The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use （ICH） issued the ICH E6（R3）： Guideline for Good Clinical Practice on January 14， 2025， which will enhance the speed and quality of global clinical trials， including those in China. As the ethical， scientific and quality standards for global drug clinical trials， the highlights of the revision in the ICH E6 （R3） include encouraging innovation to improve efficiency and quality， motivating research participants to participate in the design and implementation of clinical trials throughout the process， emphasizing quality originating from design and based on the quality management of risks， as well as underlining proportionality and standalone chapter to data governance. ICH E6 （R3） adopts an appendix and appendix structure， enabling future revisions to be more convenient and efficient. ICH E6 （R3） restructures the principles section， adding two new principles and reducing the total from 13 to 11， while incorporating extensive explanatory notes. Major revisions also encompass multiple aspects， including regular review by ethics committees to ensure the safety， rights and interests， and well-being of research participants； diversification of informed consent methods， refinement of its processes， and clarification of detailed rules for minors’ consent； qualifications， authorization， and oversight of investigators and their service providers； risk-proportionate design and implementation by sponsors； joint data governance by investigators and sponsors； and the addition and revision of terms， along with updates to three appendices. The design， implementation， and review of drug clinical trials in China are increasingly aligning with international standards. ICH E6 （R3） will accelerate the revision of China’s Guideline for Good Clinical Practice， promote the speed and quality of drug research and development， and further facilitate the internationalization of China’s new drug research and development.

Objective:To analyze the implementation and effectiveness of standardized training for medical aesthetic practitioners in Guangdong province from 2015 to 2023.Methods:Training data from 2015 to 2023 were retrospectively collected from programs organized by the Guangdong Medical Association, including sessions in aesthetic surgery, dermatology, dentistry, traditional Chinese medicine, laser aesthetics, and injectable aesthetics. The training implementation was summarized. A random sample of 120 trainees was selected to complete a questionnaire to assess training outcomes.Results:A total of 45 offline standardized training sessions were held, covering both theoretical and practical instruction. The total training duration reached 180 days, involving 6 776 participant attendances. Aesthetic surgery accounted for the highest number (1 701 attendances), followed by aesthetic dermatology (1 197 attendances). Among specialized technical programs, laser aesthetics (1 708 attendances) and injectable aesthetics (1 578 attendances) had the most participants. Most trainees (5 705 attendances) were physicians from tertiary public general hospitals. A total of 116 questionnaires were collected, with 115 participants expressing satisfaction with the course content, teaching arrangement, and training materials. All trainees passed the skills assessment and received training certificates.Conclusions:The standardized training for medical aesthetic practitioners in Guangdong province from 2015 to 2023 has been well implemented and shows favorable outcomes. It contributes to improving the technical competence of professionals in the medical aesthetics field.

Objective:To analyze the implementation and effectiveness of standardized training for medical aesthetic practitioners in Guangdong province from 2015 to 2023.Methods:Training data from 2015 to 2023 were retrospectively collected from programs organized by the Guangdong Medical Association, including sessions in aesthetic surgery, dermatology, dentistry, traditional Chinese medicine, laser aesthetics, and injectable aesthetics. The training implementation was summarized. A random sample of 120 trainees was selected to complete a questionnaire to assess training outcomes.Results:A total of 45 offline standardized training sessions were held, covering both theoretical and practical instruction. The total training duration reached 180 days, involving 6 776 participant attendances. Aesthetic surgery accounted for the highest number (1 701 attendances), followed by aesthetic dermatology (1 197 attendances). Among specialized technical programs, laser aesthetics (1 708 attendances) and injectable aesthetics (1 578 attendances) had the most participants. Most trainees (5 705 attendances) were physicians from tertiary public general hospitals. A total of 116 questionnaires were collected, with 115 participants expressing satisfaction with the course content, teaching arrangement, and training materials. All trainees passed the skills assessment and received training certificates.Conclusions:The standardized training for medical aesthetic practitioners in Guangdong province from 2015 to 2023 has been well implemented and shows favorable outcomes. It contributes to improving the technical competence of professionals in the medical aesthetics field.

Objective To investigate the interventional effect and mechanism of a novel ampelopsis hydrogel on dampness-heat accumulation syndrome of gouty arthritis. Methods A total of 90 patients with gouty arthritis who met the diagnostic criteria of western medicine and were differentiated as damp-heat accumulation syndrome of traditional Chinese medicine(TCM) were randomly divided into treatment group, control group and blank group, with 30 patients in each group. The blank group was treated with etoricoxib only, the control group was treated with etoricoxib combined with ampelopsis hydrogel, and the treatment group was treated with etoricoxib combined with external application of ampelopsis hydrogel. The clinical efficacy, time to symptom improvement, safety, comfort, changes in syndrome scores of TCM, serum inflammatory factors[C-reactive protein (CRP), tumor necrosis factor-α (TNF-α), erythrocyte sedimentation rate (ESR)], NF-κB signaling pathway-related proteins, Visual Analogue Scale (VAS) scores for pain, and joint mobility were compared among the three groups before and after treatment. Results The total effective rates in the treatment group and control group were 93.33% and 90.00%, respectively, which were higher than 70.00% in the blank group (P < 0.05). The time for improvement of pain, redness, tenderness, and limited joint mobility in the treatment group was shorter than that in the control group and blank group (P < 0.05). After 7 days of treatment, the TCM syndrome score in the treatment group was lower than that in the control group and blank group, and the levels of serum CRP, TNF-α, and ESR and the expressions of NF-κB signalingpathway-related proteins P50 and P65 in the treatment group and control group were lower than those in the blank group (P < 0.05). After 7 days of treatment, the VAS score in the treatment group was lower than that in the control group and blank group, and the comfort score in the treatment group was higher than that in the control group (P < 0.05). There was no significant difference in the incidence of adverse reactions among the three groups (P>0.05). Conclusion The effect of ampelopsis hydrogel in treating gouty arthritis is better than that of ampelopsis paste, and its mechanism may be related to the regulation of the NF-κB pathway and inhibition of inflammatory factor expression. The hydrogel is easy to use, hygienic, and comfortable, and is expected to become a safe, effective, and convenient external medicine for gouty arthritis.

Objective To explore the differential gene expression profile and small molecule drugs for chronic atrophic gastritis(CAG)by bioinformatics technology.Methods Two gene expression samples of CAG chips(GSE27411,GSE116312)were obtained through the Gene Expression Synthesis(GEO)database,screen the differentially expressed genes(DEGs)of CAG by R language,and CAG immune-related genes were obtained for gene ontology(GO)and Kyoto Encyclopedia of Genes and Genomes(KEGG)analysis.Protein-protein interaction(PPI)network was constructed using STRING database to screen out core genes,further study on immune invasion of core genes based on GSE27411 dataset,small molecular compounds interacting with core genes were predicted,molecular docking was carried out by MOE2022,and survival analysis was carried out by GEPIA2 website.Results A total of 517 DEGs were screened out based on GEO database.GO function enrichment analysis found that it mainly involved in granulocyte chemotaxis、leukocyte chemotaxis and neutrophil chemotaxis biological processes.KEGG pathway enrichment analysis showed that it mainly involved in cytokine-cytokine receptor interaction、nuclear factor kappa B signaling pathway、interleukin-17 signaling pathway.Six key genes of NR1H4、CCK、CCL20、CXCL1、LCN2、SAA1 were obtained by PPI network,through relevant verification,NR1H4 was regarded as the core gene.Immune cell infiltration analysis showed that central memory CD8 T cell、effector memeory CD4 T cell、gamma delta T cell、natural killer T cell、neutrophil and other immune cells may be involved in the development of CAG,and the neutrophil was positively correlated with NR1H4.It was predicted that six small molecular drugs,corilagin,stigmasterol,geniposide,tangeretin,chenodeoxycholic acid and epigallocatechin 3-gallate,have good binding force with NR1H4.Conclusion The potential mechanism of CAG is preliminarily explored in this study,the key gene of NR1H4 and neutrophil may play an important role in the"inflammatory cancer transformation"process of CAG,which can provide a certain reference for the study of the"inflammatory cancer transformation"mechanism of CAG.

ObjectiveTo explore the effect of Weiwei Tongtiao decoction （WTD） on chronic atrophic gastritis （CAG） rats and the underlying mechanism. MethodA total of 90 SD rats were randomized into normal control group， model group， high-dose， medium-dose， and low-dose WTD groups （18， 9， 4.5 g·kg^-1·d^-1 WTD， respectively， ig）， and weifuchun control group （0.45 g·kg^-1·d^-1 weifuchun aqueous solution， ig）， with 15 rats in each group. The N-methyl-N'-nitro-N-nitrosoguanidine （MNNG） was employed to induced CAG in rats. After the modeling （identified by histopathological examination）， the administration began and lasted 12 weeks. Then， gastric mucosa tissues of the rats were collected and stained with hematoxylin and eosin （HE）， and the pathological changes of gastric mucosa were observed under the optical microscope. Real-time PCR， immunohistochemistry （IHC）， and Western blotting were applied to examine the mRNA and protein expression of indexes in nuclear factor kappa-B （NF-κB） signaling pathway in the gastric mucosa of rats. ResultCAG rats showed irregular arrangement and morphology of the inherent glands in gastric mucosa and the glands decreased or disappeared. In addition， inflammatory cell infiltration was observed in the lamina propria of CAG rats， and about 48.4% presented intestinal metaplasia. WTD significantly alleviated the reduction of the glands and intestinal metaplasia in a dose-dependent manner. Compared with the normal control group， the model group demonstrated increase in the mRNA expression of cyclooxygenase-2 （COX-2）， NF-κB p65， interleukin （IL）-1α， IL-1β， IL-10， IL-8α， and IL-8β， and protein expression of COX-2， NF-κB p65， and IL-10 （P<0.01）. WTD and weifuchun lowered the mRNA expression of COX-2， NF-κB p65， IL-1α， IL-1β， IL-10， IL-8α， and IL-8β， and the protein expression of COX-2， NF-κB p65， and IL-10 in gastric mucosa of CAG rats （P<0.01）. The expression of the above indexes after the intervention with high-dose WTD was close to that of the normal control group. ConclusionWTD can improve or even reverse the diseased gastric mucosa of CAG rats， and the mechanism is the likelihood that WTD down-regulates the mRNA and protein expression of the indexes in NF-κB signaling pathway in gastric mucosa of CAG rats.

Gastric ''inflammation-cancer'' transformation stars from inflammation and ends as gastric cancer （GC）， and the pathogenesis is still unclear. In China， GC features high morbidity and mortality and poor prognosis， influencing the quality of life and physical and mental health of patients. Therefore， it is of great significance to construct the prevention and treatment system for GC. Chronic atrophic gastritis （CAG） plays a key role in the occurrence， development， and outcome of gastric ''inflammation-cancer'' transformation. Modern therapies for CAG generally aim at eliminating causes and alleviating clinical symptoms， which show satisfactory short-term efficacy， but the reverse and recurrence are common. Based on the holistic view， syndrome differentiation-based treatment， and the ''inflammation-cancer'' transformation in modern medicine， traditional Chinese medicine emphasizes both prevention and treatment， with individualized therapies for CAG and GC to control the transformation. According to the pathogenesis of CAG-asthenia in origin and sthenia in superficiality and deficiency-excess in complexity， this study proposed the theory of spleen deficiency and pathogen stagnation in CAG， and believed spleen deficiency， pathogen， and stagnation are respectively the root cause of， the main factor of， and the key to ''inflammation-cancer'' transformation， respectively. Spleen deficiency and pathogen stagnation are closely related to the process of the transformation. For the treatment， the spleen-invigorating and pathogen-eliminating method should be used for invigorating the spleen to consolidate original Qi， improve the blood supply in stomach， and regulate immunity， and eliminating the pathogen to relieve stagnation， reduce the occurrence of non-controllable inflammation， and improve inflammatory micro-environment. As a result， the gastric inflammation is controlled at the early stage and the gastric ''inflammation-cancer'' transformation is blocked. The gastric mucosal lesions are blocked， delayed， or even reversed. This study provides a new idea in clinical diagnosis and treatment of CAG and in the prevention of GC.

Objective:To investigate the risk factors of moderate to severe cancer-related fatigue (CRF) in patients undergoing chemotherapy of prostate cancer, and to construct a nomogram model to predict the occurrence of CRF.Methods:Using the case data questionnaire, Brief Fatigue Inventory, Social Support Rating Scale and International Prostate Symptom Scores, 724 patients of prostate cancer treated by chemotherapy in Shanghai Tenth People′s Hospital from August 2016 to June 2021 were selected and were treated with 1∶1 ratio, and the indexes of the moderate and severe CRF group (216 cases) and the non-moderate and severe CRF group (216 cases) were compared. According to the ratio of 7∶3, the envelope method was used to divide into training set and validation set. The independent risk factors of moderate and severe CRF were explored by univariate analysis and multivariate Logistic regression analysis, and the risk prediction model was established and the nomogram model was constructed. The C-index and area under ROC curve were used to verify the prediction effect of the model.Results:Multivariate Logistic regression analysis showed that BMI ranged from 24.0 to 27.9 kg/m 2 ( OR=1.733), BMI≥28.0 kg/m 2 ( OR=3.126), neutropenia occurred during chemotherapy ( OR=1.747), chemotherapy course >6 months ( OR=1.893), moderate social support level ( OR=1.244), low social support level ( OR=2.434), mild urinary tract symptoms ( OR=1.264), moderate urinary tract symptoms ( OR=3.371) and severe urinary tract symptoms ( OR=5.297) were independent risk factors for moderate and severe CRF. The nomogram model constructed according to the above risk factors was internally verified by the training set and the validation set, and its C-index was 0.854 and 0.741 respectively. The area under ROC curve training set was 0.823, and the validation set was 0.733. Conclusions:The nomogram model can effectively predict the occurrence of moderate to severe CRF in patients with prostate cancer undergoing chemotherapy.

Objective:To investigate the effect of slow intravenous infusion of low-dose mannitol on the hemodynamics of patients after cardiopulmonary bypass.Methods:Prospective, continuous inclusion of 62 patients after cardiac surgery under cardiopulmonary bypass. By random number method, they were divided into normal treatment group(group C) with 29 cases and mannitol treatment group(group M) with 33 cases. Group C was treated according to the postoperative routine treatment measures. On the basis of conventional treatment, group M received intravenous infusion of 20% mannitol injection 0.25 g/kg at 1、8、24 hours after operation, and the intravenous infusion time was 60 minutes each time. According to the hemodynamic changes during the two groups of treatment, the effect of slow intravenous infusion of low-dose mannitol on patients after cardiopulmonary bypass under cardiopulmonary bypass was analyzed.Results:In group M, CI and SVI were significantly increased after use of mannitol than before, with statistical significance( P<0.01). SVRI showed a downward trend, and the changes were statistically significant after use of mannitol( P<0.01). PAWP increased first and then decreased after operation, and the changes were statistically significant after mannitol use than before( P<0.05). RAP and MPAP had no significant changes after the first use of mannitol, but the changes after the latter two use mannitol were statistically significant than before( P<0.05). Repeated-measurement data analysis of variance was performed on the hemodynamic parameters of each group, and the results were all P<0.01. Conclusion:Postoperative slow intravenous infusion of low-dose mannitol optimizes hemodynamic status, increases stroke volume, reduces cardiac preload, improves systemic and pulmonary circulation resistance, and promotes recovery of postoperative cardiopulmonary function.

Objective:To explore the effect of the specialized nursing team model in children with severe asthma.Methods:A total of 80 children with severe asthma admitted to the Respiratory Intensive Care Unit, Tangshan Maternal and Child Health Hospital of Hebei Province from October 2018 to October 2019 were selected and divided into control group and observation group according to the random number table, with 40 cases in each group. Children in control group were given routine nursing care, and children in intervention group were treated with the specialized nursing team model, and they were all treated until discharge. We compared the efficacy, disease perception with the Brief Illness Perception Questionnaire (BIPQ) , medical phobia with the Children's Medical phobia Questionnaire, and quality of life one month after discharge with the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) .Results:On the day of discharge, the total effective rate of clinical treatment of children in observation group was significantly higher than that of control group; and the scores of BIPQ and Children's Medical phobia Questionnaire of observation group were lower than those of control group, the differences were statistically significant ( P<0.05) . One month after discharge, the scores of symptom dimension and the total score of the PAQLQ of observation group were higher than those of control group, and the differences were statistically significant ( P<0.05) . Conclusions:The specialized nursing team model has a significant effect in the nursing care of severe asthma, which is conducive to improving the clinical efficacy of children, reducing children's disease perception and medical phobia, and improving children's quality of life.