Formulating a well-defined research question and developing a scientifically sound study protocol is important for ensuring the quality of pharmacoepidemiological research.Based on the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition),this research provided an interpretation of the sections related to the formulation of research questions and the development of study protocols.First,it clarified the sources and scope of research questions,outlining a two-step approach—question generation and definition—and introduces relevant evaluation tools and defining frameworks.Furthermore,it systematically explained the key elements of a study protocol and provides an in-depth explanation of the research methodology and its critical aspects.Finally,the paper highlighted the importance of feasibility assessment,emphasizing that the process of defining research questions and study protocols is dynamic and iterative.Compared with the previous edition,the 2nd edition of the guidelines offers more detailed and updated guidance on question formulation and protocol development.It added three new elements—such as protocol archiving or registration—and three new content items,including study objectives.The 2nd edition also expanded the methodological framework and strengthens feasibility assessments,thereby enhancing the comprehensiveness and rigor of its practical guidance.By integrating guideline content with practical experience,this paper provided insights into its implications for pharmacoepidemiological research and serves as a reference for researchers in the field.

Germplasm degeneration occurs during the long-term cultivation of root-and rhizome-derived traditional Chinese medicine(RR-TCM), which seriously restricts the high-quality development of their industry. Therefore, it is urgent to solve the problem of germplasm degeneration through variety breeding. In this paper, based on previously published research articles, monographs, and news reports, the research progresses on the number and origins, breeding methods, and selection of new varieties of RR-TCM listed in the Chinese Pharmacopoeia(Edition 2020) were summarized and analyzed. The results show that there are 169 kinds of RR-TCM listed in the Chinese Pharmacopoeia(Edition 2020), originated from 223 origins with three breeding methods(i.e., seed propagation, vegetative reproduction, and tissue culture), and there are 215 species derived from seed propagation, 177 species derived from vegetative reproduction, and 164 species derived from tissue culture. To date, there are 62 origins breeding new varieties through conventional breeding, cross breeding, mutation breeding, ploidy breeding, or modern biotechnology breeding methods, including 57 origins breeding 145 new varieties through conventional breeding, 10 origins breeding 43 new varieties through mutation breeding, and seven origins breeding 12 new varieties through cross breeding method. They are used mainly to improve yield, disease resistance, and active ingredient content, but only a few new varieties have been widely used. This review will provide useful references in variety breeding, quality breeding, and standardized planting of RR-TCM.
Plant Breeding/methods* ; Plant Roots/growth & development* ; Rhizome/growth & development* ; Drugs, Chinese Herbal ; Plants, Medicinal/classification* ; Medicine, Chinese Traditional

Neural oscillatory changes play a critical role in pain and analgesia research. Previous studies on pain-related neural oscillations have primarily utilized electroencephalogram (EEG) power spectral analysis, revealing a strong correlation between alpha ( α) power and subjective pain perception. However, alpha power may be influenced by the baseline of the power spectrum, making it difficult to accurately capture the true changes in alpha oscillations. This study employed power spectral analysis and further applied a power spectral parameterization method, which decomposed the power spectrum into periodic and aperiodic components, to compare EEG α power in 50 primiparous women who underwent severe pain during the first stage of labor before and after epidural analgesia. The results indicated no significant differences in α power between pre- and post-analgesia conditions. However, following power spectral parameterization, the aperiodic component of the EEG significantly decreased after analgesia, whereas the periodic component of α power showed a significant increase. This study not only validates the effectiveness and validity of the power spectral parameterization method in analgesia research but also uncovers the differential regulatory mechanism by which analgesia modulates the periodic and aperiodic components of α oscillations.
Humans ; Electroencephalography/methods* ; Female ; Adult ; Alpha Rhythm ; Pregnancy ; Young Adult ; Analgesia, Epidural

It has been not been updated for nearly 5 years since the Pharmacoepidemiology Professional Committee of the Chinese Pharmaceutical Association released the Guide on Methodological Standards in Pharmacoepidemiology in China(1st edition)in 2019,and an update is urgently needed.This study adopts a systematic review approach to comprehensively search for global pharmacoepidemiology methodological guidelines and analyze their development status.By extracting the frameworks and key elements of the guidelines,the China's guide was compared with other included guidelines,its shortcomings were analysed,and pragmatic and feasible suggestions for improvement in line with China's national conditions,were proposed in order to provide references for updating China's guide.A systematic search was conducted by searching PubMed,Embase,CNKI,WanFang Data and 17 official websites of international academic organizations for pharmacoepidemiology and regulatory agencies from countries or regions including Europe,the United States,Japan,and China,etc.,and relevant guidelines or standards were screened based on predefined inclusion and exclusion criteria,resulting in the inclusion of 33 methodological guidelines or standards for pharmacoepidemiological studies.A qualitative synthesis approach was then employed to extract core elements from the guidelines through thematic categorization and content summarization,followed by a descriptive comparative analysis.The results indicate that the 1st edition of the China's guide provides relatively comprehensive guidance on adverse drug reaction reporting and publication of research findings.However,there are gaps in study protocol development,data analysis during study implementation,study reporting,and specific study scenarios.By integrating and drawing upon the latest international pharmacoepidemiology methodology guidelines while balancing comprehensiveness,practicality,and user-friendliness,this study provides recommendations for updating the China's guide.

Formulating a well-defined research question and developing a scientifically sound study protocol is important for ensuring the quality of pharmacoepidemiological research.Based on the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition),this research provided an interpretation of the sections related to the formulation of research questions and the development of study protocols.First,it clarified the sources and scope of research questions,outlining a two-step approach—question generation and definition—and introduces relevant evaluation tools and defining frameworks.Furthermore,it systematically explained the key elements of a study protocol and provides an in-depth explanation of the research methodology and its critical aspects.Finally,the paper highlighted the importance of feasibility assessment,emphasizing that the process of defining research questions and study protocols is dynamic and iterative.Compared with the previous edition,the 2nd edition of the guidelines offers more detailed and updated guidance on question formulation and protocol development.It added three new elements—such as protocol archiving or registration—and three new content items,including study objectives.The 2nd edition also expanded the methodological framework and strengthens feasibility assessments,thereby enhancing the comprehensiveness and rigor of its practical guidance.By integrating guideline content with practical experience,this paper provided insights into its implications for pharmacoepidemiological research and serves as a reference for researchers in the field.

Pharmacovigilance impact research(PIR),as an important application field of pharmacoepidemiology,has attracted continuous attention in recent years from drug regulatory authorities,pharmaceutical manufacturers,and the academic community both domestically and internationally.This paper provides an interpretation of PIR based on the Guide for Methodology in Pharmacoepidemiologic Research(2nd edition).First,an overview of the implications of PIR will be provided,focusing on the pathways of pharmacovigilance activities and the significant importance of conducting PIR.Second,it reviews commonly used study designs and presents illustrative case examples.Building on this,the specific statistical considerations relevant to PIR were discussed.Finally,the challenges and prospects of conducting pharmacovigilance impact studies in a scientific and standardized manner are summarized.Compared with the previous edition,the 2nd edition has expanded the application scenarios of pharmacoepidemiology to include new areas such as PIR.Drawing on the guideline content and practical experience,this paper provides a detailed introduction and case analysis of PIR,serving as a reference for researchers engaged in this field.

Objective To explore the impact of suture configuration and fixation type on the biome-chanical strength of rotator cuff repair,using a factorial design study.Methods Sixteen fresh-frozen porcine shoulder samples were randomized into an anchorless double-row suture bridge transosseous su-tures(DS)group,an anchored double-row suture bridge transosseous-equivalent(DE)group,an an-chorless X-BOX construct transosseous sutures(XS)group,and an anchored X-BOX construct transos-seous-equivalent(XE)group,each of four,according to suture configuration(double-row suture bridge,traditional X-BOX construct)and fixation type(suture anchors,transosseous sutures).Then,their fatigue resistance(first-cycle excursion,gap length difference ratio,and the percentage of ex-posed footprints)and the failure strength(the maximum failure load and the re-tear type)were mea-sured using a biomechanical material testing machine.Results Different suture configurations affected failure strength(F=39.559,P<0.001),with the double-row suture bridge groups(693.07±58.35 N,746.76±138.57 N)showing significantly higher failure strength,compared to the traditional X-BOX groups(462.90±18.91 N,421.43±90.76 N).However,the fixation type did not significantly im-pact failure strength(F=1.161,P=0.302).Moreover,the suture configuration influenced the gap differ-ence ratio(F=7.781,P=0.016),but had no significant correlation with other fatigue resistance indica-tors(P>0.05).Meanwhile,failure strength and fatigue resistance were not correlated with fixation type,and the interaction between suture and fixation type(P>0.05).The incidence of failure types for the four suture configurations was as follows:Type I tendon tear:XS>XE>DS=DE;type II tendon tear:DS>XE>XS=DE;fixing material-related failure:DE>DS=XE=XS.Conclusion The failure strength and gap formation ratio in rotator cuff repair under fatigue loading are influenced by suture configuration,whereas no significant association has been observed with respect to fixation method,whether using transosseous sutures or suture anchors.

Pharmacoepidemiology is a scientific discipline that applies epidemiological principles and methods to study the utilization and effects of pharmaceuticals in populations.It plays a crucial role in promoting rational drug use and improving public health outcomes.High-quality pharmacoepidemiological research relies on rigorous methodological frameworks.Chinese Pharmaceutical Association(CPA)has officially initiated the development/revision of the of the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)in 2024.This revision project was supported by the Pharmacoepidemiology Committee of CPA,and was led by the Department of Epidemiology and Biostatistics at Peking University School of Public Health,which provided methodological guidance,in collaboration with multidisciplinary experts from across the country.Building on the experience of the 1st edition's development,the working group conducted a qualitative systematic review,to extract key information from global pharmacoepidemiology-related guidelines,laying the foundation for the development/revision proposals of the 2nd edition.Subsequently,through two rounds of Delphi method expert consultations and qualitative interviews,alongside extensive discussions within the working group,the draft revision of the guideline was created.Finally,through an expert consensus meeting using the Nominal Group Technique(NGT),a consensus was reached,resulting in a methodological guideline that integrates international perspectives with local applicability for pharmacoepidemiological research in China.The 2nd edition consists of 41 entries,including 8 primary entries,20 secondary entries,and 13 tertiary entries.It comprehensively covers key aspects such as study protocol development,study implementation,adverse event reporting,research report writing,and dissemination of study findings.Additionally,it addresses specific application scenarios and topics,as well as the application of artificial intelligence and real-world studies.

Pharmacoepidemiology is an interdisciplinary discipline that applies epidemiological research methods to evaluate the application and effect of drugs within population.Standardizing pharmacoepidemiological research methods is crucial for ensuring the quality of research and promoting the development of the discipline.The Pharmacoepidemiology Professional Committee of Chinese Pharmaceutical Association developed the Guide on Methodological Standards in Pharmacoepidemiology(1st edition),in 2019,but has not been updated in over five years.Other,countries/regions such as Europe,America,Japan and South Korea have made a lot of progress in developing and updating the guidelines.Therefore,the rapid development of pharmacoepidemiology in our country and the growing need to align with international standards make it essential to update the guidelines.The second edition of the guidelines was developed through a process that included systematic reviews,practical surveys,and multidisciplinary collaboration.Compared with the first edition,the updated version has made many important changes in research design,data sources,specific application scenarios and more,and added new contents such as the application of artificial intelligence.The purpose of this paper is to emphasize the necessity of updating the guidelines,selecting important changes and formulating interpretation plans.It aims to provide references for relevant professionals to comprehensively understand and apply the new guidelines,and to promote the standardized development and quality of pharmacoepidemiologic research in our country,further advancing the field.

With the deepening of molecular biology and cell biology research,the regulatory mechanism of autophagy has been gradually revealed,providing new ideas for the treatment of numerous diseases.Autophagy may be closely related to pathological changes such as apoptosis resistance of fibroblast-like synoviocytes,disturbances in bone metabolic homeostasis,and antigen presentation,the regulation of autophagy homeostasis may be an important approach for the treatment of rheumatoid arthritis(RA).In this paper,we provide a review on the pathological mechanism of autophagy in RA,with a view to providing a theoretical basis for later studies.