OBJECTIVE To investigate the effect of pharmaceutical services guided by root cause analysis （RCA） in a problem-oriented manner combined with knowledge-attitude-practice （KAP） theory on reducing the incidence of protocol violations of investigational medicinal products in pediatric clinical trials. METHODS A total of 617 participants from 69 drug clinical trial projects conducted in our hospital from January 2016 to December 2020 were selected as the control group， and 868 participants from 72 drug clinical trial projects from January 2022 to December 2025 as the observation group. RCA was performed on the protocol violations of investigational medicinal product in the control group to identify the types and underlying causes. The control group received routine pharmaceutical services for drug clinical trials， while the observation group was provided with precision pharmaceutical services from the three dimensions of knowledge， attitude and practice on the basis of routine pharmaceutical services， according to the root causes identified by RCA. The occurrence of investigational medicinal products protocol violations was compared between the two groups. RESULTS The total incidence of protocol violations of investigational medicinal products， as well as the incidences of minor and major protocol violations， were all significantly lower in the observation group than in the control group （ P ＜0.001）. The main types of protocol violations in both groups included missed/under-/over-dosing of medications， non-adherence to administration time， failure to adjust dosage as required， and combined medication/vaccination in violation of the protocol. Regarding the responsible subjects of protocol violations， the incidences of protocol violations attributed to participants and their guardians as well as investigators and accidental factors were significantly lower in the observation group than in the control group （ P ＜0.001， P ＜0.001， P ＝0.025）. However， there were no statistically significant differences in the incidences of protocol violations caused by sponsor-related reasons between the two groups （ P ＞0.05）. CONCLUSIONS Pharmaceutical services led by pharmacists， based on problem-oriented RCA and combined with KAP theory， can effectively reduce the protocol violations of investigational medicinal products rate in pediatric clinical trials， thereby safeguarding the safety and rights of study participants.

Central serous chorioretinopathy(CSC)is a macular disease predominantly affecting young to middle-aged adults, characterized by serous retinal detachment in the posterior pole, leading to symptoms such as decreased central vision, visual distortion, and color changes. The disease has a certain degree of self-limitation but can recur. The pathogenesis is still uncertain and the treatment is controversial. Commonly used treatments include medication, retinal laser, photodynamic therapy(PDT)and vitreous anti-vascular endothelial growth factor(VEGF)therapy which have emerged in recent years, but the treatment of recurrent CSC is still tricky. The purpose of this article is to review the current therapeutic approaches regarding CSC, with a view to providing a reference for clinical treatment.

Objective To study the relationships between Helicobacter pylori(Hp)infection and the occurrence of osteoporosis via Meta-analysis.Methods Two researchers independently retrieved related literature related to the association between Hp infection and osteoporosis and published in such databases as PubMed,EMBASE and Cochrane Library,China Science and Technology Journal Database,China National Knowledge Infrastructure(CNKI),and Wanfang Database as of February 2024.STATA 11.0 software was used for Meta-analysis before the combined OR value and its 95％CI were calculated.Results Twenty-four studies involving 24 936 participants were included in the study.Meta-analysis showed that Hp infection was significantly associated with the risk of osteoporosis(OR:1.52,95％CI:1.17-1.99).Those infected with the CagA-positive Hp strain were more likely to develop osteoporosis(OR:2.42,95％CI:1.32-4.43).Hp infection was significantly associated with decreased bone mass(OR=1.32,95％CI:1.08-1.62),but the decrease of bone mineral density in Hp-positive patients was not significant compared with Hp negative controls.Conclusion Infection with Hp,particularly the CagA-positive strain,has been associated with an increased risk of osteoporosis.The bone health of Hp-positive patients deserves more attention.

Objective:To observe the effects of moxibustion at Shenshu(BL23)and Zusanli(ST36)on Toll-like receptor 4(TLR4)-myeloid differentiation factor 88(Myd88)signaling pathway-mediated inflammatory factors in the synovial tissue of ankle joints of rats with rheumatoid arthritis(RA),and to explore the molecular and biological mechanisms underlying the anti-inflammatory and analgesic effects.Methods:A total of 24 male Sprague-Dawley(SD)rats were randomly divided into a normal group,a model group,and a moxibustion group,with 8 rats in each group.The RA model was established with exposure to wind,cold,and damp environmental factors,along with Freund's complete adjuvant.After three days of modeling,mild moxibustion was applied to bilateral Shenshu(BL23)and Zusanli(ST36)in the moxibustion group using moxa sticks of 0.9 cm in diameter for 30 min each time,once a day for 14 d.Structural changes in the synovial tissue and cells were then observed using hematoxylin-eosin staining and transmission electron microscopy,while immunohistochemistry analysis was used to detect tumor necrosis factor(TNF)-α,interleukin(IL)-17,IL-1β,and IL-6 levels.Moreover,the protein expression levels of Myd88,TLR4,and transient potential receptor vanilloid type 1(TRPV1)in the synovial tissue were detected using Western blotting,while their mRNA expression levels were detected using reverse transcription-polymerase chain reaction.Finally,the levels of IL-1β,IL-2,IL-6,IL-17A,and TNF-α in rat serum were detected using enzyme-linked immunosorbent assay.Results:Compared to the normal group,the model group exhibited notable pathological synovial tissue damage,along with significantly higher IL-1β,IL-6,and TNF-α levels(P<0.01)and a slightly higher IL-17 content(P>0.05).Furthermore,the Myd88,TLR4,and TRPV1 protein and mRNA expression levels and serum IL-1β,IL-2,IL-6,IL-17A,and TNF-α levels were all significantly higher in the model group than in the normal group(P<0.01).Compared to the model group,the moxibustion group exhibited a lower degree of synovial tissue pathological damage,along with significantly lower IL-1β,IL-6,and TNF-α levels(P<0.05 or P<0.01)and a lower IL-17 content without statistical significance(P>0.05).Moreover,the Myd88,TLR4,and TRPV1 protein and mRNA expression levels,and serum IL-1β,IL-2,IL-6,IL-17A,and TNF-α levels were all significantly lower in the moxibustion group than in the model group(P<0.01 or P<0.05).Conclusion:Mild moxibustion at Shenshu(BL23)and Zusanli(ST36)can effectively inhibit TLR4-MyD88 signaling pathway-mediated inflammatory factor expression in the synovial tissue of ankle joints of RA rats.Furthermore,the effect of moxibustion on synovial tissue inflammation in RA rats may be attributed to TRPV1 channel activation.

Objective:To investigate the value of transabdominal bowel ultrasonography (TBUS) in evaluating the active phase of Crohn′s disease (CD) and its complications, and to compare the diagnostic efficacy of the international bowel ultrasound segmental activity score (IBUS-SAS) and the multidetector computed tomography enterography (MDCTE) score in the active phase.Methods:A totle of 103 CD patients who were admitted to the Nanjing Drum Tower Hospital from March 2021 to May 2023 were retrospectively analyzed. All patients underwent TBUS and MDCTE examinations. TBU parameters such as bowel wall thickness (BWT), color Doppler imaging signal (CDS), inflammatory fat (i-fat), and bowel wall stratification (BWS) were recorded. The patients were divided into the remission group and the active group based on the Crohn′s disease activity index. The latter group was further divided into the mild active group and the moderate-to-severe active group.Receiver operating characteristic curves (ROC) were plotted, and the diagnostic efficacy of TBUS parameters and two scoring systems in assessment of the active phase of CD was evaluated by sensitivity, specificity, area under the curve (AUC), and optimal cut-off values. Endoscopic or histopathological results were served as the gold standard for the diagnosis of intestinal strictures. The diagnostic efficacy of TBUS and MDCTE in CD complicated with intestinal stenosis were evaluated by ROC analysis. Spearman correlation analysis was performed to analyze the correlation between TBUS parameters, imaging scores, and clinical laboratory indicators such as erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and faecal calprotectin (FC).Results:In distinguishing the active phase and the remission phase of CD, BWT (a sensitivity of 85.7%, specificity of 90.9%, and cut-off value of 4.4 mm), CDS (a sensitivity of 95.7%, and specificity of 63.6%), IBUS-SAS (a sensitivity of 91.4%, specificity of 84.8%, and cut-off value of 23.8), and MDCTE score (a sensitivity of 77.1%, specificity of 75.8%, and cut-off value of 6.5) had high diagnostic efficacies. In distinguishing mild and moderate-severe active phases of CD, BWT, CDS and i-fat demonstrated high sensitivity (81.4%, 69.8% and 62.8%) and specificity (81.5%, 77.8% and 100.0%); IBUS-SAS (a sensitivity of 83.7%, specificity of 88.9%, and cut-off value of 40.0) and MDCTE score (a sensitivity of 83.7%, specificity of 85.2%, and cut-off value of8.5) had high diagnostic efficacy. In the diagnosis of CD complicated with intestinal stenosis, the AUC, sensitivity, specificity, and accuracy of MDCTE was 0.942, 94.0%, 94.3%, and 94.2%, respectively. The AUC, sensitivity, specificity, and accuracy of TBUS in the diagnosis of CD complicated with intestinal stenosis was 0.952, 96.0%, 94.3%, and 95.1%, respectively. The results of Spearman correlation analysis revealed that BWT, CDS, and i-fat have positively correlated with ESR, CRP, and FC ( r value: 0.252 to 0.451, all P<0.05). Conclusions:TBUS demonstrates good application value in evaluating the activity of CD and intestinal stenosis. IBUS-SAS has the potential application for precise assessment of CD activity.

Objective:To develop a treatment-related quality of life scale for Chinese patients with multiple myeloma (MM) and to test its reliability and validity.Methods:The initial scale was constructed through a literature search, Delphi expert correspondence, and cognitive testing. This study conducted a preliminary survey of 379 patients with MM and a formal survey of 865 patients from the hematology departments of 155 hospitals nationwide from February 2024 to March 2024. The final scale was obtained after conducting item analysis and reliability and validity tests on the initial scale.Results:The constructed scale contains 36 items covering six domains: physiological, psychological, social, treatment side effects, general health, and others. In the preliminary survey, the Cronbach’s alpha coefficient of each item ranged from 0.597 to 0.939, and the test-retest reliability was 0.747 ( P<0.001). Exploratory factor analysis extracted eight common factors with a cumulative variance contribution of 60.058%. In the formal survey, the Cronbach’s alpha coefficient of each item ranged from 0.484 to 0.930, and the test-retest reliability was 0.835 ( P<0.001). Confirmatory factor analysis revealed a comparative fit index of 0.750, a root-mean-square error of approximation of 0.090, and a root-mean-square residual of 0.067. Conclusion:The treatment-related quality of life scale for Chinese patients with MM designed in this study exhibited good reliability and validity, reflecting the impact of treatment on the quality of life of patients. This scale can provide a reference to clinicians for assessing the disease status of patients.

Objective:To evaluate the clinical efficacy, safety and treatment persistence of upadacitinib in Crohn's disease (CD) patients.Methods:The single-center retrospective cohort study was conducted. The patients with moderate-to-severe active CD initiating upadacitinib therapy from November 2023 to November 2024 in Nanjing Drum Tower Hospital were collected through searching the electronic medical records and paper-based patient databases. The primary outcome was the clinical remission rate at week 12. Secondary outcomes included the clinical response rate at week 12; clinical response and remission rates at weeks 4, 24 and 48; biomarker (fecal calprotectin or C-reactive protein) remission rates at all time points; as well as endoscopic remission and response rates, treatment persistence and safety evaluation.Results:A total of 44 CD patients were included, comprising 24 males (54.5%) and 20 females (45.5%). The median age was 33 (25, 40) years. The baseline Crohn's disease activity index (CDAI) score was 260.5 (225.9, 550.0) points. Patients had previously received a median of 2 (1, 2) biologic treatments. All 44 patients completed the 12-week induction therapy. With a median follow-up of 30.00 (16.25, 46.25) weeks, the clinical remission rate was 50.0% (22/44) at week 12. The clinical remission rate, clinical response rate, and biomarker remission rate were 52.3% (23/44), 88.6% (39/44) and 72.7% (32/44) respectively at week 4, and the clinical response rate and biomarker remission rate were 88.6% (39/44) and 77.2% (34/44) respectively at week 12. The clinical remission rates, clinical response rates and biomarker remission rates evolved to 43.3% (13/30), 86.7% (26/30) and 80.0% (24/30) at week 24, and further to 44.4% (4/9), 77.8% (7/9) and 77.8% (7/9) at week 48. During the follow-up period, 13 CD patients completing endoscopic evaluation, endoscopic remission and response rates were 30.8% and 23.1% respectively. CD-related surgery rate was 4.5% (2/44). Safety analysis demonstrated that the overall adverse events rate was 56.8% (25/44) including 7 patients with serious adverse events. A total of 8 patients discontinued treatment, among which 3 were due to primary loss of response, 1 due to secondary loss of response, 2 due to drug-related adverse events alone, and 2 due to concurrent primary loss of response and adverse events. The Kaplan-Meier curve for treatment persistence showed that among 39 CD patients who achieved clinical response at week 12, the continued treatment rates were 90.3% at week 12 and 85.3% at week 24 of follow-up. Two patients (5.6%) received dose escalation of upadacitinib, both of whom achieved clinical remission.Conclusion:Real-world research data demonstrate that upadacitinib exhibits significant clinical efficacy and a favorable safety profile in the treatment of moderate-to-severe active CD patients with prior biologic exposure, and no new unexpected adverse events are identified.

Objective:This study starts from the main problems existing in the current stage of the development of pediatric clinical research in China and focuses on the construction of a clinical research management system. By innovating the platform management model and enhancing personnel skills, we can provide support and assurance for improving the clinical research platform and its sustainable development in the future.Methods:This study established an integrated management platform for Industry-Sponsored Initiated Clinical Research Trial (IST) and Investigator Initiated Clinical Research (IIT) and implement integrated management of IST and IIT projects. At the same time, in response to the weak links in quality management, synchronous training of management and research talents should be implemented to achieve dual improvement in project management quality and platform service efficiency throughout the process.Results:We had optimized the clinical research organization structure, improved the management system, and strengthened the quality supervision of IIT projects by establishing rules and systems to improve the quality and efficiency of project management.Conclusions:Based on analyzing the current situation in China and referring to international experience, we have built a clinical research management platform in line with the development of the hospital, and implemented centralized management of the entire process of IST and IIT projects, strengthened project process quality control, which is expected to provide a reference for peers.

Objective:In response to the current situation where Investigator-Initiated Trial (IIT) management system of pediatric medical institutions in our country is inadequate and the management of high-risk projects needs to be strengthened, a pediatric hospital in Beijing has been selected as a pilot to develop a system and process suitable for IIT management. We aim to explore personalized management models for different types of research projects, especially high-risk ones, to improve the quality of pediatric IIT, reduce research risks, and enhance management efficiency.Methods:By analyzing the current management situation of high-risk pediatric IIT, optimization strategies were proposed to improve the internal IIT project management system and processes of the pilot unit, and effective management measures are promoted.Results:By revising the IIT project management system, improving the project application and approval processes, strengthening process quality control and personnel training, the risk control and quality supervision of such projects had been enhanced, thereby improving project quality and ensuring the rights and interests of research participants.Conclusions:After the pilot unit trialed a series of management measures for high-risk IIT projects, researchers' risk awareness has significantly increased, and project quality has been effectively improved. The Results provide a reference and model for peers in establishing management rules and also offer theoretical and practical foundations for improving the management system of high-risk clinical research.

Objective To explore the potential categories of exercise perception in elderly hip arthroplasty(HA)patients,analyze the prediction factors of different categories,and provide references for clinical nursing.Methods A convenience sampling method was used to select elderly HA patients treated in 6 orthopedic wards of 2 tertiary A hospitals in Guilin from October 2024 to February 2025.The general data questionnaire,Exercise Benefits and Barriers Perception Scale for Hip/Knee Throplasty Patients,Tampa Scale of Kinesiophobia,the 5-Factor Modified Frailty Index,and Self-Efficacy for Rehabilitation Outcome Scale were used for investigation.Latent profile analysis was used to identify the potential categories of exercise perception of elderly HA patients,and decision tree model was used to explore the core predictive factors of different profile.Results 222 valid questionnaires were collected,with an effective response rate of 96.52％.A total of 222 elderly HA patients were divided into 3 profiles:high benefit-low barrier group(19.82％),low benefit-high barrier group(22.07％),and mild barrier group(58.11％).Frailty,kinesophobia,rehabilitation self-efficacy,residence,educational level and daily exercise were significant predictors of latent profiles(P＜0.05),and the frailty was located in the root node of the decision tree model.Conclusion The level of exercise perception in elderly HA patients needs to be improved,and shows population heterogeneity.Medical staff should prioritize interventions for low benefit-high barrier and mild-barrier groups,implementing targeted strategies based on profile characteristics and predictive factors to improve their exercise perception.