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 discuss the effects of the"twelve needles for hands and feet"acupuncture on the brain response mechanism and acupoint specificity in hemiplegic patients after ischemic stroke using fMRI.Methods Totally 43 inpatients from Dongzhimen Hospital of Beijing University of Chinese Medicine from December 2018 to March 2023 were included.The included patients were randomly divided into a true acupoint group of 23 cases and a fake acupoint group of 20 cases using the random number table method for clinical scale evaluation and magnetic resonance scanning.The true acupoint group received"twelve needles for hands and feet"acupuncture;the fake acupoint group was treated with acupuncture by opening 1 inch next to the meridian point,once a day,for consecutive 10 d.Intervention completed,excluding subjects who fell out during the intervention process,had unsatisfactory MRI data quality and had incomplete clinical scales,and conducting data processing and analysis.Bilateral anterior central gyrus(PreCG),amygdala(AMYG),caudate nucleus(CAU),putamen lenticularis(PUT),pallidus lenticularis(PAL)and thalamus(THA)were selected as regions of interest(ROI),and the changes in Granger causality(GC)and differences in scale scores between the two groups before and after treatment were compared.Results After intervention in the true acupoint group,the GC of CAU.R → PreCG.R,AMYG.R → PAL.R was stronger than before intervention,and the GC of THA.L→PAL.L,AMYG.R→THA.R in the true acupoint group was weaker than before intervention(P<0.05);after intervention with fake acupoints,the GC of AMYG.R→PUT.L in the false acupoint group was stronger than before intervention,and the GC of THA.L→PreCG.R,AMYG.L→CAU.L was weaker than before intervention(P<0.05);the GC of THA.R→PAL.L before intervention was stronger than false acupoint group,the GC of CAU.L→PreCG.R,PUT.L→PreCG.R before intervention was weaker than fake acupoint group(P<0.05);the GC of CAU.R→PreCG.R,THA.L→PreCG.R,AMYG.R→CAU.L,THA.L→PAL.R,AMYG.L→THA.L after intervention in the true acupoint group was stronger than the false acupoint group,and the GC of AMYG.R→AMYG.L after intervention in the true acupoint group was weaker than the fake acupoint group(P<0.05).Conclusion"Twelve needles for hands and feet"acupuncture can stimulate preferential compensation of the right motor circuit,bilateral basal ganglia remodeling,and balance regulation of excitatory inhibitory effects on the thalamus in patients with radiation-induced coronary stroke,thereby improving the degree of motor dysfunction and neurological deficits;acupuncture at acupoints stimulates brain activity more than at non-acupoints,indicating acupoint specificity.

AIM:This study aims to investigate the therapeutic impact of bone marrow mesenchymal stem cell(MSC)-derived exosomes(MSC-Exos)on septic lung injury by targeting Toll-like receptor 4(TLR4)/nuclear factor-κB(NF-κB)signaling pathway.METHODS:MSC-Exos were isolated from bone marrow MSCs using ultracentrifugation.The exosomes were characterized by transmission electron microscopy(TEM),nanoparticle tracking analysis(NTA),and Western blot.A septic lung injury model was established via cecal ligation and puncture(CLP).MSC-Exos were adminis-tered intraperitoneally 3 h after CLP.Blood and lung tissue samples were collected at 6,12,24,and 72 h after CLP.Con-centrations of interleukin-10(IL-10),IL-6,IL-1β,and tumor necrosis factor-α(TNF-α)were measured by ELISA.The lung tissue damage in mice was assessed by HE staining.Expression levels of TLR4 and NF-κB were detected by RT-qP-CR and Western blot.RESULTS:The results of TEM revealed typical round and oval exosome-like structures of MSC-Exos.Western blot showed positive expression of CD63,TSG101 and HSP-70.The results of NTA indicated that the parti-cle size of MSC-Exos was(107.5±16.6)nm.Septic lung injury began to manifest 12 h after CLP and progressively worsened,peaking at 72 h after CLP.At 6 h after CLP,the level of TNF-α was markedly elevated compared to the control group,reaching its peak at 72 h after CLP.At 12 h after CLP,the levels of IL-1β,IL-10,and IL-6 were elevated com-pared to the control group,and they reached their maximum point 72 h post-CLP.The MSC-Exos intervention group ex-hibited significantly reduced lung injury compared to the CLP group,as indicated by the lung pathology scoring.In the MSC-Exos intervention group,concentrations of IL-10,IL-1β,IL-6,and TNF-α peaked at 12 h after CLP,gradually de-clined,and returned to baseline levels by 72 h.TLR4 and NF-κB expression levels were significantly increased at 6 h af-ter CLP in the CLP group,peaking at 72 h.In contrast,MSC-Exos treatment normalized TLR4 and NF-κB expression levels at 72 h after CLP.CONCLUSION:Early intervention with bone marrow MSC-Exos significantly alleviated septic lung injury by reducing the inflammatory cytokine storm,likely through downregulation of the TLR4/NF-κB signaling path-way.

Objective To evaluate the practical application of the Media Fill Test(MFT)in assessing aseptic compounding competency of personnel in Pharmacy Intravenous Admixture Services(PIVAS).Methods A multicenter controlled study was conducted across six tertiary hospitals(center ①-⑥)in China.Participants were divided into an inexperienced group(Group A,n=118)and an experienced group(Group B,n=118),each performing five MFT operations.Positive controls validated medium efficacy.Contamination rates and pass rates were analyzed using chi-square and Fisher's exact tests.Results Valid samples included 584 for Group A and 588 for Group B.The sample pass rate was 66.78%(390/584)in Group A and 91.67%(539/588)in Group B,while personnel pass rates were 46.15%(54/117)and 80.51%(95/118),respectively,with significant intergroup differences(both P<0.01).All centers except Center ⑥ showed significantly higher pass rates in Group B(all P<0.05).Conclusion MFT effectively differentiates technical proficiency levels and is suitable for training evaluation of novice PIVAS staff.

Objective To analyze the procurement data of lipid-lowering drugs in hospitals at different levels in Jiangsu Province from October 2019 to September 2023,to evaluate the impact of the volume-based procurement(VBP)policy,and to provide references for clinical rational drug use and healthcare policy optimization.Methods Based on procurement data from the Jiangsu Provincial Health Information Center,statistical analyses of procurement expenditures,defined daily doses(DDDs),and defined daily cost(DDC)were conducted.Mixed-effects models were applied to assess changes in procurement expenditures,DDDs,and DDC before and after VBP implementation.Results From 2019 to 2023,statins dominated the market in Jiangsu Province,with rosuvastatin recording the highest DDDs(748 million).Statins,traditional Chinese medicines,and cholesterol absorption inhibitors ranked highest in procurement expenditures.Tertiary hospitals accounted for the largest share of usage(47.6%)and expenditures(55.8%),while secondary hospitals had the lowest DDC(1.22 yuan)and tertiary hospitals the highest(1.89 yuan).Post-VBP,procurement expenditures and DDC decreased by 53.9%and 35.4%,respectively.Primary hospitals showed the largest expenditure reduction(61.6%),and secondary hospitals exhibited the greatest DDC decline(53.9%).DDDs increased significantly in primary care settings(e.g.,pitavastatin surged by 239.79%in secondary hospitals),while tertiary hospitals saw reduced usage of some drugs(e.g.,amlodipine/atorvastatin decreased by 7.34%).Mixed-effects models confirmed that VBP significantly reduced expenditures(OR=-1.07,P<0.01)and DDC(OR=-2.70,P<0.01)while indirectly lowering prices of non-VBP drugs.After covariate adjustment,expenditure reductions for rosuvastatin and atorvastatin narrowed,ezetimibe expenditures increased(OR=0.13,P<0.01),and pitavastatin usage declined(OR=-0.10,P<0.01).Changes in amlodipine/atorvastatin and ezetimibe lacked statistical significance due to short VBP implementation periods.Tertiary hospitals demonstrated the strictest policy adherence,with the largest expenditure and DDC reductions(P<0.01).Subgroup analysis revealed that the policy did not significantly affect clinical demand(DDDs)in hospitals at different levels,though it was considered to have triggered adjustments in medication structure.Conclusion Jiangsu's lipid-lowering drug structure aligns with guidelines(statin-based,moderate-intensity preference).VBP effectively reduced costs,with tertiary hospitals prioritizing originator-to-generic substitution and primary hospitals reflecting cost-control and demand variations.Confounding factors influenced policy evaluation.The study recommends continuous monitoring and policy optimization to enhance procurement efficiency,ensure rational clinical use,and sustain cost savings,providing insights for further healthcare reform.

Objective To evaluate the practical application of the Media Fill Test(MFT)in assessing aseptic compounding competency of personnel in Pharmacy Intravenous Admixture Services(PIVAS).Methods A multicenter controlled study was conducted across six tertiary hospitals(center ①-⑥)in China.Participants were divided into an inexperienced group(Group A,n=118)and an experienced group(Group B,n=118),each performing five MFT operations.Positive controls validated medium efficacy.Contamination rates and pass rates were analyzed using chi-square and Fisher's exact tests.Results Valid samples included 584 for Group A and 588 for Group B.The sample pass rate was 66.78%(390/584)in Group A and 91.67%(539/588)in Group B,while personnel pass rates were 46.15%(54/117)and 80.51%(95/118),respectively,with significant intergroup differences(both P<0.01).All centers except Center ⑥ showed significantly higher pass rates in Group B(all P<0.05).Conclusion MFT effectively differentiates technical proficiency levels and is suitable for training evaluation of novice PIVAS staff.

Objective To analyze the procurement data of lipid-lowering drugs in hospitals at different levels in Jiangsu Province from October 2019 to September 2023,to evaluate the impact of the volume-based procurement(VBP)policy,and to provide references for clinical rational drug use and healthcare policy optimization.Methods Based on procurement data from the Jiangsu Provincial Health Information Center,statistical analyses of procurement expenditures,defined daily doses(DDDs),and defined daily cost(DDC)were conducted.Mixed-effects models were applied to assess changes in procurement expenditures,DDDs,and DDC before and after VBP implementation.Results From 2019 to 2023,statins dominated the market in Jiangsu Province,with rosuvastatin recording the highest DDDs(748 million).Statins,traditional Chinese medicines,and cholesterol absorption inhibitors ranked highest in procurement expenditures.Tertiary hospitals accounted for the largest share of usage(47.6%)and expenditures(55.8%),while secondary hospitals had the lowest DDC(1.22 yuan)and tertiary hospitals the highest(1.89 yuan).Post-VBP,procurement expenditures and DDC decreased by 53.9%and 35.4%,respectively.Primary hospitals showed the largest expenditure reduction(61.6%),and secondary hospitals exhibited the greatest DDC decline(53.9%).DDDs increased significantly in primary care settings(e.g.,pitavastatin surged by 239.79%in secondary hospitals),while tertiary hospitals saw reduced usage of some drugs(e.g.,amlodipine/atorvastatin decreased by 7.34%).Mixed-effects models confirmed that VBP significantly reduced expenditures(OR=-1.07,P<0.01)and DDC(OR=-2.70,P<0.01)while indirectly lowering prices of non-VBP drugs.After covariate adjustment,expenditure reductions for rosuvastatin and atorvastatin narrowed,ezetimibe expenditures increased(OR=0.13,P<0.01),and pitavastatin usage declined(OR=-0.10,P<0.01).Changes in amlodipine/atorvastatin and ezetimibe lacked statistical significance due to short VBP implementation periods.Tertiary hospitals demonstrated the strictest policy adherence,with the largest expenditure and DDC reductions(P<0.01).Subgroup analysis revealed that the policy did not significantly affect clinical demand(DDDs)in hospitals at different levels,though it was considered to have triggered adjustments in medication structure.Conclusion Jiangsu's lipid-lowering drug structure aligns with guidelines(statin-based,moderate-intensity preference).VBP effectively reduced costs,with tertiary hospitals prioritizing originator-to-generic substitution and primary hospitals reflecting cost-control and demand variations.Confounding factors influenced policy evaluation.The study recommends continuous monitoring and policy optimization to enhance procurement efficiency,ensure rational clinical use,and sustain cost savings,providing insights for further healthcare reform.

Objective:To investigate the efficacy of a decellularized extracellular matrix (dECM)-quaternized chitosan (QCS)-gelatin (Gel) composite scaffold loaded with growth factors in repairing diabetic foot wounds in a rat model.Methods:A dECM-QCS-Gel composite scaffold (referred to as GDQ scaffold) was fabricated using a 3D bioprinter. Forty 8-week-old male Sprague-Dawley (SD) rats were selected to establish a diabetic foot wound model with a diameter of approximately 1 cm. Based on the treatment methods for diabetic foot wounds, the rats were divided into five groups: Control group (no treatment), Exosome group (wound covered with exosome suspension), Exosome+GDQ group (wound covered with GDQ scaffold loaded with exosome suspension), GDQ group (wound covered with GDQ scaffold alone), and Growth factor+GDQ group (wound covered with GDQ scaffold loaded with recombinant human basic fibroblast growth factor suspension). The wound healing rate was measured. Histological analysis was performed by HE staining and Masson staining. ELISA kits were used to determine the levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), IL-6, and IL-10 in wound tissues from each group. Protein expression levels of MIP-1 and MIP-2 genes were also assessed.Results:The wound healing rate of the growth factor+GDQ group on the 21st d was 94.89%±1.21%, which was higher than that of the exosome+GDQ group ( P<0.05). With increasing repair time, the expression levels of TNF-α, IL-1β and IL-6 in each group all decreased, while IL-10 increased in all groups ( P<0.05). Among them, the exosome+GDQ group (TNF-α: 46.54±1.26 pg/ml, IL-1β: 225.79±7.29 pg/ml, IL-6: 142.81±4.02 pg/ml and IL-10: 117.36±0.95 pg/ml, P<0.001) and the growth factor+GDQ group (TNF-α : 40.01±1.64 pg/ml, IL-1β: 209.15±2.98 pg/ml, IL-6: 138.50±2.61 pg/ml and IL-10: 127.66±1.23 pg/ml, P<0.05); The levels of TNF-α and IL-1β in the exosome+GDQ group were both lower than those in the exosome+GDQ group ( P<0.05), and IL-10 was higher than that in the exosome+GDQ group ( P<0.05). On the 7th d the control group showed the highest expression levels of MIP-1α and MIP-2. All other groups had lower levels, with the growth factor+GDQ group showing the lowest among them. On the 21st d, the inflammatory protein expression in the growth factor+GDQ group had further decreased and remained lower than in all other experimental groups. Conclusions:The GDQ composite scaffold, when combined with bioactive factors, can synergistically reduce inflammation in diabetic foot wounds and promote wound healing. The scaffold loaded with basic fibroblast growth factor demonstrated superior therapeutic efficacy compared to the scaffold loaded with exosomes.

As a patented characteristic medicine of Yi ethnic minority， Pingxuan capsules have the effects of nourishing the liver and kidney， pacifying the liver， and subduing Yang. With the main indications of dizziness， headache， palpitations， tinnitus， insomnia， dreaminess， waist and knee soreness caused by liver-kidney deficiency and liver Yang upward disturbance， Pingxuan capsules are widely used in the treatment of posterior circulation ischemic vertigo， vestibular migraine， benign paroxysmal positional vertigo. However， the current knowledge is limited regarding the efficacy， syndrome differentiation， and safety of this medicine. On the basis of summarizing the experience of clinicians and the existing evidence， this study invites clinical experts of traditional Chinese and Western medicine， pharmaceutical experts， and methodological experts from relevant fields across China to conduct evidence-based evaluation of Pingxuan capsules. The evaluation follows the Specifications for the Development of Clinical Expert Consensus on Chinese Patent Medicines issued by the Standardization Office of the China Association of Chinese Medicine， and reaches 5 recommendations and 16 consensus suggestions. The consensus clarifies the clinical applications， efficacy， dose， course of treatment， combination of medicines， precautions， and contraindications of Pingxuan capsules in the treatment of vertigo and explains the safety of clinical application. This consensus is applicable to clinicians （traditional Chinese medicine， Western medicine， and integrated traditional Chinese and Western medicine） and pharmacists in tertiary hospitals， secondary hospitals， and community-level medical and health institutions across China， providing a reference for the rational use of Pingxuan capsules in the treatment of vertigo. It is hoped that the promotion of this consensus can facilitate the rational use of drugs in clinical practice， reduce the risk of drug use， and give full play to the advantages of Pingxuan capsules in the treatment of vertigo diseases. This consensus has been reviewed and published by the China Association of Chinese Medicine， with the number GS/CACM330-2023.