1.Reporting Status of Clinical Practice Guideline Protocols: A Systematic Analysis
Huayu ZHANG ; Xufei LUO ; Hui LIU ; Qi ZHOU ; Yishan QIN ; Ye WANG ; Yuanyuan YAO ; Haodong LI ; Xiaohui WANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2026;17(1):255-262
To systematically analyzed the reporting status of core elements in publicly available clinical practice guideline(hereafter referred to as "guideline") protocols published domestically and internationally over the past decade, identified existing problems, and provided evidence to inform the standardized writing and publication of future guideline protocols. A systematic search was conducted in Chinese and English databases for clinical practice guideline protocols published during the past ten years. The basic characteristics and reporting of core elements—including registration information, conflict of interest management, evidence grading, development process and timeline planning, as well as dissemination and implementation—were extracted and analyzed. Chi-square tests were performed to explore associations between protocol characteristics and the reporting of core elements. A total of 94 guideline protocols were included, of which 67 were in Chinese(71.28%) and 27 were in English(28.72%). Overall, 82.98% of the guideline protocols were registered, 92.55% reported management of conflicts of interest, 97.87% reported evidence searching, 88.30% reported evidence grading, and 89.36% described dissemination and implementation strategies. However, only 55.32% reported the guideline development process, and merely 23.40% reported timeline planning. Further analysis indicated that the reporting of registration, evidence searching, development process, and timeline planning was associated with year of publication. Differences were observed between domestic and international guidelines in reporting registration, conflict of interest management, development process, time planning, and dissemination and implementation. Guidelines intended for development exhibited higher reporting rates for registration, development process, and dissemination and implementation compared to those planned for updating or adaptation. Although current guideline protocols demonstrate relatively adequate reporting of methodological elements, deficiencies remain in development process and timeline planning. Future efforts should focus on promoting the publication and standardized reporting of guideline protocols, enhancing the international recognition of registration platforms, and strengthening the development process and timeline planning to advance the scientific rigor and transparency of guideline development.
2.Characteristics of executive function impairment and related factors in patients with chronic insomnia disorder: A study based on polysomnography and neuropsychological tests
Journal of Apoplexy and Nervous Diseases 2026;43(4):303-308
Objective To investigate the characteristics of executive function impairment in patients with chronic insomnia disorder and its correlation with Objective sleep structure parameters. Methods A total of 92 patients who met the DSM-5 diagnostic criteria for chronic insomnia disorder were enrolled as chronic insomnia disorder group, and 45 healthy controls were enrolled as healthy control group. All subjects underwent assessments for anxiety and depression, overnight polysomnography, and executive function, and the two groups were compared in terms of sleep parameters (including sleep latency, sleep efficiency, total sleep time, sleep stages, and the proportion of each stage) and executive function (Stroop Color-Word Test, digit span test, and trail making test), as well as the correlation between these parameters. Results Compared with the healthy control group, the chronic insomnia disorder group had significant increases in Stroop Card C completion time, Stroop interference effect, trail making test-B completion time, and trail making test B-A time difference and significant reductions in the score of digit span backward task and the total score of digit span test (P<0.05). The correlation analysis showed that total sleep time, sleep efficiency, NREM stage 3 duration, and the proportion of NREM stage 3 were negatively correlated with Stroop Card C completion time, Stroop interference effect, trail making test-B completion time, and trail making test B-A time difference and were positively correlated with the score of digit span backward task and the total score of digit span test (P<0.05). Conversely, NREM stage 1 duration and the proportion of NREM stage 1 were positively correlated with Stroop Card C completion time, Stroop interference effect, trail making test-B completion time, and trail making test B-A time difference and were negatively correlated with the score of digit span backward task (P<0.05). Conclusion Patients with chronic insomnia disorder exhibit executive function impairment in multiple dimensions including inhibitory control, working memory, and cognitive flexibility, which are associated with the reductions in sleep efficiency and deep sleep.
3.Development and application of core competence assessment index system among drug clinical trial quality control personnel
Yu CHEN ; Qingqing JIANG ; Guo YE ; Weiran MAO ; Yuanyuan YIN ; Mengjuan ZHANG ; Pu SUN ; Xia CHEN
China Pharmacy 2025;36(24):3023-3028
OBJECTIVE To establish a core competency evaluation system for drug clinical trial quality management personnel in China and validate its application. METHODS Based on the scope of work, responsibilities, and role positioning of quality management personnel in drug clinical trials, a preliminary draft of the core competency evaluation system was constructed through literature analysis and expert consultation. The draft was refined through a Delphi method involving 17 experts who provided feedback and revisions, ultimately forming a complete evaluation system. The developed system was applied to conduct electronic surveys from March to May 2024 among 110 quality management personnel from 38 drug clinical trial institutions, comparing their scores on indicator importance and self-assessed capabilities. RESULTS The response rate of both rounds of questionnaire survey was 100%, with Kendall’s W coefficients of 0.256 and 0.277 (P<0.001 for both), and an expert authority coefficient of 0.946. The finalized evaluation system for core competencies of clinical trial quality management personnel comprised 9 primary indicators, covering individual professional competence, communication skills, implementation condition verification, informed consent process review, clinical trial execution monitoring, adverse event disposal, reporting and documentation, trial record examination, trial report auditing, and inspection of other tasks, and 107 secondary indicators. Empirical research revealed significant discrepancies between importance scores and self-assessed competency scores across 70 indicators among 110 respondents (P<0.05). Indicators with relatively notable gaps between importance scores and self-assessed competency scores included in-depth understanding of Good Clinical Practice (GCP) requirements (0.34-point gap), familiarity with national and institutional clinical trial inspection priorities (0.24-point gap),etc. CONCLUSIONS The indicator system constructed in this study has good scientificity and reliability. Clinical trial quality management personnel demonstrate deficiencies in multiple critical competencies, highlighting the urgent need for targeted training programs to enhance their overall professional capabilities.
4.Dihydromyricetin mitigates abdominal aortic aneurysm via transcriptional and post-transcriptional regulation of heme oxygenase-1 in vascular smooth muscle cells.
Weile YE ; Pinglian YANG ; Mei JIN ; Jiami ZOU ; Zhihua ZHENG ; Yuanyuan LI ; Dongmei ZHANG ; Wencai YE ; Zunnan HUANG ; Jiaojiao WANG ; Zhiping LIU
Acta Pharmaceutica Sinica B 2025;15(3):1514-1534
Abdominal aortic aneurysm (AAA) is a deadly condition of the aorta, carrying a significant risk of death upon rupture. Currently, there is a dearth of efficacious pharmaceutical interventions to impede the advancement of AAA and avert it from rupturing. Here, we investigated dihydromyricetin (DHM), one of the predominant bioactive flavonoids in Ampelopsis grossedentata (A. grossedentata), as a potential agent for inhibiting AAA. DHM effectively blocked the formation of AAA in angiotensin II-infused apolipoprotein E-deficient (ApoE-/-) mice. A combination of network pharmacology and whole transcriptome sequencing analysis revealed that DHM's anti-AAA action is linked to heme oxygenase (HO)-1 (Hmox-1 for the rodent gene) and hypoxia-inducible factor (HIF)-1α in vascular smooth muscle cells (VSMCs). Remarkably, DHM caused a robust rise (∼10-fold) of HO-1 protein expression in VSMCs, thereby suppressing VSMC inflammation and oxidative stress and preserving the VSMC contractile phenotype. Intriguingly, the therapeutic effect of DHM on AAA was largely abrogated by VSMC-specific Hmox1 knockdown in mice. Mechanistically, on one hand, DHM increased the transcription of Hmox-1 by triggering the nuclear translocation and activation of HIF-1α, but not nuclear factor erythroid 2-related factor 2 (NRF2). On the other hand, molecular docking, combined with cellular thermal shift assay (CETSA), isothermal titration calorimetry (ITC), drug affinity responsive target stability (DARTS), co-immunoprecipitation (Co-IP), and site mutant experiments revealed that DHM bonded to HO-1 at Lys243 and prevented its degradation, thereby resulting in considerable HO-1 buildup. In summary, our findings suggest that naturally derived DHM has the capacity to markedly enhance HO-1 expression in VSMCs, which may hold promise as a therapeutic strategy for AAA.
5.Life's Essential 8 scores, socioeconomic deprivation, genetic susceptibility, and new-onset chronic kidney diseases.
Panpan HE ; Huan LI ; Mengyi LIU ; Ziliang YE ; Chun ZHOU ; Yanjun ZHANG ; Sisi YANG ; Yuanyuan ZHANG ; Xianhui QIN
Chinese Medical Journal 2025;138(15):1835-1842
BACKGROUND:
The American Heart Association recently released a new cardiovascular health (CVH) metric, Life's Essential 8 (LE8), for health promotion. However, the association between LE8 scores and the risk of chronic kidney disease (CKD) remains uncertain. We aimed to explore the association of LE8 scores with new-onset CKD and examine whether socioeconomic deprivation and genetic risk modify this association.
METHODS:
A total of 286,908 participants from UK Biobank and without prior CKD were included between 2006 and 2010. CVH was categorized using LE8 scores: low (LE8 scores <50), moderate (LE8 scores ≥50 but <80), and high (LE8 scores ≥80). The study outcome was new-onset CKD, ascertained by data linkage with primary care, hospital inpatient, and death data. Cox proportional hazard regression models were used to investigate the association between CVH categories and new-onset CKD.
RESULTS:
During a median follow-up of 12.5 years, 8857 (3.1%) participants developed new-onset CKD. Compared to the low CVH group, the moderate (adjusted hazards ratio [HR], 0.50; 95% confidence interval [CI]: 0.47-0.53) and high CVH (adjusted HR, 0.31; 95% CI: 0.27-0.34) groups had a significantly lower risk of developing new-onset CKD. The population-attributable risk associated with high vs. intermediate or low CVH scores was 40.3%. Participants who were least deprived ( vs. most deprived; adjusted HR, 0.75; 95% CI: 0.71-0.79) and with low genetic risk of CKD ( vs. high genetic risk; adjusted HR, 0.89; 95% CI: 0.85-0.94) had a significantly lower risk of developing new-onset CKD. However, socioeconomic deprivation and genetic risks of CKD did not significantly modify the relationship between LE8 scores and new-onset CKD (both P -interaction >0.05).
CONCLUSION
Achieving a higher LE8 score was associated with a lower risk of developing new-onset CKD, regardless of socioeconomic deprivation and genetic risks of CKD.
Humans
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Renal Insufficiency, Chronic/epidemiology*
;
Male
;
Female
;
Middle Aged
;
Genetic Predisposition to Disease/genetics*
;
Aged
;
Risk Factors
;
Adult
;
Proportional Hazards Models
;
Socioeconomic Factors
6.Clinical Study on Chaiqin Xiaoyong Decoction (柴芩消痈饮) Combined with Jinhuang Ointment (金黄膏) for the Nodular Stage of Acne Mastitis of Liver Meridian Heat Accumulation Type:A Randomized,Double-Blind,Placebo-Controlled Trial
Tian MENG ; Feifei MA ; Yuanyuan KANG ; Mengfei SHEN ; Shengfang HU ; Meina YE ; Yiqin CHENG ; Hongfeng CHEN
Journal of Traditional Chinese Medicine 2025;66(9):920-926
ObjectiveTo evaluate the clinical efficacy and safety of the traditional Chinese medicine (TCM) compound Chaiqin Xiaoyong Decoction (柴芩消痈饮, CXD) combined with Jinhuang Ointment (金黄膏, JO) in treating the nodular stage of acne mastitis of liver meridian heat accumulation type. MethodsA randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 108 patients with liver meridian heat accumulation type acne mastitis in the nodular stage were randomly assigned to a treatment group and a control group, with 54 patients in each group. Both groups received topical application of JO once daily at a thickness of 3~5 mm for 8 hours, along with standard nursing care. On this basis, the treatment group received oral CXD granules, while the control group received placebo granules, administered twice daily, 3 sachets per dose, for 14 consecutive days. Clinical efficacy, TCM symptom scores, nodule size, visual analogue scale (VAS) pain scores, white blood cell (WBC) count, C-reactive protein (CRP) level, and systemic immune-inflammation index (SII) were compared. At the end of treatment, efficacy and safety indicators were evaluated. A 6-month follow-up was conducted to compare the proportion of patients undergoing surgical treatment. ResultsThe total clinical efficacy rate in the treatment group was 90.38% (47/52), significantly higher than 32.00% (16/50) in the control group (P<0.01). The treatment group also showed significantly lower TCM symptom scores, VAS scores, nodule size, WBC count, CRP level, and SII (P<0.05 or P<0.01). During follow-up, the surgical intervention rate in the treatment group was 5.77% (3/52), lower than 14.00% (7/50) in the control group, with a statistically significant difference (P<0.01). No significant abnormalities were observed in safety indicators before and after treatment in either group. ConclusionCXD effectively reduces nodule size and alleviates symptoms such as redness and pain in patients with acne mastitis of liver meridian heat accumulation type, improves TCM symptom scores, enhances overall clinical efficacy, and demonstrates good safety.
7.Neural interaction mechanisms between psychological and physical pain in non-suicidal self-injury and advances in clinical practice
Hong MA ; Xiangju DU ; Danni CHI ; Yubo WANG ; Xuejie YE ; Yuanyuan ZHANG
Chinese Journal of Psychiatry 2025;58(8):646-651
The interplay between psychological pain and physical pain is one of the key issues in the research of non-suicidal self-injury (NSSI). Psychological pain, driven by negative self-perception and difficulties in emotional regulation, activates specific brain regions, such as the anterior cingulate gyrus and insula, areas that overlap with neural networks involved in physical pain. Physical pain can, in turn, activate distinct neural pathways that temporarily alleviate psychological pain. However, repeated self-injury may lead to increased pain tolerance over time, contributing to a vicious cycle. This paper reviews the potential neural network connections and interactions between psychological and physical pain in the context of NSSI behavior. It also summarizes current clinical interventions and their effectiveness in treating NSSI, aiming to offer new insights for future research and clinical practice in preventing and treating NSSI.
8.Prognostic value of circulating plasma cell in newly diagnosed multiple myeloma treated with bortezomib, lenalidomide, and dexamethasone
Ruoru LIU ; Ye YAO ; Yuanyuan JIN ; Lu LIU ; Qinglin SHI ; Xuxing SHEN ; Lijuan CHEN
Chinese Journal of Hematology 2025;46(9):833-838
Objective:To investigate the prognostic value of circulating plasma cell (CPC) in patients with newly diagnosed multiple myeloma (NDMM) undergoing induction therapy with bortezomib, lenalidomide, and dexamethasone (VRD) regimen.Methods:This study retrospectively analyzed clinical data of 152 patients with NDMM treated with the VRD regimen as induction therapy in the Hematology Department of Jiangsu Provincial People’s Hospital from January 2019 to March 2024. The clinical characteristics, efficacy, and prognosis of patients with high and low CPC proportions are compared. The prognosis of patients in the CPC-positive group, CPC-negative conversion group, and CPC-negative group was analyzed.Results:This study included 152 patients with NDMM, comprising 76 males and 76 females, with a median age at onset of 62 (40–77) years. Compared with the group with CPC proportion of <0.105%, patients with CPC proportion of ≥0.105% demonstrated a higher proportion of International Staging System (ISS) stage Ⅲ ( P<0.001), Revised ISS stage Ⅲ ( P=0.023), HGB≤100 g/L ( P=0.015), β 2-microglobulin ≥3.5 g/L ( P<0.001), shorter median progression-free survival (PFS) period (24 months vs 52 months, P<0.001), and shorter median overall survival (OS) period (52 months vs not achieved, P=0.005). Patients in the CPC-negative group demonstrated a longer median PFS period (not reached vs 41 months vs 19 months, P<0.001) and median OS period (not reached vs not reached vs 26 months, P<0.001) compared with patients in the CPC-negative conversion group and CPC-positive group. Multivariate analysis revealed CPC proportion of ≥0.105% ( HR=3.79, 95% CI: 1.95–7.38, P<0.001), positive CPC after induction therapy ( HR=3.54, 95% CI: 1.41–8.87, P=0.007), and cytogenetic high risk ( HR=3.69, 95% CI: 1.85–7.37, P<0.001) as independent risk factors affecting the PFS of patients. Meanwhile, CPC of ≥0.105% ( HR=3.50, 95% CI: 1.29–9.48, P=0.014) and positive CPC after induction therapy ( HR=4.12, 95% CI: 1.13–15.03, P=0.032) are independent risk factors affecting the OS of patients. Conclusion:Patients with NDMM demonstrating high CPC expression have a worse prognosis, with CPC level as an independent prognostic factor.
9.Epidemiological analysis of the adhesion glycoprotein gene characteristics of human respiratory syncytial virus in Xi'an from 2023 to 2024
Peng ZHANG ; Yangni DENG ; Shuling LI ; Yuewen HAN ; Yujie YANG ; Jianing WEI ; Ye ZHANG ; Yuanyuan DUAN ; Rui WU ; Hailong CHEN
Chinese Journal of Microbiology and Immunology 2025;45(10):809-816
Objective:To analyze the prevalence of human respiratory syncytial virus(RSV)and the evolutionary characteristics of the adhesion glycoprotein(G)gene in Xi'an from 2023 to 2024.Methods:Respiratory specimens were collected from patients with acute respiratory infections in Xi'an between October 2023 to October 2024. RSV nucleic acid screening was performed using real-time fluorescence quantitative PCR;full-length G gene sequencing was conducted on nucleic acid-positive specimens. Genotyping characterization of the obtained sequences was performed using Nextclade v3.10.0 software.Results:A total of 2 548 respiratory tract infection samples were collected,with 104 cases(4.08%,104/2 548)testing positive for RSV. The highest RSV positivity rate was observed in children aged ≤1 year(12.24%,18/147),and significant difference in positivity rates were found among age groups(χ 2=37.868, P<0.001). Since October 2023,RSV has seen an epidemic peak during January to February 2024,and gradually declined thereafter,with no positive cases from May to September 2024. Among the 43 RSV-positive samples,12 strains were identified as subtype A(all genotype A.D.3),and 31 strains were subtype B(14 genotype B.D.4.1.1 and 17 genotype B.D.E.1). Conclusion:From October 2023 to October 2024,RSV had an epidemic peak in January and February in Xi'an,with subtype B being the predominant circulating type.
10.Diagnostic yield and safety of pancreatic cystic lesions: A comparison between EUS-FNA and EUS-FNB.
Xiaoyu YU ; Mingmei YE ; Yawen NI ; Qianqi LIU ; Pan GONG ; Yuanyuan HUANG ; Xiaoyan WANG ; Li TIAN
Journal of Central South University(Medical Sciences) 2025;50(2):227-236
OBJECTIVES:
In recent years, the incidence and detection rate of pancreatic cystic lesions (PCLs) have increased significantly. Endoscopic ultrasound (EUS) plays an indispensable role in the diagnosis and differential diagnosis of PCLs. However, evidence comparing the diagnostic performance of EUS-guided fine-needle aspiration (EUS-FNA) and fine-needle biopsy (FNB) remains limited. This study aims to compare the diagnostic yield, adequacy of tissue acquisition, and safety between EUS-FNA and EUS-FNB in evaluating PCLs to inform clinical practice.
METHODS:
A retrospective review was conducted on patients with PCLs who underwent either EUS-FNA or EUS-FNB between January 2014 and August 2021. The diagnostic yield, tissue acquisition adequacy, and incidence of adverse events were compared between the 2 groups.
RESULTS:
A total of 90 patients with PCLs were included (52 in the FNA group and 38 in the FNB group). The diagnostic yield was similar between the FNA and FNB groups (94.2% vs 94.7%, P>0.05). The adequacy of tissue acquisition was 71.2% in the FNA group and 81.6% in the FNB group (P>0.05). No statistically significant difference was observed in the incidence of adverse events between the 2 groups (P>0.05).
CONCLUSIONS
Both EUS-FNA and EUS-FNB demonstrate equally high diagnostic yields and tissue adequacy in PCLs, with excellent safety profiles. Both methods are safe and effective diagnostic tools for evaluating PCLs.
Humans
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Endoscopic Ultrasound-Guided Fine Needle Aspiration/adverse effects*
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Retrospective Studies
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Female
;
Male
;
Pancreatic Cyst/diagnostic imaging*
;
Middle Aged
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Biopsy, Fine-Needle/adverse effects*
;
Aged
;
Pancreatic Neoplasms/diagnosis*
;
Adult
;
Endosonography/methods*
;
Pancreas/pathology*
;
Diagnosis, Differential

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