To interpret the evidence-to-decision （EtD） framework and to illustrate its application in traditional Chinese medicine （TCM） guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine， thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework （formulating the question， making an assessment of the evidence， and drawing conclusions）， critical decision points and evaluation evidence within the evidence-translation process were systematically addressed， aligning with the purpose， scope， and key questions of the guideline. Qualitative research methods， such as the nominal group technique， were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation， the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified， focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment， multi-source evidence was integrated， including policy documents， literature research， and expert consensus， completing the evidence evaluation. Finally， in recommendation-forming， dispersed research evidence and expert experience were synthesized into consensus， culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development， effectively enhancing the transparency and scientific rigor of the process. Therefore， it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.

The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions （T/CACM 1563.2-2024） were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine （TCM）. This guideline was jointly developed with 23 authoritative medical and research institutions in China， under the lead of the Institute of Basic Clinical Medicine， China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM （including research and development， marketing， and application） and to establish a four-dimensional framework of "organizational structure， institutional system， information platform， and vigilance activities". Key components included the establishment of a TCM Safety Committee， the construction of nine core systems， the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use （ICH） E2B standards， alongside the risk monitoring， identification， assessment， and control during clinical trials and post-marketing phases. Therefore， this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations， the guideline compilation involved multiple rounds of expert interviews， systematic evidence integration， and broad consensus. This guideline was specified to be applicable to medical institutions at all levels， primarily addressing core issues， including the difficulty in adverse reaction identification， low reporting rates， and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous， ensuring alignment with current national laws and regulations， and was registered internationally. In the future， implementation will be promoted through standardized training， tiered dissemination， as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks， ensure patient medication safety， and promote the high-quality development of TCM.

To standardize the clinical application of oral Chinese patent medicines （CPMs）， and address the safety issues arising from their dosage form characteristics， irrational clinical use， and the lack of targeted pharmacovigilance systems， the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines， aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China （2019 revision）， the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， led a drafting group comprising 18 institutions. After multiple rounds of expert interviews， literature retrieval， evidence screening， and extensive solicitation of opinions， the Guidelines were registered internationally. Systematic standardization focused on safety monitoring， risk identification， assessment， control， and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring， known risks， and potential risks， compared to non-oral CPMs. Then， risk control measures were proposed， including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs， the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine （TCM）， which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions， pharmaceutical manufacturers， and regulatory authorities.

To interpret the evidence-to-decision （EtD） framework and to illustrate its application in traditional Chinese medicine （TCM） guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine， thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework （formulating the question， making an assessment of the evidence， and drawing conclusions）， critical decision points and evaluation evidence within the evidence-translation process were systematically addressed， aligning with the purpose， scope， and key questions of the guideline. Qualitative research methods， such as the nominal group technique， were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation， the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified， focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment， multi-source evidence was integrated， including policy documents， literature research， and expert consensus， completing the evidence evaluation. Finally， in recommendation-forming， dispersed research evidence and expert experience were synthesized into consensus， culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development， effectively enhancing the transparency and scientific rigor of the process. Therefore， it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.

The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions （T/CACM 1563.2-2024） were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine （TCM）. This guideline was jointly developed with 23 authoritative medical and research institutions in China， under the lead of the Institute of Basic Clinical Medicine， China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM （including research and development， marketing， and application） and to establish a four-dimensional framework of "organizational structure， institutional system， information platform， and vigilance activities". Key components included the establishment of a TCM Safety Committee， the construction of nine core systems， the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use （ICH） E2B standards， alongside the risk monitoring， identification， assessment， and control during clinical trials and post-marketing phases. Therefore， this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations， the guideline compilation involved multiple rounds of expert interviews， systematic evidence integration， and broad consensus. This guideline was specified to be applicable to medical institutions at all levels， primarily addressing core issues， including the difficulty in adverse reaction identification， low reporting rates， and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous， ensuring alignment with current national laws and regulations， and was registered internationally. In the future， implementation will be promoted through standardized training， tiered dissemination， as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks， ensure patient medication safety， and promote the high-quality development of TCM.

To standardize the clinical application of oral Chinese patent medicines （CPMs）， and address the safety issues arising from their dosage form characteristics， irrational clinical use， and the lack of targeted pharmacovigilance systems， the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines， aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China （2019 revision）， the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， led a drafting group comprising 18 institutions. After multiple rounds of expert interviews， literature retrieval， evidence screening， and extensive solicitation of opinions， the Guidelines were registered internationally. Systematic standardization focused on safety monitoring， risk identification， assessment， control， and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring， known risks， and potential risks， compared to non-oral CPMs. Then， risk control measures were proposed， including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs， the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine （TCM）， which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions， pharmaceutical manufacturers， and regulatory authorities.

ObjectiveTo explore the listed varieties and prescription characteristics of Chinese patent medicines for stroke in China， explore the medication rules of Chinese medicine for stroke， and provide guidance for further clinical research and development of Chinese patent medicines. MethodsExcel 2021 and the Ancient and Modern Medical Record Cloud Platform （V2.3.5） were used to systematically mine and analyze the varieties and prescriptions of Chinese patent medicines for stroke in China. ResultsA total of 244 Chinese patent medicines （two for different dosage forms of the same prescription）， 1 736 approval documents for Chinese patent medicines， 792 manufacturers， and 83 varieties of protected Chinese patent medicines were finally included in the database. The top three dosage forms were capsules （75）， pills （53）， and tablets （42）. There were 28 Chinese patent medicines for stroke in the National Essential Drug Catalogue （2018）， 129 in the National Essential Medical Insurance， Industrial Injury Insurance and Maternity Insurance Drug Catalogue （2023）， and 4 in the National Non-prescription Drug Catalogue. Among the 138 prescriptions screened out， Chinese patent medicines mainly treated stroke patients with the syndrome of Qi deficiency and blood stasis. The top three most frequent medicinal herbs were Chuanxiong Rhizoma （63）， Pheretima （47）， and Salviae Miltiorrhizae Radix et Rhizoma （47）. The medicinal herbs used were mainly warm， pungent， with the meridian tropism to the liver meridian. The correlation analysis showed that the herb pair with the highest support was Astragali Radix-Chuanxiong Rhizoma， and that with the highest confidence was Carthami Flos-Chuanxiong Rhizoma. Five herb combinations were identified based on the cluster analysis. ConclusionThe Chinese patent medicines for stroke mainly treat patients with the syndrome of Qi deficiency and blood stasis. The medicinal herbs used in the prescriptions mainly have the functions of activating blood and resolving stasis， extinguishing wind and stopping convulsions. Drug compatibility usually focuses on activating blood and resolving stasis， as well as expelling phlegm and opening orifices. This review of the varieties and prescription characteristics of Chinese patent medicines for stroke helps optimize clinical decision-making， guide drug research and development， promote medical research and scientific progress， and provide more effective support and guarantee for the treatment of stroke patients.

OBJECTIVE To evaluate the efficacy， safety and cost-effectiveness of serplulimab as a first-line treatment of small- cell lung cancer （SCLC）， and provide an evidence-based basis for drug selection in hospitals. METHODS Rapid health technology assessment was adopted； PubMed， Cochrane Library， Embase， CNKI， Wanfang， VIP and official websites of domestic and international health technology assessment agencies were systematically searched from the inception to Oct. 2024. Two reviewers independently screened the literature， assessed the quality of included studies and carried out the qualitative analysis according to the inclusion and exclusion criteria. RESULTS A total of 13 systematic reviews/meta-analyses and 9 economic studies were included， and the literature quality was generally good. In terms of effectiveness， compared with chemotherapy alone， serplulimab combined with chemotherapy significantly improved progression-free survival， overall survival， and objective response rate in patients with SCLC. In terms of safety， serplulimab combined with chemotherapy showed no significant difference in the incidence of ≥3 grade adverse events compared with chemotherapy alone in the treatment of SCLC， indicating a good safety profile； compared with combination therapies involving other immunosuppressive agents， the incidence rate of adverse events was also lower. In terms of cost-effectiveness， compared with chemotherapy alone， serplulimab combined with chemotherapy is not cost- effective， which may be related to the high price of serplulimab. CONCLUSIONS Serplulimab is effective and safe in the treatment of SCLC， but has no obvious advantage in terms of cost-effectiveness.

FU Qingzhu Nyuke·Zhongzi is a concentrated manifestation of Fu′s academic thoughts of promoting conception (Zhongzi), which affects the treatment of infertility in later generations. However, the Zhongzi chapter is named after "symptoms" and is not divided into chapters according to "syndromes, "limiting the clinical application of Fu′s thoughts of Zhongzi. The "qi circle in round" theory is the crystallization of HUANG Yuanyu′s academic thinking, advocating for qi transformation, emphasizing middle qi, and considering the four phenomena. This theory highlights the role of middle qi in the rise, fall, and circulation of disease development. The "qi cycle in round" theory, a comprehensive view of Fu′s Zhongzi chapter, reveals that FU Qingzhu emphasizes the transformation of visceral qi in diagnosing and treating infertility, focusing on the spleen, liver, and kidneys. His prescription aims to restore the overall qi mechanism of the body, highlighting the circulation of middle earth and the dredging of meridians, aligning perfectly with the theory of the "qi cycle in round." Therefore, this article argues from the perspective of the "qi cycle in round, "deconstructing the pathogenesis of Fu′s infertility based on the dereliction of spleen earth, stagnation of liver wood, and kidney yin and yang deficiency. It reorganizes Fu′s formula system of Zhongzi by mediating middle earth, soothing liver depression, and regulating kidney function, summarizing the characteristics of Fu′s thoughts of Zhongzi with the aid of qi around the waist and navel, simultaneous treatment of conqenital and acquired essence, and restriction and generation of five phases. Based on the "qi cycle in round" theory, this study explores Fu′s academic thoughts of Zhongzi to strengthen the organic integration of Fu′s academic thoughts of Zhongzi with the theory of "qi cycle in round, "providing new perspectives for the study and inheritance of Fu′s academic thoughts of Zhongzi.

ObjectiveThe central symptom of Parkinson’s disease (PD) is impaired motor function. Beta-band electrical activity in the motor network of the basal ganglia is closely related to motor function. In this study, we combined scalp electroencephalography (EEG), brain functional network, and clinical scales to investigate the effects of beta burst-period neural electrical activity on brain functional network characteristics, which may serve as a reference for clinical diagnosis and treatment. MethodsThirteen PD patients were included in the PD group, and 13 healthy subjects were included in the healthy control group. Resting-state EEG data were collected from both groups, and beta burst and non-burst periods were extracted. A phase synchronization network was constructed using weighted phase lag indices, and the topological feature parameters of phase synchronization network were compared between the two groups across different periods and four frequency bands. Additionally, the correlation between changes in network characteristics and clinical symptoms was analyzed. ResultsDuring the beta burst period, the topological characteristic parameters of phase synchronization network in all four frequency bands were significantly higher in PD patients compared to healthy controls. The average clustering coefficient of the phase synchronization network in the beta band during the beta burst period was negatively correlated with UPDRS-III scores. In the low gamma band during the non-burst period, the average clustering coefficient of phase synchronization network was positively correlated with UPDRS and UPDRS-III scores, while UPDRS-III scores were positively correlated with global efficiency and average degree. ConclusionThe brain functional network features of PD patients were significantly enhanced during the beta burst period. Moreover, the beta-band brain functional network characteristics during the beta burst period were negatively correlated with clinical scale scores, whereas low gamma-band functional network features during the non-burst period were positively correlated with clinical scale scores. These findings indicate that motor function impairment in PD patients is associated with the beta burst period. This study provides valuable insights for the diagnosis of PD.