协和医学杂志

Abstract:
Total knee arthroplasty (TKA) is currently the main treatment for end-stage knee disease. Moderate to severe pain often occurs after TKA, which seriously affects postoperative rehabilitation, patient satisfaction and overall outcome. Multimodal analgesia is considered as the ideal solution. There is no guideline for perioperative pain management in TKA in China. On the basis of the discussions by experts from Joint Surgery Branch of Chinese Orthopaedic Association and Joint Surgery Branch of Beijing Orthopaedic Association, the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to rate the quality of evidence and the strength of recommendations. Reporting Items for Practice Guidelines in Healthcare (RIGHT) checklist was strictly followed to report the guideline. Finally, 20 evidence-based recommendations were formulated based on the 20 most concerning clinical problems among orthopaedic surgeons according to evidence retrieval, quality evaluation of body evidence, and establishment of direction and intensity of recommendations through four rounds of Delphi surveys. This guideline was developed to improve the standardization of perioperative pain management in TKA in China.

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.

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.

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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Abstract:
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.

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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Abstract:
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.

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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Abstract:
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.

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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Abstract:
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.

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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Abstract:
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.

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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Abstract:
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 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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Abstract:
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.

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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Abstract:
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.

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.

Measurement and the Reference Range of Serum Insulin-like Growth Factor-1

Xian-xian YUAN, Hong-bo YANG, Hui-juan ZHU, Hui PAN

2020, 11(4): 472-478. doi: 10.3969/j.issn.1674-9081.2020.04.020

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Insulin-like growth factor-1(IGF-1) mediates the growth-promoting effect of growth hormone on peripheral tissues, which is mainly synthesized in the liver. In the circulation, most IGF-1 binds to specific binding proteins, which is more stable than growth hormone. Therefore, IGF-1 is commonly used as a diagnostic marker and treatment monitor of growth hormone deficiency and acromegaly. There are many kinds of assays that measure serum IGF-1 concentrations, including radioimmunoassay, ELISA, chemiluminescence, and mass spectrometry. Different methods have their advantages and disadvantages, so it is necessary to select the best method according to the purpose of detection. The normal reference range of IGF-1 should be established based on a random sampling of the background population. Some European and Asian countries such as Germany, Italy, Japan, and South Korea have established reference ranges of serum IGF-1 based on their own population. ZHU Hui-juan et al. from Peking Union Medical College Hospital preliminarily established the reference range of serum IGF-1 of Han Chinese adults, laying a foundation for the diagnosis and treatment of acromegaly, growth hormone deficiency, and other diseases.

Expert Consensus on Nucleic Acid of Amplification Techniques Test for the Diagnosis of Pathogens in Adult Respiratory Tract Infections(2023)

The Committee of Chinese Laboratory Medical Education, Chinese Thoracic Society of the Chinese Medical Association

2023, 14(5): 959-971. doi: 10.12290/xhyxzz.2023-0338

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Respiratory tract infection is one of the most prevalent medical conditions. Rapid and accurate diagnosis of pathogens is crucial for precise and effective treatment. However, the sensitivity of traditional microbiological and immunological techniques for respiratory pathogens detection is low.The development and clinical applications of nucleic acid testing technology have dramatically improved the ability to diagnose respiratory pathogens. The rational usage of appropriate nucleic acid testing techniques, based on the underlying diseases, the type of respiratory tract infections, and pathogen spectrum, as well as the correct understanding of its diagnostic sig- nificance, has become an important clinical challenge. Therefore, the Committee of Chinese Laboratory Medical Education and Chinese Thoracic Society initiated a multi-disciplinary Chinese expert consensus. Based on both the domestic and international guidelines and literature, the expert consensus analyzes the clinical application scenarios, technical characteristics, and performance validation requirements pertaining to real-time fluorescence polymerase chain reaction (PCR), isothermal amplification technology, digital PCR, nucleic acid point-of-care testing, and metagenomics next generation sequencing. Furthermore, it also examines the wide-ranging applications of these techniques in diagnosing and managing respiratory tract infections, including acute upper respiratory tract infections, tracheobronchitis, community-acquired pneumonia, hospital-acquired pneumonia/ventilator-associated pneumonia, acute exacerbation of chronic obstructive pulmonary disease, tuberculosis, and respiratory infections in immunocompromised adults. We hope the consensus will provide helpful reference for clinicians.

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.

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.

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疼痛综合管理：展望无痛诊疗的未来

北京协和医学院临床医学（八年制）2016级浦军

作为第五大生命体征的疼痛，不仅会引起患者躯体不适和心理变化，影响康复进程，同时也给社会带来了巨大医疗负担。如何减轻患者疼痛已成为临床及大众共同关注的热点话题。本期《协和医学杂志》重点选题方向为"疼痛综合管理"，旨在探讨近年来我国在术后急性疼痛、无痛舒适化诊疗、疑难慢性疼痛、多模式疼痛管理等方面取得的主要进展。

如何通过艺术手段展现疼痛综合管理理念是本期封面创作的重点和难点。通过翻阅大量资料，决定推翻最初欲采用疼痛评分量表来展现主题的设想，转而借鉴墨西哥弗里达卡罗画作中对疼痛的表现手法来展现这一主题。最终，画面主体以荆棘交织成网遮住夜空寓意疼痛，红色荆棘指代疼痛缠扰下患者的焦灼难安;而医生帮助患者拨开荆棘现出月光寓意镇痛，月色清冷喻示消除疼痛后的清凉宁静。整个画面以患者的第一视角穿破荆棘沐浴月光，共情长久困扰于疼痛后获得的无痛舒适体验，同时刻画医患双方并力向前，为无痛未来并肩探索的美好现状。

相信随着"舒适无痛诊疗"理念的深入传播，医疗机构和医护人员的疼痛综合管理服务意识与服务能力也将不断提升，可帮助患者在就医过程中收获更强烈的幸福感和安全感。

Vol. 15, No. 2 30 03 2024

Chinese Bimonthly CN 11-5882/R ISSN 1674-9081

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