1.Expert consensus on the phase 0 clinical trials of positron-emitting radiopharmaceuticals (2025 edition)
Lu WANG ; Jinghao WANG ; Kuan HU ; Dongning YAO ; Benzhi CAI ; Chen SHI ; Baofeng YANG ; Rui WANG
China Pharmacy 2025;36(15):1825-1831
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.
2.Baihe Wuyaotang Ameliorates NAFLD by Enhancing mTOR-mediated Liver Autophagy
Rui WANG ; Tiantian BAN ; Lihui XUE ; Xinyi FENG ; Jiyuan GUO ; Jiaqi LI ; Shenghe JIANG ; Xiaolei HAN ; Baofeng HU ; Wenli ZHANG ; Naijun WU ; Shuang LI ; Yajuan QI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):66-77
ObjectiveTo investigate the therapeutic effect of Baihe Wuyaotang (BWT) on non-alcoholic fatty liver disease (NAFLD) and elucidate its underlying mechanism. MethodC57BL/6J mice were randomly assigned to six groups: normal control, model, positive drug (pioglitazone hydrochloride 1.95×10-3 g·kg-1), and low-, medium-, and high-dose BWT (1.3,2.5 and 5.1 g·kg-1). Following a 12-week high-fat diet (HFD) inducement, the mice underwent six weeks of therapeutic intervention with twice-daily drug administration. Body weight was monitored weekly throughout the treatment period. At the fifth week, glucose tolerance (GTT) and insulin tolerance (ITT) tests were conducted. Subsequently, the mice were euthanized for the collection of liver tissue and serum, and the subcutaneous adipose tissue (iWAT) and epididymal adipose tissue (eWAT) were weighed. Serum levels of total triglycerides (TG) and liver function indicators,such as alanine aminotransferase (ALT) and aspartate aminotransferase (AST), were determined. Histological examinations, including oil red O staining, hematoxylin-eosin (HE) staining, Masson staining, and transmission electron microscopy, were performed to evaluate hepatic lipid deposition, pathological morphology, and ultrastructural changes, respectively. Meanwhile, Western blot and real-time quantitative polymerase chain reaction (Real-time PCR) were employed to analyze alterations, at both gene and protein levels, the insulin signaling pathway molecules, including insulin receptor substrate 1/2/protein kinase B/forkhead box gene O1 (IRS1/2/Akt/FoxO1), glycogen synthesis enzymes phosphoenolpyruvate carboxy kinase (Pepck) and glucose-6-phosphatase (G6Pase), lipid metabolism-related genes stearoyl-coA desaturase-1 (SCD-1) and carnitine palmitoyltransferase-1 (CPT-1), fibrosis-associated molecules α-smooth muscle actin (α-SMA), type Ⅰ collagen (CollagenⅠ), and the fibrosis canonical signaling pathway transforming growth factor-β1/drosophila mothers against decapentaplegic protein2/3(TGF-β1/p-Smad/Smad2/3), inflammatory factors such as interleukin(IL)-6, IL-8, IL-11, and IL-1β, autophagy markers LC3B Ⅱ/Ⅰ and p62/SQSTM1, and the expression of mammalian target of rapamycin (mTOR). ResultCompared with the model group, BWT reduced the body weight and liver weight of NAFLD mice(P<0.05, P<0.01), inhibited liver lipid accumulation, and reduced the weight of white fat: it reduced the weight of eWAT and iWAT(P<0.05, P<0.01) as well as the serum TG content(P<0.05, P<0.01). BWT improved the liver function as reflected by the reduced ALT and AST content(P<0.05, P<0.01). It improved liver insulin resistance by upregulating IRS2, p-Akt/Akt, p-FoxO1/FoxO1 expressions(P<0.05). Besides, it improved glucose and lipid metabolism disorders: it reduced fasting blood glucose and postprandial blood glucose(P<0.05, P<0.01), improved GTT and ITT(P<0.05, P<0.01), reduced the expression of Pepck, G6Pase, and SCD-1(P<0.01), and increased the expression of CPT-1(P<0.01). The expressions of α-SMA, Collagen1, and TGF-β1 proteins were down-regulated(P<0.05, P<0.01), while the expression of p-Smad/Smad2/3 was downregulated(P<0.05), suggesting BWT reduced liver fibrosis. BWT inhibited inflammation-related factors as it reduced the gene expression of IL-6, IL-8, IL-11 and IL-1β(P<0.01) and it enhanced autophagy by upregulating LC3B Ⅱ/Ⅰ expression(P<0.05)while downregulating the expression of p62/SQSTM1 and mTOR(P<0.05). ConclusionBWT ameliorates NAFLD by multifaceted improvements, including improving IR and glucose and lipid metabolism, anti-inflammation, anti-fibrosis, and enhancing autophagy. In particular, BWT may enhance liver autophagy by inhibiting the mTOR-mediated signaling pathway.
3.Tianjin's occupational poisoning incidence: A comprehensive analysis, 2006—2020
Ya GAO ; Xin WANG ; Qiang ZENG ; Baofeng LIU ; Yu BAI
Journal of Environmental and Occupational Medicine 2024;41(6):668-672
Background At present, occupational poisoning has become one of the most serious occupational diseases that jeopardize the health of workers in China, in addition to pneumoconiosis, with a wide range of impacts and heavy social and economic losses. Objective To analyze the characteristics and patterns of the incidence of occupational poisoning in Tianjin from 2006 to 2020, and to provide a scientific basis for the development of effective intervention measures and prevention strategies. Methods The Occupational Diseases and Health Hazards Monitoring Information System, a module of the China Disease Prevention and Control Information System, was the primary data source of the study. The case files of acute and chronic occupational poisoning diagnosed by occupational disease diagnostic institutions in Tianjin from January 1, 2006 to December 31, 2020 were retrieved from the system. The data included basic information, occupational history, disease characteristics, and employer information. Excel 2016 was used to establish database, and frequencies and composition ratios were reported. Results From 2006 to 2020, a total of 234 cases of occupational chemical poisoning were reported in Tianjin, including 49 cases of acute occupational poisoning (20.94%) and 185 cases of chronic occupational poisoning (79.06%). The number of acute occupational poisoning cases showed a rising and then falling trend, and the number of chronic occupational poisoning cases showed an overall decreasing trend. Acute occupational poisoning mainly occurred in the four districts around the city (22 cases, 44.90%), and chronic occupational poisoning mainly occurred in Binhai New Area (90 cases, 48.65%). More male cases were reported than female cases. The age of onset was concentrated at 45-55 years old. The acute occupational poisoning cases were concentrated in the group with less than 5 years of service (22 cases, 44.90%), mainly asphyxiating gas poisoning, and the highest incidence was reported in chemical raw materials and chemical products manufacturing industry. The chronic occupational poisoning cases were concentrated in the groups with a working age of 5-14 years (70 cases, 37.84%), mainly organic solvent poisoning, and the highest incidence was also reported in chemical raw materials and chemical products manufacturing industry. Conclusion The prevention and control of occupational poisoning as well as health surveillance and management in Tianjin shall be carried out in a hierarchical and focused manner in accordance with types of acute and chronic occupational poisoning chemicals in the city, regional economic differences, types of industries, and distribution of workers.
4.Angiomatoid fibrous histiocytoma:a clinicopathologic study of fourteen cases
Baofeng YANG ; Libing FU ; Nan ZHANG ; Xingfeng YAO ; Jiatong XU ; Xiaoxing GUAN ; Jianwen WANG ; Lejian HE
Chinese Journal of Clinical and Experimental Pathology 2024;40(8):818-823
Purpose To study the clinical and pathological features of angiomatoid fibrous histocytoma(AFH)and to ex-plore its diagnosis,differential diagnosis and prognosis.Meth-ods The clinicopathological and follow-up data were analyzed in 14 cases of AFH,and the literatures were reviewed.Results There were 11 males and 3 females.The age ranged from 11 months to 12 years and 11 months,with average 5.9 years.3 cases were located in limbs,and 5 cases in trunk,5 cases in head and neck region,and 1 of intracranial tumor.Histological-ly,14 cases were composed of fibrous capsules and lymphocyte sheaths,and cell nucleus were vacuolar,forming fascicles with focal whirling and synteny.Intralesional pseudoangiomatous spaces were noted in 9 cases.Calcification was found in 2 ca-ses.2 cases showed high mitotic acticity(11/10 HPF).Scle-rosing and/or myxoid stroma was seen in 3 cases.Tumors were immunopositive for desmin(10/14),EMA(12/14),CD99(12/14),SMA(9/12),ALK(7/8),and the average of Ki67 index was 16%.7 cases harbored EWSR1 rearrangenent(part-ner gene not identified),2 cases had EWSR1-ATF1 fusion and 2 EWSR1-CREB1 fusion.Clinical follow-up information was a-vailable for 14 cases(average 46 months).All the 14 cases were alive without recurrence and metastasis.Conclusion AFH is a borderline or low-grade malignant tumor,often demon-strates indolent behavior in children,but rarely recurs and me-tastasizes.The diagnosis and differential diagnosis require a comprehensive analysis of clinical features,histopathologic changes,immunohistochemical finding and EWSR1 or FUS gene detection results.
5.Missense mutation analysis of the COL7A1 gene in a pedigree with dominant dystrophic epidermolysis bullosa
Linhong YU ; Huaiyu WANG ; Changhua ZHU ; Linxin DONG ; Baofeng WU ; Lihang LIN ; Xuemin XIAO
Chinese Journal of Dermatology 2024;57(5):455-458
Objective:To detect gene mutations in a pedigree with dominant dystrophic epidermolysis bullosa (DDEB) .Methods:A 20-year-old male proband presented with repeated blisters, ulceration, pigmentation, scars on the limbs, and deformation of the nails/toenails after birth. There were 5 patients in the 3-generation family, and they all presented with typical skin lesions. Peripheral blood samples were obtained from 14 members of the pedigree (including the 5 patients) and 100 unrelated healthy controls. Whole-exome sequencing was performed in the proband to identify relevant mutation sites, which were then confirmed in the family by Sanger sequencing.Results:Genetic testing indicated that the proband and the other 4 patients all carried a missense mutation (c.7885G>A) in exon 107 of the COL7A1 gene, resulting in the substitution of glycine by arginine at amino acid position 2629 (p.G2629R). The mutation was identified neither in the 9 healthy relatives nor in the 100 unrelated healthy controls. The mutation co-segregated with DDEB in the family, and was not included in databases such as Pubmed, HGMD or ClinVar, suggesting it was a novel missense mutation. The amino acid encoded by this mutation may alter the structure of type Ⅶ collagen, thereby affecting its function.Conclusion:A novel missense mutation was identified in exon 107 of the COL7A1 gene in the family with DDEB, expanding the spectrum of mutations in the COL7A1 gene.
6.Effect of comprehensive intervention on the incidence of lactation galactostasis during breasefeeding of pregnant and delivery women
Feng WANG ; Jiandong WANG ; Baofeng GUO ; Xuexia GU ; Ping LI ; Guanrong GAO ; Chunying ZHAO
Shanghai Journal of Preventive Medicine 2023;35(5):448-452
ObjectiveTo observe the effect of comprehensive intervention on the incidence of lactation galactostasis in communities from the perspective of preventive medicine, so as to prevent the occurrence of the mammary ducts obstruction disease. MethodsA total of 400 women in the early stage of pregnancy were selected from four communities. Those in two communities were set up as the intervention group. Comprehensive intervention for the prevention and treatment of mammary ducts obstruction disease during pregnancy and "Six-step recanalization manual therapy" practical guidance were conducted on the intervention group. The pregnant women from the other two communities were the control group, who received no intervention or guidance training. The two groups were followed up at 1 month, 3 months and 5 months postpartum, and the occurrence of mammary ducts obstruction disease was investigated and interventions were carried out. ResultsThe incidence of galactostasis in the intervention group was 26.0%, 10.6% and 5.1%, respectively at 1, 3 and 5 months after delivery, and the incidence of galactostasis in the control group was 38.0%, 22.2% and 8.3%, respectively. The incidence of galactostasis at 1 month and3 months after delivery was statistically different (P<0.05), while the incidence of galactostasis 5 months after delivery was not statistically different (P>0.05). The protection rates of comprehensive intervention on galactostasis were 31.58%, 52.25% and 38.55%, respectively. ConclusionPublicity and education work of prevention and control of the mammary ducts obstruction disease and "Six-step recanalization manual therapy" practical guidance can effectively reduce the occurrence of plugged mammary ducts, and therefore should be promoted.
7.Application of Linear Accelerator on Boarding Kilovolt Fan Beam CT and Megavolt Cone Beam CT System on Set-up Errors During Radiation Treatment
Yong ZHOU ; Zeying JIANG ; Baofeng SU ; Jianfeng ZHOU ; Qian WANG ; Anting WANG ; Jingxian LIU ; Yan XUE ; Huiyi FENG ; Xiaoliang WU ; Mingxing XIAO ; Wenyong TAN
Cancer Research on Prevention and Treatment 2023;50(11):1097-1102
Objective To quantify the setup errors for the different anatomical sites of patients who received intensity-modulated radiotherapy (IMRT) with linear accelerator on-board kilovolt fan beam CT(kV-FBCT) as non-isocenter IGRT and megavolt cone beam CT (MV-CBCT) as isocenter IGRT. Methods A retrospective analysis was performedon 70 patients who underwent radiotherapy, kV-FBCT, and/or MV-CBCT scans after each routine setup prior to IMRT. The average displacement (M), systematic error (Σ), and random error (б) at different treatment sites in the left-right, anterior-posterior, and cranial-caudal directions were calculated according to the individual displacements. The formula 2.5Σ+0.7б was used to estimate the PTV margin in respective direction. For each single patient, the root mean square in three directions was used as 3D displacement. Results A total of 1130 displacements were recorded in the 70 patients. The PTV margin was estimated to be 1.9-3.1 mm in head and neck cancer, 2.8-5.1 mm in thoracic cancer, 4.6-5.1 mm in breast cancer, 3.0-5.5 mm in upper abdominal cancer, and 3.5-6.8 mm in pelvic tumor. For the 3D mean displacements, the head and neck, thoracic, breast, upper abdominal, and pelvic cancer were 2.4±1.0, 4.0±1.6, 4.1±2.0, 4.6±2.1, and 4.6±2.1 mm, respectively. The average 3D displacement obtained by kV-FBCT and MV-CBCT were 4.1 and 3.4 mm, respectively (
8.Study on the mental health status and its influencing factors among middle school students in Yi nationality areas: a case study of Xide County, Liangshan Prefecture, Sichuan Province
Zhihong WU ; Jiayi WANG ; Hexiang BAI ; Yixian QIN ; Xiaoyu FENG ; Xing GAO ; Baofeng DI ; Chunping TAN ; Aoyi TANG ; Panpan GAO ; Bili DUAN ; Jiahe LIU ; Wei SHI
Sichuan Mental Health 2023;36(2):131-136
ObjectiveTo explore the mental health status and its influencing factors among middle school students in Xide County, Liangshan Yi Autonomous Prefecture, and to provide references for mental health interventions for local middle school students. MethodsUsing a cross-sectional study design, one junior middle school and one senior middle school in Xide County, Liangshan Prefecture, Sichuan Province, were randomly selected on September 16, 2021, and two classes per grade in each school involving 288 students were recruited. Subjects were assessed using Patients' Health Questionnaire Depression Scale-9 item (PHQ-9), Generalized Anxiety Disorder Scale-7 item (GAD-7), PTSD Checklist for DSM-5 (PCL-5), Multidimensional Scale of Perceived Social Support (MSPSS) and UCLA Loneliness Scale (ULS-3). Then the scores of above scales were compared among middle school students with different demographic characteristics, and binary Logistic regression analysis was conducted to screen the influencing factors of post-traumatic stress disorder (PTSD) symptoms. ResultsAmong the respondents, 17.71% (95% CI: 0.133~0.221), 8.68% (95% CI: 0.054~0.120), 2.78% (95% CI: 0.009~0.047) and 45.83% (95% CI: 0.400~0.516) were reported to have symptoms of depression, anxiety, PTSD and loneliness, respectively. Students in senior middle school scored lower on PCL-5 and ULS-3 than those in junior middle school [(6.46±8.91) vs. (8.87±9.42), t=2.202, P<0.05; (4.67±1.65) vs. (5.60±1.88), t=4.431, P<0.01]. Regression analysis denoted that depressive symptoms (OR=7.630, P<0.05) and anxiety symptoms (OR=3.789, P<0.01) were risk factors for PTSD symptoms among middle school students. ConclusionThe middle school students in Xide County, Liangshan Yi Autonomous Prefecture suffer a high prevalence rate of depressive symptoms and loneliness, and those in junior middle school are more likely to feel a sense of strong loneliness, furthermore, depressive symptoms and anxiety symptoms are risk factors for PTSD symptoms.
9.Effects of Transcranial Direct Current Stimulation on Endurance Performance of Lower Limbs:A Systematic Review
Bin SHEN ; Songlin XIAO ; Changxiao YU ; Baofeng WANG ; Weijie FU
Journal of Medical Biomechanics 2023;38(1):E202-E208
Sports fatigue of the lower limbs is one of the important factors affecting sports performance. How to improve the anti-fatigue ability of the lower limbs during endurance exercise is the focus of the research field of human sports biomechanics. This study systematically reviewed the relevant literature on transcranial direct current stimulation (tDCS) intervention on lower limb endurance performance, summarized the effect of tDCS on lower limb endurance performance, and analyzed the influencing factors and potential mechanisms. The results showed that: tDCS intervention has a significant effect on the endurance performance of the whole lower limbs, but there is no unified conclusion on the effect on the endurance performance of the knee joint. The researchers deem that tDCS can increase the excitability of the primary motor cortex and reduce the activation of the supplementary motor area and the premotor area to producing a lower rating of perceived exertion, but cannot affect the perception of exercise-induced pain, and stimulation protocols varied across studies, which may be partly responsible. This study can provide a theoretical basis for exploring the central mechanism of tDCS to improve endurance performance, formulating rehabilitation and sports training programsfor different groups of people, and developing new stimulation equipment to enhance the human body’s anti fatigue ability.
10.Neuroprotective effects of Longxue Tongluo Capsule on ischemic stroke rats revealed by LC-MS/MS-based metabolomics approach.
Jing SUN ; Xianyang CHEN ; Yongru WANG ; Yuelin SONG ; Bo PAN ; Bei FAN ; Fengzhong WANG ; Xiaonan CHEN ; Pengfei TU ; Jiarui HAN ; Huixia HUO ; Jun LI
Chinese Herbal Medicines 2023;15(3):430-438
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.

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