There is a substantial unmet need for treatments in the field of pediatric rare diseases, and investigator initiated trial(IIT) provide a critical pathway for testing and developing new drugs or treatment strategies. However, healthcare institutions, when conducting such research, must address compliance risks related to project approval, contract management, data protection, and conflict of interest management. This study aims to analyze the particularities and challenges of IIT in pediatric rare diseases, review relevant regulations and regulatory requirements, and provide healthcare institutions with a reference framework for compliance risk management to maximize the benefits of IIT. Based on literature review, analysis of laws and regulations, practical work experience, and frameworks from other institutions, we summarize the unique aspects of pediatric rare disease IIT in terms of participant characteristics, innovative technologies, and organizational structures.On this basis, targeted compliance management recommendations are proposed, which include establishing a risk rating and full-cycle risk monitoring mechanism, a consent and ethical review mechanism tailored to pediatric participants, a robust contract management mechanism, a comprehensive data security management mechanism, and a multidisciplinary team and multi-channel compensation mechanism. The study concludes that healthcare institutions, funders, and other collaborating entities should implement compliance management in line with the characteristics of IIT to ensure the safety and effectiveness of research and facilitate innovation and development in the treatment of pediatric rare diseases.

Objective:To explore the application effect of Wenyang Jiangu Bao combined with Baduanjin in osteoporosis (OP) patients with kidney-yang deficiency.Methods:A total of 100 OP patients with kidney-yang deficiency who were initially hospitalized in Traumatology Department of the Second Affiliated Hospital of Hunan University of Chinese Medicine from January 2021 to May 2022 were selected by the convenient sampling method and they were randomly divided into the routine group, the packet group, Baduanjin group and the combined the Baduanjin group was treated with Baduanjin exercise on the basis of routine group, and the combined group was treated with Wenyang Jiangu Bao and Baduanjin combination measures on the basis of routine group. The intervention time was 12 weeks. The clinical curative effects, TCM syndrome score, lumbar bone density, the MOS Item Short from Health Survey (SF-36) score and Visual Analogue Scale (VAS) score of all groups before and after intervention were compared.Results:After intervention, the clinical curative effects of the combined group was better than that of the routine group and Baduanjin group, VAS score and TCM syndrome score were lower than those of other 3 groups, lumbar bone density and SF-36 score were higher than those of other 3 groups, and the differences were all statistically significant ( P<0.05) . Conclusions:Wenyang Jiangu Bao combined with simplified Baduanjin in treatment of osteoporosis patients with kidney-yang deficiency has a good clinical effect, which can improve the symptoms of lumbar pain and leg pain and traditional Chinese medicine symptoms of osteoporosis patients, increase the lumbar bone density of patients and improve the quality of life of them.

Circular RNA(circRNA)is an emerging class of endogenous non-coding RNA,which is widely expressed in the brain and plays an important role in a variety of biological processes.Research has shown that circRNA plays a key role in physiological and pathological processes of the brain,such as neurodevelopment,synaptic plasticity and neurodegenerative diseases through a variety of mecha-nisms such as adsorption of microRNA,binding to proteins and translation of peptides.In the field of drug addiction,the expression of circRNA is significantly changed in animal models and brains of addicts,and the regulation involves neural adaptation in brain regions that form the reward circuit such as the nucleus accumbens and prefrontal cortex.Additionally,addiction-related circRNAs are closely associated with neurotransmitter systems,signaling pathways,and neuroinflammatory responses,and they influ-ence the formation and maintenance of drug addiction by modulating gene expression networks related to drug addiction.Here,the biogenesis and regulatory mechanism of circRNA as well as its important role in brain function and drug addiction are reviewed in order to provide a new perspective for explora-tions of the pathological mechanism of drug addiction.

Objective:To investigate the value of 99Tc m-hydrazinonicotinamide (HYNIC)-prostate specific membrane antigen(PSMA) SPECT/CT imaging in biochemical recurrence of prostate cancer (PCa). Methods:From January 2018 to March 2023, 112 patients with biochemical recurrence of PCa (age (72.6±6.1) years) who underwent 99Tc m-HYNIC-PSMA SPECT/CT imaging in Henan Provincial People′s Hospital were retrospectively analyzed. According to the level of prostate specific antigen (PSA), patients were divided into 0.2 μg/L2 μg/L group. According to the Gleason score, patients were divided into Gleason score≥8 group and Gleason score <8 group. The detection rate between groups was analyzed by χ2 test, and the difference of the PSA level between groups was compared by Mann-Whitney U test. Results:PSMA imaging was positive in 77 cases and negative in 35 cases, with the detection rate of 68.8%(77/112). The detection rates of local recurrence, lymph node metastasis, bone metastasis and lung metastasis were 8.9%(10/112), 43.8%(49/112), 28.6%(32/112) and 0.9%(1/112), respectively. The detection rates of 0.2 μg/L2 μg/L groups were 44.7%(21/47), 8/12 and 90.6%(48/53), respectively ( χ2=24.44, P<0.001). The detection rates of Gleason score ≥8 group and <8 group were 76.4%(55/72) and 55.0%(22/40) ( χ2=5.47, P=0.032); the PSA level between the two groups was statistically different (3.11(0.75, 5.91) and 0.84(0.44, 2.92) μg/L; z=-2.99, P=0.003). Of the patients with PSMA positive imaging, 84.4%(65/77) changed their treatment regimen and 15.6%(12/77) continued to observe or maintain the original treatment plan. Of the patients with PSMA negative imaging, 40.0%(14/35) changed the treatment plan, 51.4%(18/35) continued to observe or maintain the original treatment plan, and 8.6%(3/35) discontinued the original treatment because no tumor metastasis was found. Conclusion:99Tc m-HYNIC-PSMA SPECT/CT imaging can provide reference for the lesion detection, treatment decision-making and follow-up observation of biochemical recurrence of PCa.

Objective:To explore the diagnostic value of quantitative 99Tc m-hydrazinonicotinamide(HYNIC)-prostate specific membrane antigen (PSMA) SPECT/CT in patients with prostate cancer. Methods:From November 2018 to March 2021, the data of 56 patients ((69.8±8.0) years) with clinically suspected prostate cancer, who had elevated radioactive uptake in prostate on 99Tc m-HYNIC-PSMA SPECT/CT images in Henan Provincial People′s Hospital, were retrospectively analyzed. According to the pathological results, patients were divided into prostate cancer group ( n=45) and non-prostate cancer group ( n=11). The xSPECT-QUANT software was used to quantitatively analyze the high uptake area of the prostate, and SUV max was measured. The independent-sample t test, Mann-Whitney U test, ROC curve and Spearman correlation analysis were used for data analysis. Results:The prostate cancer group had higher SUV max than non-prostate cancer group (10.79±5.96 vs 3.60±1.27; t=7.43, P<0.001). When SUV max≥6.46, the AUC of prostate cancer was 0.887, with the diagnostic sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 73.3%(33/45), 11/11, 100%(33/33), 47.8%(11/23), 78.6%(44/56), respectively. The SUV max of prostate cancer group was positively correlated with Gleason score ( rs=0.632, P<0.001). The SUV max of 29 patients with Gleason score≥8 was higher than that of 16 patients with Gleason score≤7 ( z=-3.89, P<0.001). There was no statistical difference in PSA level between patients with Gleason score≤ 7 and patients with non-prostate cancer ( z=-1.63, P=0.110), but the SUV max was significantly different ( z=-2.22, P=0.026). The SUV max of 23 patients with metastases was higher than that of 22 patients without metastasis (12.99±5.85 vs 8.50±5.28; t=2.69, P=0.010). ROC analysis showed that the AUC was 0.709; with SUV max≥13.02 as the threshold, the sensitivity for diagnosing prostate cancer metastases was 56.5%(13/23), the specificity was 86.4%(19/22), and the accuracy was 71.1%(32/45). Conclusions:The 99Tc m-HYNIC-PSMA SPECT/CT quantitative analysis is feasible in patients with prostate cancer. SUV max of 99Tc m-HYNIC-PSMA can be used in the diagnosis of prostate cancer, assessment of the malignancy and prediction of metastasis.

A case of polyarteritis nodosa was reviewed. The patient was a 58-year-old middle-aged man. He developed fever, headache, fatigue and other symptoms. Three weeks after, massive hematuria was seen. CT plain scan and MRI indicated blood clots in renal pelvis, and pericardium and pleural effusion. Renal arteriography indicated multiple venous fistula in both kidneys. Enhanced CT scan showed multiple small aneurysms in abdominal aortic branches, bilateral renal arteries and pancreatic arteries. The diagnosis of nodular polyarteritis was confirmed. Glucocorticoid and immunosuppressive agents were given. Meanwhile, highly selective renal arteriovenous fistula embolization was performed, Postoperative hematuria was effectively controlled, and the general condition was gradually improved. The patient was followed up for 2 months, and the condition was stable.

Background: The high sensitivity of individuals toward safety information in production activities, that is, attentional bias toward safety (ABS), can positively predict safe behaviors. It has become a hot topic in current organizational safety behavior research. However, there is no literature on its modification method. Methods: Based on the modified dot-probe task, we designed a modification training method of ABS. The training method required subjects to respond to the location of detection points that presented after safety stimulus and neutral stimulus pictures. Subjects' attentional bias values of safety and neutral pictures were measured during the experiment. Twenty-one students were selected and divided into a control group and training group to gain comparable results. Results: A novel training method was developed in this study to promote the efficacy of safety stimulus by activating ABS of the subjects. Moreover, repeated trainings and preacquired relative knowledge can enhance this effect. Conclusion This study develops an experimental approach to evaluate the effectiveness of safety education and safety training, and also provides a new research idea for accident prevention.

Background: The high sensitivity of individuals toward safety information in production activities, that is, attentional bias toward safety (ABS), can positively predict safe behaviors. It has become a hot topic in current organizational safety behavior research. However, there is no literature on its modification method. Methods: Based on the modified dot-probe task, we designed a modification training method of ABS. The training method required subjects to respond to the location of detection points that presented after safety stimulus and neutral stimulus pictures. Subjects' attentional bias values of safety and neutral pictures were measured during the experiment. Twenty-one students were selected and divided into a control group and training group to gain comparable results. Results: A novel training method was developed in this study to promote the efficacy of safety stimulus by activating ABS of the subjects. Moreover, repeated trainings and preacquired relative knowledge can enhance this effect. Conclusion This study develops an experimental approach to evaluate the effectiveness of safety education and safety training, and also provides a new research idea for accident prevention.

OBJECTIVE: To explore the relationship between occupational aluminum exposure and fasting blood glucose level in workers. METHODS: A cluster sampling method was used to select 178 occupational aluminum-exposed workers as the exposure group, and 178 workers without occupational aluminum exposure as the control group in a large aluminum factory in Shanxi Province. Glucose oxidase method was used to measure the fasting blood glucose level, and inductively coupled plasma mass spectrometry was used to measure the plasma aluminum level in these workers. A generalized linear model was used to analyze the correlation between plasma aluminum exposure level and fasting blood glucose in these workers. RESULTS: The blood aluminum level of workers in the exposure group was higher than that of the control group [median: 39.58 vs 16.67 μg/L, P<0.01]. The fasting blood glucose level of workers in the exposure group was higher than that of the control group [(5.33±0.79) vs(5.15±0.41) mmol/L, P<0.01]. The results of the generalized linear model analysis showed that the blood aluminum level of workers was positively correlated with their fasting blood glucose level after adjusting for age, body mass index, smoking, drinking, exercise, family history of diabetes, and incidence of diabetes(P<0.05). There was a dose-response relationship between the blood aluminum level and fasting blood glucose level of workers in the groups of junior high school and below and high school(all P_(trend)<0.01). There was no correlation found between blood aluminum level and fasting blood glucose level in the group of college and above(P_(trend)>0.05). There was a dose-response relationship between the blood aluminum level and the fasting blood glucose level in the workers in the non-exercise group(P_(trend)<0.01). There was no correlation found between the blood aluminum level and the fasting blood glucose level in the exercise group(P_(trend)>0.05). CONCLUSION: The blood aluminum level of workers exposed to occupational aluminum is positively correlated with their fasting blood glucose level. Higher education level or exercise can moderately reduce the effect of blood aluminum level on fasting blood glucose.

Objective To observe the retinal reattachment of suprachoroidal injection with sodium hyaluronate in the treatment of rhegmatogenous retinal detachment (RRD).Methods Twelve eyes of 12 patients with RRD diagnosed by the examinations of B-mode ultrasound,binocular indirect ophthalmoscope,OCT and scanning laser ophthalmoscope in West China Hospital of Sichuan University from October 2018 to February 2019 were included in this study.There were 7 males and 5 females,aged from 15 to 66 years,with the mean age of 32.40± 14.81 years.There were 4 eyes with BCVA＜0.1,4 eyes with BCVA 0.1-0.4,4 eyes with BCVA＞0.4.The extent of retinal detachment involves 1 to 4 quadrants.All eyes were injected with sodium hyaluronate via suprachoroidal space under non-contact wide-angle system.Surgery was performed by the same ophthalmologist with extensive surgical experience.During the operation,the retinal hole was handled with scleral freezing and laser photocoagulation.The follow-up was 2 months.The retinal reattachment was observed.Results Of the 12 eyes,6 eyes (50.00％) were anatomically reattached,4 eyes (33.33％) ere partly anatomically reattached with subretinal fluid,2 eyes (16.67％) were not reattached.The holes in 4 eyes of partly anatomically reattached with subretinal fluid were located on the choroidal pad and the holes were closed,in addition,the subretinal fluid gradually absorbed over time.Two eyes failed in retinal reattachment received vitrectomy with silicone oil tamponade or sclera buckling surgery.No severe complications such as endophthalmitis and choroidal hemorrhage were found at follow-up visits.Conclusion Suprachoroidal injection of sodium hyaluronate is an effective and safe treatment for RRD,which can promote retinal reattachment.