1.Proctor's Reporting Guideline for Implementation Strategies: Interpretation, Application, and Challenges
Jiangyun CHEN ; Jinghan LIU ; Youping ZHUANG ; Xueying CHEN ; Siyuan LIU ; Xiaoshan CHEN ; Yeqing ZHAN ; Dongmei ZHONG ; Huadan HUANG ; Dong XU
Medical Journal of Peking Union Medical College Hospital 2026;17(1):263-273
The Proctor's reporting guideline for implementation strategies represents a landmark framework in the field of implementation science, aiming to address the issue of inconsistent reporting in implementation research by standardizing the naming, definition, and operationalization of implementation strategies, thereby enhancing the credibility and utility of research findings. This paper provides an in-depth interpretation of the core connotations of this reporting guideline and illustrates its application in developing interview outlines and specifying implementation strategies, using a brief smoking cessation intervention project as a case study. Through this reporting guideline, abstract recommendations for implementation are systematically transformed into clear, multidimensional operational guides, significantly improving the transparency of strategy connotations and the replicability of actual execution. Meanwhile, the case study highlights the flexibility of the guideline, which allows researchers to adapt the content and format of strategies based on local resources and cultural contexts, thus enhancing practical adaptability while maintaining scientific rigor. However, the application of Proctor's reporting guideline still faces challenges, primarily manifested in the potential confusion surrounding the constructs of temporality and dose in practice, as well as the challenges that the inherent flexibility of the guideline may pose to the assessment of fidelity and effectiveness. Despite these limitations, the reporting guideline remains a vital tool for implementation research; future efforts should focus on optimizing its application—through refining operational guidelines, standardizing flexible adaptations, and involving stakeholders—to better guide implementation studies and continuously promote high-quality development in the field.
2.Systematic review and Metaanalysis of the association between heavy metal exposure and obesity in children and adolescents
WU Meng, LUO Lü ; er, WANG Jinghan, LIU Qin
Chinese Journal of School Health 2025;46(7):926-931
Objective:
To systematically evaluate the relationship of exposure to five heavy metals, namely lead, arsenic, cadmium, mercury and aluminum with obesity in children and adolescents, so as to provide a scientific basis for subsequent research in the area.
Methods:
Four Chinese databasesc (CBM, VIP, CNKI and Wanfang) and four foreign databases (OVID, PubMed, Web of Science and EBSCO), were searched to collect relevant studies, and the search period was from the establishment of the database to May 5, 2024. After 2 investigators independently screened the literature, extracted the data and evaluated the risk of bias of the included studies, the results were analyzed quantitatively and summarized qualitatively.
Results:
A total of 5 cohort studies on lead exposure and 17 cross sectional studies involving exposure to lead ( n =13), cadmium ( n =8), mercury ( n =8), arsenic ( n =4), and aluminum ( n =1) were included. Meta analysis of the 2 cohort studies showed that lead exposure was not associated with the risk of overweight and obesity in children ( RR=0.76, 95%CI=0.50-1.16, P >0.05). The cross sectional study Meta-analysis results showed that lead exposure was negatively associated with the risk of childhood overweight ( OR=0.70, 95%CI =0.59-0.84, 2 studies) and obesity ( OR=0.71, 95%CI =0.58-0.87, 3 studies); cadmium exposure was negatively associated with the risk of childhood overweight ( OR=0.83, 95%CI =0.73-0.95, 2 studies) and obesity risk( OR=0.70, 95%CI =0.63-0.78, 3 studies); mercury exposure increased the risk of overweight/obesity ( OR=1.42, 95%CI =1.14-1.76, 2 studies) and abdominal obesity ( OR= 1.99, 95%CI =1.45-2.73, 2 studies) in children; the group with the highest concentration of arsenic in urine had a lower risk of developing obesity compared to the group with the lowest concentration ( OR=0.39, 95%CI =0.23-0.65, 1 study), and the group with the highest concentration of aluminum in urine had a lower risk of obesity compared with the group with the lowest concentration ( OR=0.52, 95%CI =0.31-0.86, 1 study)(all P <0.05).
Conclusion
Heavy metal exposure may be a risk factor for overweight and obesity in children and adolescents, but the conclusions are inconsistent and need to be validated in further high quality prospective cohort studies.
3.Clinical efficacy of donafenib combined with PD-1 inhibitor and vascular intervention therapy in the treatment of unresectable hepatocellular carcinoma
Lan SU ; Jinghan ZHU ; Mingming LIU ; Yarong YANG ; Yu ZHANG ; Zutao CHEN
China Pharmacy 2025;36(21):2692-2698
OBJECTIVE To observe the clinical efficacy of donafenib combined with programmed death-1 (PD-1) inhibitors and vascular intervention therapy in the treatment of unresectable hepatocellular carcinoma (HCC). METHODS This retrospective study included 165 patients with unresectable HCC who were treated at the Fourth and First Affiliated Hospitals of Soochow University between June 2022 and March 2023. Among them, 89 patients received PD-1 inhibitors (tislelizumab or sintilimab, similarly hereinafter) plus vascular intervention (control group) and 76 patients received donafenib in combination with PD-1 inhibitors and vascular intervention (observation group). Short-term efficacy (3 months after treatment), long-term efficacy (2 years after treatment), the levels of liver function indexes [serum alanine amino-transferase (ALT), aspartate transferase (AST), and total bilirubin (TBil)] and tumor biomarkers [alpha fetoprotein (AFP), carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), and des-gamma-carboxy prothrombin (DCP)] before treatment and after 3 months of treatment, as well as the occurrence of adverse drug reaction (ADR) during treatment, were compared between the two groups. In addition, overall response rate (ORR) stratified by PD-1 inhibitor type was analyzed. RESULTS After treatment, the ORR was significantly higher in the observation group than in the control group (P<0.05); although the disease control rate was higher in the observation group compared to the control group, the difference was not statistically significant (P>0.05). The median overall survival of patients in the observation group was 16.9 months [95% confidence interval (CI): 14.2 to 19.1 months], which was significantly longer than that in the control group (12.4 months, 95%CI: 10.1 to 15.3 months) (P<0.05). Subgroup analysis result indicated that therapeutic advantage was consistent across both sintilimab and tislelizumab subgroups, with no significant heterogeneity (P>0.1, I 2<0.001%). Before treatment, there were no significant differences in liver function indexes or tumor marker levels between 2 groups (P>0.05). After treatment, both groups showed significant declines in these indicators compared with baseline (P<0.05), with greater reductions observed in the observation group (P<0.05). There were no statistically significant differences in overall incidence of ADR and grade ≥3 ADRs between the two groups (P>0.05). CONCLUSIONS For patients with unresectable HCC, the combination of donafenib, PD-1 inhibitors and vascular intervention therapy may achieve superior clinical outcomes without increasing the risk of treatment-related ADR.
4.Advances in the regulation of gut microbiota metabolites by traditional Chinese medicine in the treatment of diseases.
Deyi YANG ; Jinghan LIN ; Tao WANG ; Hongwei LIU
Chinese Journal of Biotechnology 2025;41(6):2236-2255
Traditional Chinese medicine (TCM) plays an important role in preventing and treating diseases and improving human health. However, the complex bioactive components and regulation of signaling pathway and network restrict the elucidation of the mechanisms of action of TCM. A human being is regarded as a super "symbiont" composed of body cells and commensal microorganisms. Gut microbiota is the core commensal microorganism system of a human body, being considered as "the second genome" and the new "organ". Alterations in gut microbiota reflect the state of body health and progression of diseases. Recent investigations have revealed that the TCM rich in polysaccharides and polyphenols can modulate gut microbiota metabolites to rehabilitate gut homeostasis, thus ameliorating diseases via regulating gut-liver axis or gut-brain axis. This review summarizes the causal relationship and mechanisms of action of TCM in the treatment of diseases from the perspective of gut microbiota metabolites. Our findings are expected to provide new insights into the mechanisms of TCM in preventing and treating diseases and guidance for TCM-based drug discovery in the future.
Humans
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Gastrointestinal Microbiome/physiology*
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Medicine, Chinese Traditional/methods*
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Drugs, Chinese Herbal/therapeutic use*
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Polyphenols/pharmacology*
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Polysaccharides/pharmacology*
5.Research advances in type 2 diabetes mellitus with obstructive sleep apnea
Jiaqi CHEN ; Jinghan XU ; Tianjiao LIU ; Li WANG ; Chunli PIAO
Journal of Chongqing Medical University 2025;50(10):1309-1316
With the increase in the obese population and the aging of the society,the incidence rates of type 2 diabetes mellitus(T2DM)and obstructive sleep apnea(OSA)continue to increase,and more than half of the patients with T2DM also suffer from OSA.T2DM patients with OSA have a higher risk of developing macrovascular and microvascular complications,which severely impairs their quality of life,and early identification of T2DM patients with OSA can improve their prognosis.This article summarizes the latest re-search advances in the pathogenesis,biomarkers,and treatment measures of T2DM with OSA,in order to provide insights for the screening,diagnosis,and treatment of T2DM with OSA.
6.Correlations of CALLY index in early pregnancy with the onset and severity of preeclampsia
Yanhua NIU ; Ximei WANG ; Yi LIU ; Yumeng WANG ; Jinghan ZHANG
Journal of Clinical Medicine in Practice 2025;29(4):97-102
Objective To investigate the correlations of CALLY index in early pregnancy with the onset and severity of preeclampsia.Methods A total of 987 pregnant women were prospectively en-rolled as study subjects,with 42 lost during follow-up,resulting in a final inclusion of 945 subjects.Based on the occurrence and severity of preeclampsia during follow-up,the pregnant women were di-vided into preeclampsia group(n=47),severe preeclampsia group(n=49),and normal group(n=849).General information and laboratory test results were collected from all pregnant women,and the CALLY index was calculated.The Pearson correlation analysis was used to explore the correlation be-tween CALLY index and severity of preeclampsia(mean arterial pressure);the receiver operating characteristic(ROC)curve was plotted to analyze the predictive efficacy of each indicator for pre-eclampsia;Cox regression analysis was used to explore the influencing factors for the onset of preeclamp-sia.Results The mean arterial pressure and 24-hour urine protein levels were higher in the severe pre-eclampsia group than those in the preeclampsia group and normal group,and higher in the preeclampsia group than those in the normal group(P<0.05).The CALLY index was lower in the severe preeclamp-sia group than in the preeclampsia group and normal group,and lower in the preeclampsia group than in the normal group(P<0.05).Pearson correlation analysis showed a negative correlation between CALLY index and mean arterial pressure(r=-0.571,P<0.001).The ROC curve showed that the area under the curve(AUC)of CALLY index for predicting preeclampsia was 0.941(95%CI,0.900 to 0.981).Multivariate Cox regression analysis showed that an increased CALLY index was an independent protective factor for the onset of preeclampsia(HR=0.185,95%CI,0.092 to 0.374,P<0.001).Conclusion The CALLY index is negatively correlated with the severity of preeclampsia and is an independent influencing factor for the onset of preeclampsia,which can be used as an auxiliary indicator to assess the onset and severity of preeclampsia in pregnant women.
7.Application the Huaxi intelligent Endoscopic Skill Training and Assessment System in minimally invasive surgery skills training: A cohort study
Jinghan WANG ; Yuchen HUANG ; Jian ZHOU ; Hu LIAO ; Lunxu LIU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(11):1540-1546
Objective To evaluate the application of the Huaxi Intelligent Endoscopic Skill Training and Assessment System in minimally invasive surgery (MIS) skills training and provide insights for optimizing MIS training models, we analyzed trainee performance during training and assessment. Methods A retrospective analysis was conducted on the use of this system across 28 medical institutions from January 2022 to January 2025. Results By January 2025, the standardized deployment of 139 simulation units had been completed. A total of 403 trainees from various surgical specialties, including thoracic surgery and general surgery, participated in five customized endoscopic skill training modules: endoscopic recognition, grasping training, positioning and placement, cutting training, and suturing training. Throughout the training period, a total of 78 participants took part in 27 formal assessments. Correlation analysis based on Spearman showed that pre-assessment training pass rates were significantly correlated with final assessment scores, indicating enhancing the quality of each training module and overall training efficacy is a key to improving the effectiveness of MIS training. Conclusion The Huaxi Intelligent Endoscopic Skill Training and Assessment System effectively supports MIS training and evaluation.
8.Comprehensive Clinical Evaluation of Nusinersen Based on Multi-criteria Decision Analysis Method
Jinghan QU ; Xin LIU ; Xin TIAN ; Pengjiao AN ; Tingting XU ; Bo ZHANG
Medical Journal of Peking Union Medical College Hospital 2024;15(5):1083-1090
To provide a theoretical basis for different drug decision-making scenarios by conducting a comprehensive clinical evaluation of nusinersen. Based on the method of multi-criteria decision analysis, a comprehensive clinical evaluation index system of nusinersen was established. This system, including core criterion model and contextualized criterion model, covered multiple evaluation dimensions such as safety, effectiveness, economy, and social attributes. The evidence of nusinersen in various criteria was summarized and integrated through systematic reviews. Then, different stakeholders were assigned weights and scores in various criteria of the core criterion model. Finally, a holistic value of nusinersen was estimatedthrough standardizing and combining the results in contextualized criterion model. The criteria, type of therapeutic benefit disease severity (0.08±0.02), unmet needs (0.08±0.01), quality of evidence (0.08±0.01), effectiveness (0.08±0.01) and safety (0.08±0.02) received the greatest weights after standardization. The higher mean scores for nusinersen versus placebo for the treatment of spinal muscular atrophy were disease severity (4.8±0.4), innovation of the drug (4.7±0.6), expert consensus or clinical practice guidelines (4.5±0.6), effectiveness (4.0±1.0) and quality of evidence (4.0±0.8).The holistic value of nusinersen was 0.41. The overall impact of the contextualized model on the evaluation of the drug was 0.26, indicating that it may overestimate the comprehensive value of nusinersen. The method of multi-criteria decision analysis proves the positive role that nusinersen plays in spinal muscular atrophy treatment.
9.Characteristics of Basal Sex Hormone Levels and Anti-müllerian Hormone Levels in 1221 Women of Different Ages:A Retrospective Study on the Law of Women Reproductive Aging in the "Seven-year Period" Theory
Wanshi LIANG ; Yiru LIAO ; Jinghan FU ; Luodan HU ; Hongyan YANG ; Jian LIU ; Fangping CHENG ; Guangning NIE
Journal of Traditional Chinese Medicine 2024;65(13):1369-1374
ObjectiveTo explore the law of women reproductive aging based on theory of "seven-year period" in traditional Chinese medicine(TCM) through analyzing the characteristics of basic sex hormone levels and anti-müllerian hormone levels in women of different ages. MethodsThe data of female who visited Guangdong Provincial Hospital of Traditional Chinese Medicine from January 2018 to December 2022 and accepted basic hormone and anti-müllerian hormone determination were collected retrospectively. According to the age of subjects, they were divided into the "1
10.Jiedu Tongluo Tiaogan Prescription Protects Pancreatic β Cell by Targeting NLRP3 Inflammasome via TGR5/cAMP Signaling Pathway
Qi ZHANG ; Yang XIAO ; Jinghan XU ; Tianjiao LIU ; Li WANG ; Chunli PIAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(11):95-103
ObjectiveTo investigate the intervention effect of Jiedu Tongluo Tiaogan prescription (JTTP) in protecting pancreatic β cells by targeting the bile acid Takeda G protein-coupled receptor 5 (TGR5)/cyclic adenosine monophosphate (cAMP) signaling pathway against NOD-like receptor protein 3 (NLRP3) inflammasome. MethodThirty-two male SPF-grade db/db mice were randomly divided into the model group, low-dose JTTP group (3.6 g·kg-1), high-dose JTTP group (7.2 g·kg-1), and metformin group (0.2 g·kg-1). Eight db/m mice were assigned to the blank control group. The mice were treated with drugs for 8 weeks, and fasting blood glucose (FBG) was measured every 2 weeks. Oral glucose tolerance tests (OGTT) were conducted after the last administration. Enzyme-linked immunosorbent assay (ELISA) was performed to detect fasting insulin (FINS), and the homeostasis model assessment of β-cell function (HOMA-β), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and IL-1β levels were calculated. Hematoxylin-eosin (HE) staining was used to observe pathological changes in mouse pancreatic tissue. Immunofluorescence was performed to detect insulin expression in mouse pancreatic tissue. Western blot and real-time quantitative polymerase chain reaction (Real-time PCR) were used to detect the expression of proteins and mRNAs of key targets in the TGR5/cAMP signaling pathway and NLRP3 inflammasome. ResultCompared with blank group, FBG, OGTT, FINS, IL-6, TNF-α and IL-1β in model group were significantly increased (P<0.01). Compared with model group, after 6 weeks of drug treatment, FBG level in JTTP group and metformin group decreased significantly (P<0.01). The results of OGTT experiment showed that compared with model group, the blood glucose levels of mice in each administration group were decreased at all time points (P<0.05, P<0.01), and the levels of FINS, TNF-α and IL-6 in JTTP dose groups and metformin group were significantly decreased. The level of IL-1β in JTTP high-dose group and metformin group was significantly decreased (P<0.01). Pancreatic pathology showed that the islets in the model group were irregular in shape, uneven in distribution, and showed signs of atrophy. The prognosis of JTTP was that the cell count increased and the boundary was clearer. Immunofluorescence results showed that the islet cells in the blank group were arranged in an orderly and full shape with appropriate insulin secretion, while the islet cells in model group were distorted in shape, atrophy in structure and less insulin secretion. The insulin content of mice in JTTP and metformin group was significantly increased. Compared with blank group, mRNA expressions of NLRP3, apoptosis-related spot-like protein (ASC) and Caspase-1 in pancreatic tissues of model group were significantly increased (P<0.01). Compared with model group, JTTP high-dose group and metformin group promoted the up-regulation of TGR5 and cAMP mRNA, and down-regulated the mRNA expressions of NLRP3, ASC and Caspase-1 (P<0.05, P<0.01). Compared with blank group, the expression of TGR5 protein in model group was significantly decreased (P<0.01). Compared with model group, TGR5 protein in JTTP high-dose group and metformin group was significantly increased (P<0.01).


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