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.Effect of Heat-sensitive Moxibustion on Quality of Life and Immune Function in Non-Small Cell Lung Cancer Patients with Qi Deficiency and Phlegm Stasis Syndrome Undergoing Chemotherapy:A Randomized Controlled Trial
Wenhao ZHAN ; Qian DING ; Zhiwei DONG ; Ting LI ; Shumei FU ; Ning TIAN
Journal of Traditional Chinese Medicine 2026;67(12):1289-1296
ObjectiveTo observe the effect of heat-sensitive moxibustion on quality of life and immune function in non-small cell lung cancer (NSCLC) patients undergoing chemotherapy. MethodsSeventy NSCLC patients with qi deficiency and phlegm stasis syndrome were randomly divided into an intervention group and a control group, with 35 cases in each group. The control group received chemotherapy combined with routine symptomatic treatment, while the intervention group additionally received heat-sensitive moxibustion since the first day of chemotherapy. Acupoints included Dazhui (GV14), bilateral Feishu (BL13), Zhongwan (CV12), Qihai (CV6), and Guanyuan (CV4). The site exhibiting the strongest heat-sensitization response was selected for moxibustion. Treatment was administered for 45 minutes per session, three times weekly for three consecutive weeks, totaling nine sessions. Before and after treatment, quality of life was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and traditional Chinese medicine (TCM) syndrome scores were evaluated. Peripheral blood levels of natural killer (NK) cells and T-lymphocyte subsets including CD3+, CD4+, and CD8+, and CD4+/CD8+ ratio were measured. Levels of programmed cell death protein-1 (PD-1), including PD-1⁺CD4⁺ and PD-1⁺CD8⁺ cells, were also assessed. Liver and renal function were monitored before and after treatment, and adverse events were recorded. ResultsIn the intervention group, 1 participant withdrew and 1 was excluded, while in the control group, 2 participants withdrew. Ultimately, 33 participants in each group were included in the final analysis. The intervention group showed significant improvements in physical, role, emotional, cognitive, and social functioning, as well as global health status after treatment, while scores for fatigue, nausea and vomiting, dyspnea, appetite loss, diarrhea, and TCM syndrome scale were significantly decreased (P<0.05). Moreover, the intervention group demonstrated higher scores in physical functioning, role functioning, and global health status, as well as lower scores for fatigue, nausea and vomiting, dyspnea, appetite loss, diarrhea, and the TCM syndrome scale than the control group (P<0.05). After treatment, the levels of peripheral NK cells and PD-1⁺CD8⁺ T cells in the intervention group increased significantly; furthermore, the intervention group exhibited higher peripheral NK cell levels and lower PD-1⁺CD8⁺ T cell levels than the control group (P<0.05). No significant differences were found in liver or renal function between the two groups (P>0.05). In addition, no adverse events such as burns or moxibustion-induced syncope occurred during the study. ConclusionHeat-sensitive moxibustion as an adjunctive therapy may enhance immune function, alleviate clinical symptoms, and improve quality of life, while demonstrating a favorable safety profile in NSCLC patients with qi deficiency and phlegm stasis.
3.Clinicopathological characteristics and prognosis of pancreatic cancer patients with fatty pancreas
Peng DONG ; Qingdi QIN ; Chaoyu PANG ; Zhiyao FAN ; Hanxiang ZHAN
Chinese Journal of Digestive Surgery 2025;24(5):617-622
Objective:To investigate the clinicopathological characteristics and prognosis of pancreatic cancer (PC) patients with fatty pancreas (FP).Methods:The retrospective cohort study was conducted. The clinicopathological data of 116 patients with PC who underwent surgery at Qilu Hospital of Shandong University from January 2013 to January 2022 were collected. There were 85 males and 31 females, aged 60(54,65)years. Observation indicators: (1) clinicopathological characteristics of PC patients with FP; (2) influencing factors for FP in PC patients; (3) prognosis of PC patients with FP. Comparison of count data between groups was conducted using the Pearson chi-square test. Multivariate analysis was conducted using the Logistic regression model. The Kaplan-Meier method was used to plot survival curve and calculate survival rate, and Cox proportional hazard model was used for survival analysis.Results:(1) Clinicopathological characteristics of PC patients with FP. Of the 116 PC patients, there were 43 cases with FP and 73 cases without FP. Cases with tumor location at pancreatic head were 36 in PC patients with FP and 46 in PC patients without FP. Cases with tumor location at pancreatic body or tail were 7 in PC patients with FP and 27 in PC patients without FP. Cases with high-density lipoprotein cholesterol ≥1.04 mmol/L were 14 in PC patients with FP and 34 in PC patients without FP. Cases with dyslipidemia were 33 in PC patients with FP and 36 in PC patients without FP. There were significant differences in tumor location, high-density lipoprotein cholesterol and plasma lipid between PC patients with and without FP ( χ2=5.600, 4.588, 5.165, P<0.05). (2) Influencing factors for FP in PC patients. Results of multivariate analysis showed that no correlation was found between tumor location, high-density lipoprotein cholesterol, plasma lipid and FP in PC patients ( P>0.05). (3) Prognosis of PC patients with FP. Eighty of the 116 PC patients were followed up for 30.8(15.1,57.5)months, with the median overall survival time of 24.0 months. Among them, 54 patients with FP had a median overall survival time of 19.5 months, 26 patients without FP had a median overall survival time of 24.6 months, showing no significant difference in survival between them ( hazard ratio=1.031, P>0.05). Conclusions:There are differ-ences in tumor location, high-density lipoprotein cholesterol and plasma lipid between PC patients with and without FP, but no correlation is found between the above indicators and FP in PC patients. There is no significant difference in prognosis between patients with and without FP.
4.Construction and evaluation of a risk prediction model for acute kidney injury in severe burn patients
He-dong XIANG ; Wen-zhao CHEN ; Hong-zhuang ZHANG ; Li-tao WEI ; Pei ZHAN ; Wei YANG ; Chang-quan LI ; Meng QIAO ; Chao-wei CHEN ; Zhi-qiang TIAN
Journal of Regional Anatomy and Operative Surgery 2025;34(10):886-891
Objective To explore the influencing factors of acute kidney injury in severe burn patients,and to construct a visual risk nomogram model.Methods A total of 390 patients with severe burn admitted to the Institute of Burn Frostbite and Tissue Function Reconstruction of Chinese People's Armed Police Force Specialty Medical Center from January 2018 to January 2022 were collected as an internal training data set,and 50 patients with severe burn admitted from February to December 2022 were collected as an external validation data set.The 390 patients of the internal training data set were divided into the acute kidney injury group and the non-acute kidney injury group according to the occurrence of acute kidney injury,and the baseline data of patients in the two groups were compared.Univariate and multivariate Logistic regression were used to analyze the risk factors of acute kidney injury in severe burn patients of the internal training data set,and a nomogram model was drawn.Subsequently,the model was verified both internally and externally.Kaplan-Meier analysis and Log-rank test were used to compare the 90-day survival rate of patients between the acute kidney injury group and the non-acute kidney injury group.Results The burn area(OR=1.18,95%CI:1.06 to 2.36,P=0.004),sequential organ failure assessment(SOFA)score(OR=1.81,95%CI:1.21 to 5.92,P<0.001),inhalation injury(OR=3.21,95%CI:1.23 to 6.35,P<0.001),neutrophil to lymphocyte ratio(NLR)(OR=1.22,95%CI:1.05 to 3.65,P<0.001)and albumin(ALB)(OR=0.78,95%CI:0.57 to 0.92,P=0.011)were the independent risk factors for the development of acute kidney injury in severe burn patients.The nomogram model was established by the above factors.The area under the receiver operating characteristic curve(AUC)of the internal training data set was 0.833(95%CI:0.752 to 0.935),the sensitivity was 81.2%,and the specificity was 83.2%.The AUC of the external validation data set was 0.842(95%CI:0.762 to 0.912),the sensitivity 87.2%,and the specificity was 78.7%.The 90-day survival rate of patients in the acute kidney injury group after burns was significantly lower than that in the non-acute kidney injury group(P<0.001).Conclusion Larger burn area,higher SOFA score,combined inhalation injury,increased NLR,and decreased ALB level are the risk factors for the occurrence of acute kidney injury in severe burn patients,which are related to the 90-day survival rate of patients after burns.The nomogram model based on the risk factors can provide certain reference for clinical individualized prevention and treatment of acute kidney injury in severe burn patients.
5.Total triterpenoids from Hovenia dulcis increase sensitivity of A549/DDP to cisplatin by inducing Nrf2-mediated ferroptosis
Xiao-lan KUANG ; Dong-ning SHEN ; Ting FU ; Fan WU ; Jian-zhan YANG ; Jin-lang ZHONG ; Bo LIU ; Fang-fang XU
Chinese Pharmacological Bulletin 2025;41(11):2128-2134
Aim To elucidate the underlying mecha-nism by which total triterpenoids extracted from Hove-nia dulcis(H-TP)enhance the sensitivity of A549/DDP cells to cisplatin.Methods The ARE-Nrf2 lu-ciferase reporter assay was applied to investigate the impact of H-TP on Nrf2 expression.Western blot was used to detect the protein levels of Keap-1/Nrf2/HO-1,Nrf2-GPX4 signaling pathway,apoptosis-related proteins of Bcl-2 and Bax.Further validation of its effects on Nrf2 was conducted by using Nrf2 activator/inhibitor.Results H-TP could enhance the sensitivi-ty of A549/DDP cells to cisplatin by modulating the expression of apoptosis-related proteins Bax and Bcl-2,inhibiting the Keap-1/Nrf2/HO-1/GPX4 signating pathway in A549/DDP cells,and inducing ferroptosis.Conclusion H-TP enhances the sensitivity of A549/DDP cells to cisplatin by inducing the Nrf2-mediated ferroptosis pathway.
6.Current status of advanced study personnel engaging in hospital-acquired infection control in a three-A hospital
Xing DONG ; Yunxi LIU ; Mingmei DU ; Yanling BAI ; Congjiao ZHAN ; Xiaona ZHANG ; Yun GE ; Zhen ZHANG ; Haixia SUN ; Rong XU ; Junlong YANG ; Xingxing ZHAO ; Hongwu YAO
Chinese Journal of Nosocomiology 2025;35(14):2214-2218
OBJECTIVE To investigate and analyze the current situation and problems of the advanced personnel en-gaging in the hospital-acquired infection control during their training period and explore the existing countermeas-ures and future development.METHODS The literatures regarding to the advanced study in China were retrieved from databases,the subjects of the literatures covered infection control-related advanced study practice,discipline construction,position competence,talent cultivation,scientific research innovation,professional title evaluation,laws,regulations and development plans.From Aug.2024 to Nov.2024,a questionnaire survey and face-to-face interviews were conducted among 36 advanced study personnel from 9 provinces of China who engaged in hos-pital-acquired infection control in the First Medical Center of Chinese PLA General Hospital.Eventually,36 ques-tionnaires were retrieved,all of which were valid with a questionnaire recovery rate of 100.00%.RESULTS Among the 36 advanced study personnel of hospital-acquired infection control,58.33%were medium-grade professional ti-tle;preventive medicine(41.67%),clinical medicine(25.00%)and nursing(16.67%)ranked the top 3 majors.The personnel engaged in the infection control for more than 6 years,and the duration of the advanced study was generally 3 or 6 months.In reality,the personnel faced the choices in terms of the purposes of further education,learning approaches and learning contents.The advanced study personnel also encountered the problems of challenges from promotion,improvement of position competency,integration with clinical training,supervision and practice,as well as physiological,psychological and family pressure.CONCLUSION Aiming at the problems that the advanced study personnel are generally concerned about,such as how to scientifically and effectively carry out hospital-acquired infection control advanced study and preset and solve the problems that may encounter,it is necessary to formulate targeted training programmes so as to provide bases and enlightenment for establishment of a long-term mechanism for advanced study of infection control in China.
7.Effects of high-fat diet intake on pharmacokinetics of rabeprazole sodium enteric-coated tablets in healthy Chinese subjects
Cai-hui GUO ; Yu-fang XU ; Cong-yang DING ; Guang-tao HAO ; Hao-jing SONG ; Xue SUN ; Zhan-jun DONG ; Wan-jun BAI
The Chinese Journal of Clinical Pharmacology 2025;41(2):225-229
Objective To evaluate the effects of fasting and high-fat diet on the pharmacokinetics of rabeprazole sodium enteric-coated tablets in healthy Chinese subjects.Methods A single-center,randomized,open,two-agent,two-sequence,four-cycle,fully repeated crossover,single-dose trial design was used in this study,healthy subjects were assigned to receive single dose of rabeprazole sodium enteric-coated tablets 0.1 g in either fasting or high-fat diet state,and blood samples were taken at different time points,respectively.The concentrations of rabeprazole sodium enteric-coated in plasma were determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS),the model method of the non-compartmental was used to calculate the pharmacokinetic parameters by Phoenix WinNonlin 8.2.Results The main pharmacokinetic parameters of rabeprazole sodium enteric-coated tablets in fasting state and high-fat diet state were as follows:Cmax were(339.63±156.47)and(318.86±132.13)ng·mL-1;t1/2 were(2.34±0.68)and(3.60±2.40)h;AUC0_t were(556.62±251.65)and(528.50±201.78)ng·mL-1·h;AUC0-∞ were(563.39±255.69)and(535.15±203.24)ng·mL-1·h;tmax were 3.65 and 6.99 h.After high-fat diet,the Cmax and AUC of rapeprazole sodium after high-fat and high-calorie diet decreased,Cmax decreased by 6.12%,AUC0-t decreased by 5.05%,AUC0-∞ decreased by 5.01%,andtmaxwas delayed by about 3.34 h.Cmax,AUC0-t and AUC0-∞ 90%confidence interval were 73.13%-115.10%,83.22%-112.28%and 83.40%-112.13%,respectively.Neither was between 85.00%-125.00%.Conclusion High-fat diet affects the absorption rate and degree of rabeprazole sodium enteric-coated,so it is suitable to be administered on an empty stomach.
8.Determination of sotagliflozin in rat plasma by UPLC-MS/MS method
Ge-xi CAO ; Xiao-xu ZHANG ; Yan-ru DENG ; Bin YAN ; Zhan-jun DONG
The Chinese Journal of Clinical Pharmacology 2025;41(2):230-234
Objective To establish a ultra-high performance liquid chromatography-tandem mass spectrometer(UPLC-MS/MS)method for determining the concentration of sotagliflozin in rat plasma and apply it to pharmacokinetic studies in rats.Methods Electrospray negative ion multi-reaction ion detection was used.Chromatographic column:EXT-C18(2.1 mm × 100.0 mm,2.7 μm);column temperature:45 ℃;mobile phase:5 mmol·L-1 ammonium acetate aqueous solution-acetonitrile;flow rate:0.35 mL·min-1;ion pairs:sotagliflozin m/z 483.3→315.1,dapagliflozin m/z 467.4→329.2;injection volume:6 μL,plasma samples were processed using methyl tert-butyl ether liquid-liquid extraction.Six male SD rats were administered a single oral dose of sogliflozin at 40 mg·kg-1,and detected the concentration of sogliflozin in plasma.Pharmacokinetic parameters were calculated using Drug And Statistics(DAS)2.1.1.Results Sotagliflozin showed good linearity within the range of 5-2 000 ng·mL-1,with intra-day and inter-day precision both less than 15%.The recovery rate,matrix effect,and stability were all within the specified range.Pharmacokinetic parameters:Cmax was(3 716.67±568.28)ng·mL-1,tmax was(1.00±0.32)h,t1/2 was(2.28±0.45)h,AUC0-t was(1.70 × 104±2 075.87)ng·mL-1·h.Conclusion This study established a method for determining the concentration of sotagliflozin in rat plasma,which is characterized by high sensitivity,rapid detection,and good repeatability.It is suitable for the determination of sotagliflozin concentration in plasma and pharmacokinetic studies.
9.Research status of autophagy in the pathogenesis of rheumatoid arthritis
Wen-xia QI ; Gang WANG ; Yan-feng YAN ; Jie-xiang TIAN ; Tao WANG ; Yong WEI ; Zhan-dong WANG ; Yuan-yuan ZHANG
The Chinese Journal of Clinical Pharmacology 2025;41(2):264-268
With the deepening of molecular biology and cell biology research,the regulatory mechanism of autophagy has been gradually revealed,providing new ideas for the treatment of numerous diseases.Autophagy may be closely related to pathological changes such as apoptosis resistance of fibroblast-like synoviocytes,disturbances in bone metabolic homeostasis,and antigen presentation,the regulation of autophagy homeostasis may be an important approach for the treatment of rheumatoid arthritis(RA).In this paper,we provide a review on the pathological mechanism of autophagy in RA,with a view to providing a theoretical basis for later studies.
10.Novel Structural Features of Isoflavone Synthase from Medicago truncatula Shed Light on Its Unique Enzymatic Mechanism
Chao SHI ; Zhao-Yang YE ; Fei XU ; Xiang-Ning DU ; Zhang-Xin CHEN ; Ming-Yue GU ; Jie DENG ; Wei WANG ; Liang-Yu LIU ; Mei-Ying WANG ; Xiao-Dong SU ; He-Li LIU ; Ming-Ying SHANG ; Li-Xin HUANG ; Zhen-Zhan CHANG
Chinese Journal of Biochemistry and Molecular Biology 2025;41(8):1204-1213,中插1-中插6
Isoflavones which mainly distributed in leguminous plants have plenty of health benefits.Isoflavone synthase(IFS)is a membrane-associated cytochrome P450 enzyme(CYP450)which carries out the unique aryl-ring migration and hydroxylation.So far,few crystal structures of plant P450s have been obtained.We determined the crystal structure of IFS from Medicago truncatula at 1.9 ? by MAD method using a selenomethionine substituted crystal and conducted molecular docking and mutagenesis study.The structure of IFS complexed with imidazole exhibits the helix Ⅰa-loop-helix Ⅰβ motif which cor-responds to helix Ⅰ of other P450s.Compared with structures of common P450s,IFS/imidazole structure contains an extra domain,i.e.,the γ-domain.The structure reveals a homodimer in which the γ-domain of one molecule interacts with the β-domain of another.The plane of heme group makes an angle of ap-proximately 40° with the helix Ⅰa-loop-helix Ⅰβ motif.Molecular docking combined with mutagenesis study suggested that Trp-128 and Asp-300 might play important roles in substrate binding and recogni-tion.Phe-301,Ser-303 and Gly-305 from the helix Ⅰa-loop-helix Ⅰβ motif may play important roles in the aryl-ring migration.These novel structural features reveal insights into the unique reaction mechanism of IFS and provide a basis for engineering IFS in leguminous crops for health purpose.

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