1.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
2.Summary of optimal evidences for early fluid resuscitation management in patients with acute pancreatitis
Li LI ; Liqun ZHU ; Wenhua ZHANG ; Yingfeng ZHOU ; Lei BAO ; Guofu SUN ; Yuanyuan MI ; Liping YANG ; Leiyuan ZHONG ; Wei ZHANG
Chongqing Medicine 2024;53(1):114-120
Objective To systematically retrieve,evaluate and integrate the best evidences on the early fluid resuscitation management in the patients with acute pancreatitis(AP)at home and abroad to provide ref-erence for clinical decision.Methods The related evidences on the early fluid resuscitation management in the AP patients were retrieved by computer from the databases of BMJ Best Practice,Up To Date,JBI,National Institute for Health and Care Excellence,Registered Nurses Association of Ontario,Guideline International Network,Scottish Intercollegiate Guidelines Network,International Association of Pancreatology,American Pancreatic Association,American College of Gastroenterology,Yimaitong,Cochrane Library,PubMed,Em-bass,CINAHL,The Web of Science,CNKI,Wanfang databases.The retrieval time limit was from the data-base establishment to March 20,2022.The literatures types included thematic evidence summarization,guide-lines,evidence summaries,systematic reviews and expert consensus.The researchers conducted the literature quality evaluation.The literatures meeting the standard conducted the evidence extraction.Results A total of 13 arti-cles were included,including 3 special subject evidence summary,4 guidelines,2 evidence summary,2 systematic evalu-ation and 2 expert consensus.A total of 16 pieces of best evidence were integrated,involving 4 aspects of organization management,evaluation and monitoring,fluid infusion strategy and health education.Conclusion It is recommended to use the target-oriented therapy for early fluid resuscitation management,and perform the fluid resuscitation immediate-ly after diagnosis,according to the patient's underlying disease,disease changes and monitoring indicators,implement precise early fluid resuscitation in order to reverse pancreatic microcirculation disorder,increase tissue perfusion and improve the patient's prognosis.
3.Bibliometric analysis of vertigo-related histopathology,vestibular rehabilitation,physical rehabilitation,and Chinese and Western medical treatments
Yiming SUN ; Xinming YANG ; Liqun CAI ; Aining LIU
Chinese Journal of Tissue Engineering Research 2024;28(34):5500-5507
BACKGROUND:Vertigo is closely related to clinical neurological disorders.When neurons are damaged or dead,it may lead to abnormalities in the vestibular system and trigger vertigo symptoms.Therefore,it is necessary to explore and analyze the hotspots related to vertigo that are common in clinical neurology. OBJECTIVE:To analyze the vertigo-related histopathological changes in clinical neurology and the research hotspots worldwide using bibliometric methods. METHODS:The WanFang database and Web of Science core set database were searched by the first author to retrieve the research-related literature published from 2014-2023 on the treatment of common vertigo in clinical neurology.A bibliometric analysis of the number of publications,country/region,institution,keywords,co-cited literature,and highly cited literature was peformed using VOSviewer_1.6.19 software to summarize the research hotspots in this research field. RESULTS AND CONCLUSION:Web of Science core set database had the highest number of 174 publications in this field in 2022,and WanFang database had the highest number of 133 publications in this field in 2020.The top 3 countries with the highest number of publications are the United States,Germany,and China.The University of Munich,Germany is the international institution with the highest number of publications in this field,while Chengdu University of Traditional Chinese Medicine is the Chinese institution with the highest number of publications in this field.The results of keyword analysis showed that the research hotspot diseases in this field in China are mainly Meniere's disease,cervical vertigo,senile vertigo,benign paroxysmal positional vertigo,isolated vertigo,and hypertensive vertigo,and the treatments include acupuncture,rehabilitation,medication(gastrodin,Banxia Baizhu Tianma Tang),and manipulative reduction.International research hotspot diseases in this field mainly include benign paroxysmal positional vertigo,vestibular disorders in new coronavirus cases,Meniere's disease,vestibular schwannoma,acoustic neuromas,and vestibular migraines,etc.,and the hotspot treatments are antivertiginous medications,antidepressant and anxiolytic treatments,and microsurgery.The results of literature co-citation analysis showed that for acute vestibular syndrome with persistent vertigo as the main symptom,three-step bedside ophthalmoscopy(HINTS:Head-Impact-Nystagmus-Strabismus Test)is more sensitive than early MRI in the diagnosis of combined strokes in patients with acute vestibular syndrome,which is the most peer-recognized method of detecting strokes in vestibular syndrome,whereas hormonal therapy is more effective to treat vestibular neuritis patients with paroxysmal vertigo as the main symptom.The results of highly cited literature analysis showed that,in the hot literature included in WanFang database in the past 10 years,acupuncture at Fengchi point and the acupuncture method of inducing resuscitation to improve posterior circulation ischemic vertigo have achieved certain results.The literature published in the past 3 years has indicated that Ginkgo biloba leaf extract+gastrodin,acupuncture+Banxia Baizhu Tang,betahistine+gastrodin,vestibular rehabilitation training+Epley Maneuver,all can improve the vertigo symptoms to different degrees.While there were no featured anti-vertigo drugs indicated in the literature in the Web of Science core set data in the recent 10 years,and most of them are based on traditional anti-vertigo drugs and microsurgery.However,there are a few case reports in the international literature in the last 3 years that found that COVID-19 infection may lead to vestibular neuritis and vertigo symptoms.The onset and progression of vertigo may be closely related to neuronal damage and regeneration.For example,viral infections,inflammatory stimuli,or other pathologic factors may lead to neuronal damage or death,thereby affecting the function of the vestibular system.Vertigo-related diagnosis and treatment standardization guidelines have been published both domestically and internationally.Currently,international guidelines recommend the combination of vestibular rehabilitation and physical rehabilitation for the treatment of vertigo,and Chinese guidelines recommend the combination of Chinese and Western medicine,reduction and acupuncture.However,the level of evidence is not very high,so a large number of large-sample,multicenter randomized controlled trials on anti-vertigo treatment are needed in the future.
4.Network pharmacology reveals the effect and mechanism of Ganoderma leucocontextum ethanol extract on improving inflammatory response in silicosis lungs
Rui QIAN ; Luoning ZHANG ; Yunyi XU ; Donglei SUN ; Liqun WANG ; Xuxi CHEN ; Yuqin YAO ; Linshen XIE
China Occupational Medicine 2024;51(1):6-15
ObjectiveTo explore the effect of Ganoderma leucocontextum ethanol extract (GLE) on silicosis and its potential molecular mechanism using network pharmacology, molecular docking technology and animal experiments. Methods i) The components of GLE were analyzed using ultra-performance liquid chromatography-Q Exactive-mass spectrometry (UPLC-QE-MS) method. The active components, potential molecular pathways and targets of GLE in the intervention of inflammation process of silicosis was explored using network pharmacology and molecular docking technology. ii) Specific pathogen free male C57BL6/J mice were divided into four groups with 10 mice in each group. The mice in the silicosis model group and GLE intervention group were given a dose of 80 μL silica suspension with a mass concentration of 50 g/L once by non-exposed tracheal instillation, and the mice in the blank control group and GLE control group were given an equal volume of sterile 0.9% sodium chloride solution. From the second day after modeling, GLE control group and GLE intervention group were given GLE at a dose of 200 mg/(kg•d) by gavage, while blank control group and silicosis model group were given the same volume of 0.9% sodium chloride solution by gavage, once per day for 35 days. After that, the histopathological changes of lung tissues of mice were observed, the lung mass coefficient, inflammation score and the ratio of collagen deposition area were calculated, and the levels of tumor necrosis factor (TNF) -α, interleukin (IL) -1β and IL-6 in the lung tissues of mice were detected by enzyme-linked immunosorbent assay. Results i) A total of 76 active components of GLE were detected by UPLC-QE-MS. Among them, 36 ingredients met the screening criteria of the five principles of drug-like components. A total of 67 potential targets of the 36 GLE active ingredients to improve the inflammatory response of silicosis were screened based on the network pharmacology theory. The result of Kyoto Encyclopedia of Genes and Genomes enrichment analysis and Gene Ontology functional analysis showed that IL signaling and cytokine signaling of immune cells played a key role in the process of anti-silicosis of GLE. The results of molecular docking showed that the top 10 targets based on the 67 intersection targets were TNF, IL6, B-cell lymphoma 2, cellular tumor antigen p53, Caspase-3 subunit p12, JUN, epidermal growth factor receptor, IL1B, 67 kDa matrix metalloproteinase-9 and prostaglandin G/H synthase 2. The result of protein-protein interaction analysis showed that glycyrrhetinic acid had the strongest affinity with the key targets TNF-α, IL-1β and IL-6, followed by ganoderma acid DM, alismatol C, ganoderma acid β and red sapogenin. ii) The results of histopathological examination showed that the inflammatory response and collagen deposition were alleviated in the lungs of mice with silicosis. The lung mass coefficient, inflammation score, ratio of collagen deposition area and IL-6 expression in lung were lower in mice of the GLE intervention group (all P<0.05), compared with the silicosis model group. However, there was no significant difference in the levels of TNF-α and IL-1β in lung tissues between the two groups (all P>0.05). Conclusion GLE may reduce silica-induced lung inflammation and fibrosis by inhibiting the IL-6 level in lung tissues of mice. Its mechanism is associated with the synergistic action of multi-components, multi-targets and multi-pathways.
5.Treatment of Small Cell Lung Cancer from the Perspective of Wind
Rong HUANG ; Liqun JIA ; Ruitao WANG ; Jianrong SUN ; Qing LIU
Journal of Traditional Chinese Medicine 2024;65(9):949-953
It is believed that wind pathogen is one of the core pathogenic factors of small cell lung cancer (SCLC). The nature and pathogenic characteristics of wind pathogen are closely related to the occurrence and metastasis of SCLC. Mainly manifested as deficiency of both qi and yin, healthy qi deficiency of SCLC makes it susceptible to invasion of external wind. Simultaneously, there are internal wind pathogenesis such as yin deficiency causing wind, blood deficiency causing wind, phlegm, stasis and toxin causing wind, liver yang transforming into wind. The internal and external winds together lead to the disease. Therefore, it is proposed to treat SCLC from wind theory, that is, boosting qi and nourishing yin to extinguish wind with taizishen (Radix Pseudostellariae), wuweizi (Fructus Schisandrae Chinensis) and others; resolving phlegm and moving stasis to dispel wind with wind-dispelling and phlegm-resolving medicinals such as jiangcan (Bombyx Batryticatus), muhudie (Semen Oroxyli), fangfeng (Radix Saposhnikoviae), tianma (Rhizoma Gastrodiae), quanxie (Scorpio) and blood-invigorating and wind-dispelling medi-cinals such as danggui (Radix Angelicae Sinensis), chuanxiong (Rhizoma Chuanxiong) and danshen (Radix et Rhizoma Salviae Miltiorrhizae); attacking toxin and dissipating masses to dispel wind with shuizhi (Hirudo), dilong (Pheretima), fengfang (Nidus Vespae), quanxie, baihuashe (Agkistrodon), jiuxiangchong (Aspongopus) and other drastic medicinals; calming liver and extinguishing wind to prevent brain metastasis of SCLC with Tianma Gouteng Beverage (天麻钩藤饮) modification.
6.TCM Guidelines for Diagnosis and Treatment of Chronic Cough in Children
Xi MING ; Liqun WU ; Ziwei WANG ; Bo WANG ; Jialin ZHENG ; Jingwei HUO ; Mei HAN ; Xiaochun FENG ; Baoqing ZHANG ; Xia ZHAO ; Mengqing WANG ; Zheng XUE ; Ke CHANG ; Youpeng WANG ; Yanhong QIN ; Bin YUAN ; Hua CHEN ; Lining WANG ; Xianqing REN ; Hua XU ; Liping SUN ; Zhenqi WU ; Yun ZHAO ; Xinmin LI ; Min LI ; Jian CHEN ; Junhong WANG ; Yonghong JIANG ; Yongbin YAN ; Hengmiao GAO ; Hongmin FU ; Yongkun HUANG ; Jinghui YANG ; Zhu CHEN ; Lei XIONG
Journal of Nanjing University of Traditional Chinese Medicine 2024;40(7):722-732
Following the principles of evidence-based medicine,in accordance with the structure and drafting rules of standardized documents,based on literature research,according to the characteristics of chronic cough in children and issues that need to form a consensus,the TCM Guidelines for Diagnosis and Treatment of Chronic Cough in Children was formulated based on the Delphi method,expert discussion meetings,and public solicitation of opinions.The guideline includes scope of application,terms and definitions,eti-ology and diagnosis,auxiliary examination,treatment,prevention and care.The aim is to clarify the optimal treatment plan of Chinese medicine in the diagnosis and treatment of this disease,and to provide guidance for improving the clinical diagnosis and treatment of chronic cough in children with Chinese medicine.
7.Clinical research progress of subretinal fibrosis secondary to age-related mac-ular degeneration
Wu SUN ; Jianguo WU ; Dong WEI ; Wanyu ZHOU ; Yan HE ; Wentao FU ; Liqun CHU
Recent Advances in Ophthalmology 2024;44(12):991-994
Subretinal fibrosis(SRF),the end pathological stage of neovascular age-related macular degeneration(nAMD),can cause severe and irreversible vision loss in patients.In recent years,the high clinical incidence of SRF and the severe visual impairment it causes have led to a rapid development of SRF-related research.In order to systematically understand the clinical progress of SRF,recent studies on SRF secondary to nAMD were reviewed in this article.
8.Construction of a competency evaluation indicator system for infection prevention and control nurses in Operating Rooms
Liqun SUN ; Zengmei ZHANG ; Haiyun ZHAO ; Ying ZHANG ; Zi JIN ; Yunfei NIE ; Wei WEI ; Yu WANG ; Shengyun LI ; Ruifang HUA
Chinese Journal of Modern Nursing 2024;30(13):1698-1705
Objective:To construct a competency evaluation indicator system for infection prevention and control nurses in Operating Rooms (hereinafter referred to as "IPC") and provide an objective basis for the management of IPC nurses.Methods:From June to November 2022, an initial competency evaluation indicator system for IPC nurses was developed through literature review and semi-structured interviews. The Delphi method was employed to consult 20 experts from 11 provinces and municipalities across the country. Analytical Hierarchy Process (AHP) and mean distribution method were applied to quantify and determine the weight of each level of indicators within the system.Results:Nineteen experts were finally included, with two rounds of questionnaire recovery rates of 95.00% (19/20) and 100.00% (19/19), respectively. The authority coefficients of the experts were 0.858 and 0.861, familiarity coefficients were 0.850 and 0.853, and coefficients of judgment basis were 0.865 and 0.868, respectively. The Kendall's W coefficient of concordance for the two rounds of inquiries were 0.139 and 0.202 ( P<0.05), respectively. The final IPC nurse competency evaluation indicator system included six primary indicators, 22 secondary indicators, and 66 tertiary indicators. Conclusions:The constructed IPC nurse competency evaluation indicator system is scientific, reasonable, objective, and comprehensive, providing a valuable reference for the capability training, assessment, entry standards, and qualification certification of IPC nurses.
9.Single-center experience on 1 147 cases of liver transplantation
Xiaopeng XIONG ; Qingguo XU ; Xiaolong MIAO ; Hao WANG ; Peng LIU ; Xinqiang LI ; Xin ZHOU ; Xin WANG ; Feng WANG ; Yong ZHANG ; Yandong SUN ; Jinzhen CAI ; Liqun WU ; Chuanshen XU ; Jianhong WANG ; Qingjun GUO
Chinese Journal of General Surgery 2024;39(5):333-338
Objective:To analyze the prognostic outcomes of 1 147 patients who underwent liver transplantation at Qingdao University Affiliated Hospital and to summarize measures to enhance the efficacy of liver transplantation.Methods:A retrospective analysis was conducted on the clinical and follow-up data of 1 147 liver transplant patients at Qingdao University Affiliated Hospital.Results:The overall postoperative 1-, 3-, and 5-year survival rates for the 1 147 liver transplant patients were 87.20%, 73.40%, and 65.60%, respectively. The survival rates for benign disease liver transplant recipients were 88.01%, 84.98%, and 81.39% at 1, 3, and 5 years post-transplant, respectively, compared to recipients transplanted for malignancies of 78.11%, 64.41%, and 60.06% (all P<0.001). Among the mid vs more recent period, patients' 1-year and 3-year postoperative survival rates were 84.20%, 70.80% vs 90.50%, 71.70%, respectively,significantly in favor of recently enrolled patients ( P=0.022). In the complex surgery group, patients' 1-, 3-, and 5-year survival rates were 82.70%, 65.50%, 56.70%, while in less complicated group, it was 89.00%, 76.50%, 69.20% ( P<0.001). The primary causes of death for benign disease recipients were multi-organ failure (4.1%), while in recipients with malignant disease primary cause of death was tumor recurrence (23.7%). Postoperative complications included primary graft dysfunction, delayed graft function recovery, portal vein thrombosis, hepatic artery thrombosis, biliary stricture, post-transplant lymphoproliferative disorder, and graft-versus-host disease, with occurrence rates of 1.05%, 6.89%, 1.92%, 0.44%, 2.00%, 0.61%, and 0.44%, respectively. Conclusions:With the continuous improvement in surgical techniques and perioperative care levels, the 3-year survival rate of recipients at our center has increased. Malignant diseases and complex liver transplantation remain crucial factors affecting recipient prognosis, highlighting the need to further enhance comprehensive treatment capabilities for patients with malignant diseases and complex surgeries.
10.Efficacy and safety of mitoxantrone hydrochloride liposome injection in treatment of peripheral T-cell lymphomas: a multicenter, non-interventional, ambispective cohort, real-world study (MOMENT)
Huiqiang HUANG ; Zhiming LI ; Lihong LIU ; Liang HUANG ; Jie JIN ; Hongyan TONG ; Hui ZHOU ; Zengjun LI ; Zhenqian HUANG ; Wenbin QIAN ; Kaiyang DING ; Quande LIN ; Ming HOU ; Yunhong HUANG ; Jingbo WANG ; Pengcheng HE ; Xiuhua SUN ; Xiaobo WANG ; Zunmin ZHU ; Yao LIU ; Jinhai REN ; Huijing WU ; Liling ZHANG ; Hao ZHANG ; Liangquan GENG ; Jian GE ; Ou BAI ; Liping SU ; Guangxun GAO ; Xin LI ; Yanli YANG ; Yijian CHEN ; Aichun LIU ; Xin WANG ; Yi WANG ; Liqun ZOU ; Xiaobing HUANG ; Dongping HUANG ; Shujuan WEN ; Donglu ZHAO ; Jun MA
Journal of Leukemia & Lymphoma 2023;32(8):457-464
Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.


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