协和医学杂志

"The Right Heart Priority" in Shock Treatment——My Paper 20 Years Later

LIU Dawei

2022, 13(6): 901-906. doi: 10.12290/xhyxzz.2022-0409

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Although the shock has long and routinely been treated, right heart and pulmonary circulation used to be the forgotten corners in clinical management. Twenty years ago, my colleagues and I published the paper Right Ventricular Function of Patients with Septic Shock: Clinical Significance and proposed the strategy of "right heart priority", in which we took right heart as a starting point, completed whole circulation pathway of blood flow clinically with hemodynamic indicators, and performed treatment based on the hemodynamic changes at real locations, degrees and responses to therapeutic interventions. Over the past 20 years, this strategy has been confirmed by many others and practiced in many hospitals worldwide. The current treatment of shock is a continuous, dynamic, target directed quantitative hemodynamic therapy and is moving from individualized treatment towards organ targeted treatment.

Treatment of Intracranial Atherosclerotic Stenosis: Current Debates and Future Directions

LUO Jichang, WANG Tao, JIAO Liqun

2022, 13(6): 907-914. doi: 10.12290/xhyxzz.2022-0592

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Intracranial atherosclerotic stenosis (ICAS) is a leading cause of ischemic stroke, especially in Asia. Since the publication of high-quality randomized controlled trials conducted by the United States in 2011, ICAS has been a subject of controversy and concerns. Recently, the results of a randomized controlled trial published in the leading international medical journal compare the effectiveness of endovascular treatment and medical treatment for ICAS in the Chinese population, which has reattracted public attention to this issue. Endovascular therapy is not inferior to medical treatment, and the benefits of endovascular therapy may be greater in drug-refractory patients with hemodynamic disorders.Therefore, this paper systematically discusses ICAS disease characteristics, treatment status, and future directions, suggesting that endovascular therapy may be of further benefit to drug-refractory patients with hemodynamic disorders, and stricter medical management and improved patient compliance will further reduce stroke recurrences and mortality.

In Shock Resuscitation, Blood Flow Should be Considered First, and Oxygen Flux Should be Optimized Second

DU Wei, WANG Xiaoting, LIU Dawei

2022, 13(6): 915-920. doi: 10.12290/xhyxzz.2022-0441

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An important milestone in human cognition of severe diseases began with a refined understanding of the hemodynamics of shock. After decades of development, the concept of hemodynamic therapy has become more perfect. The treatment of shock involves not only guided group therapy, but also bedside individualized strategies. The leading effect of blood flow has long been well understood, and the oxygen flux in the blood flow is the target index of hemodynamic resuscitation of shock. In this paper, we aim to further explore blood flow and blood oxygen flux, separate the influence factors of blood flow and oxygen flux, monitoring and recovery-guided treatment, and propose four subtypes based on blood flow and oxygen flux shock, with the hope of ushering in an era of more precise hemodynamic treatment for organ hemodynamic therapy.

New Cognition of Organ Hemodynamics: Artery-Perfusion-Vein

ZHAO Hua, WANG Xiaoting, LIU Dawei

2022, 13(6): 921-928. doi: 10.12290/xhyxzz.2022-0475

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The change of organ hemodynamics in critical patients is key to the impairment of organ function. Organ perfusion pressure is the direct power to ensure organ blood flow, which is affected by inlet organ pressure (arterial pressure) and outlet organ pressure (venous pressure). Different organs have unique perfusion pressure requirements and regulation systems for blood flow adjustment to match their physiological needs. As the supply side of organ perfusion, the blood flow of organs is influenced by mean arterial pressure (MAP)and autoregulation system. Organs with different autoregulatory abilities have different requirements for MAP, so the appropriate MAP should be decided according to the autoregulation range in clinical practice. However, organ blood flow perfusion is not only determined by the supply side, but also affected by venous reflux. Changes in arteriovenous gradient across important organs affect organ blood flow perfusion. Different organs have different tolerance levels for venous reflux disorders because their distance from the heart and the specificity of the organ itself. When conducting hemodynamic intervention, physicians should pay attention to the influence of different pressure changes on organ perfusion.

Host Response and Hemodynamics

WANG Guangjian, WANG Xiaoting

2022, 13(6): 929-935. doi: 10.12290/xhyxzz.2022-0483

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With the continuous exploration of the pathophysiological mechanisms of critical illness, the host response, a "bridge" between different etiologies and the development of critical illness, has received much attention. Host response is the focus of critical illness pathophysiology, and hemodynamics is the core of critical illness development. On the one hand, the host response has a significant impact on hemodynamics; on the other hand, the intervention of the host response through analgesic-sedative-anti-sympathetic therapy and the management of inflammation, immunity, coagulation, metabolism, and bioenergy can stabilize the hemodynamics and achieve the goal of critical illness treatment. A deepening understanding of host response not only enriches the connotation of hemodynamics but also facilitates further study and exploration of the pathophysiological mechanisms of critical illness. Therefore, we describe host response from three aspects: a new understanding of critical illness based on host response, the effect of host response on hemodynamics, and hemodynamic therapy based on the host response.

Gut Microbiota in Hemodynamics

PAN Xiaojun, CHEN Dechang

2022, 13(6): 936-941. doi: 10.12290/xhyxzz.2022-0468

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The gut microbiota is a powerful "organ" composed of prokaryotic organisms (bacteria), eukaryotic microorganisms (including fungi and protozoa) and viruses, which plays a crucial role in the nutrition metabolism, maintenance of the integrity of intestinal mucosal barrier, and immune regulation of the body. Researches have shown that intestinal microecology is related to the pathogenesis of many diseases, such as neuropsychiatric diseases, autoimmune diseases, cancer and chronic metabolic diseases. Recent studies have found that gut microbiota can regulate hemodynamics through the oxidation of trimethylamine and short chain fatty acids. At the same time, gut microbiota disorder and translocation can activate the body's inflammatory response, affecting the stability of the body's hemodynamics.In this article, we summarize the relationship between gut microbiota and hemodymamics, in order to provide reference for further research.

Particle Multimodality Monitoring and Hemodynamics

SONG Tianjiao, WANG Xiaoting, CHAO Yangong

2022, 13(6): 942-947. doi: 10.12290/xhyxzz.2022-0626

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Hemodynamic optimization is key to resuscitation of critically ill patients in intensive medicine. Delayed or improper treatment will inevitably lead to hypoperfusion, tissue hypoxia and multiple organ failure, which affects the patients' outcome. Therefore, early identification of patients at risk and implementation of adequate monitoring and guidance intervention have a profound impact on the results. The key principle of hemodynamic management is to optimize blood flow and oxygen flow according to current tissue metabolism. To achieve this goal, we need to monitor and get blood pressure, cardiac output, organ-specific automatic regulation and tissue microcirculation. However, the clinical monitoring data is huge. At the same time nearly one hundred pieces of data objectively present the pathophysiological state of the patient, and the changes of data at different time periods can describe the progress of the patients' condition. Therefore, the integrated analysis of time/ frequency domain based on millisecond-level high-resolution data will promote the understanding and practice of hemodynamics at microcosmic level, and help to facilitate clearer judgment and more precise treatment of patients' condition.

Comprehensive Assessment and Rational Decision-making: Based on Recent FindingsAbout Safety of Glucagon-like Peptide-1 Receptor Agonists

HE Liyun, ZHANG Huabing, LI Yuxiu

2022, 13(6): 948-952. doi: 10.12290/xhyxzz.2022-0391

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Glucagon-like peptide-1 receptor agonists (GLP-1RAs), as a kind of novel hypoglycemic agent, are widely used in patients with type 2 diabetes. GLP-1RAs are effective in glycemic control with low risk of hypoglycemia, significant weight loss, and cardiovascular benefit and renal protection. The most common adverse effects of GLP-1RAs are mild to moderate gastrointestinal symptoms, which generally resolve over time. The use of GLP-1RAs also increases the risk of gallbladder or biliary diseases, especially when used at higher doses, for longer durations, and for weight loss, but the absolute risk of gallbladder or biliary tract disease is small. Clinicians and patients need to carefully weigh the benefits and risks of GLP-1RAs to make decisions for the rational use of GLP-1RAs.

Heart Failure: Prevention and Treatment are Indispensable

XU Fen, ZHOU Zhou

2022, 13(6): 953-957. doi: 10.12290/xhyxzz.2022-0440

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Recently, 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure has been published. It advocates to pay equal attention to the prevention and treatment of heart failure; and emphasizes that primary prevention based on natriuretic peptides screening is essential for patients at risk for heart failure or with pre-heart failure. Furthermore, it recommends that patients with symptomatic heart failure should receive care from a multidisciplinary team to facilitate the implementation of "basic quadruple therapy" including sodium glucose cotransporter 2 inhibitors; and that patients with advanced heart failure who wish to prolong their survival should be timely referral for heart failure specialty care and assess suitability for advanced heart failure therapies.

Improve Access to Assistive Technologies and Promote Universal Health Coverage

DONG Liquan, LIU Zhihong, XIE Ganlin, LI Yanyu

2022, 13(6): 958-964. doi: 10.12290/xhyxzz.2022-0333

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Assistive technology is a subset of health technology. The resolution on improving access to assistive technology adopted by the 71st World Health Assembly illustrates that it is extremely important to integrate assistive technologies into healthcare system, which will help to achieve the sustainable development goal including universal health coverage. During this article, we introduce the history of the development of assistive technology, expounds that assistive technology plays an increasingly important role in health protection/care, rehabilitation treatment/training, functional compensation, environmental health and other health fields, And then we put forward suggestions on strengthening the understanding of assistive technology, improving relevant policies and systems, strengthening the construction of assistive technology service system, promoting R & D and production development, and building professional technical teams, so as to better achieve universal health coverage.

Guidelines for Perioperative Pain Management in Total Knee Arthroplasty in China (2022)

Joint Surgery Branch of Chinese Orthopaedic Association, Joint Surgery Branch of Beijing Orthopaedic Association

2022, 13(6): 965-985. doi: 10.12290/xhyxzz.2022-0642

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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.

Consensus on Clinical Application of the CXCR4-targeted Imaging in the Diagnosis of Primary Aldosteronism(2022)

Chinese Urological Doctor Association Adrenal Hypertension Surgery Collaborative Organization Adrenal Group, Chinese Society of Endocrinology PET group, Chinese Society of Nuclear Medicine

2022, 13(6): 986-991. doi: 10.12290/xhyxzz.2022-0584

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Subtype classification of primary aldosteronism is important but challenging. Increasing evidence has shown that ⁶⁸Ga-Pentixafor PET/CT imaging which targets CXCR4 is beneficial to the subtype classification of primary aldosteronism. Based on all the available evidence, and after in-depth discussion of a group of multi-disciplinary experts, a consensus has been established, which covers imaging technology, interpretation of results of CXCR4 imaging, and the guidance to the choice of the treatment and prognosisevaluation. The consensus is helpful for standardizing ⁶⁸Ga-Pentixafor PET/CT imaging and promoting a better diagnosis procedure in primary aldosteronism.

Interpretation on the 2021 American College of Rheumatology Guideline for the Treatment of Juvenile Idiopathic Arthritis

ZHONG Linqing, SONG Hongmei

2022, 13(6): 992-998. doi: 10.12290/xhyxzz.2022-0377

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In order to improve the prognosis of children with juvenile idiopathic arthritis (JIA), following the treatment guideline issued in 2019, the American College of Rheumatology (ACR) published new guidelines for the treatment of JIA in March 2022, including recommendations for both pharmacologic and nonpharmacologic therapies. The pharmacologic management focuses on treatment of oligoarthritis, temporomandibular joint arthritis, and systemic JIA. This article provides Chinese physicians with detailed interpretation of this guideline, for the purpose of better applying it in their clinical practice.

Update and Interpretation of 2022 National Comprehensive Cancer Network Clinical Practice Guidelines for Gastric Cancer

LIU Yuan, ZHAO Lin

2022, 13(6): 999-1004. doi: 10.12290/xhyxzz.2022-0271

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Recently, National Comprehensive Cancer Network(NCCN) released the latest version of clinical practice guidelines for gastric cancer. In this version, evaluation of peritoneal metastasis using laparoscopy with cytology has been refined. Postoperative chemoradiation is recommended as an alternative option for patients who have received less than a D2 lymph node dissection. The use of three cytotoxic drugs in a regimen should be reserved for medically fit patients with excellent performance status and easy access to frequent toxicity evaluation. More importantly, next generation sequencing (NGS) is recommended for the first time for the detection of microsatellite instability/mismatch repair(MSI/MMR)status. In addition, the recommendation for the detection of MSI/MMR status is extended to all newly diagnosed cases. Several recently developed targeted drugs and immuno-oncology therapy are included in the recommendation for sequential treatment. Precise treatment strategy based on biomarkers will inevitably become the future direction for gastric cancer. This article aims to interpret the updates to provide reference for clinical practice.

Peak Value of Central Venous Pressure and Acute Kidney Injury in Cardiac Patients After Cardiopulmonary Bypass Surgery

ZHANG Hongmin, CHEN Xiukai, WANG Xiaoting, LIU Dawei, CHAI Wenzhao

2022, 13(6): 1005-1011. doi: 10.12290/xhyxzz.2022-0448

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Objective To explore the relationship between the post-operative peak value of central venous pressure (CVPp) and the incidence of acute kidney injury (AKI) in patients who had undergone cardiopulmonary bypass surgery (CBS). Methods Clinical data were retrospectively collected from 1 May 2016 to 1 May 2018 from all patients undergoing CBS in the Department of Intensive Care Medicine, Peking Union Medical College Hospital. The CVP values immediately after transfer to ICU (CVP 0h) and at 6 h(CVP 6h), and CVPp within 48 h(CVPp 48h) of transfer to ICU, the incidence of AKI after 48 h of transfer to ICU and in-hospital mortality were recorded. The receiver operating characteristic (ROC) curve was used to evaluate the clinical value of CVP-related indicators in predicting AKI after CBS and determine the optimal threshold. The risk factors for AKI and in-hospital mortality after CBS were analysed using single factor and multifactorial Logistic regression. Results A total of 485 patients after CBS who met the inclusion and exclusion criteria were enrolled, with an incidence of AKI after 48 h of transfer to ICU of 25.2% (122/485) and an in-hospital mortality rate of 2.5% (12/485). The ROC curve analysis showed that the area under the curve (AUC) for CVPp 48h to predict AKI after CBS was 0.634 (95% CI: 0.577-0.692, P < 0.001), with an optimal threshold value of 14 mm Hg, sensitivity of 49.6% and specificity of 63.5%. Multifactorial logistic regression analysis showed that hypertension(OR=2.505, 95% CI: 1.581-3.969, P < 0.001), pulmonary hyperten-sion(OR=2.552, 95% CI: 1.573-4.412, P < 0.001), prolonged aortic block time(OR=1.009, 95% CI: 1.004-1.014, P=0.001), and CVPp 48h≥14 mm Hg(OR=1.613, 95% CI: 1.030-2.526, P=0.037) were independent risk factors for AKI after CBS; CVPp 48h≥14 mm Hg was an independent risk factor for in-hospital death(OR=8.044, 95% CI: 1.579-40.979, P=0.012). Conclusions CVPp 48h is associated with AKI in patients who have undergone CBS. The monitoring and management of CVP might be a way to improve the prognosis of these patients.

The PUMCH Conservative Classification System for Young Idiopathic Scoliosis Patients

YUAN Wangshu, CHEN Lixia, SHEN Jianxiong, SHI Weihong, ZHANG Yuhang, ZHANG Houqiang

2022, 13(6): 1012-1019. doi: 10.12290/xhyxzz.2022-0092

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Objective To establish a new method of scoliosis specific exercise(SSE) classification foryoung idiopathic scoliosis(IS) patients and evaluate its clinical practicability. Methods This study consists of two parts, the first part, a retrospective analysis, aimed at establishing Peking Union Medical College Hospital(PUMCH) conservative classification system for young IS patients and evaluating its reliability and repeatability. The research subjects were young IS patients in PUMCH from January 2013 to June 2020. The standing X-ray(A-P and lateral) and clinical appearance (bending and standing) were analyzed. The PUMCH conservative classification system was established based on PUMC surgical classification system, and the consistency test was conducted for the inter group reliability and intra group repeatability of the observers. The second part, an ambispective cohort study, aimed at verifying the role of PUMCH conservative classification system in guiding clinical treatment and evaluating its clinical practicability. The research subjects were young IS patients(4 to 17 years old) who received conservative treatment in PUMCH from July 2020 to August 2020. According to the wishes of patients and their families, they were divided into training group and control group. The control group only had regular reexamination without clinical intervention, while the training group conducted SSE based on PUMCH conservative classification system (continuous treatment for 1 year). Cobb angle difference and patient satisfaction were compared between the two groups after 1 year. Results (1) A total of 899 young IS patients who met the inclusion and exclusion criteria were selected for the retrospective study. PUMCH conservative classification system finally included 4 types and 9 subtypes after revising the single-curve(type Ⅰ), double-curve(type Ⅱ) and triple-curve(type Ⅲ) in PUMC surgical classification, and adding a micro-curve (type 0). The mean inter-observer reliability was 88.23%, with Kappa coefficient 0.862, while mean intra-observer repeatability was 92.78%, with Kappa coefficient 0.908. (2) Ambispective cohort study included 90 young IS patients who met the inclusion and exclusion criteria. There were 51 cases in the training group and 39 cases in the control group. The Cobb angle of the training group decreased from (16.61±2.88)°to (12.16±9.97)° after 1 year of treatment(P=0.002), while the Cobb angle of the control group increased from (15.74±2.75)° to (17.64±5.60)° after 1 year(P=0.014). There was clinical significance between the two groups(Cobb angle difference≥5°). After 1 year, the satisfaction score of the training group increased from 3(3, 3) to 5(3, 5)(P≤0.001), while that of the control group decreased from 3(3, 3) to 3(1, 3) (P=0.004). Conclusions A new conservative classification system for young IS patients is established. The PUMCH conservative classification system not only has good reliability and repeatability, but also has clinical practicability in guiding SSE.

Results of Neonatal Genetic Screening for Hearing Loss in Peking Union Medical College Hospital in the Past 10 Years

GAO Ruzhen, FAN Yue, YANG Tengyu, LI Dongdong, GUO Ying, JIANG Hong, XU Yingchun, CHEN Xiaowei

2022, 13(6): 1020-1027. doi: 10.12290/xhyxzz.2022-0281

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Objective To explore the operation status and effect of the neonatal deafness gene screeningin Beijing Union Medical College Hospital for the past 10 years and analyze the follow-up, genetic consultation and intervention to improve the quality of neonatal deafness gene screening. Methods From April 2012 to March 2022, the screening data of newborns with deafness genetic screening by microarray microarray in Peking Union Medical College Hospital, and the data from the genetic counseling clinic of Peking Union Medical College Hospital were retrospectively collected. The mutation loci, mutation types, genetic clinic visits and follow-up interventions of newborns who did not pass the deafness genetic screening were analyzed. Results Among 165 813 newborns, 8019 samples "failed" in the screening, accounting for 4.84%. Of the "failed" samples, 4173 cases carried GJB2 gene mutation, with a carrying rate of 2.52%; 3016 cases carried SLC26A4 gene mutation, with a carrying rate of 1.82%;570 cases carried GJB3 gene mutation, with a carrying rate of 0.34%; 405 cases carried homogeneous or heterogeneous mutation in 12S rRNA, with a carrying rate of 0.24%. During the screening, multiple mutation carriers were identified in 126 cases, all of whom had normal hearing at follow-up and were not given special intervention; 44 cases of deafness causing genotypes (except those at risk of drug-induced hearing loss), all of whom were given different interventions according to the degree of hearing loss; the presence of drug-sensitive deafness genotype was found in 405 cases, all of which were warned by drug warning cards for newborns and their maternal family members about drug use. The overall lost follow-up rate was 0.12%(204/165 813), and the overall genetic counselling rate of newborns who failed the screening was 46.10%(3697/8019). Among them, the lost rate of the first stage (from April 2012 to March 2013), the second stage (from April 2013 to December 2017) and the third stage (from January 2018 to March 2022) were 0.63%(72/11 489), 0.10%(80/81 663) and 0.07%(52/72 661), respectively. The visiting rate of genetic clinic was 38.05%(207/544), 39.44% (1496/3793) and 54.16%(1994/3682), respectively. The Cochran-Armitage trend test showed that the lost rate progressively lowered and the visiting rate gradually increased in the 3 stages (all P < 0.001). Conclusion In the past 10 years, a thorough screening, follow-up, consultation and intervention platform has been established, which can help us in the early warning, early diagnosis and early intervention of families and individuals at risk of hearing impairment.

Clinical Trials of Rare Diseases in China over One Decade: Based on the Chinese First List of Rare Diseases

CHEN Chen, HAN Xiaohong

2022, 13(6): 1028-1035. doi: 10.12290/xhyxzz.2022-0010

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Objective To explore the situation and characteristics of clinical trials of 121 rare diseases in the Chinese First List of Rare Diseases over the past 10 years and to provide reference for promoting the researchand development of orphan drugs in China. Methods The 121 rare diseases covered in the Chinese First List of Rare Diseases and Guidelines for Diagnosis and Treatment of Rare Diseases published in 2019 were retrieved as keywords on the National Medical Products Administration Registration and Information Disclosure Platform for Drug Clinical Studies (chinadrugtrials.org.cn) from November 1st, 2012 (Platform registration open time) to November 28th, 2021. The status and characteristics of rare disease clinical trials were analyzed from the perspectives of the number of registrations, geographical distribution, research fields, research design, and sample size. Results A total of 235 clinical trials were collected, including 41 items of phase Ⅰ, 22 items of phase Ⅱ, 74 items of phase Ⅲ, 15 items of phase Ⅳ, 77 items of bioequivalence clinical trials, and 6 clinical trials. During the past 10 years, the number of rare diseases clinical trials in China showed an increasing trend, with an annual average growth rate of about 54%. A total of 16 kinds of rare diseases in the Chinese First List of Rare Diseases were involved in the early phase (phase Ⅰ and phase Ⅱ) clinical trials, mainly focusing on hemophilia, idiopathic pulmonary fibrosis, multiple sclerosis, and neuromyelitis optica. The researchers of rare disease clinical trials were mainly in big cities such as Beijing, Tianjin, and Shanghai. Phase Ⅰ clinical trials of rare diseases listed in the Chinese First List of Rare Diseases in China were mainly single-center(61%, 25/41) parallel controlled studies (46%, 19/41), Phase Ⅱ clinical trials were mainly multi-center parallel controlled studies (65%, 13/22), and phase Ⅲ clinical trials were mainly multi-center (99%, 73/74) single-arm trials (64%, 47/74). The sample size in clinical trials increased with the study stage. Phase Ⅰ clinical trials were mainly restricted to 11~50 cases (83%, 34/41), 59% (13/22) of phase Ⅱ clinical trials were more than 50 cases, and 53%(39/74) of phase Ⅲ clinical trials involved 51~500 cases. Conclusions The research and development of orphan drugs in China is still at an early stage, covering few rare diseases in the Chinese First List of Rare Diseases, but it has shown a rapidly growing trend in recent years. At present, the development of rare disease drugs is still based on traditional clinical trial design. It is therefore necessary to explore more new clinical research strategies according to the disease and drug mechanism to promote the development of rare disease drugs.

Current Situation and Implications of Novel Antitumer Drugs in China

SUN Wenjuan, ZHANG Bo

2022, 13(6): 1036-1044. doi: 10.12290/xhyxzz.2021-0521

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Objective To explore the trend of antitumor drugs by comparing and analyzing the novel antitumor drugs of China and US, in order to provide a basis for the selection of antitumor drugs. Methods US Food and Drug Administration and China National Medical Products Administration databases were searched, and the drug name, marketing time, indication and other information were collected(as of April 30, 2021). The proportion of listed drugs in China were calculated. Results As of April 30, 2021, there were 122 novel antitumor drugs marketed in the US, covering 14 disease types. Among them, 41.80% (51/122) were marketedin China. The proportion of monoclonal drugs was the highest(46.15%), followed by the small molecule targeted drugs (44.58%), and antibody-drug conjugate (15.38%). The number of novel antitumor drugs increased significantly(70.59%, 36/51) since 2015, and the proportion of listed drug in China from 2015 to 2021 was 50.70%(36/71), while that from 2010 to 2014 was only 19.35%(6/31). China has imported novel antitumor drugs covering 13 disease types. The average proportion of imported novel antitumor drugs for the top 5 tumors in China was 62.15%. A total of 14 novel antitumor drugs have been independently developed in China, including 7 monoclonal drugs and 7 small molecule targeted drugs, accounting for 21.54% (14/65) of the available novel antitumor drugs in China. Among them, 11 drugs (78.57%, 11/14) have been listed since 2015. The indications of novel antitumor drugs independently developed in China cover 8 disease types (57.14%, 8/14). Conclusions There are still gaps between China and US in terms of novel antitumor drugs, but these drugs can basically meet the clinical needs in China. Since 2015, China has made progress in accelerating approval and independent innovation. We should consider the safety, effectiveness, economic and clinical necessity of the listed and unlisted drugs, so as to provide a basis for drug selection in the future.

Effect of Myofascial Release Technique for Postoperative Treatment of Stage Ⅲ Upper Limb Lymphedema in Patients with Breast Cancer

SONG Jian, PENG Li, DENG Ming, LIU Shufen, LIU Ying

2022, 13(6): 1045-1050. doi: 10.12290/xhyxzz.2022-0326

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Objective To explore the effect of myofascial release technique in the treatment of stage Ⅲ lymphedema after breast cancer surgery. Methods The clinical data of breast cancer-related stage Ⅲ lymphedema patients treated in the Department of Rehabilitation Medicine of Peking Union Medical College Hospital from January 2016 to December 2021 were retrospectively collected. According to different treatment methods, the patients were divided into manual therapy group and conventional therapy group. The conventional therapy group was treated with conventional bandage compression combined with exercise training, while the manual therapy group was treated with myofascial release technique before bandage compression and exercise training. Both groups were treated 2-3 times a week, 25-30 times in total. Limb volume, pain, range of motion (ROM), and limb function were evaluated before treatment, at the end of treatment, and 3 months after treatment, with limb volume as the primary outcome index. Results A total of 79 breast cancer patients with stage Ⅲ lymphedema who met the inclusion and exclusion criteria were enrolled, including 39 in the conventional therapy group and 40 in the manual therapy group. There was no significant difference in limb volume, visual analogue scale (VAS) score, flexion and abduction ROM, and disability arm shoulder hand (DASH) score between the two groups before treatment (all P > 0.05). Compared with the conventional therapy group, the affected limb volume in the manual therapy group was reduced at the end of treatment[(2511.70±437.08)cm³ vs. (2823.58±537.60)cm³, P=0.006] and 3 months after treatment[(2492.91±446.52)cm³ vs. (2813.90±533.87)cm³, P=0.005], and VAS and DASH scores were decreased (all P < 0.05), while the anteriorflexion and abduction ROM of the affected limb were increased 3 months after treatment (all P < 0.05). Linear regression analysis showed that in the manual therapy group the mean reduction of limb volume after treatment was 156.260 cm³(95% CI: 124.264-188.255, P < 0.001) more than that in the conventional therapy group; the mean reduction of VAS score was 0.557(95% CI: 0.163-0.951, P=0.006) more than that in the conventional therapy group; and the mean reduction of DASH score was 16.590(95% CI: 12.270-20.911, P < 0.001) more than that in the conventional therapy group; the average increase of anteriorflexion ROM was 7.390(95% CI: 2.016-12.763, P=0.007) more than that in the conventional therapy group, and the average increase of abduction ROM was 12.737(95% CI: 6.320-19.153, P < 0.001) more than that in the conventional therapy group. Conclusions Myofascial relaxation may be associated with the reduction of the volume of stage Ⅲ lymphedema in patients with breast cancer. It can relieve pain and restore joint function to a certain extent.

Right Ventricular-pulmonary Arterial Coupling in Pulmonary Hypertension: Application Advances

DUAN Anqi, LUO Qin, ZHAO Zhihui, ZHAO Qing, LIU Zhihong

2022, 13(6): 1051-1056. doi: 10.12290/xhyxzz.2021-0797

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Prognosis in pulmonary hypertension is closely associated with right heart function. In the early stage of pulmonary hypertension, the right ventricle can maintain the normal blood flow of the pulmonary circulation by increasing its contractility. As the disease progresses, the right ventricular afterload rises persistently, the right ventricle is gradually decompensated, even right heart failure occurs. Right ventricular-pulmonary arterial coupling refers to a matching between right ventricular contractility and afterload. The impairment of this coupling may be an early marker of right ventricular dysfunction. This article reviews the research progress of its assessment and application in pulmonary hypertension.

Recent Advances in the Pathogenesis of Coronary Microvascular Disease: The role of Inflammatory Reactions

CAO Jun, QIN Jinmei, XUE Weizhen

2022, 13(6): 1057-1063. doi: 10.12290/xhyxzz.2021-0782

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Coronary microvascular disease(CMVD)is the main cause of myocardial ischemia in patients with non-obstructive coronary artery disease. However, there is still a lack of comprehensive understanding of its pathophysiological mechanism due to the hidden pathogenesis and complex etiologies, which greatly restricts its clinical diagnosis and treatment. The injury of coronary artery microvascular endothelial cells is central to the induction of CMVD, and various inflammatory factors can participate in the pathogenesis of CMVD through the endothelial cell injury pathway. This article mainly reviews the possible mechanisms of inflammatory response in CMVD, in the hope of providing reference for the diagnosis, treatment and prevention of CMVD.

Peripheral Nerve Block in Patients with Diabetic Peripheral Neuropathy

WANG Jia

2022, 13(6): 1064-1068. doi: 10.12290/xhyxzz.2022-0043

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Diabetes is one of the most common metabolic conditions worldwide. Regional anesthesia has benefits in promoting the restoration of function and may avoid worse outcomes compared to general anesthesia and intravertebral anesthesia. However, patients with diabetes are susceptible to peripheral neuropathy. The incidence of complications of regional anesthesia in patients with diabetes is supposed to be higher. The aim of this review is to explore the strategies of regional anesthesia implementation, the selection of adjuvant, and the way to reduce the risk of complications. This, in turn, will allow practitioners to undertake more informed decision-making and potentially modify their anesthetic technique for patients with diabetes.

Coronary Aneurysm-like Dilation with Stenosis, Anti-phospholipid Antibody Syndrome, Nephrotic Syndrome, and Polycystic Kidney: A Case Report

WANG Yuxin, GUO Xiaoxiao, YANG Deyan, ZHAO Jiuliang, JIANG Ying, HU Rongrong, SHEN Dongchao, MAO Yueying, WANG Lin, YAN Xiaowei

2022, 13(6): 1069-1073. doi: 10.12290/xhyxzz.2021-0678

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Here we report a case that a young man had early onset myocardial infarction. Coronary angiography showed coronary aneurysm-like dilation and thromboembolism. After stents were implanted, his condition was complicated with repeated stent restenosis. Polycystic kidney, nephrotic syndrome and antiphospholipid antibody syndrome were also present. Antiphospholipid antibody syndrome, a risk factor for recurrent coronary thrombosis, can lead to nephrotic syndrome. Polycystic kidney can be characterized by nephrotic syndrome and may be combined with aneurysmal lesions due to genetic abnormalities. According to the multidisciplinary discussion and follow-up results, the patient was diagnosed as connective tissue diseases and secondary anti-phospholipid antibody syndrome, nephrotic syndrome, and coronary artery lesions. The patient's symptoms improved after treatment for the original disease. The management of this patient broadened our understanding of the etiology of coronary artery disease in young patients and demonstrated the importance of multidisciplinary clinical thinking.

Quality Improvement Project in the Healthcare Field and Standards for Quality Improvement Reporting Excellence

LI Zhenghong, QUAN Meiying

2022, 13(6): 1074-1080. doi: 10.12290/xhyxzz.2022-0210

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With the increasing usage of quality improvement (QI) methodology, the application of QI in healthcare field is gradually gaining attention. QI in healthcare field, guided by the specific aim, is to use the methodology of continuous and cyclic interventions to transform existing knowledge into clinical practice and to measure whether the interventions are effective through monitoring of quantifiable indicators, so as to improve the medical process and outcomes. In this paper, we introduce the structures of QI projects and reporting elements, including the title and abstract, introduction, results and discussion section, and offer examples for detailed explanation, with the hope of helping medical staff to better understand QI in the field of healthcare.

Design and Thought for Establishing Decision Trees Based on Clinical Practice Guidelines

SHEN Quan, LUO Xufei, SHI An'ya, LEI Ruobing, LYU Meng, HOU Tianchun, ZHANG Shu, LIU Enmei, LI Qiu, CHEN Yaolong

2022, 13(6): 1081-1087. doi: 10.12290/xhyxzz.2022-0355

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Clinical practice guidelines can facilitate the standardization of the diagnosis and treatment and improve health care quality. However, there are barriers to guideline dissemination and implementation, thus impeding the standardization of clinical practice and improvement of patient outcomes. One major barrier is that it is difficult for doctors to read and understand the unstructured text-based guidelines, and apply them in real clinical practice. This paper introduces the design of decision trees based on clinical practice guidelines, and the advantages, challenges and solutions of this approach, with the hope of providing references for promoting the transformation of textual clinical practice guidelines.

Expression of H3K27me3 in Tibetan Patients with Gastric Cancer and Its Significance

LUO Hanhuan, SHI Jie, BIANBA Zhaxi, YANG Xu, NIMA Zhuoma, WANG Qian, LI Mei, WANG Han, LIAO Ruiqian, CIREN Quzhen

2022, 13(6): 1088-1093. doi: 10.12290/xhyxzz.2021-0727

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Objective To investigate the expression and its significance of H3K27me3 in Tibetan patients with gastric cancer. Methods Clinical and pathological data were retrospectively collected from Tibetan patients with gastric cancer in the Tibet Autonomous Region People's Hospital from August 2019 to August 2021 and Tibetan non-gastric cancer patients during the same period. The expression of H3K27me3 in gastric cancer tissues, corresponding adjacent normal gastric mucosa and normal gastric mucosa of Tibetan patients with non-gastric cancer tissues was detected by immunohistochemical method, and the differences of H3K27me3 expression between gastric cancer patients with different clinical and pathological characteristics was compared. Results A total of 54 Tibetan gastric cancer patients and 55 Tibetan non-gastric cancer patients who met the inclusion and exclusion criteria were enrolled. H3K27me3 was localized in the nucleus, and the nucleus showed brownish-yellow granular staining when positively expressed. The high expression rate of H3K27me3 in gastric cancer tissues was significantly higher than that in adjacent normal gastric mucosa tissue[64.8%(35/54) vs. 29.6%(16/54), P < 0.001]and normal gastric mucosal tissue of Tibetan patients with non-gastric cancer[64.8%(35/54) vs. 34.5%(19/55), P=0.002], and the high expression rate of H3K27me3 in the adjacent normal gastric mucosa tissue was not significantly different from that in normal gastric mucosal tissue of Tibetan patients with non-gastric cancer(P=0.683). H3K27me3 expression in gastric cancer tissues was not related to gender, age, degree of differentiation, depth of invasion, maximum tumor size, Lauren's classification, lymph node metastasis, vascular and nerve invasion and TNM stage. Conclusions H3K27me3 is highly expressed in gastric cancer tissues of Tibetan people in Tibet. There is no significant difference in H3K27me3 positive expression cells in adjacent tissues and normal gastric mucosa. The significance of H3K27me3 in Tibetan patients with gastric cancer is uncertain and requires further investigations.

Establishment of the Management Systems for Off-label Drug Use in Medical Institution

ZUO Wei, LIU Rongji, NIU Ziran, DU Liping, CHANG Qing, PENG Hua, PAN Hui, ZHANG Bo

2022, 13(6): 1094-1099. doi: 10.12290/xhyxzz.2022-0128

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With the implementation of the Law on Doctors of the People's Republic of China on March 1, 2022, off-label use of drugs has been included into the legislation for the first time. The Law on Doctors of the People's Republic of China stipulates: "In the absence of effective or better treatment approaches and other special circumstances, after obtaining the informed consent of the patient/guardian/entrusted agent, the clinician can undertake a usage not specified in the drug instruction if supported with evidence. Medical institutions are suggested to establish a management system to review the suitability of prescriptions and medications and strictly standardize the medication behavior of clinicians". In view of this, Peking Union Medical College Hospital has established the management system for off-label drug use based on evidence-based methods, with the aim to strengthen its management and rational use in our hospital. The measures for off-label drug use have been formulated to safeguard the doctors' legitimate rights, as well as to strictly standardize practicing behavior. Contingency plans have been established for risk prevention and control to protect the patients' rights and escort the off-label use of drugs. Hierarchical management based on the patients' needs and the types of evidence sources for off-label medication use have been adopted to improve its feasibility.

Eosinophilic Enteritis Accompanied with Recurrent Acute Pancreatitis: A Case Resport

ZOU Long, WANG Qiang, WU Xi, WANG Zhiwei, YANG Aiming

2022, 13(6): 1100-1104. doi: 10.12290/xhyxzz.2021-0803

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This was a patient with a medical history of aspirin-aggravated respiratory disease present with eosinophilic enteritis and recurrent acute pancreatitis. Eosinophilic granulomatosis with polyangiitis was clinically suspected due to the clinical presentation of multiple systems and the histological appearance of eosinophilic infiltrate, but acute pancreatitis was rarely reported in this disease. In addition, the patient developed pancreatic pseudocyst, and delayed pseudoaneurysm hemorrhage occurred after drainage of the pseudocyst. The hemorrhage was successfully treated after angiographic embolization, and the patient remained stable after one year. The case was reported here because both the diagnosis and the management were challenging and worth learning.

Comparison and Reflection on the Training System of Foreign Critical Care Medicine Specialists

TANG Bo, CUI Na, HU Xiaoyun, LONG Yun, DU Bin

2022, 13(6): 1105-1109. doi: 10.12290/xhyxzz.2022-0125

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Critical care medicine in China has developed rapidly and played an irreplaceable role in the treatment of critically ill patients, emergency disasters and public health events. The standardized training of specialists is not only an important part of medical education after graduation, but also a conventional way to train qualified specialized clinicians. As the second batch of national pilot specialties, critical care medicine has established a national unified specialist training system, which has become an important way to cultivate professionals. This study compares the similarities and differences of critical care medicine specialty training in foreign countries from the aspects of training system and platform construction, so as to provide reference for promoting the continuous improvement of critical care specialist training system in China.

Teaching Effect after Changing Mode of Continuing Medical Education during the COVID-19 Pandemic

WANG Hanbi, CHEN Jie, ZHANG Zhiyuan, ZHAO Chunxia, WU Tong, MEN Xiaoliang, LI Zhaozhao, SUN Aijun

2022, 13(6): 1110-1113. doi: 10.12290/xhyxzz.2022-0291

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Objective To explore the teaching effect of the teaching mode changed from traditional teaching to online teaching after the outbreak of coronavirus disease 2019 (COVID-19) pandemic. Methods Relying on the Beijing Women's Health Care Technology Improvement Project, the online and offline continuing medical education was carried out, to train the obstetrician and gynecologist working in 16 maternal and child health care hospitals in 16 administrative regions of Beijing, which was planned from September 2020 to December 2025. This study retrospectively collected the assessment results of the two teaching modes from March 2021 to December 2021 (the first year of the teaching plan), and compared the teaching effects. Results Online teaching completed three sessions of 30 live online conference courses, with about 25 000 participants, including 4757 obstetricians and gynecologists from 16 maternal and child health care hospitals in Beijing. A total of 82 on-site teaching courses were held for offline teaching, and 1771 gynecologists and obstetricians from 16 maternity and child care hospitals in Beijing participated in the study. The scores of online teaching and offline teaching were 90.88±4.88 and 88.65±4.35, respectively. Conclusions Online teaching maybe has similar teaching effects as offline teaching. Compared with offline teaching, online teaching has more advantages, such as convenience, efficiency and economy, which is worthy of promotion and application in the context of the COVID-19 pandemic.

A Study on the Invention of Folin-Wu Method and Hsien Wu's Contribution in the Process

DU Hailin, GU Xiaoyang, LI Jiashan

2022, 13(6): 1114-1120. doi: 10.12290/xhyxzz.2022-0335

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The Folin-Wu method is one of the classic methods for blood glucose determination. It is the representative scientific research achievement of Hsien Wu, one of the most celebrated biochemists in China. This study focuses on the invention process of the Folin-Wu method by referring to the original papers of Folin and Hsien Wu and relevant second-hand historical materials. The implication of competition and cooperation in scientific community on further improvement of the Folin-Wu method is also discussed. The purpose is to evaluate the influence of the Folin-Wu method based on historical data, and to further clarify the academic contribution of Hsien Wu in the research process of this method.

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2022 Vol. 13, No. 6

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