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.

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.

To address the difficulty in accurately detecting pulmonary nodules of different properties,a full-scale channel feature aggregation encoding and decoding network(FCFA-Net)is employed to assist experienced physicians in diagnosis.The network which consists of SMC,full-scale feature aggregator,autocorrelation feature enhancer,channel feature hierarchy extraction decoder and binomial constraint loss function can fully extract shallow and deep features from CT images for realizing the segmentation of pulmonary nodules of different sizes and shapes.Compared with UNet,UNet++and TransUnet,FCFA-Net increases the accuracy by 9.96%,7.84%and 3.75%,recall rate by 5.50%,2.96%and 1.37%,mean intersection over union by 11.35%,7.16%and 4.18%,F1 score by 8.07%,5.87%and 3.10%,respectively.Additionally,ablation experiment results demonstrate that each structure is effective and can achieve the best result within the acceptable parameter range.

To address the difficulty in accurately detecting pulmonary nodules of different properties,a full-scale channel feature aggregation encoding and decoding network(FCFA-Net)is employed to assist experienced physicians in diagnosis.The network which consists of SMC,full-scale feature aggregator,autocorrelation feature enhancer,channel feature hierarchy extraction decoder and binomial constraint loss function can fully extract shallow and deep features from CT images for realizing the segmentation of pulmonary nodules of different sizes and shapes.Compared with UNet,UNet++and TransUnet,FCFA-Net increases the accuracy by 9.96%,7.84%and 3.75%,recall rate by 5.50%,2.96%and 1.37%,mean intersection over union by 11.35%,7.16%and 4.18%,F1 score by 8.07%,5.87%and 3.10%,respectively.Additionally,ablation experiment results demonstrate that each structure is effective and can achieve the best result within the acceptable parameter range.

AIM: To investigate the preventive and therapeutic effects of Hawthorn flavone on hyperlipidemia and atherosclerosis rats. METHODS: The atherosclerosis model was established by high fat diet plus vitamin D2. The blood lipid levels, heart index, atherosclerosis index (AI1, AI2) and coronary heart index were measured in each group. The histopathological changes of aorta were observed by oil red O staining, HE staining and Masson staining. ELISA experiments were used to detect IL-6, ICAM-1, MCP-1 and VCAM-1 protein level. RESULTS: Compared with normal group, total cholesterol (TC), triglyceride (TG), low density lipoprotein (LDL-C), heart index, atherosclerosis index (AI1, AI2) and coronary index in atherosclerosis model group were significantly increased (P<0.01), while high density lipoprotein cholesterol (HDL-C) was significantly decreased (P<0.01). The pathological score of aorta and the degree of fibrosis were significantly increased (P<0.01). Compared with model group, TC, TG, LDL-C, heart index, atherosclerosis index (AI1, AI2) and coronary heart index were significantly decreased (P<0.01), and high-density lipoprotein cholesterol (HDL-C) was significantly increased (P<0.01) in medium, high dose hawthorn flavonoids and atorvastatin groups. The pathological score of aorta significantly decreased and the degree of fibrosis significantly improved (P<0.01). The variation trend of blood lipid levels in hyperlipidemia rats is basically consistent with atherosclerotic rats. Meanwhile, compared with model group, the medium, high dose hawthorn flavonoids and atorvastatin groups could significantly inhibit the expression levels of IL-6, MCP-1, ICAM-1 and VCAM-1 adhesion molecules (P<0.01). CONCLUSION: The hawthorn flavone can inhibit the formation of aortic endothelial atherosclerotic plaque, reduce the degree of fibrosis and inflammation of atherosclerotic plaque in rats, and achieve the purpose of anti-atherosclerosis. Meanwhile, the hawthorn flavone has the effect of regulating blood lipid.

Objective:To investigate the clinical characteristics of de novo malignancies (DNMs) after liver transplantation (LT) and to study the clinical management strategies.Methods:Adult LT recipients who were regularly followed-up in the Organ Transplantation Center, the Affiliated Hospital of Qingdao University from January 2005 to April 2021 were enrolled in this study. The clinical characteristics of DNMs were retrospectively analyzed. Of 601 LT recipients, there were 105 females and 496 males, aged (51.4±9.6) years old. They were divided into the DNMs group ( n=26) and the non-DNMs group ( n=575) according to whether there were DNMs on followed-up. Clinical data including age, sex, basic diseases before LT and operation time were collected. These patients were follow-up in outpatient clinics. Results:Twenty-six patients were diagnosed to develop DNMs after LT, but there were 28 DNMs (of which 2 patients were diagnosed to have DNMs twice). The incidence of DNMs after LT was 4.3% (26/601), the median time from LT to DNMs was 42 (20, 70) months, and the cumulative incidence rates of DNMs were 0.5%, 2.0%, 6.3%, 21.0% and 34.5% at 1, 3, 5, 10 and 15 years after LT, respectively. Among the 28 DNMs, digestive system tumors were most common, with 17 lesions (60.7%), followed by 3 lesions (11.1%) of lung cancer, 2 lesions (7.4%) of lymphoproliferative diseases, and 1 lesion (3.7%) of cervical cancer, thyroid cancer, soft palate cancer, eyelid cancer, laryngeal cancer, and prostate cancer. The follow-up time of 55.9 (36.6, 102.5) months in the DNMs group after LT was longer than the 33.4 (18.5, 58.9) months in the non-DNMs group ( P<0.001). The 1, 5, and 10 year survival rates of patients with DNMs after LT were 96.3%, 83.5%, and 49.8%, respectively. The 1, 5, and 10 year survival rates of patients with non-DNMs after LT were 94.5%, 77.7%, and 75.4%, respectively. There was no significant difference in the cumulative survival rates between the two groups (log rank=0.402, P=0.526). Conclusion:The incidence of DNMs in LT recipients was 4.3%. The majority of them were digestive system tumors. Early diagnosis and treatment of DNMs significantly improved the prognosis and quality of life of these patients.

Objective To observe the expression of discs large hom olog 4 (DLG4) protein in hippocam-pus, am ygdala and frontal cortex of rats and evaluate postsynaptic density in heroin dependence. Meth-ods The rat heroin dependent m odel was established by increasing intraperitoneal injection of heroin. DLG4 proteins in hippocam pus, am ygdala and frontal cortex of heroin dependent 9, 18, 36 days rats w ere detected with im munohistochem ical staining and com pared with that in the control group. Results DLG4 proteins in hippocam pus, am ygdala and frontal cortex w ere gradually reduced with extension of heroin dependent tim e. Conclusion Heroin dependence can affect postsynaptic density of hippocam pus, am ygdala and frontal cortex. The changes becom e m ore apparent with extension of heroin dependence tim e.

Objective:To establish a method for the determination of dexamethasone in Verdihong paints to ensure safety and ef-fectiveness of the clinical medicines. Methods:An HPLC method with a Dikma C18 column (150 mm × 4. 6 mm, 5 μm) was used, the mobile phase was a mixture of methanol-water-glacial acetic acid (80∶20∶0. 5), the detection wavelength was at 240nm, the injec-tion volume was 20 μl, the column temperature was 30℃ and the flow rate was 1. 0 ml·min-1 . Results:The standard curve of dexa-methasone was linear over the range of 3. 0-96. 0μg·ml-1(r=0. 999 7). The average recovery was 99. 45% with RSD of 1. 01%(n=9). Conclusion:The method is simple with good reproducibility, and can be used in the determination of dexamethasone in Verdihong paints.

BACKGROUND:Diagnosis of deep venous thrombosis has been reported in the literatures, but whether the combination with risk prediction scoring system and a variety of laboratory index increase the diagnosis rate of deep venous thrombosis remains unclear.
OBJECTIVE:To improve the diagnosis sensitivity of traumatic deep venous thrombosis of lower extremity using Wel s scoring system combined D-dimer and fibrin degradation product.
METHODA total of 82 patients with low limb fractures and spine fracture were included in this study, those patients with high risk factors of deep venous thrombosis or with the history of deep venous thrombosis were excluded. After admission, the fol owing indicators of deep venous thrombosis were determined, including
D-dimer, fibrin degradation product, fibrinogenase, prothrombin time, activated partial thrombokinase time, blood platelets count, C-reaction protein, and erythrocyte sedimentation rate. In addition, Doppler ultrasound detection of double lower limbs deep vein was performed, and the results were recorded. According to scoring system of deep venous thrombosis of lower extremity (Wel s scoring system), the patients were assigned into low-risk, middle-risk and high-risk cases.
RESULTS AND CONCLUSION:Doppler ultrasound detection showed that, there were 30 cases in deep venous thrombosis group, and 52 cases in non-deep venous thrombosis. The peak value of D-dimer and fibrin degradation product showed significant differences between the two groups (P<0.05). According to Wel s scoring system, there were 13 low-risk cases, 32 middle-risk cases, and 37 high-risk cases. The diagnosis rate of deep venous thrombosis using D-dimer and fibrin degradation product:positive prediction value for middle-risk deep venous thrombosis was 44.44%and for high-risk deep venous thrombosis was 70.97%. Logistic regression analysis showed that, in the middle-risk and high-risk deep venous thrombosis cases, the Wel s score has a positive correlation with laboratory test and Doppler ultrasound detection of deep venous thrombosis (P<0.05). The score of Wel s scoring system combined D-dimer and fibrin degradation product have clinical significances for the formation of deep venous thrombosis of lower extremity after trauma.