OBJECTIVE To provide a reference for standardizing the conduct of positron-emitting radiopharmaceuticals’ phase 0 clinical trials （hereinafter referred to as “phase 0 clinical trials”） and advancing the development of innovative drug by medical institutions. METHODS Initiated by the First Affiliated Hospital of Jinan University， a panel of experts consisting of pharmacy， clinical medicine and medical ethics from multiple institutions was established to investigate the current landscape， and discuss the necessary conditions， procedures， and other aspects for conducting phase 0 clinical trials in medical institutions by integrating relevant national policies， regulations and expert consensus. Finally， an agreement was reached to formulate this consensus. RESULTS & CONCLUSIONS Currently， most medical institutions have deficiencies in pharmaceutical care during the management of radiopharmaceuticals and the phase 0 clinical trials. In conjunction with the Expert Consensus on the Establishment of Nuclear Pharmacist Positions， this consensus explicitly defines the responsibilities of nuclear pharmacists in the phase 0 clinical trials on the basis of the Expert Consensus for the Application of Positron Emission Tomography Radioligands for Translational Study in the Phase 0 Clinical Trials （2020 edition）， providing a guidance for high-quality participation of nuclear pharmacists from medical institutions in China in phase 0 clinical research. Additionally， in consideration of some constraints imposed by current relevant regulations， this consensus also proposes strategic recommendations， such as encouraging medical institutions to form a consortium， leading to the establishment of dedicated bases or industrial parks， holding significant implications to strengthen institutional capacity for advancing radiopharmaceutical innovation through phase 0 clinical trials.

OBJECTIVE To analyze the clinical characteristics and influential factors of drug-induced liver injury （DILI） in children caused by intravenous azithromycin. METHODS Clinical data of 157 DILI pediatric cases caused by intravenous azithromycin， reported by the Hengshui Adverse Drug Reaction Monitoring Center from January 2015 to January 2025， were collected as the observation group. Clinical data of pediatric patients who received intravenous azithromycin but did not develop DILI during the same period at Hengshui People’s Hospital were collected in a 1∶1 ratio to serve as the control group. The clinical classification， severity and prognosis of DILI in pediatric patients from the observation group were analyzed. Univariate and multivariate Logistic regression analyses were used to screen the independent risk factors for DILI in children caused by intravenous azithromycin. RESULTS Among 157 DILI cases， 92 cases （58.60%） had hepatocellular injury-type， 51 cases （32.48%） had cholestatic-type， and 14 cases （8.92%） had mixed-type. DILI severity was grade 1 in 117 cases （74.52%）， grade 2 in 33 cases （21.02%）， and grade 3 in 7 cases （4.46%）. Liver function had all recovered after stopping medication and symptomatic treatment. Combined with acetaminophen [OR＝3.769， 95%CI （1.615， 8.235）， P＝0.021]， daily dose of azithromycin＞10 mg/kg [OR＝ 2.237， 95%CI （1.075， 4.655）， P＝0.034] were independent risk factors for DILI in children caused by intravenous azithromycin. CONCLUSIONS Hepatocellular injury-type and cholestatic-type are relatively common in children with DILI caused by intravenous azithromycin， with mild severity being predominant and showing a favorable prognosis. Combination with acetaminophen and daily dose＞10 mg/kg are independent risk factors for azithromycin-induced DILI in children.

OBJECTIVE: The present study aimed to evaluate the therapeutic effect and explore the underlying mechanisms of Longxue Tongluo Capsule (LTC) on ischemic stroke rats. METHODS: Twenty-six rats were randomly divided into four groups, including sham group, sham + LTC group, MCAO group, and MCAO + LTC group. Ischemic stroke rats were simulated by middle cerebral artery occlusion (MCAO), and LTC treatment group were orally administrated with 300 mg/kg of LTC once daily for seven consecutive days. LTC therapy was validated in terms of neurobehavioral abnormality evaluation, cerebral infarct area, and histological assessments. The plasma metabolome comparisons amongst different groups were conducted by UHPLC-Q Exactive MS in combination with subsequent multivariate statistical analysis, aiming to finding the molecules in respond to the surgery or LTC treatment. RESULTS: Intragastric administration of LTC significantly decreased not only the neurobehavioral abnormality scores but also the cerebral infarct area of MCAO rats. The interstitial edema, atrophy, and pyknosis of glial and neuronal cells occurred in the infarcted area, core area, and marginal area of cerebral cortex were improved after LTC treatment. A total of 13 potential biomarkers were observed, and Youden index of 11 biomarkers such as LysoPC, SM, and PE were more than 0.7, which were involved in neuroprotective process. The correlation and pathway analysis showed that LTC was beneficial to ischemic stroke rats via regulating glycerophospholipid and sphingolipid metabolism, together with nicotinate and nicotinamide metabolism. Heatmap and ternary analysis indicated the synergistic effect of carbohydrates and lipids may be induced by flavonoid intake from LTC. CONCLUSION The present study could provide evidence that metabolomics, as systematic approach, revealed its capacity to evaluate the holistic efficacy of TCM, and investigate the molecular mechanism underlying the clinical treatment of LTC on ischemic stroke.

Objective To evaluate the rupture risk of carotid atherosclerotic plaque under cervical rotatory manipulation. Methods The fluid-structure interaction (FSI) model of carotid atherosclerotic plaque was established, and tensile deformation of the plaque and lumen under cervical rotatory manipulation was simulated.Mechanical parameters such as the maximum flow shear stress(FSS), the maximum wall shear stress (WSS), the maximum plaque wall stress (PWS), wall tensile stress (WTS) and wall pressure (WP) of the plaque and lumen were recorded. Results Under 16% carotid tensile deformation, the maximum WSS of the plaque was 40.54 Pa. The maximum PWS was 66.16 kPa, which was far smaller than the threshold of plaque rupture.The maximum WTS of fiber cap and the maximum strain were 156.75 kPa and 0.56, which were larger than the fracture strain range. The maximum WTS of the lumen was 1 040.30 kPa, which approached the threshold of medial membrane rupture and might cause vascular injury. Conclusions When the cervical spine rotates to the end range of motion, large carotid artery stretch may cause damage to epidermal tissues of the plaque, leading to abscission. Lesions, ulcers, bleeding and vascular damage may form inside the plaque, which will affect stability of the plaque. Cervical rotatory manipulation should be performed cautiously in patients with cervical diseases who also have carotid atherosclerotic plaques.The finite element assessment of plaques before manipulation may be an effective safety screening method.

Objective:To investigate the expression of circhipk3 in microglial cells in heat-induced neurological injury, and to preliminary analyze the effect of circhipk3 on microglial polarization in heat-induced neurological injury.Methods:Mice were randomly (random number) divided into a control group and a heat radiation disease 0.8 h group (HS 0.8), a heat radiation disease 8h group (HS 8), and a heat radiation disease 24 h group (HS 24). By establishing a mouse model of heat shock (HS), heat-damaged brain tissue was obtained, microglia were isolated and RNA was extracted. Quantitative PCR method was used to detect M1 and M2 marker molecules in microglia, and to evaluate the polarization direction and type of microglia. The expression level of circhipk3 was detected in microglial cells in heat-induced neurological injury, and the effect of circhipk3 on microglial polarization was further elucidated by intervening the expression of circhipk3 in microglial cells.Results:The expression of CD45 and CD11-b in the HS 8 group was significantly higher than that in the control group [(4.41±0.18) vs. (1±0.15), P=0.000], [(3.47±0.19) vs (1±0.15), P=0.000] , and the CD45 and CD11-b of the HS 24 group was significantly lower than that of the HS 8 group [(1.34±0.15) vs. (4.41±0.18), P=0.000], [(1.38±0.21) vs. (3.47±0.19), P= 0.001]. At the same time, the expression of CD206, FIZZ and Arg1 in the HS 8 group started to increase compared with the control group [(1.59±0.16) vs. (1±0.12), P=0.014], [(1.62±0.15) vs. (1±0.15), P=0.002 ], [(2.23±0.28) vs. (1±0.19), P=0.004], and CD206, FIZZ, and Arg1 in the HS 24 group were significantly higher than those in the control group [(2.67±0.20) vs. (1±0.12), P=0.002], [(2.19±0.15) vs. (1±0.15), P=0.000], [(3.04±0.18) vs. (1±0.19), P=0.001]; circhipk3 mimicis significantly increased the expression of Arg1 [(7.26± 0.06) vs. (3.86±0.06), P=0.000]; at the same time, circhipk3 inhibitor promoted the expression of CD45 and HO-1 [(2.96±0.03) vs. (1.63±0.09), P=0.000], [(2.52±0.10) vs. ( 1.30±0.02), P=0.000]. Conclusions:Microglial cells are predominantly M1-type in early neurological injury of heat radiation disease. HO-1 may be one of the microglial M1-type markers. The high expression of circhipk3 in microglial cells mainly promotes its transformation to M2 type.

Objective:To investigate the standardized training needs of new nurses in Yunnan province and provide scientific basis for the formulation of standardized training programs for new nurses.Methods:From December 2019 to September 2020, nurses from all 5 provincial tertiary Class A hospitals in Yunnan Province were selected as the research objects. A questionnaire survey was conducted among 712 nurses selected by the convenience sampling method, among which 456 were new nurses and 256 were senior nurses. The questionnaire was designed by the research team based on the Training Outline for Newly Recruited Nurses, which mainly included three dimensions of knowledge, skills and attitude.Results:The total score of new nurses and senior nurses on standardized training requirements for new nurses were (575.32 ± 85.76) points and (583.16 ± 86.32) points, which were above the average level. There was no statistically significant difference between the scores of training theme needs of new nurses and those of senior nurses ( t value was -1.168, P>0.05). Conclusions:The total score of standardized training needs of new nurses is above the average level, and the demand for knowledge dimension in standardized training of new nurses is the strongest. It is suggested to develop a systematic and scientific standardized training plan for new nurses according to the training needs and training methods.

Objective:To investigate the implementation procedures and dosimetric verification of the first patient treated with total body irradiation (TBI) based on volumetric modulated arc therapy (VMAT).Methods:Two sets of CT images were acquired under the head-in first and foot-in first to contour the planning target volume (PTV) of the cranial and caudal segments to accomplish the treatment of the whole body length, on which two interrelated plans of 5 subsequent isocenters with a total of 15 VMAT fields were performed to cover all PTVs. The plans were prescribed to ensure 90% PTV dose coverage with a total dose of 12 Gy in 6 fractions. Firstly, a dose optimization was performed on the caudal CT images, then the cranial CT images were optimized based on the dose distribution of the caudal CT images. The evaluation of the final treatment plan was carried out based on a plan sum of both two sets of images. The parameters of PTV and organs at risk (OARs) were measured by dose volume histograms from the accumulated plan. The quality assurance comprised the verification of the VMAT plans for each individual isocenter via Delta4 phantom. The dose distribution in the overlapped region between two adjacent central fields was verified with EBT3 film. The absolute dose at the overlapped region between two images was measured via Pinpoint chamber. In vivo dosimetry on the patient′s skin was monitored by MOSFET dosimeters. The results of planning parameters and treatment duration were analyzed. Results:The mean doses of two segments of PTVs were 12.45 Gy and 12.37 Gy. The mean dose for the lung was 10.8 Gy. The machine unit (MU) and mean treatment delivery time were 2 883 MU and 24.3 min, and the mean total time per fraction was 121 min. The mean 3%/3 mmγ-analysis pass rate for each isocenter VMAT plan was (99.74±0.42)%, and the mean 5%/5 mmγ-analysis pass rate for the overlapped region was (90.11±2.72)%. The average deviation of absolute dose in the overlap region of the caudal and cranial images was (3.6±0.4)%. In vivo measurement of 8 points on the patient showed that the dose of each region was ranged from 1.57 Gy to 2.04 Gy. Conclusion:According to the results of dosimetric verification, TBI based on multi-isocenter VMAT can be applied in clinical practice, which remains to be improved in terms of dose distribution, measurement results and clinical efficiency.

Peritoneal adhesions are fibrous tissues that tether organs to one another or to the peritoneal wall and represent the major cause of postsurgical morbidity. Enterolysis at repeat surgeries induces adhesion reformation that is more difficult to prevent than primary adhesion. Here we studied the preventive effects of different approaches of berberine treatment for primary adhesion, and its effects on adhesion reformation compared to Interceed. We found the primary adhesion was remarkably prevented by berberine through intraperitoneal injection 30 min before abrasive surgery (pre-berberine) or direct addition into injured cecum immediately after the surgery (inter-berberine). Rats with adhesion reformation had a more deteriorative collagen accumulation and tissue injury in abrasive sites than rats with primary adhesion. The dysregulated TIMP-1/MMP balance was observed in patients after surgery, as well as adhesion tissues from primary adhesion or adhesion reformation rats. Inter-berberine treatment had a better effect for adhesion reformation prevention than Interceed. Berberine promoted the activation of MMP-3 and MMP-8 by directly blocking TIMP-1 activation core, which was reversed by TIMP-1 overexpression in fibroblasts. In conclusion, this study suggests berberine as a reasonable approach for preventing primary adhesion formation and adhesion reformation.

Objective:To understand the status quo of patient safety cultural cognition among nurses in a senior friendly hospital, and analyze the influencing factors of their patient safety cultural cognition, in order to provide a basis for formulating nursing safety management measures.Methods:Totally 360 clinical in-service nurses from 26 nursing units in a senior friendly hospital were investigated with the Hospital Survey on Patient Safety Culture (HSOPSC) and the Nurse Psychological Contract Scale. Single factor analysis, correlation analysis and multiple linear regression analysis were used to analyze the influencing factors of their patient safety cultural cognition.Results:The total score of nurses' patient safety cultural cognition was (173.74±16.04) , which was positively correlated with the total score of psychological contract and the scores of its various dimensions ( P<0.01) . Multiple linear regression analysis showed that the hospital's team responsibility and development responsibility were the influencing factors for the scores of nurses' patient safety cultural cognition. Conclusions:Generally, nurses have a good understanding of patient safety culture. There is still much room for improvement in the hospital responsibilities of the nurses' psychological contract, especially the hospital's team responsibility and development responsibility. Managers should improve the level of nurses' psychological contract by supporting team behavior in hospital management and providing guarantees for development, so as to further enhance the nurses' patient safety cultural cognition, and enabling nurses to form positive awareness and behaviors of patient safety.

Objective:To investigate the situation of wearing protective equipment in the process of X-ray radiation examination (including DR and CT) in a 3A general hospital, so as to provide technical basis and solutions for better reducing the radiation dose of accompanying patients.Methods:From November 1, 2018 to June 30, 2019, the accompanying examinee 6 who had to stay in the examination room during the radiology examination (X-ray and CT examination) of a 3A general hospital from June 1, 2018 to June 30, 2019 was selected 535 people were divided into three groups according to whether they were reminded and instructed to wear protective equipment: group A was not reminded (group A) , group B was reminded to wear protective equipment, and group C was reminded and instructed to wear protective equipment (Group C) .Results:The wearing rates of protective equipment of the three groups were 35.0% (744/2126) , 85.2% (1858/2181) and 91.0% (2028/228) , and the complete wearing rates were 15.0% (319/2126) , 54.8% (1195/2181) and 88.0% (1960/228) , respectively. 4% (1450/3060) , 28.6% (876/3060) , 24.0% (734/3060) , respectively. 523 patients refused to wear protective equipment. The main reasons were emotion (33.8%, 177/523) and time (32.5%, 170/523) .Conclusion:The intervention of radiation workers can effectively improve the correct wearing rate of protective equipment and reduce the radiation exposure of accompanying people.