1.Reporting quality and influencing factors of patient-reported outcomes in randomized controlled trials of lung cancer: Based on the CONSORT-PRO extension
Guiying ZHANG ; Yueyuan YOU ; Xiaoqin ZHOU ; Jing LI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(03):322-331
Objective To evaluate the reporting quality and influencing factors of patient-reported outcome (PRO) data in randomized controlled trials (RCTs) of lung cancer. Methods RCTs of lung cancer with PRO as either primary or secondary endpoints were searched from PubMed, EMbase, Medline, CNKI, Wanfang Data, and VIP databases between January 1, 2010 and April 20, 2024. Reporting quality of included RCTs were assessed based on the CONSORT-PRO extension. Descriptive statistics and bivariate regression analysis were used to describe the reporting quality and analyze the factors influencing the reporting quality. Results A total of 740 articles were retrieved. After screening, 53 eligible RCTs of lung cancer with 22 780 patients were included. The patients were mainly with non-small cell lung cancer (84.91%), with the median sample size of the included studies was 364.0 (160.5, 599.5) patients. The primary PRO tool used was the EORTC QLQ-C30 (60.38%). There were 52 (98.11%) studies whose PRO measured the domain of "symptom management of cough, dyspnea, fatigue, pain, etc.", and 45 (84.91%) studies measured "health-related quality of life". Multicenter studies accounted for 84.91%, and randomized non-blind trials accounted for 62.26%. PRO was used as the primary endpoint in 33.96% of the studies and as secondary endpoints in 66.04%. The reliability and validity of the PRO tools were explicitly mentioned in 11.32% and 7.55% of the studies, respectively. The average completeness of reporting according to the CONSORT-PRO guidelines was 60.00%, ranging from 25.00% to 93.00%. The main factors affecting the completeness of CONSORT-PRO reporting included sample size and publication year. For every increment in sample size, the completeness of reporting increased by 27.5% (SE=0.00, t=2.040, P=0.046). Additionally, studies published after 2018 had a 67.2% higher completeness of reporting compared to those published in or before 2018 (SE=17.8, t=–3.273, P=0.006). Conclusion The study reveals that the overall reporting quality of PRO in lung cancer RCTs is poor. Particularly, the reporting of PRO measures reliability and validity, PRO assumptions, applicability, and handling of missing data need further improvement. Future research should emphasize comprehensive adherence to the CONSORT-PRO guidelines.
2.Study on the characteristic chromatogram of Shexiang Jiegu Capsule and determination of seven components by HPLC
Xiaocui YU ; Xiwen WANG ; Guiying ZHANG ; Junwei XU ; Yuwei ZHU ; Dan HU
Journal of Pharmaceutical Practice and Service 2025;43(8):395-399
Objective To establish the characteristic atlas of Shexiang Jiegu Capsule and determine the contents of seven active components (hydroxysafflor Yellow A, paeoniflorin, ferulic acid, naringin, ligustilide, catechin, epicatechin). Methods Octadecyl silane bonded silica gel was used as the filling agent, the mobile phase was composed of methanol-0.05% phosphoric acid by gradient elution, the detection wavelength was 245 nm, flow rate was 1.0 ml/min, column temperature was 30℃. The similarity of the fifteen batches of sample was evaluated in line with the TCM Chromatographic Fingerprint (2012 edition), and the contents of seven active components were determined. Results The HPLC fingerprint of Shexiang Jiegu Capsules was established. The similarity of fingerprint between fifteen batches of samples and control fingerprint was between 0.893 and 0.992. The results of methodological investigation for the determination of seven active components in fifteen batches of samples all met the requirements. Conclusion The established characteristic atlas of Shexiang Jiegu Capsules had high specificity and good repeatability, which could provide scientific basis for quality control of Shexiang Jiegu Capsules.
3.Zingiberis Rhizoma Alleviates Inflammatory Bowel Disease Through Regulating TLR4/MAPK Signaling Pathway in Ly6Chi Monocytes/Macrophages
Yalan LI ; Chonghao ZHANG ; Huachen LIU ; Jialong SU ; Na LI ; Mengyu ZHOU ; Guiying PENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):66-75
ObjectiveTo investigate the potential mechanisms of Zingiberis Rhizoma in treating inflammatory bowel disease (IBD) by integrating network pharmacology with in vitro and in vivo experiments. MethodsTraditional Chinese Medicine Systems Pharmacology Database And Analysis Platform (TCMSP), Traditional Chinese Medicine Integrated Database (TCMID) Database were used to obtain the active component targets of Zingiberis Rhizoma. GeneCards was used to obtain the IBD targets. DAVID was used to perform Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analyses on core targets. Cytoscape 3.10.2 was used to establish the "active component-disease target-signaling pathway" interaction network. Mice were randomly assigned to control, model, and Zingiberis Rhizoma (400 mg·kg-1) groups. An IBD model was induced via dextran sulfate sodium (DSS). The colonic tissue was collected post-treatment to assess histology, expression of Ly6C+ monocytes/macrophages, and mRNA levels of Toll-like receptor 4 (TLR4), and inflammatory cytokines. The effect of Zingiberis Rhizoma aqueous extract on RAW264.7 cell viability was evaluated. Furthermore, the effects of the extract at 100, 10, and 1 mg·L-1 on LPS-induced differentiation of RAW264.7 cells into Ly6Chi monocytes/macrophages, mRNA levels of TLR4 and inflammatory cytokines, and protein levels of factors in the TLR4/mitogen-activated protein kinase (MAPK) signaling pathway. ResultsA total of 241 targets were identified for Zingiberis Rhizoma and 6 787 for IBD, with 122 shared targets among Zingiberis Rhizoma, ulcerative colitis (UC), and Crohn's disease (CD). The enrichment analyses yielded 297 GO terms and 88 KEGG pathways. Associations were noted between Zingiberis Rhizoma's active component targets and IBD targets. In vivo experiments: Compared with the control group, the model group showed decreased body weight and disease activity index (DAI)(P<0.01), shortened colon length, damaged mucosal epithelium with inflammatory cell infiltration, raised pathological scores (P<0.05), increased Ly6Chi and Ly6Clo monocytes/macrophages (P<0.05), and up-regulated mRNA levels of TLR4, TNF-α, IL-1β, and IL-6 (P<0.05) and protein levels of TLR4, phosphorylated extracellular signal-regulated protein kinase 1/2 (p-ERK1/2), and phosphorylated p38 MAPK (p-p38 MAPK) (P<0.05). Zingiberis Rhizoma intervention reversed these changes and reduced Ly6Chi monocytes/macrophages (P<0.01). In vitro experiments: compared with the control, LPS increased the proportion and number of Ly6Chi monocytes/macrophages and mRNA levels of TLR4, TNF-α, IL-1β, and IL-6 (P<0.01) and enhanced the expression of TLR4, p-ERK1/2, and p-p38 MAPK (P<0.05). Zingiberis Rhizoma reduced Ly6Chi monocytes/macrophages (P<0.05), down-regulated the mRNA levels of inflammatory cytokines (P<0.05), and suppressed the TLR4/MAPK pathway (P<0.05). ConclusionZingiberis Rhizoma alleviates IBD by suppressing the TLR4/ERK/p38 MAPK signaling pathway and reducing inflammatory cytokine levels in Ly6Chi monocytes/macrophages.
4.Mume Fructus Restores Intestinal Mucosal Epithelial Barrier Through MEK/ERK Signaling Pathway in Mouse Model of Inflammatory Bowel Disease
Huachen LIU ; Chonghao ZHANG ; Yalan LI ; Jie LIU ; Jialong SU ; Na LI ; Shaoshuai LIU ; Qing WANG ; Guiying PENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):76-85
ObjectiveTo clarify the repair effect of Mume Fructus on the intestinal mucosal epithelial barrier in the mouse model of inflammatory bowel disease (IBD) and explore the repair mechanism. MethodsThirty-six male C57BL/6 mice were randomly assigned into six groups: normal, model, low-, medium-, and high-dose (200, 400, and 800 mg·kg-1) Mume Fructus, and sulfasalazine (300 mg·kg-1). Except the normal group, the rest groups had free access to 2% dextran sulfate sodium (DSS) solution for seven days to establish the IBD model, followed by a seven-day drug intervention. The body weight change and disease activity index (DAI) were recorded. After the last administration, spleen and colon tissue samples were collected to analyze the differences in colon length and spleen index. Hematoxylin-eosin staining was used to observe the morphology of the colon tissue. The level of diamine oxidase (DAO) in the serum was measured by the DAO assay kit. Immunohistochemistry was employed to determine the expression of tight junction proteins such as Claudin-1, Occludin, and zonula occludens-1 (ZO-1) in the colon tissue. Real-time PCR was performed to measure the mRNA levels of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β) in the colon tissue. Finally, Western blot was employed to determine the protein levels of mitogen-activated protein kinase kinase (MEK), extracellular signal-regulated kinase (ERK), phosphorylated (p)-MEK, and phosphorylated ERK in the colon tissue. ResultsCompared with the normal group, the model group exhibited decreases in body weight and colon length (P<0.01), increases in DAI, spleen index, and serum DAO level (P<0.01), damaged colonic epithelium and goblet cells, and obvious infiltration of inflammatory cells. In addition, the model group exhibited higher positive expression of Claudin-1, Occludin, and ZO-1 (P<0.01), higher mRNA levels of TNF-α and IL-1β (P<0.01), and higher protein levels of p-MEK and p-ERK (P<0.05, P<0.01) than the normal group. However, sulfasalazine and three doses of Mume Fructus markedly decreased the body weight and DAI (P<0.05), recovered the colon length and spleen index, alleviated colon tissue damage, lowered the level of DAO in the serum (P<0.01), and down-regulated the mRNA levels of TNF-α and IL-1β (P<0.01) and the protein levels of p-MEK and p-ERK (P<0.05). Sulfasalazine and low- and medium-dose Mume Fructus increased the positive expression of Occludin, Claudin-1, and ZO-1 (P<0.05, P<0.01). Furthermore, high-dose Mume Fructus elevated the protein expression of Occludin (P<0.05). ConclusionMume Fructus can restore the expression of intestinal epithelial tight junction proteins by inhibiting the phosphorylation of proteins in the MEK/ERK signaling pathway and down-regulating the levels of TNF-α and IL-1β, thus repairing the intestinal mucosal barrier in the mouse model of IBD.
5.Regulatory Effect of Modified Wumeiwan on Th17/Treg Balance and Intestinal Microbiota in Ulcerative Colitis with Dampness-heat Obstruction Syndrome in Human Flora-associated Model
Chonghao ZHANG ; Peiguang MA ; Huachen LIU ; Jialong SU ; Jie LIU ; Yalan LI ; Guichuan XU ; Na LI ; Guiying PENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):86-93
ObjectiveTo investigate the modulating effect of modified Wumeiwan (MWMW) on the ulcerative colitis (UC)-associated intestinal helper T cell 17 (Th17)/regulatory T cell (Treg) balance and intestinal flora by using a human flora-associated model of UC patients with dampness-heat obstruction syndrome, thus providing a new idea for the UC-related research and therapeutic strategies. MethodsThe 24 male C57BL/6J mice were randomized into normal control, model, and MWMW groups (n=8). Model and MWMW groups were first treated with an antibiotic cocktail (vancomycin, 0.1 g·kg-1; neomycin sulfate, 0.2 g·kg-1; ampicillin, 0.2 g·kg-1; metronidazole, 0.2 g·kg-1) for 21 days. At the end of antibiotic treatment, the gavage of fecal microbiota suspension from UC patients with dampness-heat obstruction syndrome was started at a dose of 0.2 mL·d-1 for 19 consecutive days, by which a human flora-associated model of UC was obtained. The MWMW group was administrated daily with MWMW liquid (12.5 g·kg-1), while the normal control and model groups were administrated by gavage with an equal amount of sterile water for 7 consecutive days. The symptoms of dampness-heat obstruction were observed. The colon length and spleen index were measured and calculated, and the proportions of Th17 and Treg cells were detected by flow assay. The intestinal flora was analyzed by 16S rRNA high-throughput sequencing. ResultsCompared with the normal control group, the model group showed shortened colon (P<0.05) and increased spleen index (P<0.01). Compared with the model group, the MWMW group showed prolonged colon (P<0.01) and decreased spleen index (P<0.05). After the intervention of MWMW, the Th17 proportion and Th17/Treg ratio in the colon decreased (P<0.01), and the proportion of Treg cells increased (P<0.05). The number of species and alpha and beta diversity of intestinal flora in mice were regulated by MWMW (P<0.05). In terms of intestinal flora composition, MWMW increased the relative abundance of several phyla (Firmicutes, Proteobacteria, Fusobacteriota, Actinobacteriota, and Gemmatimonadota), the genus Bacteroides, and two species (Bacteroides thetaiotaomicron and B. fragilis) in model mice. Moreover, Spearman's correlation analysis showed that the relative abundance of B. thetaiotaomicron and B. fragilis were negatively correlated with the Th17 level (P<0.05). In addition, the above changes in intestinal flora caused the changes in microbial genes involved in 14 pathways, such as glycolysis, amino acid degradation, inorganic nutrient metabolism, biosynthesis of pyrimidine deoxyribonucleotides, antibiotic resistance, and degradation of polysaccharides. ConclusionsThe human flora-associated model successfully simulated the changes (marked by a decrease in the abundance of Bacteroides) of intestinal flora in UC patients with dampness-heat obstruction syndrome. MWMW can enrich the abundance of beneficial bacteria such as B. thetaiotaomicron and B. fragilis and promote the synergistic intestinal immune modulation with the metabolic functions centered on glycolysis, amino acid metabolism, and nucleotide synthesis through bacterial polysaccharide utilization sites to reduce the Th17/Treg ratio, thereby exerting a protective effect on UC.
6.Analysis of abnormal individual dose monitoring results in 206 medical institutions in a selected region in 2024
Hua TUO ; Wenyan LI ; Lantao LIU ; Guiying ZHANG ; Zeqin GUO ; Heyan WU
Chinese Journal of Radiological Health 2025;34(4):471-476
Objective To analyze the abnormal individual dose monitoring results in 206 medical institutions in a selected region in 2024, and to propose improvement measures. Methods Individuals with monitoring results exceeding the investigation level were subjected to high-dose investigation, and the results were statistically analyzed. Results In 2024, the individual dose monitoring of 206 medical institutions in a selected region showed 1.04% abnormal results. The proportions of abnormal results from primary, secondary, and tertiary medical institutions were 12.22%, 3.33%, and 84.45%, respectively. In analysis of the causes of abnormal results, 52.53% of the cases were due to personal dosimeters left in the radiation workplace, and 20.20% were due to the confusion in wearing personal dosimeters inside and outside the lead apron. In analysis of the occupational distribution of the radiation workers with abnormal monitoring results, interventional radiology and diagnostic radiology accounted for 73.34% and 24.44%, respectively. Statistical analysis of the dose range showed that doses in the ranges of 1.25-2.0 mSv and 2.0-5.0 mSv accounted for 42.22% and 33.33%, respectively. In the report of abnormal monitoring results, the proportions of reporting notional dose and reporting measured results accounted for 88.89% and 11.11%, respectively. Among institutions with consecutive abnormal results, primary, secondary, and tertiary medical institutions accounted for 15.39%, 7.69%, and 76.92%, respectively. Conclusion The level of the hospital, occupational type, the perceived importance of the hospital to the management of radiation protection, and the perceived importance and compliance of the radiation workers with the individual dose monitoring are potential causes of abnormal results. It is recommended that employers should enhance radiation protection training for their radiation workers to ensure proper wearing and storage of dosimeters, and progressively improve the standardization and effectiveness of individual dose monitoring practice.
7.Diagnostic value of pepsinogen determination in children peptic ulcer
Yi WANG ; Li ZHANG ; Nan WU ; Guiying CHEN
Chongqing Medicine 2024;53(19):2949-2953,2959
Objective To investigate the value of pepsinogen(PG)in diagnosing children peptic ulcer.Methods A total of 855 children patients completing gastroscopic examination in this hospital due to nausea,vomiting,abdominal pain,gastrointestinal bleeding and other gastrointestinal symptoms from July 2019 to January 2024 were selected as the study subjects.According to the gastroscopic examination results,they were divided into the healthy physical examination group(n=223),chronic gastritis group(n=418),chronic gas-tritis combined with duodenal bulbar inflammation(n=168)and gastric ulcer and duodenal bulbous ulcer group(peptic ulcer group,n=46).A total of 503 study subjects perfected the 13C breath test and divided into Helicobacter pylori(Hp)positive and Hp negative according to the test results.Serum PGⅠ,PGⅡ and PGⅠ/PGⅡ levels in all study subjects were measured by latex immunoturbidimetry.The differences of this indi-cator among different ages and different gastric diseases and its diagnostic value in peptic ulcer were analyzed.Results The proportion of female children patients in the peptic ulcer group was significantly lower than that in the other 3 group,and the difference was statistically significant(P<0.05).The PGⅠ level of children pa-tients<7 years old in the chronic gastritis group was lower than that of the children patients>12 years old group,and the difference was statistically significant(P<0.05).The PG level of the children patients<7 years old in chronic gastritis combined with duodenal bulbar inflammation group was lower than that in the children patients>12 years old group,the PGⅡ level in the children patients<7 years old,7-12 years was lower than that in the children patients>12 year old,and the difference was statistically significant(P<0.05).Compared with the healthy physical examination group,the PGⅠ level in the chronic gastritis group was increased,the PGⅠ and PGⅡ levels in the chronic gastritis combined with duodenal bulbar inflammation group were increased,the PGⅠ/PGⅡ ratio was decreased,the PGⅠ and PGⅡ levels in the peptic ulcer group were increased and the PGⅠ/PGⅡ ratio was decreased,and the differences were statistically significant(P<0.05).Compared with the chronic gastritis group,the PGⅠ/PGⅡ ratio in the chronic gastritis combined with duodenal bulbar inflammation group was decreased,the PGⅠ and PGⅡ levels in the peptic ulcer group were increased,the PGⅠ/PGⅡ ratio was decreased,and the differences were statistically significant(P<0.05).Compared with chronic gastritis combined with duodenal bulbar inflammation group,the PGⅠ and PGⅡ lev-els in the peptic ulcer group were increased,the PGⅠ/PGⅡ ratio was decreased,and the differences were sta-tistically significant(P<0.05).The area under the curve(AUC)of PGⅠ and PGⅡ for predicting peptic ul-cer was 0.689 and 0.785 respectively,the maximal Youden index served as the optimal diagnostic cutoff val-ue,when PGⅠ was 69.25 μg/L,its Youden index reached the maximal value,the sensitivity for diagnosing peptic ulcer was 67.4%,the specificity was 72.3%;when PGⅡ was 12.25 μg/L,its Youden index reached the maximal value,the sensitivity for diagnosing peptic ulcer was 71.7%,the specificity was 76.1%.Compared with the Hp negative,Hp positive PGⅠ and PGⅡ in the chronic gastritis combined with duodenal bulbar in-flammation group were increased,the PGⅠ/PGⅡ ratio was decreased,the Hp positive PGⅠ/PGⅡ ratio in the peptic ulcer group was decreased,and the differences were statistically significant(P<0.05).Conclusion PG could be used to diagnose children peptic ulcer.
8.HPLC method for the simultaneous determination of hydroxyphenyl esters and quaternary ammonium bacteriostatic agents in eye drops
Jin GAO ; Dan HU ; Yi BAO ; Xiaocui YU ; Zexin WANG ; Jing LIU ; Guiying ZHANG ; Yingying ZHAO ; Zhenyu CAO ; Chunpu LI ; Xiaoxu HONG
Drug Standards of China 2024;25(3):234-243
Objective:To establish a general method for the simultaneous determination of hydroxyphenyl esters and quaternary ammonium bacteriostatic agents in eye drops.Methods:The chromatographic analysis was per-formed on an Agilent C18 column(4.6 mm ×250 mm,5 μm)with 1%triethylamine solution(pH adjusted to 5.0 with phosphoric acid)as mobile phase A and methanol as mobile phase B.Gradient elution was performed at col-umn temperature of 40 ℃.The detection wavelength was 214 nm,the flow rate was 1 mL·min-1,and the injec-tion volume was 20 μL.Results:Methylparaben,ethylparaben,propylparaben,butylparaben,benzalkonium chlo-ride and benzalkonium bromide were 0.11-559.0,0.10-513.0,0.10-258.8,0.11-270.5,1.07-537.0 and 1.03-512.8 μg·mL-1,respectively.The linear range was good(r>0.999).The average recoveries of meth-ylparaben,benzalkonium bromide and benzalkonium chloride were 104.7%(RSD=1.3%),102.6%(RSD=1.1%)and 100.9%(RSD=1.1%),respectively.The contents of bacteriostatic agent in 100 batches of eye drops from 36 varieties of 12 enterprises were determined,and the accurate results were obtained.Conclusion:This meth-od provides a reference for the content quality control and safety evaluation of bacteriostatic agents in eye drops.
9.Pathogenesis and targeted therapy of pemphigus
Rufan YAN ; Jieyue LIAO ; Ziyu GUO ; Nan YAO ; Wenyu ZHOU ; Shuaihantian LUO ; Guiying ZHANG ; Ming ZHAO
Chinese Journal of Dermatology 2024;57(4):374-378
In recent years, with the in-depth study of pemphigus, new pathogenesis has been identified based on the desmoglein antibody-mediated immune response mechanism, and new progress has been made in targeted therapy. This review summarizes recent advances in the pathogenesis and targeted therapy of pemphigus.
10.Construction and practice of a "three progressions, four integrations, and five cocultivation" talent cultivation system for nursing professional groups under the 1+X certificate system
Jie NIU ; Guiying NAN ; Huan LI ; Zhaoxia MENG ; Ran ZHANG ; Qian ZHU ; Aijun ZHOU ; Ling YAN ; Xianghua LI
Chinese Journal of Practical Nursing 2024;40(19):1441-1446
Objective:To explore the talent cultivation model of nursing professional group under the 1+X certificate system, to build a talent cultivation system for nursing professional groups with "three progressions, four integrations, and five cocultivation"Methods:From 1 July 2021 to 31 December 2023, built a professional group course system of "mutual sharing of foundations, mutual generation of majors, mutual selection of positions, and progressive improvement of abilities". Aligned course content with X certificate content. Deepen the reform of the three education systems, create a "dual teacher" teaching team that combines full-time and part-time work, and build teaching resources that connect the cloud and the ground. The application effect of this model was evaluated in 2021 nursing majors in Cangzhou Medical College by cluster sampling.Results:There were 748 students majoring in nursing in class of 2021, 150 boys aged 19-22(20.00 ± 1.23), 598 girls, aged 19-21(19.00 ± 2.57). There were 118 students majoring in midwifery in class of 2021, all of them were girls, aged 18-20(18.00 ± 2.11). There were 128 students majoring in rehabilitation therapy technology in class of 2021, 66 boys aged 19-21(19.00 ± 2.11), 62 girls aged 19-21(19.00 ± 2.54). Nursing professional group completed the "Basic Nursing Technology Training Guidance", "Elderly Care" and other 5 self-compiled textbooks, 730 students had participated in the X certificate assessment, 729 students e passed the assessment, the passing rate was 99.9%.Conclusions:The talent cultivation model of "three progressions, four integrations, and five co cultivation" in the nursing professional group can cultivate students′ professional abilities, and cultivate a composite technical and skilled talent with multiple abilities and interconnections in one job.

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