The prescription of Qidong Yixin oral liquid is derived from the experience of national medical master Ren Jixue in treating viral myocarditis （VMC）. It has the functions of tonifying Qi， nourishing the heart，calming the mind， and relieving palpitations. It is used to treat VMC and angina pectoris of coronary heart disease caused by deficiency of both Qi and Yin. However，the understanding of its efficacy evidence， advantageous aspects， dosage and administration， and medication safety remains insufficient in clinical practice. Therefore，the development of the Expert Consensus on the Clinical Application of Qidong Yixin Oral Liquid （hereinafter referred to as consensus） was initiated. Consensus strictly followed the process and methods of the expert consensus on the clinical application of Chinese patent medicines of the China Association of Chinese Medicine，successively completing multiple tasks such as the consensus project initiation，determination of clinical problems，evidence search and evaluation，formation of recommendation opinions and consensus suggestions，solicitation of opinions，peer review， submission for review and release， and so on. Consensus formed a total of 10 recommendation opinions and 12 consensus suggestions，clarifying the clinical positioning，efficacy advantages，syndrome differentiation，dosage and administration，combination therapy，timing of medication，adverse reactions，contraindications， and precautions of Qidong Yixin oral liquid，indicating that it has good clinical advantages and safety in the treatment of VMC and angina pectoris of coronary heart disease，providing norms and references for physicians to safely and rationally apply Qidong Yixin oral liquid. Consensus was reviewed and approved for release by the Standardization Office of the China Association of Chinese Medicine on December 23， 2024. Standard number：GSCACM-376-2024.

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.

To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems， including insufficient safety information in package inserts， amplified medication risks in special populations， and non-standard clinical practices， thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China （2019 revision） and the GB/T 1.1—2020 standard， a systematic search was performed in the Chinese Pharmacopoeia （2020 edition）， the Catalog of Medicines Covered by Medical Insurance （2022 edition）， Chinese databases ［China Network of Knowledge Infrastructure （CNKI）， Wanfang Data （Wanfang）， and VIP journal resource integration service platform （VIP）］， and international databases （Cochrane Library， PubMed， and EMbase）. Guideline outlines were developed through questionnaire surveys， expert interviews， and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine （TCM） incompatibility， as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia （2020 edition） and 58 from the Catalog of Medicines Covered by Medical Insurance （2022 edition）. Safety-related items in the corresponding package inserts were collected， and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting， and opinions from 61 external experts were solicited. A pharmacovigilance framework was established， covering the full chain of "monitoring， identification， assessment， and control". Based on seven anatomical sites， including nasal， ocular， and oral mucosa， a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions"， "Contraindications"， and "Precautions"， clinical procedure standardization in healthcare institutions， risk control， and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration， filling the current gap in international pharmacovigilance standards in this field， while offering technical support for safety management across the full life cycle of medicines for mucosal administration.

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.

To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems， including insufficient safety information in package inserts， amplified medication risks in special populations， and non-standard clinical practices， thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China （2019 revision） and the GB/T 1.1—2020 standard， a systematic search was performed in the Chinese Pharmacopoeia （2020 edition）， the Catalog of Medicines Covered by Medical Insurance （2022 edition）， Chinese databases ［China Network of Knowledge Infrastructure （CNKI）， Wanfang Data （Wanfang）， and VIP journal resource integration service platform （VIP）］， and international databases （Cochrane Library， PubMed， and EMbase）. Guideline outlines were developed through questionnaire surveys， expert interviews， and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine （TCM） incompatibility， as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia （2020 edition） and 58 from the Catalog of Medicines Covered by Medical Insurance （2022 edition）. Safety-related items in the corresponding package inserts were collected， and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting， and opinions from 61 external experts were solicited. A pharmacovigilance framework was established， covering the full chain of "monitoring， identification， assessment， and control". Based on seven anatomical sites， including nasal， ocular， and oral mucosa， a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions"， "Contraindications"， and "Precautions"， clinical procedure standardization in healthcare institutions， risk control， and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration， filling the current gap in international pharmacovigilance standards in this field， while offering technical support for safety management across the full life cycle of medicines for mucosal administration.

According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition,the Chinese Pharmacopoeia 2025 has been completed.Among them,52 new pharmaceutical excipients monographs have been added,and the total number has reached 387.245 pharmaceutical excipients monographs have been revised,of which 109 monographs have only textual revisions and 136 monographs have substantive revi-sions.This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025,which can contribute to accurately understand and utilize the stand-ards in Chinese Pharmacopoeia.

According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition,the Chinese Pharmacopoeia 2025 Edition has been completed.Among them,52 new pharmaceutical excip-ients monographs have been added,an increase of 15.5%compared with the 2020 Edition,and the total number has reached 387.This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition,which can contribute to accurately under-stand and utilize the standards in Chinese Pharmacopoeia.

Objective:To evaluate preoperative high-resolution thin-layer cervical enhanced CT used to predict the venous route of the submental flap reflux vein and its relationship with adjacent structures in order to guide the anatomical understanding and protection of submental flap in pharyngeal cancer surgery.Methods:Sixty consecutive patients with pharyngeal cancer who underwent submental flap repair surgery in our department from March 2022 to December 2024, as well as 60 patients who were accepted neck dissection suffering other cancers, were selected. Before surgery, high-resolution cervical enhanced CT scans were performed, and the position of the transverse section of the facial vein in the venous phase horizontal image gradually variation tendency was focused layer by layer. The direction and adjacent relationship of the submental flap reflux veins were determined and recorded. Combined with 60 patients with other head and neck tumors who underwent neck dissection in our department during the same period (a total of 120 cases, 240 sides), the classification and management of the draining veins of Fang′s mental flap were conducted. Type Ⅰ mainly drains into the internal jugular vein; Type Ⅱ mainly drains into the external jugular vein and Type Ⅲ mainly drains into the anterior jugular vein (often accompanied by an external jugular draining branch). The status and proportion of venous drainage were analyzed.Results:Vascular predictive coincidence rate was 98.3% (59/60) among the 60 patients with pharyngeal cancer. Only one patient was predicted to have a simple return to the external jugular vein. However, during the operation, in addition to the main return to the external jugular vein, a small portion also returned to the internal jugular vein. Submental flap reflux vessels were classified into three types based on intraoperative submental flap venous return in 60 cases of laryngopharyngeal cancer, in conjunction with the analysis of venous return patterns from 240 cervical CT scans. Type Ⅰ mainly refluxed to the internal jugular vein, accounting for 42.1%. Type Ⅱ mainly refluxed to the external jugular vein (47.9%). Type Ⅲ mainly refluxed to the anterior jugular vein (10.0%). The total detection rate of CT reading of 240 venous reflux was 98.7% (237/240). Vascular predictive coincidence rate was 97.9%(235/240).Conclusion:The detailed analysis of submental venous return vessels can accurately predict the direction of reflux veins and its surrounding areas by preoperative high-resolution enhanced CT scan. This provides reliable guidance for the anatomy and protection of the submental flap reflux veins during surgery.

Objective:To investigate the effect of ultrasound-guided lower transverse abdominal muscle plane (TAP) block combined with esketamine intravenous controlled analgesia on postoperative patients with colorectal cancer (CRC) .Methods:A total of 120 CRC patients admitted to Linyi Central Hospital from Aug. 2022 to Aug. 2024 were selected and divided into control group and observation group according to random number table method, with 60 cases in each group. The control group received esketamine intravenous controlled analgesia, and the observation group was combined with TAP under ultrasound guidance on the basis of the control group. The postoperative recovery, pain numerical score (NRS), heart rate and mean arterial pressure of 1h, 8h and 48h were compared between the two groups. The levels of serum interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-1 β (IL-1 β) and adverse reactions were compared before anesthesia (T0), 24h (T1) and 48h (T2) after surgery. Results:The feeding time and the first exhaust time in the observation group were shorter than those in the control group ( P<0.05). The NRS scores of the observation group were lower than those of the control group at 1h, 8h and 48h after operation ( P<0.05). The heart rate and mean arterial pressure of both groups increased at 8h and 48h after surgery, and the observation group was lower than the control group ( P<0.05). Serum IL-6, IL-10 and IL-1 β in both groups were higher than those in T0 at T1 and T2, and IL-6 and IL-1 β in observation group were lower than those in control group, and IL-10 was higher than those in control group ( P<0.05). The incidence of adverse reactions in observation group was lower than that in control group ( P<0.05) . Conclusion:Ultrasound-guided TAP combined with esketamine intravenous controlled analgesia can effectively accelerate the postoperative recovery of CRC patients, reduce the level of pain, and alleviate the inflammatory response of the body, with high safety.

Objective To evaluate the clinical evidence and overall value of Shuangdan Mingmu Capsule in treating diabetic retinopathy(DR),highlight its advantages and characteristics,clarify the exact clinical positioning for DR,and propose a reference that can aid the National Medical Management Department in its decision-making.Methods This study combined qualitative and quantitative evaluation methods.Multiple method ologies were used to analyze the"6+1"dimensions.Each dimension was measured using the Multi-criteria Decision Analysis Model and calculated using CSC software V2.0.Results SRS monitored since the launch of Shuangdan Mingmu Capsule were general adverse reactions and those reported in the literature;phase Ⅱ,Ⅲ,and Ⅳ clinical studies primarily focused on the gastrointestinal system,no serious adverse reactions were reported,and the safety was rated as A.When Shuangdan Mingmu Capsule was combined with calcium hydroxybenzenesulfonate or laser photocoagulation in the treatment of DR in a meta-analysis,it further enhanced ophthalmologic parameters such as macular thickness,hemorrhagic spot area,leakage area,best-corrected visual acuity,and the degree of visual field defect.It also increased serum vascular endothelial growth factor and platelet-derived growth factor levels,the scores from the low vision quality of life scale and ultrasound indexes,and the validity was rated as grade A.A pharmacoeconomic evaluation study of Shuangdan Mingmu Capsule combined with calcium hydroxybenzenesulfonate compared to calcium hydroxybenzenesulfonate alone for DR treatment indicated that assuming the per capita disposable income in 2023 was applied as the willingness-to-pay threshold for patients,with an ICER of 3,730.98—which is approximately 2.85％of the per capita disposable income in 2023—the treatment regimen of Shuangdan Mingmu Capsule combined with calcium hydroxybenzenesulfonate was more economical than the calcium hydroxybenzenesulfonate treatment plan alone.The economy was rated as grade B.Therefore,Shuangdan Mingmu Capsule can meet clinical needs,and the formula includes medicines to tonify the liver and kidney,activate blood,and clear the channels,which is a combination of both symptomatic and fundamental treatments.Shuangdan Mingmu Capsule can also tonify the kidney,nourish the liver,stimulate blood circulation,and improve eyesight,and it is rated as grade A for innovativeness.Therefore,the drug is widely used,has no special technical and administrative requirements,is convenient to carry,and does not need to be administered at special times.The comprehensive questionnaire survey indicated that the appropriateness of the drug is good(grade B),that the production capacity is sufficient,and that the accessibility has been rated as grade B.This drug originates from ancient prescriptions of Er Zhi Pill and Liuwei Dihuang Pill,which have a long-standing reputation in traditional medicine.The combination of disease and evidence embodies the Chinese medicine characteristics of holistic concept and identification of evidence-based treatment,and the special features of Chinese medicine are rated as grade A.Conclusion The clinical value of Shuangdan Mingmu Capsule was evaluated as Class A by synthesizing the"6+1"dimensions and calculated using CSC V2.0 software.The clinical value of Shuangdan Mingmu Capsule is Class A.However,clinical needs must be focused upon and transformed into relevant clinical medication policies,providing a strong reference for the efficacy research of clinical trials.