The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines （hereinafter referred to as the Guidelines） is first specialized in the field of drug safety for oral Chinese patent medicines （OCPMs） in China. Rooted in China's healthcare context， the Guidelines address the unique usage patterns and risk characteristics of OCPMs， filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines， and to promote the standardized development of pharmacovigilance practices for OCPMs， this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting， the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment， the Guidelines were examined from three dimensions of formulation components， medication behaviors， and population to address complex safety issues arising from medicinal constituents， irrational use， and individual susceptibility. In the area of risk control， the analysis focused on context-based interventions and dynamic closed-loop management strategies， exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore， this paper evaluated the applied value of the Guidelines and identified implementation challenges， such as insufficient capacity at the primary-care level and limited digital infrastructure. In response， the study proposed optimization strategies including establishing a dynamic updating mechanism， strengthening training at the grassroots level， and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders （including manufacturers）， pharmaceutical distributors， healthcare institutions， and research organizations， ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.

Sinisan is a classical prescription developed and applied by ancient medical experts and it is first recorded in the Treatise on Cold Damage written by ZHANG Zhongjing in the Eastern Han Dynasty. Later physicians have modified this prescription based on this original one. The bibliometrics methods were used to analyze the key information and research trend of Sinisan. According to the inclusion and exclusion criteria， 69 pieces of effective data were extracted， involving 67 ancient traditional Chinese medicine （TCM） books. The results showed that the name， composition， and decocting methods of Sinisan in later generations were inherited from the original record in the Treatise on Cold Damage. The original plants of medicinal materials used in Sinisan are basically clear. We recommend Bupleuri Radix as the dried root of Bupleurem scorzonerifolium， Paeoniae Radix Alba as the dried root of Paeonia lactiflora， Aurantii Fructus as the dried fruit of Citrus aurantium， Glycyrrhizae Radix et Rhizoma as the dry root and rhizome of Glycyrrhiza uralensis. Raw materials of Bupleuri Radix and Paeoniae Radix Alba， Aurantii Fructus stir-fried with bran， and stir-fried Glycyrrhizae Radix et Rhizoma should be used for preparation of Sinisan. According to measurement system in the Han Dynasty， a bag of Sinisan is composed of 1.25 g Bupleuri Radix， 1.25 g Paeoniae Radix Alba， 1.25 g Aurantii Fructus， and 1.25 g Glycyrrhizae Radix et Rhizoma. The materials should be grounded into coarse powder and taken with a proper amount of rice soup， 3 times a day. Sinisan has the effects of regulating qi movement and harmonizing the liver and spleen. It can be used for treating reversal cold in limbs and cold damage. In modern clinical practice， Sinisan can be used to treat chronic gastritis， irritable bowel syndrome， and dyspepsia. The above research results provide scientific reference for the future research and development of Sinisan.

ObjectiveTo investigate and analyze an outbreak of rotavirus infectious diarrhea in a prison in Chongqing Municipality, to provide a basis for adult rotavirus surveillance and prevention, and to explore the public health problems in special settings. MethodsA retrospective survey was conducted to collect and analyze data on individual cases with diarrheal disease on-site. The clinical characteristics, as well as the temporal, spatial and geographical distribution patterns of the epidemic were described. Multi-pathogen detection tests were conducted both on diarrhea cases and environmental samples, with viral genotyping performed on positive samples. A case-control analysis was performed to identify the causes of the outbreak, and an SEIR model was adopted to predict the outbreak trend and evaluate the effectiveness of interventions. ResultsA total of 65 cases were found among the inmates, with an attack rate of 2.03%. The predominant clinical manifestations included diarrhea (89.23%), watery stool (73.85%), and dehydration (18.46%). The epidemic curve indicated a “human-to-human” transmission pattern, with an average incubation period of 5‒6 days. The attack rates among chefs in the main canteen (80.00%, 8/10) and caterers (28.33%, 17/60) were significantly higher than those of other inmates （P<0.05）. Multi-pathogen polymerase chain reaction (PCR) testing detected positive for group A rotavirus, with the viral genotyping identified as G9P [8] strain. Factors such as unprotected "bare-handed" food distribution among cases with diarrhea (OR=9.512, 95%CI: 4.261‒21.234) and close contact with diarrhea cases (OR=3.656, 95%CI: 1.719‒7.778) were the possible cause of the outbreak. The SEIR model (r₀=5, α=0.3, β₁=0.08, β₂=0.04) was constructed using prison inmates as susceptible population, aiming at fitting the initial transmission trend of the outbreak, and the epidemic rate declined rapidly after intervention measures were implemented (r_t≈0). ConclusionThis rare rotavirus infection diarrhea outbreak among adults in confined settings suggests that the construction of public health prevention and control systems in prison may be overlooked. Cross infection during meal processing and distribution in the canteens of such settings is likely to be the cause of the outbreak. Given the potential neglect of public heath system construction in special settings, it is imperative to enhance the surveillance and monitoring of rotavirus and other intestinal multi-pathogens among adults, as well as the construction of public health prevention and control systems in these special settings.

Pulpotomy, which belongs to vital pulp therapy, has become a strategy for managing pulpitis in recent decades. This minimally invasive treatment reflects the recognition of preserving healthy dental pulp and optimizing long-term patient-centered outcomes. Pulpotomy is categorized into partial pulpotomy (PP), the removal of a partial segment of the coronal pulp tissue, and full pulpotomy (FP), the removal of whole coronal pulp, which is followed by applying the biomaterials onto the remaining pulp tissue and ultimately restoring the tooth. Procedural decisions for the amount of pulp tissue removal or retention depend on the diagnostic of pulp vitality, the overall treatment plan, the patient's general health status, and pulp inflammation reassessment during operation. This statement represents the consensus of an expert committee convened by the Society of Cariology and Endodontics, Chinese Stomatological Association. It addresses the current evidence to support the application of pulpotomy as a potential alternative to root canal treatment (RCT) on mature permanent teeth with pulpitis from a biological basis, the development of capping biomaterial, and the diagnostic considerations to evidence-based medicine. This expert statement intends to provide a clinical protocol of pulpotomy, which facilitates practitioners in choosing the optimal procedure and increasing their confidence in this rapidly evolving field.
Humans ; Calcium Compounds/therapeutic use* ; Consensus ; Dental Pulp ; Dentition, Permanent ; Oxides/therapeutic use* ; Pulpitis/therapy* ; Pulpotomy/standards*

Objective To analyze the efficacy of different nucleoside(acid)analogs(NAs)used as monotherapy and in combination with pegylated interferon α-2b(Peg-IFN-α-2b)in the treatment of chronic hepatitis B(CHB).Methods A retrospective analysis was conducted on 229 CHB patients who visited the Hepatology Department of the Third People's Hospital of Kunming from September 2022 to August 2023.Patients were divided into six groups based on their antiviral regimen:entecavir(ETV)group(A,n=47),ETV combined with Peg-IFN-α-2b group(B,n=19),Tenofovir Alafenamide(TMF)group(C,n=64),TMF combined with Peg-IFN-α-2b group(D,n=35),Tenofovir Disoproxil Fumarate(TDF)group(E,n=29),and TDF combined with Peg-IFN-α-2b group(F,n=35).The blood routine,liver function,kidney function,HBV serological markers,and HBV-DNA levels were compared before and after 24 weeks of treatment.Results After 24 weeks of treatment,there were no statistically significant differences in efficacy rates and HBV-DNA positivity rates between the monotherapy with NAs and the combination with Peg-IFN-α-2b(P>0.05).Comparing before and after treatment,the ETV group had the highest effective rate,while TDF combined with Peg-IFN-α-2b group had the lowest effective rate.TDF group had the highest efficiency,while ETV combined with Peg-IFN-α-2b group had the lowest efficiency.Except for ETV+Peg-IFN-α-2b and TDF+Peg-IFN-α-2b groups,the HBV-DNA positivity rates in the other four groups were significantly lower after treatment compared to before(P<0.05).There was a significant difference in HBsAg levels among the different treatment regimens of monotherapy with NAs and combination with Peg-IFN-α-2b(P=0.0483).Additionally,except for the ETV and TDF groups,the serum HBsAg levels in the other four groups were significantly lower after treatment compared to before(P<0.05).There were no significant difference in LSM and GFR before and after treatment(P>0.05).In the monotherapy groups,ALT and GGT levels were significantly lower after treatment compared to before(P<0.05),while in the combination Peg-IFN-α-2b group,WBC,NEUT,and PLT levels were significantly lower after treatment compared to before(P<0.05).Conclusion Combination therapy with Peg-IFN-α-2b can reduce HBsAg levels and may be more effective in controlling the virus;however,it may cause adverse reactions such as bone marrow suppression,increasing risks.Physicians and patients need to weigh the benefits against the risks and develop personalized treatment plans based on individual circumstances.

With the rapid development of the interdisciplinary area of artificial intelligence and medicine, large language model (LLM) has been widely used in the fields such as diagnosis and treatment, medicine, and healthcare. LLM has unique advantages in the field of traditional Chinese medicine (TCM), such as high consistency with the "Four Diagnostic Methods", perfect combination of natural language and self-supervised learning in TCM, the ability to adapt to the characteristics TCM formulas, and the assistance in TCM diagnosis and treatment. At present, various LLM models have been developed, including the "Qihuang Ask Big Model" and the Digital Traditional Chinese Medicine Big Model "GLM-130B", but they still face challenges such as value mismatch and medical abuse, increased demand for interpretability, lack of advanced technology, and domestic policy access. This article reviews the evolution of LLM, its unique advantages and applications in the field of TCM, the problems and challenges, and the future development trends, in order to providereference for the further promotion of LLM in traditional medicine.

Chemical cleaning and disinfection are crucial steps for eliminating infection in root canal treatment.However,irrigant selection or irrigation procedures are far from clear.The vapor lock effect in the apical region has yet to be solved,impeding irrigation efficacy and resulting in residual infections and compromised treatment outcomes.Additionally,ambiguous clinical indications for root canal medication and non-standardized dressing protocols must be clarified.Inappropriate intracanal medication may present side effects and jeopardize the therapeutic outcomes.Indeed,clinicians have been aware of these concerns for years.Based on the current evidence of studies,this article reviews the properties of various irrigants and intracanal medicaments and elucidates their effectiveness and interactions.The evolution of different kinetic irrigation methods,their effects,limitations,the paradigm shift,current indications,and effective operational procedures regarding intracanal medication are also discussed.This expert consensus aims to establish the clinical operation guidelines for root canal irrigation and a position statement on intracanal medication,thus facilitating a better understanding of infection control,standardizing clinical practice,and ultimately improving the success of endodontic therapy.

Objective:To analyze and compare the health education efforts of respiratory infectious diseases at home and abroad.Methods:The literature related to health education and popular science of respiratory infectious diseases included in the databases of China National Knowledge Infrastructure (CNKI) and Web of Science (WOS) from January 1, 2003 to December 31, 2023 was searched. A total of 4 686 articles were retrieved in CNKI, 1 540 articles unrelated to the theme were excluded, and 3 146 Chinese articles were obtained. In the WOS database, 7 724 articles were retrieved, 3 685 articles about the clinical mechanism of diseases, pharmacology, and other research topics were excluded, and 4 039 English articles were obtained. The information of annual publications, institutions, authors and keywords was analyzed by using CiteSpace visualization software, and the publication status, research hotspots and development trends of health education related to respiratory infectious diseases at home and abroad were analyzed.Results:Since 2003, the number of publications in health education on respiratory infectious diseases at home and abroad had shown a fluctuating growth trend, and in 2020, the field showed a sharp growth trend at home and abroad. There was no core author group in this field in China, and the network density of domestic authors was 0.006 5, and the network density of foreign authors was 0.009 6. The domestic institutions were mainly the Center for Disease Control and Prevention and medical institutions, including Guangzhou Chest Hospital (29 articles) and the Chinese Center for Disease Control and Prevention (10 articles); Foreign research institutions were mainly higher education institutions, including the University of London (91 articles) and Harvard University (67 articles). The network density of domestic was 0.001 3, and the network density of foreign publishing institutions was 0.026 3, the network density was greater than that of Chinese publishing institutions. The emergence of "COVID-19" "Avian influenza" "Knowledge, Attitude, Practice" and "mental health" in China had strong burst (burst intensity: 46.41, 12.12, 10.33, 8.5); "Coronavirus" "coverage" "Avian influenza" and "COVID-19 vaccine" in foreign countries had strong burst (burst intensity: 14.34, 11.06, 10.73, 10.02).Conclusions:At present, the health education of respiratory infectious diseases at home and abroad has received great attention. But the cooperation between domestic authors and research institutions is loose, and the close collaboration needs to be strengthened. There are differences in the research focus of health education on respiratory infectious diseases at home and abroad.

Objective:This paper analyzed the current situation of clinical research continuing review in China, and puts forward countermeasures to strengthen continuing review in combination with the requirements of the Measures for the Ethical Review of Life Science and Medical Research Involving Humans, so as to provide a certain reference for standardizing the ethical continuing review of research institutions.Methods:Through literature research, this paper systematically sorted out the current situation of continuing review, and analyzed many problems and related reasons in the process of continuing review of clinical research in China based on the practical experience of ethical review.Results:The requirements for continuing review in the Measures for Ethical Review of Life Science and Medical Research Involving Humans included demphasizing the implementation of continuing review, the entrusted ethics committee should be responsible for continuing review, clarifying the responsibility for continuing review of cooperative research, clarifying the responsibility of participating research institutions for continuing review, and increasing the responsibility of the ethics committee to supervise the submission of continuing review. Countermeasures to strengthen continuing review included the health authorities urging research institutions to strengthen continuing review, research institutions to increase efforts to implement continuing review, establishing a standardized continuing review process, strengthening the ethics training of researchers and other relevant personnel, establishing a multi-channel communication and consultation method between the ethics committee and researchers, strengthening the review capacity of ethics committee members, allocating a corresponding number of ethics committee staff, and using information technology to improve quality and efficiency.Conclusions:Continuing review is indispensable in the whole process of research development, and all parties should take measures to ensure the quality and efficiency of continuing review, standardize continuing review, and promote the healthy development of life science and medical research.

Objective:To analyze the current situation of the archives management of ethics committees in China, combine the requirements of the Implementation Regulations of the Archives Law of the People′s Republic of China and the ethics review regulations, and propose countermeasures to strengthen the archives management of ethics committees, thereby further standardizing the archives management of ethics committees.Methods:Through the literature research method, this study systematically reviewed the current situation of the archives management of ethics committees and analyzed its problems and causes in China in combination with related practice experiences.Results:The requirements for ethics committee archives included supervision and management, the establishment of rules and regulations, personnel, site and environment, storage period, confidentiality, and information construction. Countermeasures to strengthen the archives management of ethics committees were suggested including strict daily supervision, strengthening management awareness, establishing and improving the scientific management system and standard operating procedures, setting up independent ethics committee offices and dedicated archives, strictly implementing the confidentiality system, strengthening information construction, and improving utilization rate.Conclusions:To better construct and manage ethics committee archives, a standardized archives management system should be established to effectively evaluate the quality of ethics review and ensure the proper functions of the ethics committee.