Transesophageal echocardiography: A bibliometric analysis from 1979 to 2022.

OBJECTIVE: Heart disease poses a significant global health challenge. Transesophageal echocardiography (TEE) has gained prominence in clinical practice because of advancements in visual medicine. The present bibliometric analysis provides an overview of TEE research, identifies trends, and highlights emerging topics. METHODS: A comprehensive search of TEE-related literature from the establishment of the Web of Science Core Collection (WOSCC) until 2022 was conducted. Utilizing the CiteSpace software, we performed an in-depth analysis of the literature data encompassing disciplines, publication years, countries, institutions, authors, journals, cited references, and keywords. RESULTS: A total of 17 032 TEE-related articles were included in this study. The most active disciplines in TEE research were Cardiac & Cardiovascular Systems, Anesthesiology, and Respiratory System. The number of publications displayed a consistent upward trajectory over the years. Notably, research contributions predominantly originated from developed countries, mainly Europe and North America, with the United States, Germany, Italy, and Japan leading the way. Analysis of institutions, authors, and journals revealed the United States' significant role in TEE research. Furthermore, the analysis of cited references and keywords identified the treatment of patent foramen ovale and its association with stroke as emerging hot topics in recent years. CONCLUSIONS: This study highlights that TEE remains a research hotspot, with the United States at the forefront. Future research should investigate the relationship between heart disease and brain function.

The effect of simulation of sectional human anatomy using ultrasound on students' learning outcomes and satisfaction in echocardiography education: a pilot randomized controlled trial.

BACKGROUND: Effective teaching methods are needed to improve students' abilities in hand-eye coordination and understanding of cardiac anatomy in echocardiography education. Simulation devices have emerged as innovative teaching tools and exhibited distinctive advantages due to their ability to provide vivid and visual learning experiences. This study aimed to investigate the effect of simulation of sectional human anatomy using ultrasound on students' learning outcomes and satisfaction in echocardiography education. METHODS: The study included 18 first-year clinical medical students with no prior echocardiography training. After randomization, they underwent a pre-test to assess basic knowledge. Following this, the students were divided into two groups: traditional teaching (traditional group) and simulation of sectional human anatomy using ultrasound (digital group). Each group received 60 min of instruction. Post-tests were assigned to students at two different time points: immediately after the lecture, and one week later (referred to as post-tests 1, and 2). In addition, anonymous questionnaires were distributed to students after class to investigate their satisfaction with teaching. RESULTS: Both groups showed significant improvement in their scores on post-test 1 compared to pre-test (traditional group: from 33.1 ± 8.8 to 48.1 ± 13.1, P = 0.034 vs. digital group: from 35.0 ± 6.7 to 58.0 ± 13.2, P = 0.008). However, there were no significant differences between the two groups in several post-test comparisons. Student satisfaction ratings revealed that the digital group experienced significantly greater satisfaction in areas such as subject interest, teaching style, course alignment, and interaction compared to the traditional group. Additionally, 80% of the digital group strongly endorsed the use of simulation of sectional human anatomy using ultrasound for echocardiography teaching, highlighting its effectiveness. CONCLUSIONS: Simulation of sectional human anatomy using ultrasound may improve students' understanding of echocardiography and satisfaction with the course. Our study provides evidence supporting the use of simulation teaching devices in medical education. Further research is needed to explore the long-term impact of this teaching method on students' learning outcomes and its integration into the medical curriculum. TRIAL REGISTRATION: http://www.chictr.org.cn (registration number: ChiCTR2300074015, 27/07/2023).

Pharmacovigilance in China: Evolution and future challenges.

Drug-related adverse reactions are among the main reasons for harm to patients under care worldwide and even their deaths. The pharmacovigilance system has been proven to be an effective method of avoiding or alleviating such adverse events. In 2019, after two decades of implementation of the drug-related adverse reaction reporting system, China formally implemented a pharmacovigilance system with the Pharmacovigilance Quality Management Standards and a series of supporting technical documents created to improve the safety of medication given to patients. China's pharmacovigilance system has faced many problems and challenges during its implementation. This spontaneous reporting system is the main source of data for China's medication vigilance activities, but it has not provided sufficiently powerful evidence for regulatory decision-making. In conformity with the health-centred drug regulatory concept, the Chinese government has accelerated the speed of examination and approval of urgently needed clinical drugs and orphan drugs along with the requirement to improve the safety supervision of these drugs after their listing. China's marketing authorization holders (MAHs) must strengthen their pharmacovigilance capabilities as the primary responsible departments for drug safety. Chinese medical schools generally lack professional courses on pharmacovigilance. The regulatory authorities have recognized such problems and have made efforts to improve the professional capacity of pharmacovigilance personnel and to strengthen cooperation with stakeholders through the implementation of an action plan of medication surveillance and the establishment of a patient-based adverse events reporting system and active surveillance systems, which will help China bridge the gap to bring its pharmacovigilance practice up to standards.

An Unusual Cause of Aortic Regurgitation in a Patient With Bicuspid Aortic Valve.

Aortic fibrous strands are considered residual tissue from aortic valve development. Rupture of these strands is an important albeit uncommon cause of aortic regurgitation (AR). The authors describe a 67-year-old man who was admitted to the authors' hospital with sudden onset shortness of breath and diagnosed with severe AR. The patient was scheduled for Bentall surgery. The transesophageal echocardiogram (TEE) found multiple fibrous strands that were present in multiple locations of the aortic valve, some of which were ruptured. Ruptured fibrous strands are in the differential diagnosis in patients presenting with acute AR without a more conventional explanation, and TEE is instrumental in securing the diagnosis.

Oridonin alleviates the inhibitory effect of lipopolysaccharide on the proliferation and osteogenic potential of periodontal ligament stem cells by inhibiting endoplasmic reticulum stress and NF-κB/NLRP3 inflammasome signaling.

BACKGROUND: The aim of this study was to investigate the protective effect and mechanism of oridonin in an in vitro lipopolysaccharide (LPS)-induced human periodontal ligament stem cells (hPDLSCs) model of periodontitis. METHODS: Primary hPDLSCs were isolated and cultured, and then the expression of surface antigens CD146, STRO-1 and CD45 of hPDLSCs was detected by flow cytometry. The mRNA expression level of Runx2, OPN, Col-1, GRP78, CHOP, ATF4 and ATF6 in the cells was tested by qRT-PCR. MTT was taken to determine the cytotoxicity of oridonin at different concentrations (0-4 µM) on hPDLSCs. Besides, ALP staining, alizarin red staining and Oil Red O staining were utilized to assess the osteogenic differentiation (ALP concentration, mineralized calcium nodule formation) and adipogenic differentiation abilities of the cells. The proinflammatory factors level in the cells was measured by ELISA. The protein expression level of NF-κB/NLRP3 pathway-related proteins and endoplasmic reticulum (ER) stress-related markers in the cells were detected by Western blot. RESULTS: hPDLSCs with positive CD146 and STRO-1 expression and negative CD45 expression were successfully isolated in this study. 0.1-2 µM of oridonin had no significant cytotoxicity on the growth of hPDLSCs, while 2 µM of oridonin could not only greatly reduce the inhibitory effect of LPS on the proliferation and osteogenic differentiation of hPDLSCs cells, but also inhibit LPS-induced inflammation and ER stress in hPDLSCs cells. Moreover, further mechanism research showed that 2 µM of oridonin suppressed NF-κB/NLRP3 signaling pathway activity in LPS-induced hPDLSCs cells. CONCLUSIONS: Oridonin promotes proliferation and osteogenic differentiation of LPS-induced hPDLSCs in an inflammatory environment, possibly by inhibiting ER stress and NF-κB/NLRP3 pathway. Oridonin may have a potential role in the repair and regeneration of hPDLSCs.

[New outlook on safety of traditional Chinese medicine: concept and practice].

Profound changes have taken place in human disease spectrum, constitution spectrum, and drug use behavior, and the safety of traditional Chinese medicine(TCM) faces new trends and problems. In particular, serious adverse reactions/events such as liver injury and kidney injury caused by non-toxic TCM have been frequently reported, overturning people's understanding of TCM safety, and even shaking the public's confidence in the development of TCM. In the new era of globalization, correctly understanding the situation and problems of TCM safety and addressing the dilemmas in safety evaluation and risk prevention of TCM are the key missions to be undertaken by TCM practitioners. This paper suggests that the situation and problems of TCM safety should be viewed objectively and dialectically, and the use standard of TCM should be advanced with the times. Furthermore, this paper puts forward the new conception and methodology of TCM safety(including one innovative understanding, two types of evaluation modes, tri-elements injury hypothesis; four-quadrant risk decision processes, and five-grade safety evidence body) for the first time, hoping to provide new theories, new strategies, new methods and successful examples for solving the safety problems of TCM.

[Interpretation on Consensus on drug-induced liver injury by CIOMS Working Group:liver injury attributed to herbal and dietary supplements].

With the increase in the medical level, the improvement of adverse drug reaction(ADR) monitoring systems, and the enhancement of public awareness of safe medication, drug safety incidents have been frequently reported. Drug-induced liver injury(DILI), especially liver injury attributed to herbal and dietary supplements(HDS), has globally attracted high attention, bringing great threats and severe challenges to the people for drug safety management such as clinical medication and medical supervision. Consensus on drug-induced liver injury had been published by the Council for International Organizations of Medical Sciences(CIOMS) in 2020. In this consensus, liver injury attributed to HDS was included in a special chapter for the first time. The hot topics, including the definition of HDS-induced liver injury, epidemiological history, potential risk factors, collection of related risk signals, causality assessment, risk prevention, control and management were discussed from a global perspective. Based on the previous works, some experts from China were invited by CIOMS to undertake the compilation of this chapter. Meanwhile, a new causality assessment in DILI based on the integrated evidence chain(iEC) method was widely recognized by experts in China and abroad, and was recommended by this consensus. This paper briefly introduced the main contents, background, and characteristics of the Consensus on drug-induced liver injury. Significantly, a brief interpretation was illustrated to analyze the special highlights of Chapter 8, "Liver injury attributed to HDS", so as to provide practical references for the medical staff and the researchers who worked on either Chinese or Western medicine in China.

Continuous transthoracic echocardiographic monitoring for changes in maternal cardiac hemodynamics during cesarean section under combined epidural-spinal anesthesia: a prospective, observational study.

The change in maternal hemodynamics during cesarean section has not been well studied. Continuous transthoracic echocardiography can monitor cardiac function continuously. This study aimed to evaluate the effectiveness of maternal hemodynamic parameters monitoring during cesarean section using continuous transthoracic echocardiography. In this prospective, observational study, women with an uncomplicated singleton pregnancy scheduled for elective cesarean section at term under combined spinal-epidural anesthesia were enrolled. Maternal hemodynamic parameters were assessed by continuous transthoracic echocardiography at 11 pre-set time points. The image quality of continuous transthoracic echocardiography was evaluated before measurement was performed. Totally, one hundred parturients were recruited, and transthoracic echocardiography images with sufficient quality for further analysis were obtained in 72 women. Following anesthesia, maternal heart rate decreased by 11.18% and cardiac output decreased by 7.82%, but stroke volume remained stable. After delivery of the neonate and placenta, stroke volume and cardiac output increased by 21.09% and 22.33%, respectively. End-diastolic volume also increased significantly after delivery of the neonate, but end-systolic volume was unchanged. Following delivery of the neonate, fractional shortening increased till the end of the cesarean section while total peripheral resistance decreased significantly. In conclusion, continuous transthoracic echocardiographic monitoring revealed that there were significant changes in hemodynamic parameters during cesarean section after delivery of the newborn and placenta, which warranted further investigation.

Relative Risk Analysis of Liver-related Adverse Drug Reactions in Children Based on China's National Spontaneous Reporting System.

OBJECTIVE: To compare the risk of liver-related adverse drug reactions (ADRs) in children and adults. STUDY DESIGN: A case/non-case analysis on spontaneous reports based on the China National Adverse Drug Reactions Monitoring System database were conducted, focusing on events of liver-related ADRs in children younger than 14 years of age. Both the relative risk of liver-related ADRs in children vs entire population and the risk stratification in children were expressed as a measure of disproportionality using the reporting odds ratio (ROR). RESULTS: There were 1206 cases of pediatric liver-related ADRs identified from 2012 to 2016, accounting for 2.82% of the entire population. The greatest ROR values in children from 0 to 14 years vs the entire population were observed for analgesics (3.97, 95% CI 3.27-4.81), respiratory (2.60, 95% CI 1.04-6.43), antineoplastic (2.29, 95% CI 2.02-2.58), immunomodulatory (1.91, 95% CI 1.44-2.53), and antimicrobial agents (1.47, 95% CI 1.33-1.63). Notably, infants aged 0-1 years showed significantly greater risk (3.14, 95% CI 2.85-3.48) of liver-related ADRs than the other age groups of children. For infants, analgesics (3.21, 95% CI 2.20-4.66) and antimicrobials (3.15, 95% CI 2.50-3.97) agents were found to have the greatest adjusted RORs than other drug categories. The highest RORs were found for meropenem, amoxicillin, fluconazole, vancomycin, cefaclor, and ceftazidime in the antimicrobial agents for infants. CONCLUSIONS: Children are sensitive to liver-related ADRs caused by several specific drug categories, and infants are the most sensitive.

The Value of Shear Wave Elastography in Predicting the Risk of Endometrial Cancer and Atypical Endometrial Hyperplasia.

OBJECTIVES: To evaluate shear wave elastography (SWE) technology diagnosis value of endometrial cancer (EC) and atypical endometrial hyperplasia (AEH), and to establish predictive logistic regression models for the diagnosis of EC and AEH. METHODS: Clinical information collection, transvaginal conventional ultrasonography, and SWE check were performed on 122 patients, who were perimenopausal or postmenopausal vaginal bleeding with ≥4.5 mm thick endometrium. The maximal (Emax) and mean (Emean) of Young's modulus for the endometrium were obtained. Using pathology as the gold standard, ROC curves were plotted to evaluate Young's modulus on the diagnostic effectiveness of EC and AEH. Single-factor analysis and bivariate logistic regression methods were applied to assess the clinical variables, transuaginal conventional ultrasonography variables, and Young's modulus on the identification of EC and AEH. RESULTS: Out of 122 cases of endometrial lesions, 85 cases were benign lesions, and the remaining 37 cases were EC and AEH. The Emax and Emean for the benign group were 29.80 ± 11.40 and 17.96 ± 8.05 kPa, respectively. The Emax and Emean values for EC and AEH group were 59.49 ± 16.95 and 38.46 ± 17.10 kPa, respectively. Emax and Emean for both groups were statistically significant, with p <.001. In the logistical regression analysis, endometrial thickness, Color score, and Young's modulus were identified as independent risk factors for EC and AEH. CONCLUSIONS: SWE technology plays an important role in the diagnosis of EC and AEH, and the diagnostic effectiveness would be higher when combined with conventional ultrasonography.

Simulation-based training following a theoretical lecture enhances the performance of medical students in the interpretation and short-term retention of 20 cross-sectional transesophageal echocardiographic views: a prospective, randomized, controlled trial.

BACKGROUND: Both simulation-based training and video-based training serve as educational adjuncts for learning TEE among medical students. In the present study, we hypothesized that simulation-based training would better enhance the performance of medical students in the interpretation of 20 cross-sectional views compared to video-based training. METHODS: A total of 120 4th-year undergraduate medical students were enrolled in the present study. The study began with a pre-test of all the participants, followed by a 90-min theoretical lecture and a post-test. Subsequently, the participants were randomly divided into the video-based group (Group V) and simulation-based group (Group S). Next, Group V received 60 min of TEE video learning, while Group S received 60 min of TEE simulator training. After the respective training, both the groups undertook the retention-test 1 and retention-test 2, 1 week and 1 month later, respectively. The performance for each test was evaluated by five views, which were selected randomly and, respectively, from a set of 20 cross-sectional views. The primary outcome was the performance of the retention-test 1. Secondary outcomes included: (1) comparison the performances of the pre-test, post-test, and retention-test 2 between two groups; (2) comparison the performances of pre-test and post-test in the same group; (3) comparison the performances of retention-test 1, and retention-test 2 in the same group. RESULTS: Better performances were observed in Group S in both retention-test 1 (Group V: 63.2 [52.6, 77.6] vs. Group S: 89.5 [68.4, 100.0], P < 0.001) and retention-test 2 (Group V: 58.0 [48.0, 72.0] vs. Group S: 74.0 [64.0, 80.0], P < 0.001) compared to Group V. No statistically significant differences were observed in the performances of pre-test (Group V: 8.3 [4.2, 12.5] vs. Group S: 8.3 [4.2, 12.5], P = 0.825) or post-test (Group V: 46.2 [38.5, 57.7] vs. Group S: 44.2 [38.5, 56.7], P = 0.694) between the two groups. The improvement had been observed in the post-test, compared with pre-test in the same group, respectively (Group V in post-test: 46.2 [38.5, 57.7] vs. Group V in pre-test: 8.3 [4.2, 12.5], P < 0.001; Group S in post-test: 44.2 [38.5, 56.7] vs. Group S in pre-test: 8.3 [4.2, 12.5], P < 0.001). However, the performance in retention-test 2 was significantly reduced, compared with retention-test 1 in the same group, respectively (Group V in retention-test 2: 58.0 [48.0, 72.0] vs. Group V in retention-test 1: 63.2 [52.6, 77.6] P = 0.005; Group S in retention-test 2: 74.0 [64.0, 80.0] vs. Group S in retention-test 1: 89.5 [68.4, 100.0], P < 0.001). CONCLUSIONS: Following a 90-min theoretical lecture, simulation-based training better enhanced the performance of medical students in the interpretation and short-term retention of 20 cross-sectional views compared to video-based training. TRIAL REGISTRATION: http://www.chictr.org.cn ( ChiCTR2000033519 , 3/June/2020).

Overexpressed IGFBP5 promotes cell proliferation and inhibits apoptosis of nucleus pulposus derived from rats with disc degeneration through inactivating the ERK/MAPK axis.

It is previously suggested that insulin-like growth factor binding proteins (IGFBPs) potentially share an association with disc degeneration (DD) that causes back pain. This study aimed at exploring the functional relevance of IGFBP5 in DD by establishing a rat model of DD. The nucleus pulposus (NP) cells were transduced with IGFBP5-shRNA or IGFBP5 overexpression to determine the cellular processes (proliferation, apoptosis, as well as colony formation). The protein levels of apoptosis-related proteins were evaluated. Furthermore, NP cells were treated with the extracellular signal-regulated kinases/mitogen-activated protein kinase (ERK/MAPK) pathway inhibitor (PD98059) followed by measurement of ERK protein level and ERK phosphorylation content. The NP cells showed suppressed proliferation and colony formation ability, yet promoted apoptosis after transfection with IGFBP5-shRNA. It was found that silencing of IGFBP5 could lead to the ERK/MAPK axis activation, as indicated by an elevated ERK protein level and ERK phosphorylation content. However, overexpression of IGFBP5 could reverse all the reaction induced by silenced IGFBP5. These key findings demonstrate that overexpressed IGFBP5 inactivates the ERK/MAPK axis to stimulate the proliferation and inhibit apoptosis of NP cells in a rat model of DD.

Hemorrhage and associated fistula formation in a left atrial myxoma causing coronary artery steal syndrome.

A 59-year-old woman with episodes of chest pain was diagnosed with cardiac myxoma. Transesophageal echocardiography (TEE) showed a massive vascularized tumor and there was a blood stream spurting from the internal cavity of tumor into left atrium through an interconnected sinus tract. Coronary artery angiography (CAG) indicated that the mass was enhanced upon the administration of contrast media, which spouted into the cardiac chamber. This is the first case to report the development of the coronary artery steal syndrome due to hemorrhage and associated fistula formation in a left atrial myxoma, which was detected by TEE and confirmed by CAG.

Preoperative Blindfold Training Prevents Pediatric Psychological Behavior Disorders During the Anesthesia Recovery Period: A Randomized Controlled Trial.

PURPOSE: To identify the effectiveness and feasibility of blindfold training on preventing pediatric psychological behavior disorders during the anesthesia recovery period. DESIGN: This study investigated the effect of blindfold training through the assessment of anxiety, delirium, and pain in children during the anesthesia recovery period. METHODS: This study was a prospective, randomized, controlled trial. Pediatric patients were randomized into either a control (routine practice) or blindfold training group (routine practice + blindfold training). Anxiety, delirium, and pain levels of children were assessed by the modified Yale Preoperative Anxiety Scale, Pediatric Anesthesia Emergence Delirium scale, and the Face, Legs, Activity, Cry, Consolability scale. FINDINGS: The blindfold training group had significantly lower scores for emergence delirium, anxiety, and pain during the anesthesia recovery period and a lower incidence of anesthesia complications (all P's < .05). CONCLUSIONS: Preoperative blindfold training was able to reduce anxiety, pain, and the incidence of delirium during the anesthesia recovery period in pediatric patients.

Tailored Holder for Continuous Echocardiographic Monitoring.

Hemodynamic monitoring is essential for prompt and effective interventions in intensive care unit patients. We developed a custom-made transthoracic echocardiography transducer holder consisting of transducer holder and skin patch attachment. This holder allowed continuous transthoracic echocardiography monitoring in 5 adult patients with circulatory failure due to shock, and 6 pediatric patients after successful percutaneous closure of a ventricular septal defect. One case of an unexpected hemopericardium was promptly diagnosed and pericardiocentesis was performed, and 1 patient required extracorporeal membrane oxygenation support.

Irisin-mediated protective effect on LPS-induced acute lung injury via suppressing inflammation and apoptosis of alveolar epithelial cells.

It is considered that the essence of acute lung injury (ALI) is an excessive and uncontrolled inflammatory response in lung, of which mainly is attributed to the release of inflammatory mediators. Recent studies demonstrated that irisin, which is a metabolism associated factor after physical exercise could suppression of inflammation by regulating cellular signaling pathways, however, the underlying molecular mechanism remains to be determined. The present study aimed to reveal the potential mechanism responsible for the anti-inflammatory effects of irisin on LPS-induced acute lung injury in mice and in A549 cells. The results of histopathological changes showed that irisin ameliorated the lung injury that was induced by LPS in time- and dose-dependent manner. QRT-PCR assays demonstrated that irisin suppressed the production of IL-1ß, IL-6, MCP-1 and TNF-α, and western blot assays demonstrated that irisin suppressed apoptosis of ALI. The expression of caspase-3 and Bax were decreased and Bcl-2 was increased by irisin administration. Further study was conducted on nuclear factor (NF)-κB and mitogen-activated protein kinase (MAPK) using pathways using western blots. The results showed that irisin inhibited reduced LPS-induced activation of MAPK and NF-κB signaling. All results indicated that irisin has protective effect on LPS-induced ALI in mice and in A549 cells. Thus, irisn related with physical exercise may be a potential therapy for the treatment of pulmonary inflammation.

Irisin suppresses the migration, proliferation, and invasion of lung cancer cells via inhibition of epithelial-to-mesenchymal transition.

Irisin is involved in promoting metabolism, immune regulation, and affects chronic inflammation in many systemic diseases, including gastric cancer. However, the role of irisin in lung cancer is not well characterized. To determine whether irisin has a protective effect against lung cancer, we cultured A549 and NCI-H446 lung cancer cells and treated them with irisin. We detected the proliferation by MTT assay, and assessed the migration and invasion of the cells by scratch wound healing assay and Tran-swell assay. The expression levels of epithelial-to-mesenchymal transition (EMT) markers and the related signaling pathways were detected by western blot analysis. Meanwhile, an inhibitor of PI3K was used to investigate the effect of irsin. Finally, the expression of Snail was detected. We demonstrated that irisin inhibits the proliferation, migration, and invasion of lung cancer cells, and has a novel role in mediating the PI3K/AKT pathway in the cells. Irisin can reverse the activity of EMT and inhibit the expression of Snail via mediating the PI3K/AKT pathway, which is a key regulator of Snail. These results revealed that irisin inhibited EMT and reduced the invasion of lung cancer cells via the PI3K/AKT/Snail pathway.

[Systematic evaluation for safety of traditional Chinese medicine Areca catechu and its preparations].

The authors systemically evaluated and analyzed the safety of Areca catechu from domestic and foreign literatures about the herbal origin, toxicity recorded in ancient/current documents, safety case reports of clinical A. catechu, experimental studies on toxicity in recent years, and differences of safety risk between edible and medicinal A. catechu. Subsequently, they proposed a preliminary summary about the clinical characteristics and potential risk factors of safety related cases of A. catechu and its preparations. According to the authors, although clinical adverse events of A. catechu were fewer and controllable, clinicians shall stillstrictly standardize its application, and rationally combine it with other herbs, while strengthening fundamental and clinical studies related to safety, so as to give better guidance to safety application of A. catechu in clinic.

[Expert consensus on the design and implementation of clinical safety centralized monitoring study of Chinese medical injection].

Along with the increase of clinical application, the safety of traditional Chinese medicine gained more and more attentions. In particular, the safety evaluation of Chinese medical injections has become a mandatory task should be completed by pharmaceutical companies under the supervision of China Food and Drug Administration(CFDA). Due to the weak foundation of previous studies, the safety issues of Chinese medical injections have not been fully understood, and lack of scientific and rational risk management programs. Clinical safety centralized monitoring(CSCM) is an important method for post-market safety evaluation of Chinese medicine. Due to the lack of appropriate norms and procedures, the quality of similar research is uneven, and the results vary. Combined with practical experience with experts' suggestions, we developed this expert consensus on the design and implementation of CSCM from three stages (design, implementation and report) with 20 technical points, which will provide technical support for future CSCM studies.