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.

Objective: To investigate the damaging effects of red blood cell supernatant (RBC-S) stored for different durations (7 d, 14 d, and 28 d) on vascular endothelial cells, and to explore the underlying mechanisms using bioinformatics analysis, so as to provide references for optimizing red blood cell transfusion strategies. Methods: Human umbilical vein endothelial cells (HUVECs) were co-cultured with RBC-S stored for 7, 14 and 28 days, designated as the 7 d group, 14 d group and 28 d group respectively, which were collectively defined as the experimental groups. Cell damage was evaluated by cell proliferation assay (Cell Counting Kit8, CCK8), lactate dehydrogenase (LDH) release assay, 4′, 6diamidino2phenylindole (DAPI) staining, and flow cytometry for apoptosis and reactive oxygen species (ROS) levels. The damage degree of RBC-S on vascular endothelial cells was assessed by statistical analysis of damage data among different groups. Since the damage effect reached a plateau at all time points, the 28 d storage group was selected as the representative for further mechanistic studies. Transcriptomic analysis was performed to explore the role of frizzled class receptor 1 (FZD1) and Wnt signaling pathway in red blood cell storagerelated endothelial dysfunction. Results: Compared with the control group, the storage groups treated with 7 d, 14 d, and 28 d RBC-S showed significantly decreased cell proliferation rates [control group 100%, 7 d group (69.51±2.30)%, 14 d group (74.54±2.89)%, 28 d group (73.59±2.36)%, P<0.05], significantly reduced numbers of DAPI-stained cell nuclei [control group (213±12.5) per field, 7 d group (140.33±17.04) per field, 14 d group (152.00±23.72) per field, 28 d group (144.33±19.09) per field, P<0.05] and significantly increased LDH release [control group (1), 7 d group (8.33±1.41), 14 d group (9.23±0.83), 28 d group (9.16±0.60), P<0.05]. There was no significant difference in the degree of damage caused by RBC-S among different storage groups (P>0.05). With the prolongation of storage time, free hemoglobin (FHb) gradually increased [control group (not detected), 7 d (16.57±6.38) mg/L, 14 d (76.80±22.83) mg/L, 28 d (286.97±29.02) mg/L, P<0.05]. The apoptotic rate (20.53±2.94)% and ROS relative intensity (5.13±0.91) in the 28 d storage group were significantly higher than those in the control group (P<0.05). Transcriptomic analysis showed that FZD1 played a key role in vascular endothelial dysfunction induced by red blood cell storage and was closely related to the Wnt signaling regulatory network. Conclusion: RBC-S stored for 7 d, 14 d, or 28 d can all significantly damage vascular endothelial cells, and the damaging effect reaches a plateau at 7 d of storage. Mechanistic investigation of the 28 d group indicated that the downregulation of the FZD1/Wnt signaling pathway may play a critical role in vascular endothelial dysfunction induced by red blood cell storage, providing a theoretical basis for further optimizing red blood cell storage and transfusion strategies.

Objective To observe the value of contrast-enhanced ultrasound(CEUS)for evaluating DeBakey Ⅰ aortic dissection involved renal artery.Methods Totally 137 patients with DeBakey Ⅰ aortic dissection involved renal artery were retrospectively enrolled,including 132 cases involved unilateral and 5 cases involved bilateral renal arteries.The opening of totally 274 renal arteries in bilateral kidneys were observed.Taken CT angiography(CTA)as reference standard,the renal artery opened in true lumen was considered as unaffected,while opened in false lumen or true-false lumen were both considered as affected.Relative CEUS manifestations were observed,and their value for evaluating involved renal artery or not were analyzed.Results CTA showed that 132 renal arteries opened in true lumens,90 opened in false lumens and 52 opened in true-false lumens.CEUS diagnosed 131 renal arteries opened in true lumens,111 opened in false lumens and 32 opened in true-false lumens,and the sensitivity for diagnosing DeBakey Ⅰ aortic dissection involved renal artery was 90.84％,81.08％and 90.63％,respectively.The consistency between CEUS and CTA for evaluating renal artery opened in true lumen or false lumen was good(Kappa=0.786).Logistic regression analysis showed that the time to peak(TTP)and peak intensity(PI)of time intensity curve(TIC)were both impact factors for differentiating renal artery opened in true lumen or false lumen,as well as true lumen or true-false lumen(both P＜0.05),while the area under the curve(AUC)of TIC was impact factor for differentiating renal artery opened in true lumen or false lumen(P＜0.05).The AUC of receiver operating characteristic curve of the combination of TTP,PI and AUC of TIC for differentiating renal artery opened in true lumen or false lumen,true lumen or true-false lumen and false lumen or true-false lumen was 0.703,0.686 and 0.493,respectively.Conclusion CEUS was helpful for evaluating DeBakey Ⅰ aortic dissection involved renal artery.

OBJECTIVE To explore the value of healthcare failure mode and effect analysis mode(HFMEA)com-bined with enhanced management of link quality in centralized processing of rigid endoscopic instruments.METHODS Totally 80 pieces of rigid endoscopic instruments that were recycled by the endoscopy room of otolar-yngology department of The First Medical Center of PLA General Hospital from Jan.2022 to Dec.2022 were as-signed as the control group,and 70 pieces of rigid endoscopic instruments that were recycled under the HFMEA model combined with enhanced management of link quality from Jan.2023 to Dec.2023 were assigned as the ex-perimental group.The effect of the management and the qualified rate of instruments were compared between the two groups of instruments,compare the satisfaction under the different intervention modes.RESULTS The scores of instrument disassembly and assembly,cleaning procedures,cleaning quality,environmental management and packaging quality were higher in the experimental group than in the control group(P＜0.05).The unqualified rate of instruments of the experimental group was 10.00％,lower than 23.75％of the control group(x2=4.926,P=0.026).The staff's satisfaction with the work of the experimental group was 91.67％,higher than 66.67％of the control group(Z=2.026,P=0.043).CONCLUSION For the centralized management of rigid endoscopic in-struments,the implementation of the enhanced management of link quality under the HFMEA mode can effective-ly improve the effect of management of the instruments and reduce the unqualified rate of recycled instruments,demonstrating a positive effect on raising the staff's satisfaction with the recycle process of instruments.

Objective:To investigate the effect of Gexia Zhuyu decoction on Toll-like receptor 4 (TLR4)/Nuclear factor-kappaB (NF-κB) signaling pathway on ulcerative colitis and intestinal mucosal barrier.Methods:A total of 86 cases of ulcerative colitis admitted to Xi′an Traditional Chinese Medicine (TCM) Hospital from March 2019 to July 2023 were prospectively included and divided into observation group and control group according to random number table method, with 43 cases in each group. The control group was treated with mesalazine enteric-coated tablets; The observation group was treated with mesalazine enteric-coated tablets combined with Gexia Zhuyu decoction for removing stasis. The clinical efficacy of the two groups was compared in terms of TCM syndrome score, intestinal mucosal barrier function index [diamine oxidase (DAO), D-lactic acid (D-LA)], TLR4/NF-κB signaling pathway expression and inflammatory factor index [interleukin-6 (IL-6), interleukin-8 (IL-8), tumor necrosis factor-α (TNF-α)] before and after treatment. The occurrence of adverse reactions was also compared.Results:The total effective rate of observation group was higher than that of control group (χ 2=4.074, P=0.044). Before treatment, there was no significant difference in TCM syndrome scores between the two groups (all P>0.05). After treatment, the TCM syndrome scores of both groups were lower than those before treatment (all P<0.05), and the TCM syndrome scores of the observation group were lower than those of the control group (all P<0.05). Before treatment, there were no significant differences in D-LA and DAO levels between the two groups (all P>0.05). After treatment, the levels of D-LA and DAO in both groups were lower than before treatment (all P<0.05), and the levels of D-LA and DAO in the observation group were lower than those in the control group (all P<0.05). After treatment, the mRNA expressions of TLR4 and NF-κB in both groups were decreased compared with those before treatment, and the mRNA expressions of TLR4 and NF-κB in the observation group were lower than those in the control group (all P<0.05). After treatment, the levels of IL-6, IL-8 and TNF-α in both groups were decreased compared with those before treatment (all P<0.05), and the levels of IL-6, IL-8 and TNF-α in the observation group were lower than those in the control group (all P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups (χ 2=2.346, P=0.126). Conclusions:The application of Gexia Zhuyu decoction in the treatment of ulcerative colitis can not only effectively improve the clinical symptoms, signs and intestinal mucosal barrier function, but also improve the inflammatory response by mediating TLR4/NF-κB signaling pathway.

Objective To systematically evaluate the CIinical indexes of western medicine combined with salvianolate in patients affected with diabetes and chronic microvascular complications.Methods Relevant RCTs in China National Knowledge(CNKI),Wanfang Date,Chinese Scientific Journal Database(VIP),PubMed and other databases were searched by computer,and the search time was limited from the foundation of each database to December,2023.Rev Man 5.3 and Stata 15.0 software were used for meta analysis,and TSA 0.9.5.10 Beta software was used for trial sequential analysis(TSA).Results A total of 33 RCTs(2690 patients)were finally involved.The meta-analysis results showed that compared with western medicine,combined with alvianolate could significantly improve the Clinical total effective rate,decrease fasting and postprandial blood glucose,improve vascellum endothelial function{ET-1[MD=-82.46,95%CI(-122.25,-42.67),P<0.05]、NO[MD=11.50,95%CI(7.22,15.78),P<0.05]},lower oxidative stress{SOD[MD=13.18,95%CI(10.26,16.11),P<0.05]、MDA[SMD=-1.43,95%CI(-1.94,-0.92),P<0.05]、Hcy[MD=-6.85,95%CI(-10.58,-3.12),P<0.05]},reduce inflammatory markers{hs-CRP[MD=-3.77,95%CI(-4.90,-2.64),P<0.05]、sICAM-1[MD=-212.59,95%CI(-289.48,-135.70),P<0.05]、IL-6[MD=-14.14,95%CI(-17.73,-10.54),P<0.05]},improve renal function{Scr[MD=-18.69,95%CI(-28.34,-9.03),P<0.05]、BUN[MD=-1.30,95%CI(-1.92,-0.67),P<0.05]、UAER[MD=-37.75,95%CI(-49.40,-26.10),P<0.05].There was no statistical difference in the incidence of adverse reactions between the two groups(P>0.05).TSA further affirmed salvianolate had beneficial effect on serum ET-1、SOD、IL-6、Scr and BUN.Conclusion Compared with the conventional therapy of western medicine,the combined medication of salvianolate and chemical medicine achieves much better Clinical effects on diabetes and chronic microvascular complications.Considering the limitations of the included studies,more large sample and high-quality randomized controlled trials are needed to prove our conclusions.

Objective To investigate the effect of transcutaneous auricular vagus nerve stimulation(taVNS)on quality of early postoperative recovery in patients undergoing thoracoscopic lung resection.Methods A total of 168 patients scheduled for elective thoracoscopic lung resection(wedge resection,segmentectomy,lobectomy)under general anesthesia were enrolled and randomly assigned to active-taVNS group(group T)or sham-taVNS group(group S)(n=84).Participants received four consecutive 30-minute sessions of active stimulation or sham stimulation at four time points:(1)the afternoon prior to the surgery,(2)the morning of the surgery,(3)following extubation,and(4)the first afternoon post-surgery.The Quality of Recovery-15(QoR-15)scores of the patients,the Numerical Rating Scale(NRS)scores at rest and during cough at 24,48,and 72 hours after surgery were recorded;and the usage of opioids within 48 hours after surgery was recorded;the duration of chest tube indwelling,incidence of severe pulmonary complications,postoperative hospital stay and adverse reactions to the stimulation(such as nausea and vomiting,fever,constipation,dizziness and itching)were observed.Results Compared with group S,group T exhibited significantly higher QoR-15 scores at 24,48,and 72 h postoperatively,lower NRS pain scores during resting and coughing,and reduced opioid consumption within 48 hours postoperatively(P<0.05).There were no significant differences between the two groups in the duration of chest tube indwelling,incidence of severe pulmonary complications,hospital stay,and the incidence of adverse reactions to the stimula-tion(P>0.05).Conclusion TaVNS can significantly improve quality of early postoperative recovery in patients undergoing thoracoscopic lung resection,and provide more effective postoperative analgesia without increasing the risk of postoperative complications.

BACKGROUND:Studies have found that massage can reduce blood sugar,promote myogenic factor expression,and increase skeletal muscle content.The extracellular matrix is an important component of skeletal muscle,and association between massage and extracellular matrix and their mechanism of action are still unclear.OBJECTIVE:To explore the effect of massage on extracellular matrix collagen deposition in type 2 diabetic sarcopenia rats.METHODS:Totally 24 Wistar male rats were randomly divided into blank group,model group,and massage group.High-fat diet combined with the streptozotocin method was used to establish a type 2 diabetes mellitus and sarcopenia model.After successful model establishment,the massage group used abdominal massage combined with hind limbs.After 8 weeks of treatment,the fasting blood glucose and serum insulin levels of the rats were measured.The skeletal muscle mass was detected by dual-energy X-ray.The exhaustion time was measured by small animal treadmill.The sliding angle was measured by inclined board test.The pathological changes of skeletal muscle tissue were observed by hematoxylin-eosin staining.The skeletal muscle collagen deposition was observed by Masson staining.The mRNA and protein expressions of type Ⅰ and type Ⅲ collagen in skeletal muscle were detected by qPCR and western blot assay.RESULTS AND CONCLUSION:(1)Compared with the model group,the blood glucose(P＜0.05)and serum insulin(P＜0.01)decreased in the massage group.(2)Compared with the model group,the skeletal muscle mass,running exhaustion time,and the angle of inclined plate experiment were increased in massage group(P＜0.05).(3)Compared with the model group,the skeletal muscles of the massage group were arranged neatly,muscle atrophy was improved,and collagen fiber deposition was reduced.(4)Compared with the model group,the expression levels of type Ⅰ and type Ⅲ collagen mRNA and protein in skeletal muscle were decreased in the massage group(P＜0.05).(5)The results suggest that massage can enhance insulin sensitivity,lower blood sugar,improve skeletal muscle mass,strength and function,and diminish collagen deposition in rats with type 2 diabetes,and may be a potential target for massage to exert its therapeutic effects.

Objective To explore the role and potential mechanisms of plasma-activated solution(PAS)in alleviating dextran sulfate sodium salt(DSS)-induced ulcerative colitis.Methods We constructed a DSS-induced ulcerative colitis mouse model and evaluated the effect of PAS in vivo by observing mouse weight,calculating disease activity indexes,detecting inflammatory factors and oxidative stress indicators through ELISA.We also evaluated the effect of PAS on colon cell proliferation and migration ability through clone formation experiments,scratch experiments,and used Western blotting to determine the expression levels of proliferation-related proteins.Results PAS significantly reversed DSS-induced weight loss and increased disease activity indexes in mice(P＜0.05).The serum inflammatory cytokine levels(TNF-α,IL-6 and IL-1β)in PAS group were significantly reduced compared to those in DSS group(P＜0.05).PAS treatment could improve the imbalance of colonic redox homeostasis including changes of malondialdehyde,catalase and superoxide dismutase caused by DSS(P＜0.05).After the use of endothelial nitric oxide synthase inhibitors,changes in various indicators caused by in vivo PAS disappeared(P＜0.001).The clone formation ability of colon cells was stronger in the group treated with PAS,and the expression of proliferation-related proteins increased.Cell scratch experiments suggested that intervention with PAS could reverse the decrease in cell migration ability caused by lipopolysaccharide(P＜0.001).After the application of endothelial nitric oxide synthase inhibitors,the pro-proliferative and migratory effects of PAS disappeared(P＜0.05).Conclusion PAS alleviate DSS-induced colitis in mice and promote colonic epithelial cell repair through the eNOS pathway.