OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs， and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization （WHO）， strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States， and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions； research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center， and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions， including topic selection， evaluation implementation， evidence evaluation， and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs， which can effectively guide the high-quality and high-efficient development of this work， enhance the standardized output and transformation application value of evaluation evidence， and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.

Existing emotion recognition research is typically limited to static laboratory settings and has not fully handle the changes in emotional states in dynamic scenarios. To address this problem, this paper proposes a method for dynamic continuous emotion recognition based on electroencephalography (EEG) and eye movement signals. Firstly, an experimental paradigm was designed to cover six dynamic emotion transition scenarios including happy to calm, calm to happy, sad to calm, calm to sad, nervous to calm, and calm to nervous. EEG and eye movement data were collected simultaneously from 20 subjects to fill the gap in current multimodal dynamic continuous emotion datasets. In the valence-arousal two-dimensional space, emotion ratings for stimulus videos were performed every five seconds on a scale of 1 to 9, and dynamic continuous emotion labels were normalized. Subsequently, frequency band features were extracted from the preprocessed EEG and eye movement data. A cascade feature fusion approach was used to effectively combine EEG and eye movement features, generating an information-rich multimodal feature vector. This feature vector was input into four regression models including support vector regression with radial basis function kernel, decision tree, random forest, and K-nearest neighbors, to develop the dynamic continuous emotion recognition model. The results showed that the proposed method achieved the lowest mean square error for valence and arousal across the six dynamic continuous emotions. This approach can accurately recognize various emotion transitions in dynamic situations, offering higher accuracy and robustness compared to using either EEG or eye movement signals alone, making it well-suited for practical applications.
Humans ; Electroencephalography/methods* ; Emotions/physiology* ; Eye Movements/physiology* ; Signal Processing, Computer-Assisted ; Support Vector Machine ; Algorithms

Objective: To analyze the results of national external quality assessment (EQA) for transfusion compatibility test from 2018 to 2023, with the aim of providing references for improving laboratory testing quality and ensuring the safety of clinical blood transfusion. Methods: Three EQA programs were conducted annually, each distributing 22 quality assessment samples. Participating transfusion laboratories were required to complete testing within specified deadlines and to submit results along with documentation of testing methodologies, reagents, and equipment used. National Center for Clinical Laboratories (NCCL) conducted statistical analysis of laboratory results, evaluated testing outcomes and related circumstances, and provided feedback to participating laboratories. EQA data from transfusion laboratories across China from 2018 to 2023 were collected and systematically analyzed. Results: From 2018 to 2023, the qualification rates for all five items (ABO forward typing, ABO reverse typing, Rh blood group typing, antibody screening, and cross-matching) were 67.59%, 77.11%, 77.38%, 72.78%, 79.96%, and 85.16%, respectively. The mean qualification rates for ABO forward typing, ABO reverse typing, RhD blood group typing, antibody screening, and cross-matching over the past six years were 96.25%±0.59%, 90.45%±4.52%, 96.05%±0.71%, 90.88%±2.86%, and 88.34%±3.48%, respectively. The qualification rates in 2019, 2020, 2022, and 2023 all showed a stable trend of "blood stations>tertiary hospitals>secondary hospitals". The mean qualification rate of laboratories in secondary hospitals from 2018 to 2023 was significantly lower than those of laboratories in tertiary hospitals and blood stations (P<0.05), while no significant difference was observed between laboratories in tertiary hospitals and blood stations (P>0.05). The micro column agglutination method was the most widely used in all five tests. In the four test items, namely ABO forward typing, ABO reverse typing, antibody screening, and cross-matching, there was a statistically significant difference in the qualification rate of micro column agglutination method compared to other methods (P<0.05). There was a statistical difference in the qualification rate between manual and automated detection using micro column agglutination method in the cross-matching tests (P<0.05), whereas no significant difference was noted for the other test items (P>0.05). Conclusion: From 2018 to 2023, the number of laboratories participating in EQA activities has been increasing year by year, and the qualification rate has shown an overall upward trend. The type of laboratory is a key factor affecting the qualification rate, and the testing capabilities of some laboratories still need to be improved. The micro column agglutination method is widely used in transfusion compatibility tests. The established EQA program effectively monitors quality issues in laboratories, drives continuous improvement, and ensures sustained enhancement of testing standards to safeguard clinical blood safety.

Objective:To observe the effect of Liuzijue on post-stroke fatigue patients with the type of Qi deficiency and blood stasis and the effect of pulmonary function.Method:From March 2022 to March 2023,a total of 68 post-stroke fatigue patients with Qi deficiency and blood stasis who were hospitalized in the Affiliated Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine and met the criteria were selected,the patients were divided into therapy group(n=34)and control group(n=34)according to random number table.The control group was treated with conventional reha-bilitation combined with conventional respiratory therapy,the therapy group was treated with conventional reha-bilitation combined with Liuzijue,30 minutes/time,5 times/week,a total of 12 weeks.The fatigue severity scale score(FSS),Qi Deficiency Syndrome and Blood Stasis factor diagnostic scale score,vital capacity(VC),forced vital capacity(FVC),peak expiratory flow(PEF),and maximal voluntary ventilation(MVV)were assessed in both groups before and after treatment.Result:After 12 weeks of treatment,the FSS scores and the Qi deficiency syndrome and blood stasis factor di-agnostic scale score exhibited significant differences in the therapy group compared with those before treatment(P＜0.05),and significant improvement compared with those in the control group(P＜0.05).The significant differ-ences were found in the VC、FVC、PEF and MVV of both two groups between before and after treatment(P＜0.05),and the degree of improvement was more pronounced in the therapy group.Conclusion:The Liuzijue applied to post-stroke fatigue patients with Qi deficiency and blood stasis can better improve the fatigue score and Qi deficiency syndrome and blood stasis score,as well as improve the level of pulmonary function of patients,which is worthy of clinical application.

Objective:To analyze the results of national external quality assessment (EQA) for transfusion compatibility test in 2023, and provide reference for quality management of clinical transfusion compatibility testing.Methods:The EQA of clinical transfusion compatibility testing by NCCL was performed 3 times in 2023 among included laboratories. The panel consisting of 22 samples was distributed to 4 186 laboratories across 31 provinces (Including 2 961 tertiary hospital laboratories, 1 085 secondary hospital laboratories, 23 primary hospital laboratories, 106 blood station laboratories and 11 independent clinical laboratories). Each panel contains 11 red blood cell and 11 plasma samples per 1.5 ml/tube. Each participant laboratory of the EQA program was required to carry out the detection and return results in expected time. Statistical analysis and evaluation on the reported results were conducted by NCCL from the aspects of regional distribution, laboratory grading, testing methodology, reagent and testing system usage.Results:The qualification rates of EQA for five items including ABO positive typing, ABO reverse typing, RhD blood type, antibody screening, and cross matching were 96.68%, 95.10%, 96.46%, 95.32%, and 91.04%, respectively. The EQA qualification rate of tertiary hospital laboratories was 87.77% (2 599/2 961), which was significantly higher than the 77.79% (844/1 085) of secondary hospital laboratories. There were significant differences in the qualification rate of participating laboratories among different regions. The utilization rates of micro column agglutination method in ABO positive typing, ABO reverse typing, RhD blood type, antibody screening, and cross matching were 80.81% (10 080/12 474), 75.06% (9 337/12 440), 81.38% (10 118/12 433), 89.59% (11 104/12 394) and 76.25% (9 495/12 453), respectively. The qualification rate of micro column agglutination method was significantly higher than that of saline slide method in ABO positive typing detection ( P<0.05). The qualification rate of micro column agglutination method was significantly higher than that of the polyamine method and anti-human globulin test tube method in antibody screening ( P<0.05). There were statistically significant differences in qualification rate of 7 reagents in ABO reverse typing, antibody screening and cross matching ( P<0.05). There was no statistically significant difference in the qualification rate between the two detection systems for other reagents, except for the ABO reverse typing where the qualification rate of reagent 1 in a single system was higher than that in a mixed system ( P<0.05). Conclusion:The testing capabilities of clinical laboratories in different regions and different type varied significantly in China. Micro column agglutination method was the most popular selection in transfusion compatibility testing. The regents used in these laboratories showed good performance. However, the detection efficiency of some reagents still need to be improved. EQA could be used to evaluate, monitor, and improve the quality of testing.

Purpose To investigate the clinicopathological features,differential diagnosis and prognosis of atypical fibroxanthoma(AFX).Methods Pathological features of 15 cases of AFX and 3 cases of pleomorphic dermal sarcoma(PDS)misdiagnosed as AFX were retrospectively analyzed by hematoxylin and eosin staining and immunohistochemical EnVision staining technology.Clinical information was collected and analyzed,and the relevant literatures were re-viewed.Results The age of the 15 patients with AFX ranged from 18 to 78 years,with an average age of 57 years.4 cases occurred in the head and neck,and 11 cases occurred in the trunk and limbs.3 patients with PDS misdiagnosed as AFX were aged from 56 to 60 years,with an average age of 58 years.The tumors were located in the trunk and limbs.Microscopically,15 cases of AFX and 3 cases of PDS misdiagnosed as AFX were composed of proliferative pleo-morphic and atypical spindle cells interspersed with a varying number of multinucleated cells.15 cases of AFX tumors were superficial and located in the dermis.In 3 cases of PDS misdiagnosed as AFX,1 case was located in subcutane-ous adipose tissue,1 case had superficial subcutaneous extension,and the third case had positive basal margin.Immu-nohistochemically,the immunophenotypes of the two groups were consistent.CD10 was expressed in all cases,CD68 was positive in most cases,SMA was expressed in a few cases,desmin was focal expressed in a very few cases,and S-100,SOX10,CD34,HMB-45,Melan A,STAT6 and CK(AE1/AE3)were not expressed in all cases.Ki67 prolifera-tion index ranged from 2％to 30％.15 patients with AFX were followed up from 12 to 108 months.One patient had tumor recurrence 1 year and 3 years after operation due to positive basal margin.Most of the other patients underwent extended resection after diagnosis and were in good condition without tumor recurrence and metastasis.3 cases of PDS misdiagnosed as AFX were followed up for 31 to 78 months.One patient had lung metastasis after 2 years,one patient recurred 4 times after operation,and the other patient died after 4 times of recurrence.Conclusion AFX is a rare dis-ease with similar pathological characteristics and immunophenotype to PDS.AFX can be diagnosed only when the tumor is small and completely confined to the dermis.When the maximum diameter of the tumor is more than 3 cm,or the presence of any form of subcutaneous extension requires a high level of vigilance for PDS.Careful differentiation and correct classification of AFX and PDS are very important for the treatment and prognosis of the disease.

Objective To analyze the practical value of spiral CT three-dimensional reconstruction techniquein evaluating triplane fractures of the distal tibia.Methods A retrospective analysis was conducted on183 patients with triplane fractures of the distal tibia admitted to Sichuan Orthopedic Hospital from January 2021 to March 2023.All patients underwent both X-ray and spiral CT examinations.Taking surgical reduction results as the gold standard for diagnosis,the diagnostic accuracies of X-ray examination and spiral CT three-dimensional reconstruction technique for triplane fractures of the distal tibia were analyzed.Results Fracture classification according to the number of fracture fragments showed that among the 183 patients with triplane fractures of the distal tibial,there were 44 cases of four-part fractures,62 cases of three-part fractures,and 77 cases of two-part fractures.The classification by the location of epiphyseal injury in the distal tibia showed 175 cases of lateral type and 8 cases of medial type.According to whether the fracture line involved the articular surface,they were categorized into 94 cases of type I,60 cases of type II,and 29 cases of type III.For the classification of the number of fracture fragments,X-ray misdiagnosed 9 cases of four-part fractures as three-part or two-part fractures,and 21 cases of three-part fractures as two-part fractures,resulting in a diagnostic accuracy of 83.60%.For theclassification of fracture line and articular surface position,X-ray led to misdiagnosis or inaccurate diagnosis in 39 cases,with a diagnostic accuracy of 78.69%.When spiral CT three-dimensional reconstruction technique was used to classify the number of fracture fragments,only 1 case of four-part fracture was misdiagnosed as three-part fracture,and 2 cases of three-part fractures were misdiagnosed as four-part fractures or two-part fractures,yielding a diagnostic accuracy of 98.36%.For the diagnosis of the positional relationship of the fracture line to the articular surface,spiral CT three-dimensional reconstruction technique had 8 misdiagnoses,with a corresponding diagnostic accuracy of 95.63%.Conclusion Spiral CT three-dimensional reconstruction technique can stereoscopically display the spatial information of the triplane fractures of the distal tibia,such as the location,shape,type,and articular surface,exhibiting high accuracy for classification diagnosis and significant application value in the reduction and treatment of triplane fractures of the distal tibia.

OBJECTIVE To analyze the chemical constituents of Heihuang Chizhu Granules and the blood composition of rats af-ter administration by UPLC-Q-TOF-MS/MS.METHODS A Waters ACQUITY UPLC HSS T3 column(3 mm×100 mm,1.8 μm)was eluted with acetonitrile-0.1%formic acid as mobile phase,and the data were collected in electrospray ion source positive and neg-ative ion mode and then identified with the reference retention time,precise molecular weight,secondary fragment ions,and references to relevant literature.RESULTS A total of 104 chemical components were identified from Heihuang Chizhu Granules,including 26 flavonoids,24 organic acids,14 triterpenoids,8 terpenoids,7 phenylpropanoids,11 monoglycosides,and 14 other components(phe-nols,alkaloids,etc.).On this basis,39 blood-entering components were identified in the plasma of rats administered via gavage,in-cluding 28 prototypes and 11 metabolites.CONCLUSION The chemical constituents of Heihuang Chizhu Granules and the compo-nents entering the blood of rats are analyzed and identified for the first time in this study,and the results provide a scientific basis for the basic research of Heihuang Chizhu Granules and the establishment of process quality control standards.

Objective:To investigate the therapeutic effect of Brucea javanica oil emulsion combined with chemotherapy for advanced lung squamous cell carcinoma.Methods:A retrospective cohort study was conducted. The clinical data from 120 patients with lung squamous cell carcinoma at stage Ⅳ in Shanxi Province Cancer Hospital between January 2019 and December 2020 were retrospectively analyzed. According to the treatment regimens, all patients were divided into Brucea javanica oil emulsion combined with chemotherapy group (the observation group, 60 cases) and chemotherapy alone group (the control group, 60 cases). Immune function, efficacy, and chemotherapy-related adverse effects were compared between the 2 groups before and after treatment.Results:Among 120 patients, there were 77 males and 43 females, with the age of (67±7) years. There were no statistically differences in basic information between the 2 groups (all P > 0.05). The proportion of CD4 + cells and the ratio of CD4 + to CD8 + in the observation group after treatment increased compared to those before treatment, while the proportion of CD8 + decreased (all P < 0.001). In the control group, the proportions of CD3 +, CD4 +, NK cells decreased after treatment (all P < 0.001). There were no statistically significant differences in the T cell subsets between the 2 groups before treatment (all P > 0.05); after treatment, the proportions of CD3 +, CD4 +, NK cells and the ratio of CD4 + to CD8 + in the observation group were all higher than those in the control group, and the proportion of CD8 + cells was lower than that in the control group (all P < 0.001). The disease control rate (DCR) in the observation group was higher than that in the control group [73.3% (44/60) vs. 55.0% (33/60)], and the difference was statistically significant ( χ2 = 4.39, P = 0.036). The median progression-free survivals (PFS) time was 7.833 months (95% CI: 6.927-8.739 months), 5.433 months (95% CI: 3.878-6.988 months), and the difference was statistically significant ( χ2 = 4.84, P = 0.028). The incidence of leukopenia was 38.3% (23/60), 60.0% (36/60), respectively in the observation group and the control group ( χ2 = 5.64, P = 0.018); the incidence of thrombocytopenia was 21.7% (13/60), 38.3% (23/60), respectively in the observation group and the control group ( χ2 = 3.97, P = 0.046). Conclusions:Brucea javanica oil emulsion combined with chemotherapy can improve immune function, increase DCR, and reduce myelosuppression of patients with advanced lung squamous cell carcinoma.

Objective To observe the effect of Buyang Huanwu Decoction combined with Tirofiban on cerebral oxygen metabolism and neurological function in patients with ischemic stroke.Methods A total of 110 patients with ischemic stroke of qi deficiency and blood stasis type who were treated at Rizhao Central Hospital from October 2022 to October 2024 were selected.The patients were randomly divided into a control group and a combined group using a random number table,with 55 patients in each group.The control group received intravenous infusion of Tirofiban,while the combined group was given additional Buyang Huanwu Decoction orally on the basis of treatment for the control group.The course of treatment for both groups covered 2 weeks.Before and after treatment,the changes in traditional Chinese medicine(TCM)syndrome scores,National Institutes of Health Stroke Scale(NIHSS)scores,oxidative stress response,neurological function,platelet function,and indicators associated with cerebral oxygen metabolism in both groups were observed.Results(1)After treatment,the scores of TCM syndromes of sudden dizziness,hemiplegia,shortness of breath and fatigue,and pale and dull complexion were decreased in both groups compared with those before treatment(P＜0.05),and the decrease in the combined group was significantly superior to that in the control group(P＜0.01).(2)After treatment,the levels of serum oxidative stress response indicators of glutathione peroxidase(GSH-Px)and superoxide dismutase(SOD)were increased(P＜0.05),while the levels of serum oxidized low-density lipoprotein(ox-LDL)and malondialdehyde(MDA)were decreased(P＜0.05)in both groups compared with those before treatment.The combined group showed more significant increase in serum GSH-Px and SOD levels and more significant decrease in serum ox-LDL and MDA levels than the control group(P＜0.01).(3)After treatment,the platelet function indicators of platelet aggregation rate and platelet adhesion rate were decreased in both groups compared with those before treatment(P＜0.05),and the decrease in the combined group was significantly superior to that in the control group(P＜0.01).(4)After treatment,arterial oxygen content(CaO2)was increased(P＜0.05),while the levels of cerebral oxygen extraction rate(ERO2),and cerebral arteriovenous oxygen content difference[D(a-jv)O2]were decreased in both groups compared with those before treatment(P＜0.05),and the changes of the levels in the combined group were more obvious than those in the control group(P＜0.01).(5)Ater treatment,the neurological function indicators of NIHSS scores and serum neuron-specific enolase(NSE)level were decreased in both groups compared with those before treatment(P＜0.05),while the levels of serum brain-derived neurotrophic factor(BDNF)and nerve growth factor(NGF)were increased(P＜0.05).The combined group showed significant decrease in NIHSS scores and serum NSE level and significant increase in serum BDNF and NGF levels compared to the control group(P＜0.01).Conclusion For the treatment of patients with qi deficiency and blood stasis type of ischemic stroke,Buyang Huanwu Decoction combined with Tirofiban is effective on reducing TCM syndrome scores,improving cerebral oxygen metabolism and neurological function indicators,and inhibiting oxidative stress response,with significant therapeutic effects.