1.Effects of deep hyperthermia on immune function during postoperative adjuvant chemotherapy in patients with colorectal cancer
Lei ZHAO ; Hongbo WANG ; Wenzhi LIU ; Feng LIN ; Jian YU ; Mingjun SUN ; Baosheng YU ; Yunxiao ZHONG ; Yougang CUI ; Xu ZHANG ; Yupeng YI ; Na WANG ; Daocheng WU ; Chenyang LI ; Pan HU ; Ning FENG
Chinese Journal of Radiation Oncology 2025;34(5):461-467
Objective:To explore the effects of deep hyperthermia on chemotherapy-related adverse effects and immune-inflammatory indicators in the patients undergoing postoperative adjuvant chemotherapy for colorectal cancer.Methods:This retrospective study included 52 patients who underwent surgery for colorectal cancer at the Affiliated Zhongshan Hospital of Dalian University from September 2021 to December 2023. The patients were divided into two groups based on treatment method: the combination group ( n=29) received postoperative adjuvant chemotherapy combined with deep hyperthermia, while the chemotherapy group ( n=23) received postoperative adjuvant chemotherapy alone. Both groups were treated with the XELOX regimen (oxaliplatin + capecitabine). The degree of bone marrow suppression during treatment was assessed by analyzing peripheral blood parameters, including hemoglobin, leukocyte count, neutrophil count, and platelet count. Immune-inflammatory indicators, including complement, procalcitonin (PCT), interleukin-6 (IL-6), systemic immune-inflammation index (SII), neutrophil-to-lymphocyte ratio (NLR), and platelet-to-lymphocyte ratio (PLR), were compared before and after treatment in both groups to evaluate the effects of deep hyperthermia on the immune-inflammatory response. Chi-square test or Fisher's exact test (two-tailed) was used to compare bone marrow suppression rates, and the immune-inflammatory indicators between the two groups were compared using t-tests or non-parametric tests, depending on whether the data conformed to a normal distribution. Results:In terms of myelosuppression, the incidence rates of moderate to severe decreases in leukocytes, neutrophils, platelets, and hemoglobin in the combination group were 31%, 31%, 21%, and 14%, respectively, compared to 52%, 61%, 48%, and 9% in the chemotherapy group. The change in PCT levels before and after treatment was significantly greater in the combination group than in the chemotherapy group ( P = 0.010). Both the combination group and the chemotherapy group showed significant reductions in SII, NLR and PLR after treatment, and the differences were statistically significant (all P < 0.05). The change in NLR before and after treatment was significantly greater in the combination group than in the chemotherapy group ( P = 0.031). Conclusions:Deep hyperthermia can alleviate chemotherapy-induced adverse effects such as thrombocytopenia and neutropenia in patients undergoing postoperative adjuvant chemotherapy for colorectal cancer. It also appears to improve the inflammatory response in these patients.
2.Interpretation of the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)(Ⅲ):comparison of global guidelines
Jinan YAN ; Yunxiao WU ; Xiaolu NIE ; Houyu ZHAO ; Siyan ZHAN ; Feng SUN
Chinese Journal of Pharmacoepidemiology 2025;34(3):241-259
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.
3.Revision process of the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)
Jinan YAN ; Yunxiao WU ; Xiaolu NIE ; Houyu ZHAO ; Siyan ZHAN ; Feng SUN
Chinese Journal of Pharmacoepidemiology 2025;34(2):121-135
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.
4.Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)and their series interpretation(1):an overview
Yunxiao WU ; Jinan YAN ; Xiaolu NIE ; Houyu ZHAO ; Siyan ZHAN ; Feng SUN
Chinese Journal of Pharmacoepidemiology 2025;34(1):2-11
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.
5.Multi-center clinical study on the efficacy and safety of combined lienal polypeptide injection therapy in children with Mycoplasma pneumoniae pneumonia
Qi CHENG ; Yunxiao SHANG ; Han ZHANG ; Jiujun LI ; Ning CHEN ; Lishen SHAN ; Nan YANG ; Lihua NING ; Xuemei BAI ; Jianhua LIU ; Yuling HAN ; Jichun WANG ; Jing LI ; Yong FENG ; Liyun LIU ; Li CHEN ; Si LIU ; Qinzhen ZHANG ; Jia ZHENG ; Fengchao LI ; Sukun LU ; Yun ZHANG ; Xiaoyi CHAI
International Journal of Pediatrics 2025;52(3):204-210
Objective:To observe the efficacy and safety of combined lienal polypeptide injection therapy in the treatment of Mycoplasma pneumoniae pneumonia(MPP)in children aged 3 to 14 years old in multiple clinical centers.Methods:A randomized,controlled,multi-center clinical study design was adopted.A total of 240 hospitalized children aged 3 to 14 years old with MPP from 7 hospitals from September 1,2023 to January 31,2024 were included.According to the severity of pneumonia,they were divided into the mild MPP group with 80 cases and the severe MPP/refractory MPP(SMPP/RMPP)group with 160 cases,and then randomly divided into the control group and the experimental group at a ratio of 1 ∶1,using the random number table method.After screening,subjects entered a treatment period of 5 to 7 days.The control group was treated with azithromycin,while the experimental group was treated with azithromycin plus lienal polypeptide injection .The recovery of lung CT,length of hospital stay,duration of fever,cough score,whether mild cases developed into severe or refractory cases,duration of hormone use,use of intravenous immunoglobulin(IVIG),bronchoscopy treatment,and immune function were observed between the two groups to evaluate the efficacy of lienal polypeptide injection.Adverse events after medication,vital signs,blood routine,urine routine,liver function,myocardial enzymes,renal function,and electrocardiogram were observed to evaluate the safety. Results:A total of 231 subjects have completed the trial in the 7 hospitals,including 118 cases in the experimental group and 113 cases in the control group.Main observation index:the rate of lung CT aggravation in the experimental group was lower than that in the control group(2.6% vs 15.3%, P<0.01),and the difference was statistically significant.Secondary indexes:there were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and immunoglobulin between the two groups(all P>0.05).However,the rate of cases of plastic bronchitis(PB)found under bronchoscopy in the experimental group was lower than that in the control group(0 vs 18.8%, P=0.03),and the difference was statistically significant.Among the mild MPP(72 cases),there were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and the improvement rate of lung CT between the two groups(all P>0.05).However,compared with the control group,the rate of cases developing into SMPP/RMPP in the experimental group was less(24.3% vs 48.6%, P=0.03),and the difference in IgG before and after treatment was small[0.53(-0.04,1.18)g/L vs 1.33(0.48,2.25)g/L, P=0.01].Among the SMPP/RMPP cases(159 cases),the rate of cases of PB found under bronchoscopy in the experimental group was less than that in the control group(0 vs 20%, P=0.04),and the rate of cases with aggravated lung CT in the experimental group was less than that in the control group(1.3% vs 19.5%, P<0.01),and the improvement rate of lung CT in the experimental group was higher than that in the control group(88.8% vs 75.3%, P=0.03),with statistically significant differences.There were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and immunoglobulin between the two groups(all P>0.05).Two cases in the experimental group developed rashes,which improved after the drug was discontinued.There were no serious adverse reactions such as abnormal vital signs like dyspnea and cyanosis due to the use of lienal polypeptide injection.There were no obvious changes in blood routine,liver function,myocardial enzymes,renal function,electrocardiogram,and urine routine values before and after medication compared with the baseline. Conclusion:The combined use of lienal polypeptide injection in the treatment of MPP in children can reduce the probability of the transformation from mild cases to SMPP/RMPP,reduce the rate of aggravation of the image findings,promote the absorption of lung inflammation,reduce the rate of PB found under bronchoscopy,and has good safety.
6.Analysis of the current application of the Consolidated Framework for Implementation Research in the field of public health
Xinping WANG ; Yunxiao WU ; Wangnan CAO ; Xiaolin WEI ; Siyan ZHAN ; Feng SUN
Chinese Journal of Epidemiology 2025;46(8):1446-1450
Evidence-based public health, as the forefront of modern public health practice, has increasingly important in public health field. However, a significant gap remains between the available evidence and its practical application. Effectively disseminating and implementing evidence-based public health practice in real-world settings has become a key challenge in contemporary public health research. In this context, Implementation Science has emerged as a vital discipline. This paper explores the critical role of Implementation Science in public health, reviews the origins and core components of the Consolidated Framework for Implementation Research (CFIR), and analyzes the current application of CFIR in public health through bibliometric methods. Additionally, it discusses specific examples to further elucidate the steps involved in using the CFIR and its application contexts. The findings indicate that since 2015, research on CFIR in public health has progressively increased, showing a continuous upward trend. CFIR applications mainly address context-specific facilitators, health decision-making, barrier and facilitator identification, and community-based participatory evaluation, predominantly employing qualitative and mixed-methods research. This paper not only reviews and analyzes the current use of CFIR in public health but also provides a detailed discussion on its application. The goal is to offer valuable insights for the development of Implementation Science research within China's public health sector.
7.Analysis of the current application of the Consolidated Framework for Implementation Research in the field of public health
Xinping WANG ; Yunxiao WU ; Wangnan CAO ; Xiaolin WEI ; Siyan ZHAN ; Feng SUN
Chinese Journal of Epidemiology 2025;46(8):1446-1450
Evidence-based public health, as the forefront of modern public health practice, has increasingly important in public health field. However, a significant gap remains between the available evidence and its practical application. Effectively disseminating and implementing evidence-based public health practice in real-world settings has become a key challenge in contemporary public health research. In this context, Implementation Science has emerged as a vital discipline. This paper explores the critical role of Implementation Science in public health, reviews the origins and core components of the Consolidated Framework for Implementation Research (CFIR), and analyzes the current application of CFIR in public health through bibliometric methods. Additionally, it discusses specific examples to further elucidate the steps involved in using the CFIR and its application contexts. The findings indicate that since 2015, research on CFIR in public health has progressively increased, showing a continuous upward trend. CFIR applications mainly address context-specific facilitators, health decision-making, barrier and facilitator identification, and community-based participatory evaluation, predominantly employing qualitative and mixed-methods research. This paper not only reviews and analyzes the current use of CFIR in public health but also provides a detailed discussion on its application. The goal is to offer valuable insights for the development of Implementation Science research within China's public health sector.
8.Interpretation of the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)(Ⅲ):comparison of global guidelines
Jinan YAN ; Yunxiao WU ; Xiaolu NIE ; Houyu ZHAO ; Siyan ZHAN ; Feng SUN
Chinese Journal of Pharmacoepidemiology 2025;34(3):241-259
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.
9.Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)and their series interpretation(1):an overview
Yunxiao WU ; Jinan YAN ; Xiaolu NIE ; Houyu ZHAO ; Siyan ZHAN ; Feng SUN
Chinese Journal of Pharmacoepidemiology 2025;34(1):2-11
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.
10.Revision process of the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)
Jinan YAN ; Yunxiao WU ; Xiaolu NIE ; Houyu ZHAO ; Siyan ZHAN ; Feng SUN
Chinese Journal of Pharmacoepidemiology 2025;34(2):121-135
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.

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