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@#OBJECTIVE To provide reference for guiding the individualized drug therapy management of imatinib for gastrointestinal stromal tumor （GIST）， with the goal of enhancing patient survival rates and improving their quality of life. METHODS Using a nominal group technique， a multidisciplinary （clinical， pharmaceutical and evidence-based） expert panel was formed to create the Consensus of Chinese Experts on Individualized Medication Management of Imatinib for Gastrointestinal Stromal Tumors outline through joint discussions. The expert panel conducted systematic retrieval， analysis， and summarization of the outline’s content， and reached relevant consensus based on China’s current situation， clinical needs， and research evidence. An external expert panel was also formed， comprising experienced multidisciplinary experts in clinical practice. Delphi method questionnaire was employed to openly collect the external experts’ opinions， which were then organized， summarized， analyzed， provided with feedback， revised， and finally formed into a consensus. RESULTS & CONCLUSIONS The drafting of this consensus included the clinical application of imatinib in neoadjuvant therapy for GIST patients， adjuvant therapy for adult patients with significant risk of recurrence after surgical resection， and drug therapy for patients with recurrent， metastatic， or unresectable tumors； pharmaceutical monitoring and long-term medication management. This consensus provides standardized processes and methods for medical institutions in individualized drug therapy management for GIST patients and holds significant importance in improving the clinical efficacy of imatinib and ensuring drug safety.
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In recent years， the incidence of pulmonary nodules has kept rising. To give full play to the advantages of traditional Chinese medicine （TCM） in the treatment of pulmonary nodules and identify the breakthrough points of integrating TCM with Western medicine， the China Association of Chinese Medicine organized medical experts in TCM and western medicine to carry out in-depth discussion regarding this disease. The discussion encompassed the modern medical advances， TCM theories of etiology and pathogenesis， the role and advantages of TCM in the whole course management of pulmonary nodules， contents and methods of research on pulmonary nodules， and science popularization work， aiming to provide a reference for clinical practice and scientific research. After discussion， the experts concluded that the occurrence of pulmonary nodules was rooted in the deficiency of the lung and spleen and triggered by phlegm dampness， blood stasis， and Qi stagnation. TCM can treat pulmonary nodules by controlling and reducing nodules， improving physical constitution， ameliorating multi-system nodular diseases， reducing anxiety and avoiding excessive diagnosis and treatment， and serving as an alternative for patients who are unwilling or unfit for surgical treatment. At present， the optimal diagnosis and treatment strategy for pulmonary nodules has not been formed， which needs to be further studied from multiple perspectives such as clinical epidemiology， biology， and evidence-based medicine. The primary task of current research is to find out the advantages， effective prescriptions， and target populations and determine the effective outcomes of TCM in the treatment of pulmonary nodules. At the same time， basic research should be carried out to explore the etiology and biological behaviors of pulmonary nodules. The expert consensus on the diagnosis and treatment of pulmonary nodules with integrated TCM and Western medicine needs to be continuously revised to guide clinicians to conduct standardized， scientific， and accurate effective diagnosis and treatment.
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@# In recent years, the number of lung surgeries has increased year by year, and the number of patients with postoperative cough has also increased gradually. Chronic cough after lung surgery seriously affects patients' quality of life and surgical outcome, and has become one of the clinical problems that clinicians need to solve. However, there is currently no guideline or consensus for the treatment of chronic cough after lung surgery in China, and there is no standardized treatment method. Therefore, we searched databases such as PubMed, Web of Science, CNKI, and Wanfang databases ect. from 2000 to 2023 to collected relevant literatures and research data, and produced the first expert consensus on chronic cough after lung surgery in China by Delphi method. We gave 11 recommendations from five perspectives including timing of chronic cough treatment, risk factors (surgical method, lymph node dissection method, anesthesia method), prevention methods (preoperative, intraoperative, postoperative), and treatment methods (etiological treatment, cough suppressive drug treatment, traditional Chinese medicine treatment, and postoperative physical therapy). We hope that this consensus can improve the standardization and effectiveness of chronic cough treatment after lung surgery, provide reference for clinical doctors, and ultimately improve the quality of life of patients with chronic cough after lung surgery.
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ObjectiveTo evaluate the methodological and reporting quality of clinical practice guidelines for Chinese patent medicine （CPM） with internationally recognized tools the appraisal of guidelines for research and evaluation （AGEREE） Ⅱ and reporting items for practice guidelines in healthcare （RIGHT）， thereby providing refe-rence for the clinical application and future development of CPM guidelines. MethodsDatabases including CNKI， VIP， Wanfang and Sinomed were searched for CPM guidelines， as well as medlive.cn， websites of China Association of Chinese Medicine and Chinese Medical Association， and reference lists of the included papers. The quality of the guidelines was evaluated using the AGREE Ⅱand RIGHT tools， and consistency tests were performed using Interclass Correlation Coefficient， and descriptive analysis and chi-square test were used to analyze the reporting rate for each domain and the average score for each item. ResultsFinally， 140 CPM guidelines were included， of which 51 were disease-oriented and 89 were drug-oriented， all of which were issued by China. For 51 disease-oriented CPM guidelines， the highest average score of all six AGREE Ⅱ domains was 73.32% for clarity， and the lowest was 26.80% for application； for 89 drug-oriented CPM guidelines， the highest average score was 55.62% for scope and purpose， and the lowest was 31.32% for rigour of development. In terms of the seven domains of the RIGHT checklist， the highest reporting rate was 68.26% for background， and lowest was 27.45% for other areas regarding the disease-oriented CPM guidelines； the highest reporting rate was 61.31% for background， and the lowest was 4.49% for other areas regarding drug-oriented CPM guidelines. The average reporting rate was higher for disease-oriented than drug-oriented CPM guidelines in three domains of AGREE Ⅱ （rigour of development， clarity of presentation， editorial independence）， as well as four domains of RIGHT checklist （basic information， evidence， funding and declaration and management of interests， and other areas）. ConclusionThe overall methodology and reporting quality of the current CPM guidelines still need to be improved. It is recommended that future guideline development teams should strictly refer to the AGREE Ⅱ and RIGHT checklist， and take into account of the characteristics of CPM guidelines and relevant methodo-logical suggestions in the development and reporting of CPM guidelines， thereby guiding the clinical use of CPM in a better way.
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Recommendation formation is a key component of clinical practice guidelines for Chinese patent medicine （CPM）， and should encompass the determination of the strength and direction of the recommendation， the rationale for the recommendation， and the methodology for implementing the recommendation. Recommendations can be formed through formal consensus and informal consensus. The strength and direction of recommendations for CPM guidelines should be determined by considering the quality of evidence for CPMs， the priority of the clinical questions， the pros and cons of efficacy and adverse effects， patient acceptance， the feasibility of the recommendation and the availability of resources， social fairness， economic benefits， and other influencing factors. In order to better guide guideline developers to consider these factors more rationally， this article provideed a detailed explanation of each factor in the context of the characteristics of TCM.
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@#his consensus aims to introduce the applications of 4K high-definition technology and fluorescence technology in thoracic surgery, summarize and categorize the technical support for pulmonary segment surgery, and innovatively propose technical support for precise sleeve resection of pulmonary segments. It provides a reference for clinical use, points out the direction for the research and innovation of domestically produced high-end endoscopes, promotes the widespread application of excellent domestically produced medical endoscopes, and facilitates the development of domestically produced medical equipment.
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Pancreatic cancer is a relatively common tumor of the digestive system， with difficulties in early-stage diagnosis and an extremely high degree of malignancy. Molecular diagnostic technology based on tumor biomarkers， combined with the existing gold standard in clinical practice， is of great clinical significance to achieve early accurate identification， timely treatment and intervention， and reduction in mortality. Previous studies have shown that miRNAs show high specificity in terms of types and expression levels in different pathological stages of pancreatic cancer and can thus be used in monitoring the development and progression of pancreatic cancer. Since a single miRNA has a limited diagnostic potential， the combination of different miRNAs may effectively improve the diagnostic efficiency of early-stage pancreas carcinogenesis. Based on related research advances in recent years， this consensus document aims to fill the gap in molecular diagnostic technology in the guidelines for the clinical diagnosis and treatment of pancreatic cancer and provide expert guidance and recommendations.
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Stem cell clinical research is a hot frontier research. The ethical review of stem cell clinical research is full of challenges. Currently, clinical researches lack specific operational guidelines. Considered the related laws and regulations, and the operability of practical work, experts from the field of stem cells, such as law, ethics and management, will form a consensus on the basis of full discussion and continuous revision. It will provide reference for the operation of the ethics committee of corresponding institutions, and lay a certain foundation for the establishment of national expert consensus in the future, so as to promote the effective guidance of ethical review practice and quality evaluation of stem cell research.
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At present， there is no consensus on the diagnosis， treatment， and management of pulmonary nodules with integrated traditional Chinese and Western Medicine in China. To establish the clinical management strategy of pulmonary nodules with integrated medicine， a consensus was formed after full discussion by the experts from the Cancer Committee of Chinese Association of Integrative Medicine and the Cancer Committee of Beijing Association of Chinese Medicine according to the guidelines for pulmonary nodules issued in recent years and the clinical practice of multiple hospitals in the treatment of cancers with integrated Chinese and Western medicine. This consensus involves the existing clinical management guidelines of pulmonary nodules and the intervention methods of traditional Chinese medicine （TCM）. Considering the therapeutic positioning and value of TCM， this consensus standardizes the whole-process management of pulmonary nodules with integrated traditional Chinese and Western medicine， which will help more patients.
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Cancer related anemia (CRA) is a common side effect in patients with tumors, the incidence of which is related to tumor type, treatment regimen, the duration of chemotherapy, etc. The pathogenesis of CRA has not been fully defined. CRA may lead to chemotherapy dose reduction or may even delay chemotherapy. Patients with CRA require red blood cell transfusion, thus increasing the treatment cost, reducing the efficiency of chemotherapy and the patient's quality of life, and shortening the survival time. The main treatments of CRA include red blood cell transfusion, iron supplements, erythropoietin, and so on. Based on recent literature and clinical studies, the expert committee of the China Anti-Cancer Association drew up the consensus on the diagnosis and treatment of anemia related to tumor in China (2023 edition). The 2023 consensus incorporates the latest evidence-based medicine evidence and Traditional Chinese Medicine related content and aims to provide more reliable diagnosis and treatment plans for Chinese oncologists to help improve CRA and the quality of life in patients with cancer.
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Humains , Consensus , Qualité de vie , Anémie/prévention et contrôle , Tumeurs/thérapie , Chine/épidémiologieRésumé
Breast cancer is the most common malignant tumor in women around the world, and it is also a common cause of death in female patients with malignant tumors in China, which seriously harms women's health. At present, with the application of comprehensive treatment approaches, breast cancer has become one of the most effective solid tumors. Platinum drugs are widely used in malignant tumors, and they are also commonly used as effective chemotherapeutic drugs for breast cancer. To regulate the application of platinum drugs in breast cancer, the experts from Breast Cancer Group, Branch of Oncologist, Chinese Medical Doctor Association, discuss and approve the "Guidelines for clinical application of platinum drugs in breast cancer (2023 edition)" . This guideline is developed from the "Expert consensus on the clinical application of platinums in advanced breast cancer (2020 version)" , which is updated from the latest evidence based on breast cancer at home and abroad, for platinum drugs in breast cancer clinical use, application scheme, efficacy analysis and treatment of adverse effects. This guideline aims to guide clinicians to use drugs rationally, and to further standardize the diagnosis and treatment.
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Femelle , Humains , Tumeurs du sein/anatomopathologie , Platine/usage thérapeutique , Consensus , ChineRésumé
Lung cancer is the most common cancer and the leading cause of cancer death in China. Non-small cell lung cancer (NSCLC) is the most common histological type of lung cancer. Mutations of driver genes have major impacts on incidence and progression of lung cancer. Advances in molecular biology research and clinical research have promoted the discovery of rare tumor driver genes, as well as the development and application of new targeted drugs. Nearly 1% to 2% of NSCLCs harbor RET fusions, and this patient population may not respond well to traditional treatments like chemotherapy or radiation therapy. After the new highly selective RET inhibitors pralsetinib (BLU-667) and selpercatinib (LOXO-292) entered clinical application, the diagnosis and treatment of RET fusion positive NSCLC has made breakthrough progress. At present, there is a lack of guiding consensus on the standardized diagnosis and treatment of RET fusion-positive NSCLC in China. The Society of Cancer Precision of Chinese Anti-Cancer Association and Lung Cancer Expert Group of Chinese Medical Journal, invited 38 experts form respiratory medicine, medical oncology, oncology radiotherapy and pathology to form a consensus development group. Based on the existing research evidence, combined with China's clinical practice experience, a standardized process for the diagnosis and treatment of advanced RET fusion-positive NSCLC is proposed, including suitable populations and methods for RET gene fusion, treatment drug selection, treatment of resistance to highly selective RET inhibitors, and management of adverse reactions to treatment, with a view to providing guidance for clinicians.
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Humains , Carcinome pulmonaire non à petites cellules/génétique , Chine , Consensus , Tumeurs du poumon/génétique , Inhibiteurs de protéines kinases/usage thérapeutique , Protéines proto-oncogènes c-ret/génétiqueRésumé
Breast cancer is the most common malignant tumor in women, of which the majority is early breast cancer (EBC). The strategy of postoperative adjuvant treatment relies mainly on the clinicopathologic characteristics of patients, but there are certain deficiencies if only depending on it to assess treatment benefits and disease prognosis. Multigene testing tools can evaluate the prognosis and predict therapeutic effects of breast cancer patients to guide the clinical decision-making on whether to use adjuvant chemotherapy, radiotherapy, and endocrine therapy by detecting the expression levels of specific genes. The consensus-writing expert group, based on the characteristics, validation results, and accessibility of the multigene testing tools and combined with clinical practice, described the result interpretation and clinical application of OncotypeDx(®) (21-gene), Mammaprint(®) (70-gene), RecurIndex(®) (28-gene), EndoPredict(®)(12-gene), and BreastCancerIndex(®) (BCI, 7-gene) for hormone receptor-positive and human epidermal growth factor receptor 2-negative EBC. The development and validation process of each tool was also briefly introduced. It is expected that the consensus will help guide and standardize the clinical use of multigene testing tools and further improve the level of precise treatment for EBC.
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Humains , Femelle , Tumeurs du sein/génétique , Consensus , Peuples d'Asie de l'Est , Pronostic , Traitement médicamenteux adjuvant , Récepteur ErbB-2/génétiqueRésumé
Quantitative real-time polymerase chain reaction (qPCR) is one of the most widely used molecular pathological diagnostic techniques in China due to its advantages of the simple operation, short turnaround time, high sensitivity, and standardizable result analysis. However, in clinical practice, there is not yet an expert consensus to guide molecular pathological diagnostics of tumor using qPCR techniques in terms of validation and verification of method performance, quality management and interpretation of complex results. Therefore, this expert consensus aims to provide standardized opinions on the practical application of qPCR techniques, and suggestions on how to deal with common problems and abnormal results, and reach a Chinese expert consensus on the clinical practice of qPCR techniques in molecular pathological diagnostics of tumor, in order to standardize the testing process, improve the accuracy of results, and promote the clinical applications of qPCR techniques.
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Humains , Réaction de polymérisation en chaine en temps réel , Consensus , Peuples d'Asie de l'Est , Tumeurs , ChineRésumé
Non-small cell lung cancer (NSCLC) with oncogenic driver mutations was previously deemed " forbidden territory" for immunotherapy. With the growing understanding of the impact of target drugs on the immune microenvironment and the continuous generation of clinical evidence, immunotherapy is expected to bring new hope for the NSCLC with oncogenic driver mutations. This consensus is updated based on the Chinese expert consensus on immunotherapy for advanced non-small lung cancer with oncogenic driver mutations (2022 edition), and developed by the consensus expert panel through symposiums, combining the latest medical evidence and clinical practice. After thorough discussion, the expert panel reached new consensuses on 3 clinical questions: in patients with ALK fusion who are progressing on tyrosine kinase inhibitor(TKI) therapy, immune checkpoint inhibitors (ICIs)-based treatment is not recommended; ICIs-based treatment is recommended for patients with HER-2 mutations; ICIs-based treatment is recommended for NSCLC patients with MET exon 14 skipping after resistance to the targeted therapy. At the same time, with the continuous accumulation of clinical evidence, the recommendation levels of the three consensus opinions were adjusted in this update: the recommendation of ICIs combined with anti-angiogenesis therapy for patients with extensive progression after EGFR-TKIs resistance was adjusted to the level of strong; the ICIs recommendations for patients with advanced KRAS mutant and BRAF mutant NSCLC were adjusted to the level of consistent and strong, respectively. This updated consensus, combined with the latest evidence and clinical experience widely recognized by the expert panel in the immunotherapy of driver gene mutation advanced NSCLC, aims to provide standardized guidance for the clinical practice in China.
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Humains , Carcinome pulmonaire non à petites cellules/génétique , Consensus , Immunothérapie , Tumeurs du poumon/génétique , Mutation , Microenvironnement tumoral , ChineRésumé
@#Cushing′s syndrome(CS)is a clinical syndrome caused by a variety of causes, with main manifestations exhibited by central obesity, purple skin striae, hypertension, and diabetes. In patients with adrenocorticotropic hormone(ACTH)-dependent CS, the result of bilateral inferior petrosal sinus sampling(BIPSS)is the gold standard for determining the source of ACTH in the absence of routine imaging findings.However, the indications, contraindications, operating procedures, precautions and outcome judgments of BIPSS differ from one medical center to another, and there are currently no international and domestic clinical guidelines and expert consensus on BIPSS. In order to further improve the operation specifications of BIPSS in the diagnosis process of difficult CS, the Hypothalamic and Pituitary Disease Group of the China Alliance for Rare Diseases and the Innovation Center of Pituitary Diseases of Peking Union Medical College Hospital organized experts in endocrinology, interventional radiology, neurosurgery and laboratory in China to formulate this consensus. This consensus aims to provide standardized methodological guidance for the use of BIPSS in the differential diagnostic process of CS in clinical practice.
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RhD antigen is the most immunogenic antigens in the Rh blood group system and can cause hemolytic transfusion reactions (HTRs) and severe hemolytic disease of the fetus and newborn (HDFN). RhD-negative red blood cell (RBC) is a scarce resource in China, and RhD-negative patients face challenges in timely blood transfusion. For different populations that were initially negative for RhD (saline method), what techniques should be used, how to issue test report and when should " Asian type" DEL (RHD*01EL.01, c.1227G>A) be identified are the confusions of blood transfusion workers in the process of clinical blood supply. More than 200 technical experts discussed and reached a consensus on blood transfusion compatibility testing for Chinese population. The purpose of the consensus is to further standardize and refine the RhD blood group testing strategy, provide technical support for achieving accurate blood transfusion for patients with different RhD blood groups, continuously improve the levels of prevention and treatment for RhD-HTRs and RhD-HDFN, and lay a foundation for the future development of industry standards concerning RhD blood group testing strategy.
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The killer-cell immunoglobulin-like receptor(KIR) gene family exhibits complex genetic diversity. In addition to allele level polymorphisms, KIR genes show extra diversity at haplotype content as well as copy number variation. In order to standardize the KIR gene testing, the Working Party on Histocompatibility, Chinese Society of Blood Transfusion (CSBT)and Shenzhen Blood Center organized experts to discuss and reach a consensus on KIR gene testing based on KIR-related literature and practical experience. The present consensus has summarized the techniques for identifying the diversity of KIR genes, quality control, testing report and its applications, aiming to improve the accuracy of KIR gene testing results.
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Transfusion associated graft versus host disease (TA-GVHD) is a serious transfusion adverse reaction. It is widely believed that transfusion of irradiated blood is the most effective method to prevent TA-GVHD. There are some problems in the application of irradiated blood in China, such as slow development, insufficient understanding, and non-standard application. This consensus was completed after in-depth discussion by experts in the fields of transfusion medicine, hematology, and pediatrics in China. The Writing Group mainly discuss key technical points and clinical applications related to irradiated blood, and proposes 23 related recommendations. This consensus aims to standardize and promote the rational use of irradiated blood, minimize the risk of TA-GVHD in recipients and lay the foundation for developing more standardized guidelines in the future.
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At present, ABO-incompatibility hematopoietic stem cell transplantation (ABOi-HSCT) accounts for 30%~50% of the total HSCT, and is no longer a major obstacle to HSCT. Transfusion therapy is an important treatment for HSCT patients during transplantation, and correct blood typing and blood selection of blood component are particularly important.For patients with ABOi-HSCT, one of the challenging issues for laboratory technician is to complete ABO blood group testing and report before, during, and after ABOi-HSCT, as well as the selection of blood components that balance transfusion safety and efficacy. This consensus was jointly discussed by domestic experts in transfusion medicine and hematology in China, and 7 recommended opinions were extracted to further standardize the blood typing and blood component infusion strategies for ABOi-HSCT patients, provide technical support for standardized blood typing reports and accurate blood component infusion for HSCT patients, and continuously improve the safety and efficacy of blood transfusion.