1.Expert consensus on dispensing management of intravenous infusion drugs for clinical trials in PIVAS
Xingchen YANG ; Wenhuan FU ; Donghui LAO ; Jing ZHAO ; Jianzhong ZHANG ; Group PHARMACY ; Committee HOSPITAL ; Association Pharmaceutical SHANGHAI
China Pharmacy 2025;36(1):1-6
OBJECTIVE To further standardize the dispensing management standard of intravenous infusion drugs for clinical trials in pharmacy intravenous admixture services (PIVAS), and provide reference for medical institutions to provide high-quality pharmaceutical services. METHODS Initiated by PIVAS Group, Hospital Pharmacy Professional Committee, Shanghai Pharmaceutical Association, jointly led by Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Shanghai Geriatric Medical Center, a writing group was established by PIVAS experts from multiple medical institutions to discuss the basic requirements and dispensing process of intravenous infusion drugs for clinical trials in PIVAS. The experts from the leading unit sorted out, summarized, analyzed, fed back and revised the opinions, and finally reached Expert Consensus on Dispensing Management of Intravenous Infusion Drugs for Clinical Trials in PIVAS. RESULTS & CONCLUSIONS The main contents of this consensus include information management, operation process, fund management and document management of intravenous infusion drugs for clinical trials in PIVAS. This consensus establishes a more standardized model for dispensing management of intravenous infusion drugs for clinical trials in PIVAS, by standardizing clinical trail drug management operational procedures, accurately recording and preserving drug-related information, with the aim of achieving standardized and meticulous management of PIVAS’s receipt of clinical trial drugs.
3.Clinical and therapeutic analysis of 22 patients with traumatic spinopelvic dissociation.
Min WU ; Jianzhong GUAN ; Xiaotian CHEN ; Xiaopan WANG ; Peishuai ZHAO ; Yongsheng WANG ; Jiaqiang CHEN ; Leyu LIU ; Renjie LI
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(6):692-700
OBJECTIVE:
To review the clinical characteristics of patients with traumatic spinopelvic dissociation (SPD) and explore the diagnostic and therapeutic methods.
METHODS:
A clinical data of 22 patients with SPD who underwent surgical treatment between March 2019 and August 2024 was retrospectively analyzed. There were 13 males and 9 females, with an average age of 35.5 years (range, 14-61 years). The causes of injury included falling from height in 16 cases, traffic accidents in 5 cases, and compression injury in 1 case. Sacral fractures were classified based on morphology into "U" type (9 cases), "H" type (7 cases), "T" type (4 cases), and "λ" type (2 cases). According to the Roy-Camille classification, there were 4 cases of type Ⅰ, 12 cases of type Ⅱ, 2 cases of type Ⅲ, and 4 cases of type Ⅳ. The Cobb angle was (35.7± 22.0)°. Sixteen patients were accompanied by lumbosacral trunk and cauda equina nerve injury, which was classified as grade Ⅱ in 5 cases, grade Ⅲ in 5 cases, and grade Ⅳ in 6 cases according to the Gibbons grading. The time from injury to operation was 2-17 days (mean, 5.7 days). Based on the type of sacral fracture and sacral nerve injury, 6 cases were treated with closed reduction and minimally invasive percutaneous sacroiliac screw fixation, 16 cases were treated with open reduction and lumbar iliac fixation (8 cases)/triangular fixation (8 cases). Among them, 11 patients with severe fracture displacement and kyphotic deformity leading to sacral canal stenosis or bony impingement within the sacral foramen underwent laminectomy and sacral nerve decompression. X-ray films and CT were reviewed during followed-up. The Matta score was used to evaluate the quality of fracture reduction. At last follow-up, the Majeed score was used to assess the functional recovery, and the Gibbons grading was used to evaluate the nerve function.
RESULTS:
All operations were successfully completed. All patients were followed up 8-64 months (mean, 20.4 months). Two patients developed deep vein thrombosis of the lower limbs, 2 had incision infections, and 1 developed a sacral pressure ulcer; no other complications occurred. Radiological examination showed that the Cobb angle was (12.0±6.8)°, which was significantly different from the preoperative one ( t=6.000, P<0.001). The Cobb angle in 16 patients who underwent open reduction was (14.9±5.5)°, which was significantly different from the preoperative one [(46.8±13.9)° ] ( t=8.684, P<0.001). According to the Matta scoring criteria, the quality of fracture reduction was rated as excellent in 8 cases, good in 7 cases, fair in 5 cases, and poor in 2 cases, with an excellent and good rate of 68.2%. Bone callus formation was observed at the fracture site in all patients at 12 weeks after operation, and bony union achieved in all cases at last follow-up, with a healing time ranging from 12 to 36 weeks (mean, 17.6 weeks). At last follow-up, the Majeed score was rated as excellent in 7 cases, good in 10 cases, fair in 4 cases, and poor in 1 case, with an excellent and good rate of 77.3%. One patient experienced a unilateral iliac screw breakage at 12 months after operation, but the fracture had already healed, and there was no loss of reduction. Among the 16 patients with preoperative sacral nerve injury, 11 cases showed improvement in nerve function (6 cases) or recovery (5 cases).
CONCLUSION
SPD with low incidence, multiple associated injuries, and high incidence of sacral nerve injury, requires timely decompression of the sacral canal for symptomatic sacral nerve compression, fractures reduction, deformities correction, and stable fixation.
Humans
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Adult
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Female
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Male
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Retrospective Studies
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Middle Aged
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Spinal Fractures/diagnostic imaging*
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Adolescent
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Sacrum/diagnostic imaging*
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Fracture Fixation, Internal/methods*
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Young Adult
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Pelvic Bones/surgery*
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Treatment Outcome
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Bone Screws
4.Abnormal elevation of growth hormone in patients with pituitary adenoma combined with cirrhosis: A case report.
Yanlei WANG ; Min DUAN ; Jianzhong XIAO ; Wenhui ZHAO
Journal of Peking University(Health Sciences) 2025;57(2):400-402
The oral glucose growth hormone suppression test is commonly used in the clinical diagnosis of acromegaly, but its results can be influenced by a variety of factors. This case report discusses a patient with a pituitary tumor and concurrent liver cirrhosis, highlighting the complexities in interpreting test results under such conditions. The patient, a 54-year-old male, presented with blurred vision as his primary complaint. Notably, the physical examination revealed no changes in facial features, no enlargement of hands or feet, and no other symptoms typically associated with acromegaly, which might otherwise suggest excessive growth hormone activity. Magnetic Resonance Imaging (MRI) of the pituitary gland indicated that the gland was within normal size parameters, but a small low-intensity lesion mea-suring approximately 3 mm×2 mm identified. This finding was consistent with a pituitary microadenoma. The patient's fasting growth hormone levels were significantly elevated at 8.470 μg/L, compared with the normal range of less than 2.47 μg/L. Conversely, fasting insulin-like growth factor-1 (IGF-1) levels were notably low, recorded at 41 and 52 μg/L, whereas the normal range for a person of his age was between 87 and 234 μg/L. Other pituitary hormones, including those regulating the thyroid, adrenal cortex, and sex hormones, were found to be within normal ranges. Despite this, during the glucose growth hormone suppression test, an abnormal elevation of growth hormone was observed. To investigate further, the patient was administered branched-chain amino acids, and the suppression test was repeated. However, the abnormal elevation of growth hormone persisted, indicating a failure to normalize the response. Given the patient's lack of clinical signs typically associated with elevated growth hormone secretion, the history of liver cirrhosis became a significant consideration. The disparity between elevated growth hormone levels and reduced IGF-1 levels suggested that the pituitary lesion was a non-functional adenoma rather than a source of excess hormone production. Consequently, it was concluded that the abnormal response of growth hormone to the glucose suppression test was likely related to the patient's liver cirrhosis. In addition to chronic liver disease, various other conditions could influence the results of the oral glucose tolerance growth hormone suppression test. According to the literature, factors such as puberty, diabetes, anorexia nervosa, and protein malnutrition could also affect test outcomes. These conditions could cause similar abnormalities in growth hormone dynamics, complicating the diagnosis. Therefore, clinicians must be vigilant and consider these potential influences when interpreting test results.For an accurate diagnosis of acromegaly, it is essential to combine clinical symptoms, detailed medical history, and imaging studies. The presence of conditions like liver cirrhosis should prompt careful interpretation of the test results, ensuring that other contributing factors are not overlooked. This comprehensive approach is crucial to avoid misdiagnosis and to ensure that appropriate treatment strategies are implemented based on a thorough understanding of the patient's overall health status.
Humans
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Male
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Middle Aged
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Pituitary Neoplasms/blood*
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Liver Cirrhosis/blood*
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Adenoma/blood*
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Human Growth Hormone/blood*
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Insulin-Like Growth Factor I/metabolism*
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Acromegaly/etiology*
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Magnetic Resonance Imaging
5.Partial knockout of NtPDK1a/1b/1c/1d enhances the disease resistance of Nicotiana tabacum.
Qianwei REN ; Hujiao LAN ; Tianyao LIU ; Huanting ZHAO ; Yating ZHAO ; Rui ZHANG ; Jianzhong LIU
Chinese Journal of Biotechnology 2025;41(2):670-679
The protein kinase A/protein kinase G/protein kinase C-family (AGC kinase family) of eukaryotes is involved in regulating numerous biological processes. The 3-phosphoinositide- dependent protein kinase 1 (PDK1), is a conserved serine/threonine kinase in eukaryotes. To understand the roles of PDK1 homologous genes in cell death and immunity in tetraploid Nicotiana tabacum, the previuosly generated transgenic CRISPR/Cas9 lines, in which 5-7 alleles of the 4 homologous PDK1 genes (NtPDK1a/1b/1c/1d homologs) simultaneously knocked out, were used in this study. Our results showed that the hypersensitive response (HR) triggered by transient overexpression of active Pto (PtoY207D) or soybean GmMEKK1 was significantly delayed, whereas the resistance to Pseudomonas syrangae pv. tomato DC3000 (Pst DC3000) and tobacco mosaic virus (TMV) was significantly elevated in these partial knockout lines. The elevated resistance to Pst DC3000 and TMV was correlated with the elevated activation of NtMPK6, NtMPK3, and NtMPK4. Taken together, our results indicated that NtPDK1s play a positive role in cell death but a positive role in disease resistance, likely through negative regulation of the MAPK signaling cascade.
Nicotiana/virology*
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Disease Resistance/genetics*
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Plant Diseases/immunology*
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Plants, Genetically Modified/genetics*
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Gene Knockout Techniques
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Plant Proteins/genetics*
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CRISPR-Cas Systems
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Protein Serine-Threonine Kinases/genetics*
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3-Phosphoinositide-Dependent Protein Kinases/genetics*
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Pyruvate Dehydrogenase Acetyl-Transferring Kinase
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Tobacco Mosaic Virus/pathogenicity*
6.Research and analysis of the blending types and workload of PIVAS in China
Hongmei LYU ; Jing ZHAO ; Yuqi FU ; Jianzhong ZHANG
China Pharmacy 2024;35(18):2203-2206
OBJECTIVE To assess the blending types and workload of pharmacy intravenous admixture services (PIVAS) in China. METHODS By questionnaire survey, the working status of PIVAS in different levels of hospitals nationwide was investigated, involving the types of blending infusion, daily blending volume of hazardous drugs infusion, parenteral nutrition solution, general and antibacterial drug infusion, intravenous bolus drugs, skin test solution and intravenous agents, as well as the daily packing volume. RESULTS A sample of 750 PIVAS in 30 provinces (autonomous regions, municipalities) across China were surveyed by questionnaire, involving 621 tertiary hospitals and 90 secondary hospitals. The main types of liquid preparation were intravenous infusion, followed by parenteral nutrition solution, and chemotherapy pump (including chemotherapy infusion), accounting for 99.73%, 79.47% and 43.33%, respectively. The daily blending volume of hazardous drugs infusion, parenteral nutrition solution, general and antibacterial drug infusion, intravenous bolus drugs, skin test solution and intravenous agents in PIVAS of tertiary hospitals were 23.00 (9.00, 56.50) sets, 31.00 (13.97, 74.00) bags, 813.00 (375.00, 2 061.75) bags, 426.00 (210.00, 987.00) bags, 30.00 (6.00, 155.00) ampoules, 30.00 (7.13, 136.84) ampoules, 3 200.00 (1 684.50, 5 554.50) ampoules respectively, while the daily packing volume was 218.50 (52.26, 559.00) bags; above indexes of PIVAS in secondary hospital were 4.00(2.00,12.00)sets, 8.90(3.00,23.00)bags, 270.50(108.00, 2 061.75)bags, 157.00(71.00,987.00)bags, 5.85 (3.75,141.00) ampoules, 0 ampoule, 1 349.00(548.10,2 408.00)ampoules, 107.50(33.25,207.00)bags. CONCLUSIONS The scope of blending types of PIVAS has been significantly expanded, and tertiary hospitals are significantly higher than secondary hospitals in the blending and packing volumes of all types of intravenous fluids and drugs dispensed, showing obvious advantages in dealing with complex medications and high-risk treatments.
7.Investigation and analysis of the medical prescription approval in PIVAS in China
Jing ZHAO ; Lulu SUN ; Hongmei LYU ; Jianzhong ZHANG
China Pharmacy 2024;35(19):2340-2344
OBJECTIVE To know about the current status of medical order auditing in pharmacy intravenous admixture service (PIVAS) of medical institutions nationwide, further improve the management of medical orders in PIVAS, and reduce and eliminate the occurrence of intravenous medication administration errors. METHODS Through the questionnaire survey method, to address the problems and current situation of PIVAS medical order auditing in medical institutions nationwide, experts from each province (autonomous region, municipality directly under the central government) in the research group were responsible for organizing the PIVAS directors of relevant medical institutions in their provinces to fill in the questionnaires on medical order audit and inappropriate medical order interventions, and conduct a statistical analysis of the results. RESULTS A total of valid 751 responses were received to the PIVAS questionnaire on the review of medical prescriptions. Our PIVAS medical order audit is mainly carried out by a combination of manual and computer. The median number of medical orders were audited by PIVAS per day were 700.00-771.00; the median number of new medical orders were audited by PIVAS per day were 209.68-215.00; medical order auditing rates were 85.50%-92.44% averagely; the inappropriate doctor’s orders accounted for 1.82%-1.89% averagely; the intervention rates of inappropriate medical orders ranged 74.90%-79.41%, the success rates of intervention were 79.62%-87.28% averagely; the medication refund rates were 2.92%-3.08%. CONCLUSIONS Most of the PIVAS in China’s healthcare institutions use medical order review software to assist in the review of medical orders, and there are cases of individual PIVAS in which medical orders are not reviewed comprehensively and inappropriate orders are not intervened in, and the standards and processes of medical prescription review need to be improved. It is recommended to emphasize the pharmacist’s responsibility system, standardize the use of prescription review software; gradually expand the scope of medical order review, and adopt a multi-departmental collaborative approach so as to increase the success rate of intervention for inappropriate prescriptions and reduce the rate of PIVAS withdrawals.
8.Efficacy and safety of CM310 in moderate-to-severe atopic dermatitis: A multicenter, randomized, double-blind, placebo-controlled phase 2b trial
Yan ZHAO ; Jianzhong ZHANG ; Bin YANG ; Jingyi LI ; Yangfeng DING ; Liming WU ; Litao ZHANG ; Jinyan WANG ; Xiaohong ZHU ; Furen ZHANG ; Xiaohua TAO ; Yumei LI ; Chunlei ZHANG ; Linfeng LI ; Jianyun LU ; Qingchun DIAO ; Qianjin LU ; Xiaoyong MAN ; Fuqiu LI ; Xiujuan XIA ; Hao CHENG ; Yingmin JIA ; Guoqing ZHAO ; Jinchun YAN ; Bo CHEN
Chinese Medical Journal 2024;137(2):200-208
Background::Atopic dermatitis (AD) affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods::This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 120 eligible patients were enrolled and randomized (1:1:1) to receive subcutaneous injections of 300 mg CM310, 150 mg CM310, or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI-75) score from baseline at week 16. Safety and pharmacodynamics were also studied.Results::At week 16, the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups (70% [28/40] for high-dose and 65% [26/40] for low-dose) than that in the placebo group (20%[8/40]). The differences in EASI-75 response rate were 50% (high vs. placebo, 95% CI 31%–69%) and 45% (low vs. placebo, 95% CI 26%–64%), with both P values <0.0001. CM310 at both doses also significantly improved the EASI score, Investigator’s Global Assessment score, daily peak pruritus Numerical Rating Scale, AD-affected body surface area, and Dermatology Life Quality Index compared with placebo. CM310 treatment reduced levels of thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase, and blood eosinophils. The incidence of treatment-emergent adverse events (TEAEs) was similar among all three groups, with the most common TEAEs reported being upper respiratory tract infection, atopic dermatitis, hyperlipidemia, and hyperuricemia. No severe adverse events were deemed to be attributed to CM310. Conclusion::CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.Trial Registration::ClinicalTrials.gov, NCT04805411.
9.Expert opinions on operation rules of Morita therapy outpatient service
Jiangbo LI ; Zucheng WANG ; Yuhua CUI ; Yingzhi LU ; Weijie QU ; Haiyin ZHANG ; Fuqiang MAO ; Fengqing QIE ; Wanghong SHI ; Qinfeng ZHANG ; Lingyi PAN ; Ling ZHANG ; Jianzhong LI ; Guangcheng CUI ; Tongxian CHEN ; Xiuqing MA ; Wei RONG ; Jianjun ZHANG ; Qingfang ZHONG ; Yanchi ZHANG ; Boquan ZHANG ; Xinrui WANG ; Wenyou MA ; Qingtao REN ; Yongfa JING ; Huanzhong LIU ; Zhenjian YU ; Laitian ZHAO ; Tianming HAN ; Xue HAN
Chinese Mental Health Journal 2024;38(1):68-72
Morita therapy has been bom for more than 100 years.Inpatient Morita therapy is highly oper-able and easy to master.It can improve many refractory neuroses through four-stage treatment.But more neuroses are treated in outpatient clinics,and Morita therapy cannot be used in hospitalized patients.Therefore,the formula-tion of expert opinions on outpatient operations is particularly important.This paper is based on domestic and for-eign references,and after many discussions by domestic Morita therapy experts,and then drew up the first version of the expert opinions on operation of outpatient Morita therapy.Meanwhile the operation rule of Morita therapy in three stages of outpatient treatment was formulated:in the etiological analysis stage,under the theoretical guidance of Morita therapy,analyze the pathogenic factors,to improve treatment compliance and reduce resistance;during the operating stage,guide patients to engage in constructive and meaningful actions,realizing the achievement of letting nature take its course principle;in the cultivating character and enriching life stage,pay attention to positive infor-mation,expanding the scope and content of actions,improving the ability to adapt to complex life,and preventing recurrence caused by insufficient abilities.It will lay a foundation for the promotion of Morita therapy in domestic outpatient clinics,so that more patients with neurosis and other psychological diseases could receive characteristic Morita therapy treatment in outpatient clinics.
10.Construction of a diagnostic model based on random forest and artificial neural network for peri-implantitis
Haoran YANG ; Yuxiang CHEN ; Anna ZHAO ; Tingting CHENG ; Jianzhong ZHOU ; Ziliang LI
West China Journal of Stomatology 2024;42(2):214-226
Objective This study aimed to reveal critical genes regulating peri-implantitis during its development and construct a diagnostic model by using random forest(RF)and artificial neural network(ANN).Methods GSE-33774,GSE106090,and GSE57631 datasets were obtained from the GEO database.The GSE33774 and GSE106090 da-tasets were analyzed for differential expression and functional enrichment.The protein-protein interaction networks(PPI)and RF screened vital genes.A diagnostic model for peri-implantitis was established using ANN and validated on the GSE33774 and GSE57631 datasets.A transcription factor-gene interaction network and a transcription factor-micro-RNA(miRNA)regulatory network were also established.Results A total of 124 differentially expressed genes(DEGs)involved in the regulation of peri-implantitis were screened.Enrichment analysis showed that DEGs were mainly associated with immune receptor activity and cytokine receptor activity and were mainly involved in processes such as leukocyte and neutrophil migration.The PPI and RF screened six essential genes,namely,CD38,CYBB,FCGR2A,SELL,TLR4,and CXCL8.The receiver oper-ating characteristic curve(ROC)indicated that the ANN model had an excellent diagnostic performance.FOXC1,GA-TA2,and NF-κB1 may be essential transcription factors in peri-implantitis,and hsa-miR-204 may be a key miRNA.Con-clusion The diagnostic model of peri-implantitis constructed by RF and ANN has high confidence,and CD38,CYBB,FCGR2A,SELL,TLR4,and CXCL8 are potential diagnostic markers.FOXC1,GATA2,and NF-κB1 may be essential transcription factors in peri-implantitis,and hsa-miR-204 plays a vital role as a critical miRNA.

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