces risks of cardiovascular mortality and heart failure rehospitalization, achieving comparable therapeutic and management outcomes to those observed in core hospital-treated patients.

Objective:To investigate the value of the five-sectional screening method of the central nervous system（CNS）in early detection of fetal CNS abnormalities during the first trimester.Methods:The data of pregnant women who underwent nuchal translucency（NT）screening at the Affiliated Suzhou Hospital of Nanjing Medical University from September 2018 to September 2023 were retrospectively analyzed. And a five-sectional screening method of CNS was performed in all fetuses at the meantime. The five-sectional screening protocol in the first trimester consists of the mid-sagittal plane of the fetal head，trans-ventricular plane，trans-thalamus plane，axial plane of the fetal head at the posterior fossa level，and the sagittal plane of the fetal spine. All fetuses underwent ultrasound screening during the second trimester and the third trimester sequentially after NT screening. All the ultrasound findings were tracked，and all fetuses were followed up until delivery or after induction. Fetuses with CNS abnormalities found or suspected in the first trimester were reviewed by at least one senior physician，and follow-up examinations were routinely performed after 2 weeks to further confirm the diagnosis or find other abnormalities that may be present.Results:A total of 13 679 fetuses were screened，included 11 415 singleton pregnancies and 1 132 twin pregnancies. Among them，there were 289 cases of missed follow-up and unexplained fetal death，included 263 singleton pregnancies and 13 twin pregnancies. A total of 13 390 fetuses were finally included，among which，35 cases developed CNS abnormalities with 34 cases detected by prenatal ultrasound and 1 case of closed spina bifida missed in prenatal diagnosis，and the detection rate of CNS malformation by prenatal ultrasound was 97.14%（34/35）. Of the 35 fetuses with CNS abnormalities，24 were detected by the CNS five-sectional screening method in the first trimester，with a sensitivity of 68.57%，a specificity of 100%，a positive predictive value of 100%，and a negative predictive value of 99.92%. Among them，there were 2 cases of anencephaly，3 cases of exencephaly and 6 cases of encephalocele were all detected in the first trimester. In addition，6 cases of holoprosencephaly，3 cases of severe ventriculomegaly，2 cases of open spina bifida，and 2 cases of Dandy-Walker malformation were detected in the first trimester. In this study，1 case of agenesis of corpus callosum（ACC），1 case of arachnoid cyst，1 case of lissencephaly，1 case of schizencephaly，and 1 case of mega cisterna magna were not detected in early pregnancy.Conclusions:The fetal five-sectional screening method of CNS in the first trimester has high specificity，positive predictive value and negative predictive value for the detection of fetal CNS abnormalities，but the sensitivity is moderate. The five-sectional screening method for CNS in early pregnancy may be an effective method for early detection of fetal CNS abnormalities.

Objective:To investigate the diagnostic value of fetal cardiac ultrasound view visualization in the first trimester for congenital heart disease（CHD）.Methods:A retrospective analysis was performed on 13 323 singleton fetuses who underwent first-trimester（11-13 +6 weeks）ultrasound screening at the Ultrasound Medicine Center，the Affiliated Suzhou Hospital of Nanjing Medical University from January 2018 to June 2024. Cardiac views including the four-chamber view（4CV），left ventricular outflow tract view（LVOT），and Results:The study group showed significantly higher rates of "poorly visualized" 4CV，LVOT，and 3VT than the control group（2.70% vs. 0.14%， P=0.005；36.49% vs. 4.76%， P<0.001；36.49% vs.2.46%， P<0.001）. The efficacies of combination 1（any view abnormal）and combination 2（any view "poorly visualized" or "abnormal"）were comparable，with AUCs of 0.86 and 0.85（ P=0.424）. The AUCs of combination 3（3VT "poorly visualized" or any view "abnormal"）and combination 4（4CV "poorly visualized" or any view "abnormal"）were 0.88 and 0.86（ P=0.424），all significantly higher than combination 5（LVOT "poorly visualized" or any view "abnormal"，AUC=0.84，all P<0.05）. Conclusions:"Poorly visualized" cardiac views in the first trimester demonstrate good diagnostic efficacy for CHD，particularly when 3VT or 4CV are affected，warranting heightened clinical vigilance for fetal cardiac anomalies.