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2012, 3(2): 227-231. doi: 10.3969/j.issn.1674-9081.2012.02.021
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Human Gut Microbiome and Diseases: Current Status, Opportunity and Challenges
FANG Yuan, PAN Yuanlong, ZHU Baoli
2022, 13(5): 713-718. doi: 10.12290/xhyxzz.2022-0288
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The human microbiome, the second genome of the human body, can determine human health status. Microbiome research has prompted humans to re-understand the relationship between microbiota and individuals, as well as microbiota and the ecological environment. A comprehensive and systematic study of the structure and function of human gut microbiome and an analysis of the interaction and regulation mechanism of the relevant core bacteria will bring revolutionary theoretical innovations to solve the health problems of humans, and the resulting disruptive technological innovation has the potential to provide better solutions for microbiome research.
Correlation between Gut Microbiome and Disease Severity in Patients with Acute Pancreatitis: A Prospective Cross-sectional Study
HAN Ziying, SONG Kai, FAN Zhengyang, SONG Xiao, HU Xiaomin, WU Dong
2022, 13(5): 800-811. doi: 10.12290/xhyxzz.2022-0255
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  Objective  To investigate the gut microbiome composition and changes and its association with disease severity in patients with acute pancreatitis (AP).  Methods  This study was a prospective cross-sectional analysis. The subjects of the study were AP patients in Peking Union Medical College Hospital from June 2018 to January 2022 and healthy volunteers. The clinical data and stool samples of the two groups were collected, the 16S rRNA of the gut microbiome was DNA sequenced, and bioinformatic analysis was performed. The differences in gut microbiome between the two groups were compared, and the correlation between the intestinal flora and the severity of AP was analyzed by receiver operating characteristic(ROC) curve.  Results  A total of 60 AP patients and 20 healthy volunteers were enrolled. Among the AP patients, 20 were mild AP, 20 were moderately severe AP, and 20 were severe AP. During hospitalization, 22 cases were transferred to ICU, while 38 cases were not. In α diversity analysis, the Shannon index of AP patients was significant decreased compared to healthy volunteers (P < 0.05). β diversity of the two groups was significantly different. At the phylum, family, genus and species levels, there were also significant differences in the microbiome composition between the two groups. Linear discriminant analysis effect size analysis revealed that g_Escherichia-Shigella, g_Enterococcus, and f_Enterococcaceae were dominant in AP patients while g_Blautia, and g_Bifidobacterium were dominant in healthy volunteers. Function analysis found that multiple amino acid biosynthesis pathways were blocked in gut microbiome of AP patients, and potential pathogenicity and migration ability of gut microbiome increased significantly. In subgroup analysis, g_Enterococcus was increased and g_Bacteroidaceae was decreased in ICU patients compared to non-ICU patients. Based on the probability of disease index, the ROC curve showed that the area under the curve for identifying AP patients and AP patients transferred to ICU were 0.996 and 0.743.  Conclusions  The pathogenic bacteria increased and the beneficial bacteria decreased in the gut microbiome of AP patients. Changes in gut microbiota are related to the severity of AP disease and therefore have the potential to be used as novel biomarkers for AP.
Expert Consensus on Clobazam in the Treatment of Refractory Epilepsy (2022)
Multi-disciplinary Team for Rare Diseases, Peking Union Medical College Hospital National Rare Diseases Committee
2022, 13(5): 768-782. doi: 10.12290/xhyxzz.2022-0421
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After regular anti-epileptic drug treatment, the symptoms of most patients with epilepsy can be well controlled or relieved, but 30%-40% of patients with epilepsy, after long-term drug treatment, still suffer from repeated seizures and develop refractory epilepsy. Lennox-Gastaut syndrome, Dravet syndrome and epilepsy with myoclonic-atonic seizures are all refractory epilepsy that originate in childhood and seriously threaten the physical and mental health of patients. In 2011, clobazam was approved by the US Food and Drug Administration for the adjunctive treatment of epileptic seizures in patients with Lennox-Gastaut syndrome aged≥2 years. The drug has also been used in the treatment of Dravet syndrome and epilepsy with myoclonic-atonic seizures. Currently, the mechanism of action of clobazam is still unclear, but it may exert pharmacological effects by binding to the benzodiazepine site on the γ-aminobutyric acid A receptor. In vivo, clobazam and N-desmethylclobazam are mainly metabolized by CYP3A4 and CYP2C19, and the interaction with other drugs should require vigilance in clinical application. Meanwhile, attention should also be paid to the blood concentration of N-desmethylclobazam and monitoring of drug-related adverse reactions in CYP2C19 poor metabolizers. To promote further standardization of clinical application of clobazam in our country, and to ensure the effectiveness and safety of clobazam, the Multi-disciplinary Team for Rare Diseases, Peking Union Medical College Hospital and the National Rare Diseases Committee organized experts and scholars in related fields, and after many discussions and revisions, finally formed this consensus for clinical reference.
Expert Consensus on Clinical Research Methodology of Traditional Chinese Medicine in the New Era
Chinese Medicine Group, Clinical Epidemiology and Evidence-based Medicine Association of Chinese Medical Association
2022, 13(5): 783-788. doi: 10.12290/xhyxzz.2022-0428
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To address the challenges of the new era and promote the rational application of clinical epidemiology and evidence-based medicine methods in traditional Chinese medicine (TCM), Chinese Medicine Group, the Clinical Epidemiology and Evidence-based Medicine Association of Chinese Medical Association, gathered the related experts from all over the country and developed a consensus to improve the application of clinical epidemiology and evidence-based medicine methods in TCM. Delphi survey, consensus meetings and nominal groups were adopted in the process. This consensus summarizes the major challenges in the research of TCM and provides theoretical guidance for the development and application of clinical epidemiology and evidence-based medicine in TCM.
Interpretation on Management Guideline for the Off-label Use of Drugs in China(2021 Edition)
ZUO Wei, LIU Rongji, SUN Yajia, ZHANG Bo, CHEN Yaolong, ZHANG Shuyang
2023, 14(1): 86-93. doi: 10.12290/xhyxzz.2022-0588
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Off-label drug use represents a reasonable need for diagnosis and treatment in some cases, but it faces potential risks with drug safety and legal challenges. However, there was no guideline on how to manage the off-label drug use in China. Therefore, Peking Union Medical College Hospital, in cooperation with Evidence-based Medicine Center of Lanzhou University, established a working group and an expert group consisting of multidisciplinary group of experts to develop the Management Guideline for the Off-label Use of Drugs in China (2021). The Guideline is guided by the Law on Doctors of the People's Republic of China and the World Health Organization Guideline Development Manual. This is the first management guideline on the off-label use of drugs, aiming to improve the stakeholders' understanding of this topic and establish a standardized management procedure in China. This guideline has determined nine questions and proposed a total of twenty-three recommendations. The English version of the guideline was published in September 2022. This paper offers a detailed interpretation of the key points of the guidelines in order to provide suggestions and references for the management of off-label drug use.
The Role of the Gut Microbial Metabolites in Autoimmune Diseases
JIANG Xu, YANG Huaxia, ZHANG Fengchun
2022, 13(5): 747-752. doi: 10.12290/xhyxzz.2022-0246
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The gut microbiota and their metabolites play a critical role in the maintenance of host immune homeostasis. The dysbiosis and gut microbiota-derived metabolites are closely associated with the initiation and development of multiple autoimmune diseases. Among the microbiota metabolites, short-chain fatty acids, tryptophan and its derivatives, and bile acids are the most widely studied. In this review, the metabolic pathway of the microbiota metabolites, their functions in the immune response and the current findings on their correlation with autoimmune diseases are summarized, with the hope of revealing the role of gut microbiota-derived metabolites on the pathogenesis of autoimmune diseases.
Chinese Guidelines for Diagnosis and Treatment of Human Immunodeficiency Virus Infection/Acquired Immunodeficiency Syndrome(2021 edition)
Acquired Immunodeficiency Syndrome and Hepatitis C Professional Group, Society of Infectious Diseases, Chinese Medical Association, Chinese Center for Disease Control and Prevention
2022, 13(2): 203-226. doi: 10.12290/xhyxzz.2022-0097
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In 2005, the first edition of the guidelines for the diagnosis and treatment of acquired immunodeficiency syndrome(AIDS) was formulated by the AIDS Professional Group of the Society of Infectious Diseases of Chinese Medical Association, which was updated in 2011, 2015, and 2018, respectively. The 2021 edition of the guidelines was revised on the basis of the fourth edition and updated according to the national clinical practice and the latest research results. The new research progress in opportunistic infections, antiretroviral therapy, post-exposure prophylaxis (PEP), pre-exposure prophylaxis (PrEP), the whole course of the management of HIV infection, and prevention of mother to child transmission was updated in these guidelines. In the 2021 edition, the indications, medication regimen, follow-up and monitoring, and precautions of PrEP are introduced in detail. This edition of guidelines will be updated regularly according to the latest clinical evidence.
The Standard for Diagnosis and Treatment of Chinese Colorectal Cancer(2023 Version)
General Office of National Health Commission of the People's Republic of China, Oncology Branch of the Chinese Medical Association
2023, 14(4): 706-733. doi: 10.12290/xhyxzz.2023-0315
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Prospect of Gut Microbiota-based Intervention in Autoimmune Disease Control
ZHAO Lidan, MENG Xia, XU Haojie, ZHANG Fengchun
2022, 13(5): 740-746. doi: 10.12290/xhyxzz.2022-0245
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Gut microbiota is indispensable for the maintenance of human immune homeostasis. Dysbiosis and translocation of gut microbes as well as aberrance of microbiome metabolites, which are commonly seen in many autoimmune diseases, are suggested to participate in the breakdown of immune tolerance and the excessive inflammatory responses. The involved mechanisms include immune equilibrium skewing, molecular mimicry, bystander activation and epitope spreading, which contributes to the initiation and progression of autoimmune diseases. In addition, the microbial biotransformation of antirheumatic drugs help determine the bioactivity and toxicity of these drugs. Herein, gut microbiota-based intervention may shed light on developing novel strategies for prophylaxis and treatment of autoimmune diseases. In this review, recent advances in exploring the potential pathogenic role of gut microbiota in autoimmunity are summarized and the prospect of applying microbiota-based intervention in systemic autoimmune diseases is addressed.
Annual Research Progress of Glioma in China in 2021
CHEN Wenlin, WANG Yaning, XING Hao, LIANG Tingyu, SHI Yixin, WANG Hai, YANG Huiyu, LIU Qianshu, LI Junlin, GUO Xiaopeng, WANG Yu, MA Wenbin
2022, 13(5): 760-767. doi: 10.12290/xhyxzz.2022-0235
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Glioma, the most prevalent primary malignant tumor of the central nervous system, has a high degree of malignancy and poor prognosis for patients. At present, the researches of glioma mainly focus on the investigation of the mechanism of tumor occurrence and the discovery of new therapeutic methods and agents. In-depth researches have also been conducted on the optimization of molecular pathological typing of glioma, improvement of diagnostic imaging techniques and formulation of comprehensive treatment guidelines. In this review, we summarize the achievements and important progress made by Chinese medical scientists in the field of glioma in 2021, and propose possible future research directions with the aim of providing reference for clinical research.
The Core Methods and Key Models in Evidence-based Medicine
CHEN Yaolong, SUN Yajia, LUO Xufei, YU Xuan
2023, 14(1): 1-8. doi: 10.12290/xhyxzz.2022-0686
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This study reviews the core methods and models that have emerged from the development of evidence-based medicine over the past 30 years, including the PICO question model, systematic reviews, grading of evidence quality and strength of recommendations, reporting guidelines, the 5S pyramid of evidence resources, and evidence ecosystem. The above methods and models constitute the theoretical system, promote the progress of evidence-based medicine and provide the internal impetus for its development. The clarification of the core methods and key models of evidence-based medicine will help scholars and researchers fully understand its scientific philosophy, explore its future direction in light of current development trends, achieve its renewal and iteration, and further promote the construction of evidence-based science and the development of multidisciplinary integration.
Interpretation on the Updated Points of Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)
JIN Bao, DU Shunda, MAO Yilei, SANG Xinting
2022, 13(5): 789-795. doi: 10.12290/xhyxzz.2022-0274
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Since the publication of the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2019 Edition), many new high-level evidence in line with evidence-based medicine has emerged in the diagnosis and treatment of liver cancer at home and abroad, especially, a number of research results in line with Chinese liver cancer patients have been published. In order to further standardize the diagnosis and treatment of liver cancer in China, the National Health Commission organized multidisciplinary experts in the field of liver cancer to revise and update the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition), aiming to increase the overall cancer 5-year survival rate by 15%, a goal mentioned in the " Healthy China 2030" Planning Outline. We interpret the main update points of the 2022 version, with the hope of promoting the widespread discussion and dissemination of the new version.
Gastrointestinal Diseases and Gut Microbiome Therapy
HUANG Ziyu, ZUO Tao, LAN Ping
2022, 13(5): 732-739. doi: 10.12290/xhyxzz.2022-0208
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Gut microbiome regulates host metabolism and immunity via their metabolites, secretions, and cellular components, and protects the host from pathogen invasion. Low diversity and dysfunction of the gut microbiome caused by environmental changes, unhealthy dietary habits and lifestyles, and antibiotics abuse are closely related to disease pathogenesis. Gut microbiome can serve as diagnostic and therapeutic tools for diseases related to gut microbiome dysbiosis. In this article, we aim to review the latest study advances on gut microbiome in the pathogenesis and therapeutics of gastrointestinal diseases, such as Clostridium difficile infection, Helicobacter pylori infection, inflammatory bowel disease, and irritable bowel syndrome, so as to shed light on the prospect of gut microbiome modulations in disease therapies.
Gut Microbiome and Cardiovascular Health: Heart and Gut are Inextricably Linked
ZHAO Xinyue, HU Xiaomin, ZHANG Shuyang
2022, 13(5): 725-731. doi: 10.12290/xhyxzz.2022-0444
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In recent years, with the progress of multi-omics and next-generation sequencing technology, the association between gut microbiome and cardiovascular diseases has attracted great attention around the world. Gut microbiota, as a "microbial organ", directly regulates the host's health status through lipopolysaccharide, metabolites like trimethylamine oxide and short-chain fatty acids, and affects the host's immunity through bacteria and their products. "Gut-heart axis" may be a breakthrough in the prevention and treatment of cardiovascular diseases. The paper briefly discusses the relationship between gut microbiome and cardiovascular diseases, the possible ways in which gut microbes affect cardiovascular health, and the regulation of gut microbiota by various factors.
2015, 6(6): 453-453.
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Clinical Features of Childhood Behçet 's Disease Like Trisomy 8: A Summary of 19 Cases
ZHAO Wanwen, LIU Haimei, ZHANG Tianyu, YANG Sirui, SUN Li, SONG Hongmei
2023, 14(2): 299-305. doi: 10.12290/xhyxzz.2022-0683
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  Objective  The clinical characteristics of children with Behçet's disease like trisomy 8 (T8-BD) diagnosed and treated in multi-centers were summarized, so as to improve the understanding and treatment ability of clinicians.  Methods  Clinical data of children with T8-BD who were hospitalized in the First Hospital of Jilin University, Children's Hospital of Fudan University and Peking Union Medical College Hospital from January 2016 to June 2022 were retrospectively collected, and then based on the literature, to summarize their general data, symptoms and signs, auxiliary examination results, and treatment and prognosis.  Results  A total of 6 children with T8-BD hospitalized in the First Hospital of Jilin University, Children's Hospital of Fudan University and Peking Union Medical College Hospital and 13 children with T8-BD recorded in 10 literature reports were included. Among the 19 children with T8-BD, there were 4 males (21.1%) and 15 females (78.9%). The median age of onset was 8 years (range: 0-16 years). The main clinical manifestations were oral ulcer (94.7%), vulvar ulcer (57.9%) and fever (57.9%, including 4 cases with periodic fever-like manifestations). There were 14 cases (73.7%) of malignant hematologic diseases, 9 cases (47.4%) of digestive tract lesions, 7 cases (36.8%) of skin lesions, and 1 case (5.3%) of cerebrospinal fluid pressure elevation. There were 7 cases (36.8%) of abnormal development, including 5 cases of developmental delay, 3 cases of deep folds, 3 cases of joint deformity, 1 case of special facial appearance, 1 case of intellectual impairment, and 1 case of agenesis of corpus callosum. Auxiliary examination showed hemocytopenia in 11 cases (57.9%); C-reactive protein increase in 11 cases (57.9%), and erythrocyte sedimentation rate increase in 9 cases (47.4%). In terms of treatment, 11 cases (57.9%) were treated with glucocorticoid, 9 cases (47.4%) with traditional immunosuppressant, 6 cases (31.6%) with biological agents, 6 cases (31.6%) with hematopoietic stem cell transplantation and 3 cases (15.8%) with chemical agents. In terms of prognosis, 4 cases (21.1%) died, all of which were complicated with hematologic malignancies.  Conclusions  The common clinical symptoms of T8-BD are oral ulcers, vulvar ulcers and fever, which can be combined with digestive tract lesions, skin lesions, hematologic malignancies and developmental abnormalities. However, some children are accompanied by other atypical manifestations at the onset of the disease, to which clinicians should pay attention to identify. Overall, the prognosis of children with T8-BD is reasonable, but patients with hematologic malignancies have poor response to immunosuppressive therapy and increased risk of death.
Acceleration of Precision Medicine in Pediatric Rheumatic and Immunologic Diseases
MA Mingsheng, SONG Hongmei
2023, 14(2): 229-233. doi: 10.12290/xhyxzz.2023-0080
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Rheumatic and immunologic diseases in children may involve multiple genes and interactions between genetic and environmental factors. There are no validated biomarkers that are predictive of treatment response. Treatment is largely based on symptoms, treatment guidelines, physician experience, and medicine accessibility. The application of precision medicine in pediatric rheumatic and immunologic diseases is in its infancy. This article focuses on the progress of precision medicine in juvenile idiopathic arthritis and pediatric systemic lupus erythematosus, in order to build a precision diagnosis and treatment system for pediatric rheumatic and immunologic diseases, and improve children's quality of life.
Characteristics of Gut Microbiota and Their Association with Lymphocyte Subsets and Disease Activity in Ankylosing Spondylitis
SONG Ziyi, ZHANG Shengxiao, ZHAO Rong, QIAO Jun, SONG Shan, CHENG Ting, WANG Caihong, LI Xiaofeng
2022, 13(5): 821-830. doi: 10.12290/xhyxzz.2022-0064
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  Objective  To investigate the characteristics of gut microbiome and their associations with lymphocyte subsets and disease activity in patients with ankylosing spondylitis (AS).  Methods  This study was a retrospective analysis. The subjects of the study were AS patients who were hospitalized in the Second Hospital of Shanxi Medical University from December 2019 to June 2020, as well as gender- and age-matched healthy controls (HCs). The fecal samples were collected, and the V3-V4 variable regions of 16S rRNA gene of gut microbiome were sequenced for bioinformatics analysis. Peripheral venous blood was collected from AS patients to determine peripheral blood lymphocyte subsets and disease activity indicators. Spearman correlation test was used to analyze the correlations between the relative abundances of gut microbiota and peripheral blood lymphocyte subsets as well as disease activity in AS patients.  Results  A total of 62 AS patients (11 with low disease activity, 26 with high disease activity, and 25 with extremely high disease activity) and 62 healthy people who met the inclusion and exclusion criteria were enrolled. As for α-diversity, ACE and Chao1 indices were lower in AS than in HCs(P < 0.05). Bray curtis distance-based β-diversity analysis revealed significant difference in the microbial community between AS and HCs (P < 0.01). As for the composition of the gut microbiome, Firmicutes, Bacteroidetes, and Proteobacteria were the dominant phyla in the gut microbiota of both groups, but there were differences in the abundance of various bacteria at the phylum and genus levels. In Stamp analysis, fecal microbial communities in AS differed significantly from those in HCs, which were characterized by higher abundances of phylum Proteobacteria and Patescibacteria(all P < 0.05) and a lower abundance of phylum Firmicutes and Fusobacteriota (all P < 0.05). At the genus level, the abundances of Escherichia-Shigella, Klebsiella and Enterococcus were increased while those of Prevotella and Faecalibacterium were decreased in AS patients compared to HCs(all P < 0.05). Spearman correlation analysis showed that the relative abundances of Faecalibacterium, Ruminococcus and Klebsiella in AS patients were significantly positively correlated with disease activity or its related indicators(all P < 0.05). There were positive correlations between Agathobacter and T cell (r=0.302, P=0.017), CD4+T cell (r=0.310, P=0.014), B cell (r=0.292, P=0.021), Th2 cell (r=0.429, P < 0.001), Th17 cell (r=0.288, P=0.023), Streptococcus and B cell (r=0.270, P=0.034), Prevotella and Th1 cell (r=0.279, P=0.028), Th17 cell (r=0.262, P=0.040), CAG-352 and Th1 cell (r=0.283, P=0.030). There were negative correlations between Escherichia-Shigella and Th2 cell(r=-0.261, P=0.040), other Enterobacteriaceae and CD4+T cell (r=-0.255, P=0.046).  Conclusions  The diversity of gut microbiota is reduced in AS patients. The abundance of pathogenic bacteria in AS patients is increased, which is correlated with changes in peripheral blood lymphocyte subsets and disease activity. Dysbiosis may be involved in the occurrence and development of AS.
Clinical Efficacy, Safety and Pharmacokinetics of Tracing Injection of Mitoxantrone Hydrochloride for Tracing Sentinel Lymph Nodes in Thyroid Carcinoma: A Phase Ⅰ Clinical Trial
CHEN Shaobo, LIU Weinan, ZHANG Shengjie, SUN Jian, YANG Rui, WANG Shujun, CHEN Ge
2021, 12(5): 729-735. doi: 10.12290/xhyxzz.2021-0281
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  Objective  To investigate the staining and tracing effect of mitoxantrone hydrochloride injection for tracing lymph nodes in radical thyroidectomy, and its safety and tolerability.  Methods  In this study, a single-centered, open-labeled, blank control trial was designed. According to the principle of dose escalation, the human tolerance test and kinetic test were performed in dose groups one by one. Patients scheduled for radical thyroidectomy in Peking Union Medical College Hospital from December 2016 to March 2017 were prospectively enrolled as subjects. The subjects were divided into the blank control group and the test groups. The blank control group routinely underwent surgery without tracer injection; the test groups were injected with 0.2 mL, 0.4 mL, 0.6 mL, 0.8 mL, or 1.2 mL of mitoxantrone hydrochloride for tracing in the thyroid gland after exposing the surgical field, and an escalation test was performed in the five dose groups from low to high. The primary efficacy measures were lymph node tracing rate and lymph node staining rate; the secondary efficacy measures were staining-degree scores of lymph nodes and the success rate of tracing persistence. Changes in signs of subjects were recorded for safety assessment. Venous blood was collected from the subjects before administration and at 10 min, 20 min, 30 min, 60 min, 90 min and 120 min after administration to calculate the kinetic parameters.  Results  A total of 27 subjects were included, including 3 subjects in the blank control group, and 3, 3, 6, 6 and 6 subjects in the 0.2 mL, 0.4 mL, 0.6 mL, 0.8 mL and 1.2 mL dose group, respectively. When the test proceeded to the third dose group (0.6 mL), the injection site of the subjects was saturated with the injection dose, and the test was terminated. Therefore, a total of 15 subjects completed the test. No lymph node was stained in blank control group.The lymph nodes of 12 subjects showed blue staining, and the parathyroid glands were not stained and negatively visualized. There was significant difference in the staining-degree scores of lymph nodes before and after administration in the 0.2 mL, 0.4 mL and 0.6 mL dose groups (P < 0.05). The average staining rates of lymph nodes were 90.47%, 91.67% and 91.36%, respectively. And the average tracing rates of lymph nodes were 79.17%, 100% and 98.67%, respectively. In the test groups, the duration of lymph node dissection was 5-20 min; no stained lymph nodes faded, and the success rate of tracing was 100%. In the safety evaluation, no serious adverse events occurred in the blank control group and test groups, and the cause of adverse events was certainly not related to this tracer. Kinetic tests showed that the tracer was rapidly absorbed after glandular injection; the blood concentration peaked at 10 min after injection (the maximum plasma concentration was 13.1 μg/L) and it was rapidly eliminated.  Conclusions  The use of 0.2-0.6 mL mitoxantrone hydrochloride injection in radical thyroidectomy can play a better role in tracing lymph nodes, with high safety and good tolerance.
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