The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections （hereinafter referred to as the Guidelines） were released by the China Association of Chinese Medicine， with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections （TCMIs）. The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， along with 30 experts in TCM pharmacovigilance， clinical practice （TCM， as well as integrated traditional Chinese and Western medicine），and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field， both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1： Rules for the structure and drafting of standardizing documents， the WHO Handbook for Guideline Development，and other methodological norms. Based on international norms，national laws and regulations，and scientific research results in the field of pharmacovigilance， methods adopted included expert interviews，literature research，nominal group technique， and Delphi method. Then， key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring"，"identification"，"assessment"，and "control". The development process of the Guidelines included project initiation， international registration， expert interviews， literature search， and evaluation. Based on the research results of these steps，a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback， the final version was formed. The Guidelines came into effect on January 8，2024，providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process，this study elucidates the background，methodological framework，and key development steps of the Guidelines.

The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections （hereinafter referred to as the Guidelines） were released by the China Association of Chinese Medicine， with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections （TCMIs）. The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， along with 30 experts in TCM pharmacovigilance， clinical practice （TCM， as well as integrated traditional Chinese and Western medicine），and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field， both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1： Rules for the structure and drafting of standardizing documents， the WHO Handbook for Guideline Development，and other methodological norms. Based on international norms，national laws and regulations，and scientific research results in the field of pharmacovigilance， methods adopted included expert interviews，literature research，nominal group technique， and Delphi method. Then， key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring"，"identification"，"assessment"，and "control". The development process of the Guidelines included project initiation， international registration， expert interviews， literature search， and evaluation. Based on the research results of these steps，a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback， the final version was formed. The Guidelines came into effect on January 8，2024，providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process，this study elucidates the background，methodological framework，and key development steps of the Guidelines.

ObjectiveTo address the limitations of the current quality standard for Polygalae Radix（PR）， which relies on a single component for quality assessment and struggles to holistically control its intrinsic quality， by constructing a comprehensive quality evaluation system integrating "macro-characterization of chemical profile， synchronous quantification of multiple index components， and quantitative analysis of multi-components by single marker（QAMS） for key component groups". This study aims to facilitate the scientific revision of the quality standard for PR. MethodsHigh performance liquid chromatography（HPLC） characteristic chromatograms were established for 11 batches of PR medicinal materials（YZ）， 10 batches of PR decoction pieces（YP）， and 10 batches of licorice-processed PR decoction pieces（ZYZ）， followed by similarity evaluation and identification of common peaks. HPLC-QAMS was developed for xanthones（sibiricaxanthone B， polygalaxanthone Ⅺ， polygalaxanthone Ⅲ） in the characteristic chromatograms. Simultaneously， the external standard method（ESM） was used to determine the contents of the corresponding xanthones and 3，6'-disinapoyl sucrose in YZ， YP， and ZYZ， followed by multivariate statistical analysis and Spearman correlation analysis. ResultsThe similarity between the characteristic chromatograms of 31 batches of PR samples and the reference chromatogram was>0.9. A total of 13 common peaks were identified， and 10 of these peaks were characterized through reference standard comparison. The successfully constructed QAMS method showed that the relative correction factors（RCFs） of sibiricaxanthone B and polygalaxanthone Ⅺ to polygalaxanthone Ⅲ were 0.76 and 0.88， and their relative retention times（RRTs） were 0.85 and 0.97， respectively. The results calculated by the QAMS method showed no significant difference from those obtained by the ESM. According to the limit standard for polygalaxanthone Ⅲ in the 2020 edition of the Pharmacopoeia of the People's Republic of China（hereinafter referred to as the Chinese Pharmacopoeia）， the pass rate of 31 batches of samples was only 19.35%. Multivariate statistical analysis indicated certain compositional differences between different batches of YZ and YP， as well as between YP and ZYZ， with 3，6'-disinapoyl sucrose identified as the main differentiating component. Furthermore， correlation analysis revealed that the content of polygalaxanthone Ⅲ was positively correlated with the contents of sibiricaxanthone B and polygalaxanthone Ⅺ， but showed no association with the content of 3，6'-disinapoyl sucrose. ConclusionIt is recommended that the content limit for polygalaxanthone Ⅲ in YZ，YP and ZYZ be revised to not less than 0.07%， or the total content of polygalaxanthone Ⅲ， sibiricaxanthone B and polygalaxanthone Ⅺ be not less than 0.18%. The newly established triple quality control model of "holistic control via characteristic chromatograms， precise quantification of oligosaccharide esters， and efficient detection of xanthones by QAMS" provides a systematic and precise solution for quality evaluation of PR and similar Chinese herbal medicines.

Tuberous sclerosis complex (TSC) is an autosomal dominant genetic disorder primarily caused by pathogenic variants in the TSC1 or TSC2 genes. It is characterized by multisystem hamartomatous lesions and neuropsychiatric manifestations. Here we report a young male patient with TSC involving multiple organs, caused by a heterozygous frameshift mutation in TSC2 (c.2071delC, p.Arg691Alafs^*7). The patient initially presented with classic facial angiofibromas and hypomelanotic macules, and subsequently developed psychiatric and behavioral disturbances with auditory hallucinations. Neuroimaging revealed an intracranial mass lesion, which was confirmed as a subependymal giant cell astrocytoma on postoperative histopathology following surgery performed at an outside institution. After admission, the patient underwent a comprehensive diagnostic workup, and multidisciplinary treatment evaluation revealed extensive multisystem involve-ment, including the nervous system, skin, kidneys, lungs, heart, eyes, pancreas, liver and bones. Combined with relevant literature, this article discusses the molecular mechanisms, clinical phenotypes, and comprehensive management of TSC, in order to provide a reference for the standardized and individualized management of this disease.

Objective From the perspective of China's health service system,to evaluate the economy of the first-line treatment of advanced squamous non-small cell lung cancer with serplulimab combined with chemotherapy.Methods A three-state partitioned survival model was constructed,and the cost-effectiveness method was used to evaluate the economy of serplulimab combined chemotherapy in the first-line treatment of advanced squamous non-small cell lung cancer.The clinical data were collected from the ASTRUM-004 trial.The quality adjusted life years(QALYs)were used as the output index and the incremental cost-effectiveness ratio(ICER)was calculated.The stability of the model was verified by sensitivity analysis,and the situation analysis was carried out for the decrease of the price of serplulimab.Results The results of basic analysis showed that the cost of the combination group increased by 1 951 442 yuan compared with the placebo combination chemotherapy group,and the ICER was 2 498 816.54 yuan/QALY.Single factor sensitivity analysis showed that PFS state utility value,body weight,and serplulimab price had a greater impact on ICER.Probabilistic sensitivity analysis showed that the basic analysis results are robust.The results of the scenario analysis showed that when the price of serplulimab was reduced by 20％and 80％,it was not economical.Conclusions From the perspective of the China's health service system,currently,the combination therapy of serplulimab with chemotherapy is not cost-effective in the first-line treatment of advanced squamous cell lung cancer compared to placebo combination therapy.

Objective To study the effect and duration of point-of-use filters on the improvement of endoscopic fi-nal rinse water quality.Methods The final rinse water end at the gastroscope manual cleaning workstation in the Endoscopy Centre of the First Affiliated Hospital with Nanjing Medical University was selected to install a tap ter-minal filter;five specimens of final rinse water were collected consecutively before the installation,immediately after the installation,and 1-11 weeks after the installation.At each sampling time,the staff responsible for clea-ning and disinfecting were asked whether the flow rate of discharged water could satisfy the working demand;the final rinse water was inoculated on R2A culture medium with membrane filter method,bacterial colony forming unit(CFU)was calculated after 30℃ incubation for 5 days.Results The qualified rates of endoscopic final rinse water before point-of-use filter installation was 0,immediately after and 1-9 weeks after installation were both 100％,10 and 11 weeks after installation were 80.0％and 20.0％,respectively.The mean CFU of endoscopic final rinse wa-ter before point-of-use filter installation was 102 CFU/100 mL,immediately after and 1-9 weeks after installation were both ≤2 CFU/100 mL,10 and 11 weeks after installation were 8 and 18 CFU/100 mL,respectively.The feedback from the cleaning and disinfection staff before installation,immediately after installation,and 1-11 weeks after installation indicated that the flow rate of discharged water gradually slowed down over time,but could still meet the work requirements.Conclusion The point-of-use filter can quickly and effectively improve the quality of endoscopic final rinse water,with use duration of up to 9 weeks after installation;Its biggest advantage is that it can serve as the final barrier to all integrated measures,playing a supplementary role in case of any problems occu-rring in the front-end process,and ensuring the microbial quality of the final rinse water to the greatest extent possible.

Objective To analyze the literature on drug treatment pathways to sort out the development process,and to present the research status,hotspots,and trends.Methods Researches on drug treatment pathways were retrieved from the WoSCC,CNKI,Wanfang Database,and VIP Chinese Journal Database from the time of database establishment to October 312024.The CiteSpace 6.3.R1 and VOSviewer 1.6.20 were used to generate visual maps,including publications,countries,journals,institutions,authors,and keywords.Results A total of 150 papers were included,45 in Chinese and 105 in English.The number of Chinese and English research publications has increased significantly in the past five years.The United States has the largest number of publications in this field.There is relatively little cooperation among domestic research groups,but international cooperation is closer.In Chinese journals,research topics in this field mainly focus on the whole process from formulation to implementation of drug treatment pathways.Perioperative drug use,chronic drug use,and adjuvant drug use are research hotspots.In recent years,attention to clinical pharmacists and evidence-based pharmacy has increased.English journals mainly focus on cancer treatment-related research,with current research focusing on patient experience and social benefits.Conclusion Research in the field of drug treatment pathways in English journals is developing rapidly,but no core journal area has been formed specifically in this area.At present,the research on drug treatment pathways in Chinese journals is in its initial stage and is advancing rapidly,but the overall number is still relatively small,the research content and diseases involved are limited,and the research system is not perfect.Chinese researchers should pay attention to the research hotspot,broaden the research topic and further improve the quantity and quality of the research in this field.

This article analyzes the development and current status of clinical pathways(CPs)in the United States,the European Union,and Japan.CPs are standardized treatment models based on medical evidence and guidelines,aiming to improve therapeutic outcomes,reduce costs,ensure treatment consistency,enhance medical service efficiency,and increase patient satisfaction.The United States has promoted CPs since 1985,driving their development through legislation and professional associations to improve service quality and reduce medical expenditures.The European Union supports the development and evaluation of CPs through the European Pathway Association,emphasizing the improvement of patient treatment outcomes.Japan uses CPs as a tool to improve the quality of medical services,with an emphasis on multidisciplinary collaboration.All three have shown positive effects of CPs in improving medical service efficiency and reducing costs.However,they also face challenges such as overemphasis on cost control,lack of transparency,and physician cooperation.China can draw on these experiences to promote the development of CPs and enhance the quality and efficiency of medical services.

Objective To analyze the literature on drug treatment pathways to sort out the development process,and to present the research status,hotspots,and trends.Methods Researches on drug treatment pathways were retrieved from the WoSCC,CNKI,Wanfang Database,and VIP Chinese Journal Database from the time of database establishment to October 312024.The CiteSpace 6.3.R1 and VOSviewer 1.6.20 were used to generate visual maps,including publications,countries,journals,institutions,authors,and keywords.Results A total of 150 papers were included,45 in Chinese and 105 in English.The number of Chinese and English research publications has increased significantly in the past five years.The United States has the largest number of publications in this field.There is relatively little cooperation among domestic research groups,but international cooperation is closer.In Chinese journals,research topics in this field mainly focus on the whole process from formulation to implementation of drug treatment pathways.Perioperative drug use,chronic drug use,and adjuvant drug use are research hotspots.In recent years,attention to clinical pharmacists and evidence-based pharmacy has increased.English journals mainly focus on cancer treatment-related research,with current research focusing on patient experience and social benefits.Conclusion Research in the field of drug treatment pathways in English journals is developing rapidly,but no core journal area has been formed specifically in this area.At present,the research on drug treatment pathways in Chinese journals is in its initial stage and is advancing rapidly,but the overall number is still relatively small,the research content and diseases involved are limited,and the research system is not perfect.Chinese researchers should pay attention to the research hotspot,broaden the research topic and further improve the quantity and quality of the research in this field.

This article analyzes the development and current status of clinical pathways(CPs)in the United States,the European Union,and Japan.CPs are standardized treatment models based on medical evidence and guidelines,aiming to improve therapeutic outcomes,reduce costs,ensure treatment consistency,enhance medical service efficiency,and increase patient satisfaction.The United States has promoted CPs since 1985,driving their development through legislation and professional associations to improve service quality and reduce medical expenditures.The European Union supports the development and evaluation of CPs through the European Pathway Association,emphasizing the improvement of patient treatment outcomes.Japan uses CPs as a tool to improve the quality of medical services,with an emphasis on multidisciplinary collaboration.All three have shown positive effects of CPs in improving medical service efficiency and reducing costs.However,they also face challenges such as overemphasis on cost control,lack of transparency,and physician cooperation.China can draw on these experiences to promote the development of CPs and enhance the quality and efficiency of medical services.