Safety and efficacy evaluation of Simo decoction and Arecae semen in herbal medicine practice.

Objective: The traditional Chinese patent medicine (TCPM), Simo decoction (Simo decoction oral solution), with its primary ingredient Arecae semen (Binglang, Areca catechu L.), known for its potential carcinogenic effects, is the subject of this study. The research aims to analyze the effectiveness and potential risks of Simo decoction, particularly as a carcinogen, and to suggest a framework for evaluating the risks and benefits of other herbal medicines. Methods: The study is based on post-marketing research of Simo decoction and Arecae semen. It utilized a wide range of sources, including ancient and modern literature, focusing on the efficacy and safety of Simo decoction. The research includes retrospective data on the sources, varieties, and toxicological studies of Arecae semen from databases such as Pubmed, Clinical Trials, Chinese Clinical Trial Registry, China National Knowledge Infrastructure, WHO-UMC Vigibase, and China National Center for ADR Monitoring. Results: Common adverse drug reactions (ADRs) associated with Simo decoction include skin rash, nausea, vomiting, abdominal pain, and diarrhea. However, no studies exist reporting the severe ADRs, such as carcinogenic effects. Arecae semen is distributed across approximately 60 varieties in tropical Asia and Australia. According to the WHO-UMC Vigibase and the National Adverse Drug Reaction Monitoring System databases, there are currently no reports of toxicity related to Arecae semen in the International System for Classification of ADRs (ISCR) or clinical studies. Conclusion: Risk-benefit analysis in TCPM presents more challenges compared to conventional drugs. The development of a practical pharmacovigilance system and risk-benefit analysis framework is crucial for marketing authorization holders, researchers, and regulatory bodies. This approach is vital for scientific supervision and ensuring the safety and efficacy of drug applications, thus protecting public health.

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).

The CT Classification of Multilevel Cervical Ossification of the Posterior Longitudinal Ligament to Guide Hybrid Anterior Controllable Antedisplacement and Fusion vs. Posterior Laminoplasty.

OBJECTIVE: For precise and minimally invasive treatment of ossification of the posterior longitudinal ligament of the cervical spine, the lifting segment is minimized, anterior controllable antedisplacement and fusion (ACAF) was refined and improved. In addition, the development of appropriate surgical procedures for the ossification of each segment was rarely reported. Therefore, this study aimed to compare the efficacy and safety of hybrid anterior controlled antedisplacement fusion (Hybrid ACAF) with laminoplasty for multilevel ossification of the posterior longitudinal ligament (OPLL). METHODS: Between May 2018 and May 2021, 70 patients with multilevel OPLL were divided into a hybrid ACAF group and a laminoplasty group according to surgical methods. All patients were followed up for at least 1 year. Japanese Orthopaedic Association (JOA) score and recovery rate (JOARR), (VAS, NDI) score and C2-C7 Cobb angle, the sagittal vertical axis of the neck (SVA), and complications (cerebrospinal fluid leakage, C5 paralysis, etc.) were compared between the two groups by t test or non-parametric test. RESULTS: The operation time of hybrid ACAF was longer. C5 paralysis and axial pain were more common in the laminoplasty group, while dysphagia and hoarseness were more common in the hybrid ACAF group. At the last follow-up, the hybrid ACAF group had better recovery and maintenance of cervical lordosis and sagittal plane balance and a higher JOA score and recovery rate than the laminoplasty group. CONCLUSIONS: Hybrid ACAF can reduce the number of vertebral bodies and expand the decompression range, which is safe, effective, and tailored to local conditions. Compared with laminoplasty, hybrid ACAF is a precise alternative for patients with OPLL.

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.

Retraction: Structural characterization and anticancer potency of centipede oligopeptides in human chondrosarcoma cancer: inducing apoptosis.

[This retracts the article DOI: 10.1039/D0RA04811A.].

Aripiprazole-induced liver injury: a spontaneous reporting database study.

Background: There have been individual case reports of aripiprazole in recent years, both domestically and internationally, but no analysis of the characteristics of the occurrence of adverse reactions/events of drug-induced liver injury with aripiprazole using spontaneous reports has been seen. Methods: Using a retrospective study approach, the 452 adverse reaction/event reports of aripiprazole-induced liver injury collected by the China Adverse Drug Reaction Monitoring System from 1 January 2012 to 31 December 2016 were analyzed and evaluated, and exploring it's the clinical characteristics and related risk factors for liver injury occurrence. Results: Among 452 cases of aripiprazole-induced liver injury ADR/ADE reports, there were 121 cases classified as serious, accounting for 26.8% of the total. There were 250 male and 202 female patients, with a male-to-female ratio of 1.24:1. The age of patients ranged from 11 to 77 years old, with an average age of (34.56 ± 12.81) years old, and a high proportion of young adults in the total population. Some patients had used the drug off-label or at a higher than recommended dosage. The onset of liver injury was generally within 15-90 days after continuous use, while some patients are also accompanied by nausea, vomiting, and weight gain. 70% of the combined drug instructions listed that may cause liver injury. Conclusion: In clinical practice, healthcare professionals should pay closely attention to the adverse reactions and risk factors of liver injury caused by aripiprazole. If there are potential risk factors for liver injury, early and regular monitoring of liver function should be carried out to reduce the occurrence of adverse reactions.

[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.

[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.

Rapid and persistent bactericidal cotton fabrics finished facilely with reactive N-halamine.

Cotton fabrics (CFs) with persistent and rapid bactericidal capability would be of great significance for daily health protection because CFs are very suitable for the growth and reproduction of microorganisms. Herein, we developed a reactive N-halamine compound, 3-(3-hydroxypropyl diisocyanate)-5,5-dimethylhydantoin (IPDMH), that can be covalently bound to a CF to generate a bactericidal CF after chlorination (CF-DMF-Cl) without damaging its surface morphology. The antibacterial rates of CF-DMF-Cl (0.5 wt% IPDMH) against the gram-negative bacterium Escherichia coli (E. coli) and gram-positive bacterium Staphylococcus aureus (S. aureus) reached 99.99 % and were maintained at 90 % (against E. coli) and 93.5 % (against S. aureus) after 50 laundering cycles. The combination of contact killing and release killing mechanisms by CF-PDM-Cl leads to its rapid and persistent bactericidal activity. In addition, CF-DMF-Cl exhibits adequate biocompatibility, well-maintained mechanical properties, air/water vapor permeability and whiteness. Therefore, the proposed CF-DMF-Cl has great potential applications as a bactericidal CF for use in medical textiles, sportswear, home dressings, and so on.

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.

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.

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.

Landscape of DILI-related adverse drug reaction in China Mainland.

Drug-induced liver injury (DILI) is a type of bizarre adverse drug reaction (ADR) damaging liver (L-ADR) which may lead to substantial hospitalizations and mortality. Due to the general low incidence, detection of L-ADR remains an unsolved public health challenge. Therefore, we used the data of 6.673 million of ADR reports from January 1st, 2012 to December 31st, 2016 in China National ADR Monitoring System to establish a new database of L-ADR reports for future investigation. Results showed that totally 114,357 ADR reports were retrieved by keywords searching of liver-related injuries from the original heterogeneous system. By cleaning and standardizing the data fields by the dictionary of synonyms and English translation, we resulted 94,593 ADR records reported to liver injury and then created a new database ready for computer mining. The reporting status of L-ADR showed a persistent 1.62-fold change over the past five years. The national population-adjusted reporting numbers of L-ADR manifested an upward trend with age increasing and more evident in men. The annual reporting rate of L-ADR in age group over 80 years old strikingly exceeded the annual DILI incidence rate in general population, despite known underreporting situation in spontaneous ADR reporting system. The percentage of herbal and traditional medicines (H/TM) L-ADR reports in the whole number was 4.5%, while 80.60% of the H/TM reports were new findings. There was great geographical disparity of reported agents, i.e. more cardiovascular and antineoplastic agents were reported in higher socio-demographic index (SDI) regions and more antimicrobials, especially antitubercular agents, were reported in lower SDI regions. In conclusion, this study presented a large-scale, unbiased, unified, and computer-minable L-ADR database for further investigation. Age-, sex- and SDI-related risks of L-ADR incidence warrant to emphasize the precise pharmacovigilance policies within China or other regions in the world.

Case report: Bi-atrial thrombus after occlusion of atrial septal defect with acute cerebral infarction and pulmonary embolism.

A 49-year-old man presented to the hospital with symptoms of acute cerebral infarction and pulmonary embolism who underwent transcatheter closure of atrial septal defect a year before. Transthoracic echocardiography showed a 13 × 9 mm hypoechoic mass attached to the left-atrial side of the device, which was suspected to be a neoplasm or thrombus. The patient was indicated for surgery after multidisciplinary discussion due to ineffective medical therapy and typical stroke and pulmonary embolism symptoms. Three-dimensional transesophageal echocardiography (3D-TEE) revealed left-atrial vegetation (21 × 16 mm) and right-atrial vegetation (8 × 6 mm) attached to the device, which was confirmed as thrombus by surgical separation and laboratory examination. This case highlights the importance of 3D-TEE and a multidisciplinary team in the diagnosis and therapy of device-related thrombus.

Age-Associated Risk of Liver-Related Adverse Drug Reactions.

Objective: Aging population is generally considered more sensitive to adverse drug reactions (ADRs). Yet, big data-based quantitative evidence currently does not exist to support this concept. This study aims to investigate age-associated risks of liver-related ADR (L-ADR). Methods: Spontaneous reporting data from 2012 to 2016 were retrieved from the China National ADR Monitoring System. The risk ratio (RR) was used to quantify the relative risk of L-ADR of each age group. The reporting odds ratio (ROR) was used to quantify the correlation with the risk of L-ADR of each drug category or drug in older adults. Results: Totally, 64,702 L-ADR reports were retrieved, covering ages from 1 to 116, with a median age of 49. The RR values increased exponentially with the increase of age, which indicates that the relative risk of L-ADR increased by 33% for every 10-year increase in age. The age cutoff point for relative high risk of L-ADR was estimated at 52.0 years old (RR = 1). In 17 categories composed of 270 drugs, the top 3 drug categories with a high correlation to the risk of L-ADR in older adults were antiarrhythmic (ROR, 5.75; 95% CI: 4.45-7.42), antilipemic (ROR, 4.77; 95% CI: 4.53-5.02), and antihypertensive (ROR, 2.97; 95% CI: 2.59-3.41). Conclusions: This research illustrates quantitatively that aging is a potential risk factor for L-ADR, with a 33% increase in relative risk for every 10-year increase in age. Risk management should be addressed for older adults when those drugs with a high correlation to the risk of L-ADR are used.

Association Between Drug Treatments and the Incidence of Liver Injury in Hospitalized Patients With COVID-19.

The outbreak of coronavirus disease 2019 (COVID-19) has led to the emergence of global health care. In this study, we aimed to explore the association between drug treatments and the incidence of drug-induced liver injury (DILI) in hospitalized patients with COVID-19. A retrospective study was conducted on 5113 COVID-19 patients in Hubei province, among which 395 incurred liver injury. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated by Cox proportional hazards models. The results showed that COVID-19 patients who received antibiotics (HR 1.97, 95% CI: 1.55-2.51, p < 0.001), antifungal agents (HR 3.10, 95% CI: 1.93-4.99, p < 0.001) and corticosteroids (HR 2.31, 95% CI: 1.80-2.96, p < 0.001) had a higher risk of DILI compared to non-users. Special attention was given to the use of parenteral nutrition (HR 1.82, 95% CI: 1.31-2.52, p < 0.001) and enteral nutrition (HR 2.71, 95% CI: 1.98-3.71, p < 0.001), which were the risk factors for liver injury. In conclusion, this study suggests that the development of DILI in hospitalized patients with COVID-19 needs to be closely monitored, and the above-mentioned drug treatments may contribute to the risk of DILI.

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.

Analysis on the medication rule of traditional Chinese medicine in the treatment of COVID-19 patients.

Objective: To describe patterns of utilization of traditional Chinese medicine (TCM) in the treatment of patients with coronavirus disease 2019 (COVID-19). Methods: Adult patients with COVID-19 who received TCM treatment were divided into a non-serious group (mild and moderate types) and a serious group (severe and critical types) according to their admission conditions. The medical records and prescriptions of these patients were investigated to determine their TCM utilization patterns. Results: In all, 3,872 COVID-19 patients were included. Oral Chinese traditional patent medicine (CPM) was the most commonly used type of TCM, followed by decoction. The proportion of multi-drug combinations was higher than single drug use (55.0% vs. 45.0%). Decoction combined with oral CPM was the most common combination (39.1%, 1,514/3,872). Orally administered, injected, and externally applied CPM were significantly more common in the serious group than in the non-serious, while decoction and non-drug TCM treatments were more common in the non-serious than in the serious group. Multi-drug combinations were used for the majority of patients in both groups, mainly in the form of decoctions combined with oral CPM. Among the serious patients, injected CPM was more often used in patients who died during treatment (35.0%, 36/103). The two most common medication patterns were decoction combined with oral CPM and oral CPM alone in the two finally discharged groups. Oral CPM alone or used in combination with injected CPM were seen most commonly in the death group. Significant differences were established in TCM utilization and medication patterns among patients in three groups who had different prognoses and outcomes. Conclusions: The treatment measures and medication patterns of TCM commonly used in COVID-19 patients with the range of conditions found in this study should be further explored in the future to provide a more complete reference for COVID-19 treatment.

An investigation of pharmacovigilance and reporting of adverse drug reactions in hospitals: a cross-sectional study in China.

BACKGROUND: Pharmacovigilance is a science that plays a significant role in reducing ADRs and helps predict adverse reactions to drugs in community. To safely use drugs in treatment and prevention of disease, adverse drug reaction has been paid more attention. OBJECTIVES: To evaluate the future needs of existing systems, the paper investigated the current state of pharmacovigilance and the reporting of ADR in Chinese hospitals. METHODS: This cross-sectional, questionnaire-based study involved 10,063 pharmacists, doctors, and nurses from primary, secondary, and tertiary hospitals in all 31 provinces of China. It was commissioned by the National Centre for ADR Monitoring of China and conducted in March 2020. Three areas were assessed: sociodemographic characteristics of participants, awareness of the pharmacovigilance system, and the current state of hospitals' reporting of ADRs. Chi-square tests were used to calculate P values. RESULTS: Health care professionals had heard the term "pharmacovigilance" previously (89.40%) and knew the reporting object (68.47%), content (65.94%), and range (64.83%) of pharmacovigilance. Most hospitals dispatched responsible professionals (87.64%) and departments (86.25%) to monitor ADR reporting. A total of 58.66% of tertiary medical, 45.25% of secondary, and 38.90% of primary hospitals extracted ADRs from a hospital information system. Moreover, 53.09% of tertiary medical, 38.93% of secondary, and 23.89% of primary hospitals had established a prescription automatic screening system to warn about risks for ADRs. Health care professionals' reports (99.92%) and patient feedback (77.99%) were included in most hospitals' ADR reporting. CONCLUSIONS: Chinese health care professionals generally have good awareness of pharmacovigilance, and pharmacovigilance is relatively more advanced in China compared to other developing countries.