ObjectiveThis paper aims to observe the role of Danlou tablet in treating coronary heart disease （CHD） with phlegm-stasis intermingling syndrome in minipigs by improving platelet function and explore the potential pharmacological mechanism of Danlou tablet in regulating platelet function by using proteomics technology. MethodsThirty Bama minipigs were randomly divided into a normal control group （6 pigs） and a high-fat diet group （24 pigs）. After 2 weeks of high-fat diet feeding， the high-fat diet group was randomly subdivided into a model group， an atorvastatin group （1 mg·kg^-1）， and Danlou tablet groups （0.6 g·kg^-1 and 0.3 g·kg^-1）. All groups continued to receive a high-fat diet for 8 weeks after the procedure. The normal control group was given a regular diet， underwent only coronary angiography， and did not receive an interventional injury procedure. The model group and each administration group were fed a high-fat diet. Two weeks later， they underwent a coronary angiography injury procedure. After the procedure， drugs were mixed into the feed every morning for 8 consecutive weeks， with the minipigs maintained on a continuous high-fat diet during this period. Quantitative proteomics technology was further used to study platelet proteins， and differential proteins were obtained by screening. Bioinformatics analysis was performed to analyze key regulatory proteins and biological pathways involved in the therapeutic effect of Danlou tablet on CHD with phlegm-stasis intermingling syndrome. ResultsCompared with the normal control group， the model group showed a significant increase in total cholesterol （TC）， triglyceride （TG）， high-density lipoprotein cholesterol （HDL-C）， and low-density lipoprotein cholesterol （LDL-C） of minipigs' serum （P<0.01）， a significant shortening in prothrombin time of （PT） （P<0.01）， a coagulation function index， and an increase in whole blood viscosity （P<0.01） and platelet aggregation rate （P<0.01）. Moreover， the platelet morphology was altered， and the contents of endothelin-1 （ET-1） and nitric oxide （NO） were significantly increased （P<0.01）. Hemodynamic parameters were obviously abnormal， including significantly decreased systolic blood pressure （SBP）， diastolic blood pressure （DBP）， mean arterial pressure （MAP）， left ventricular systolic pressure （LVSP）， and left ventricular maximal positive dp/dt （LV+dp/dt_max） （P<0.01）. Left ventricular maximal negative dp/dt （LV-dp/dt_max） was significantly increased （P<0.01）. Besides， there were myocardial cell hypertrophy， obvious edematous degeneration， massive interstitial inflammatory cell infiltration， high degree of fibrosis， and coronary endothelial atherosclerosis. TC and TG levels in minipigs' serum were significantly reduced in Danlou tablet groups with 0.6 g·kg^-1 and 0.3 g·kg^-1 （P<0.05， P<0.01）， compared with those in the model group. LDL-C was decreased in the Danlou tablet group with 0.6 g·kg^-1 （P<0.05）. The whole blood viscosity under low and high shear conditions was significantly reduced in the Danlou tablet group with 0.6 g·kg^-1 （P<0.05）. In groups with all doses of Danlou tablet， maximum aggregation rate （MAR） and average aggregation rate （AAR） were significantly decreased （P<0.05， P<0.01）， and platelets' morphological changes such as pseudopodia extension were reduced. ET-1 levels in the serum were significantly reduced. In the Danlou tablet group with 0.6 g·kg^-1， NO level in the serum was reduced （P<0.05）. In groups with all doses of Danlou tablet， DBP and MAP were significantly increased （P<0.05）. In the Danlou tablet group with 0.6 g·kg^-1， LVSP and LV+dp/dt_max were significantly increased （P<0.05， P<0.01）， and LV-dp/dt_max was significantly decreased （P<0.05）. In groups with all doses of Danlou tablet， edematous degeneration in myocardial tissue was milder， and coronary artery lesion degree was significantly alleviated. Compared with the normal control group， there were 94 differentially expressed proteins in the model group， including 81 up-regulated and 13 down-regulated proteins. Compared with the model group， the Danlou tablet group with 0.6 g·kg^-1 showed 174 differentially expressed proteins， including 100 up-regulated and 74 down-regulated proteins. A total of 30 proteins were reversed after Danlou tablet intervention. Bioinformatics analysis revealed that its pharmacological mechanism may exert anti-platelet activation， aggregation， and adhesion effects through biological pathways such as regulation of actin cytoskeleton， platelet activation pathway， Fcγ receptor-mediated phagocytosis， as well as proteins such as growth factor receptor-bound protein 2 （GRB2）， Ras-related C3 botulinum toxin substrate 2 （RAC2）， RAC1， and heat shock protein 90 alpha family class A member 1 （HSP90AA1）. ConclusionDanlou tablet can effectively reduce platelet activation and aggregation， exerting a good therapeutic effect on CHD with phlegm-stasis intermingling syndrome in minipigs. Its pharmacological mechanism may involve regulating biological pathways such as actin cytoskeleton and platelet activation pathway， as well as proteins like GRB2， RAC2， RAC1， and HSP90AA1， thereby exerting a pharmacological effect in anti-platelet activation， aggregation， and adhesion.

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.

ObjectiveTo systematically evaluate the efficacy and safety of Qi-reinforcing and blood-activating/stasis-expelling Chinese patent medicines in the treatment of coronary microvascular disease （CMD）. MethodsPubMed， Cochrane Library， CNKI， Wanfang Data， and VIP were searched for the randomized controlled trials （RCTs） on the treatment of CMD with Chinese patent medicines for reinforcing Qi and activating blood/expelling stasis with the time interval from inception to December 31， 2023. The primary outcome indicators included the index of microcirculatory resistance （IMR）， coronary flow reserve （CFR）， and corrected TIMI flow frame count （cTFC）. The secondary outcome indicators included symptomatic efficacy， left ventricular ejection fraction （LVEF）， hypersensitive C-reactive protein （hs-CRP）， nitric oxide （NO）， and adverse events. Cochrane risk-of-bias assessment tool 2.0 （RoB 2.0） and Stata 17.0 were used for literature quality evaluation and meta-analysis of the included RCTs. The Grading of Recommendations， Assessment， Development and Evaluation （GRADE） was used to evaluate the quality of evidence. ResultsA total of 36 RCTs were included in this study， involving 3 029 patients. Compared with conventional Western medicine alone， the combined use of Chinese patent medicines for reinforcing Qi and activating blood/expelling stasis and Western medicine reduced the IMR ［mean difference （MD）=-5.93， 95% confidence interval （95%CI） ［-8.73，-3.14］， n=382， P<0.01］， cTFC （MD=-9.35， 95%CI ［-13.94，-4.76］， n=618， P<0.01）， and hs-CRP ［standard mean difference （SMD）=-1.50， 95%CI ［-1.90，-1.11］， n=1 483， P<0.01］， improved the CFR （SMD=1.14， 95%CI ［0.08，2.19］， n=304， P=0.03）， symptomatic efficacy ［relative risk （RR）=1.36， 95%CI ［1.21，1.53］， n=756， P<0.01］， LVEF （MD=4.39， 95%CI ［2.31，6.47］， n=533， P<0.01）， and NO （SMD=3.16， 95%CI ［2.07，4.25］， n=946， P<0.01） of CMD patients. In terms of safety， the combined therapy reduced the occurrence of adverse events in CMD patients （RR=0.49， 95%CI ［0.29，0.82］， n=591， P=0.01）. GRADE showed moderate quality evidence for adverse events， low quality evidence for cTFC， symptomatic efficacy， LVEF， and NO， and very low quality evidence for IMR， CFR， and hs-CRP. ConclusionBased on microcirculatory function indicators， the combined use of Qi-reinforcing and blood-activating/stasis-expelling Chinese patent medicines and Western medicine may further improve the coronary microvascular function in CMD patients with good safety. The above conclusions remain to be verified with high-quality clinical trials.

Objective:To review drug clinical trial development in Shaanxi province and to understand the effectiveness of the implementation of a record system in promoting drug clinical trial development.Methods:Based on the data of drug clinical trials in Shaanxi province released on the official website of the National Medical Products Administration, this study made a statistical analysis of the number of drug clinical trial institutions, regional distribution, registered majors and principal investigators, and the development of drug clinical trial projects.Results:After implementing drug clinical trial institution registration, the drug clinical trial institutions in Shaanxi Province developed rapidly, increasing from 20 in the qualification period to 46, with a growth rate of 130%. A total of 113 specialties were recorded, of which the highest number of professional records were for endocrinology and oncology. 46 institutions recorded 1, 094 principal investigators and participated in 3803 drug clinical trial projects. However, only 8 institutions had undertaken drug clinical trial projects as group leaders.Conclusions:The number of drug clinical trial institutions in Shaanxi province increased significantly, reflecting a good overall development status. However, issues still exist, such as unbalanced development of clinical trial resources within the region, insufficient researchers with the ability to conduct clinical trials, relatively concentrated drug clinical trial projects, and lack of experience in undertaking clinical trials as a group leader.

It is believed that "deficiency qi retention and stagnation" is the fundamental pathogenesis of coronary microvascular dysfunction （CMD） after percutaneous coronary intervention （PCI）. Patients often have severe coronary vessel congestion before PCI， leading to emptiness in the heart's collaterals， which results in deficiency of healthy qi， poor movement of blood and body fluids， so the heart collaterals are susceptible to stagnation and stasis，then phlegm and stasis generate； after PCI， it is easy to damage the healthy qi then lead to qi deficiency， causing qi， blood， and body fluids fail to transport， thereby leading to blood stasis and phlegm turbidity retention， generating heat and wind to damage the heart and body. It is proposed that the prevention before PCI should replenish qi and collaterals， expel blood stasis and resolve phlegm， to support "deficient qi" in heart collaterals and prevent "stagnation" after PCI. Postoperative management should focus on replenishing qi and protecting the collaterals， eliminating pathogen and controlling development， so as to avoid exacerbating deficiency and stagnation by damaging healthy qi， and eliminate pathogen and unblock the collaterals to interrupt the pathogenesis， which prevent "retention and stagnation" from changes.

Objective:To understand the current status and characteristics of clinical trials for oral diseases in China, for the purpose of providing a reference for the research and development of oral diseases in China.Methods:Retrieving the information on clinical trials related to oral diseases registered on the "Platforms for drug clinical trial registration and information" of the National Medical Products Administration from the date of the database establishment to December 31, 2024. The number of clinical trials, type of drugs, trial phases, indication, trial scope, design types were statistically analyzed.Results:As of December 31, 2024, a total of 578 drug clinical trials for oral disease were registered, accounting for 2.1% (578/27 905) of the clinical trials disclosed on the platform during the same period. Bioequivalence clinical trials accounted for the highest proportion [73.9% (427/578)], followed by Phase Ⅰ [9.0% (52/578)], Phase Ⅱ [8.0% (46/578)], and Phase Ⅲ [4.5% (26/578)]. The 578 clinical trials involved 149 types of trial drugs, mainly chemical drugs, among which 127 were developed by domestic pharmaceutical enterprises and 27 by international pharmaceutical enterprises (the five investigational drugs have undergone clinical trials by both domestic and international pharmaceutical companies). The project leader units of the 578 drug clinical trials were distributed in 27 provinces, autonomous regions, municipalities, and Hong Kong Special Administrative Region. Excluding 427 bioequivalence clinical trials, the project leader units of 151 new drug clinical trials showed a significant aggregation phenomenon, and only three specialized oral hospitals have served as project leader units for drug clinical trials.Conclusions:The number of drug clinical trials for oral disease in China has generally shown an increasing trend, but there are still problems such as small number of clinical trials, low proportion of investment in new drug development and international multicenter trials, concentrated indications of clinical trials and insufficient clinical trial experience in specialized oral medical institutions. Enhancing the enthusiasm and innovation capabilities of domestic pharmaceutical enterprises in the research and development of oral diseases drugs, exploring the advantages of traditional Chinese medicine/natural medicine resources for oral diseases, and establishing a clinical research system in specialized oral medical institutions are of great significance for the development of oral drugs.

OBJECTIVE: To compare the effects of double-channel core decompression (CD) combined with medullary cavity irrigation with those of simple CD on progression of collapse and clinical outcomes in non-traumatic osteonecrosis of the femoral head (ONFH). METHODS: A retrospective analysis was conducted on the clinical data of 19 patients (30 hips) with non-traumatic ONFH who underwent double-channel CD combined with medullary cavity irrigation and admitted between January 2024 and October 2024 (CD+irrigation group). According to a 1: 2 ratio, 54 patients (60 hips) who underwent simple CD and were matched in terms of age, gender, and body mass index (BMI) were included as the control (CD group). There was no significant difference in baseline data such as age, gender, BMI, affected side, ONFH type, preoperative Association Research Circulation Osseous (ARCO) stage, bone marrow edema stage, visual analogue scale (VAS) score for pain, and Harris score between the two groups ( P>0.05). The postoperative discharge time and occurrence of complications were recorded for both groups. The VAS scores before operation and at discharge after operation were compared, and the differences between pre- and post-operation (change values) were calculated for intergroup comparison. The Harris scores before operation and at discharge and 3 months after operation were also compared. During follow-up, X-ray film, CT, and MRI were performed for reexamination. The ARCO stage and bone marrow edema stage were evaluated at 3 months after operation and compared with those before operation to determine whether there was radiological progression or relief. RESULTS: All incisions in both groups healed by first intention after operation, with no infection, femoral neck fracture, or other operation-related complications. All patients were followed up, and the follow-up time of the CD+irrigation group was (146.8±27.7) days, and that of the CD group was (164.3±48.2) days; there was no significant difference between the two groups ( t=1.840, P=0.069). There was no significant difference in the length of hospital stay between the two groups ( P>0.05). At discharge after operation, the VAS score of the CD+irrigation group was significantly lower than that of the CD group ( P<0.05), and the change value was significantly higher than that of the CD group ( P<0.05). The Harris scores at discharge and 3 months after operation in the CD+irrigation group were significantly higher than those in the CD group ( P<0.05). The Harris score gradually increased with time, and the differences between different time points were significant ( P<0.05). Radiological reexamination showed that there was no significant difference in the ARCO stage and the incidence of radiological progression between the two groups at 3 months after operation ( P>0.05); however, the bone marrow edema stage and the degree of bone marrow edema relief in the CD+irrigation group were better than those in the CD group, with significant differences ( P<0.05). CONCLUSION Double-channel CD combined with medullary cavity irrigation can significantly alleviate hip joint pain and improve joint function in patients with non-traumatic ONFH, reduce the degree of bone marrow edema in the femoral head, and delay the progression of ONFH.
Humans ; Femur Head Necrosis/therapy* ; Retrospective Studies ; Male ; Female ; Decompression, Surgical/methods* ; Therapeutic Irrigation/methods* ; Adult ; Treatment Outcome ; Middle Aged ; Femur Head/surgery*

Objective To systematically evaluate the clinical effects of remote ischaemic preconditioning (RIPC) in elective vascular surgery. Methods Electronic searches were conducted in The Cochrane Library, PubMed, EMbase, Web of Science, CNKI, Wanfang Data, VIP Database, and CBM. Relevant randomized controlled trials (RCTs) were screened according to inclusion and exclusion criteria. Meta-analysis was performed using RevMan 5.3 software, and the risk of bias was assessed using the Cochrane risk of bias tool. Results A total of 15 studies involving 1 382 patients were included. The meta-analysis results showed no statistically significant difference between RIPC and non-RIPC groups in reducing perioperative mortality in elective vascular surgery (P>0.05). There were also no statistically significant differences between the two groups of vascular surgery patients regarding the incidence of myocardial infarction, renal injury, postoperative stroke, postoperative length of hospital stay, duration of surgery or total anesthesia time, or the incidence of limb injury, arrhythmia, heart failure, and pneumonia (P>0.05). Conclusion For patients undergoing elective vascular surgery, there are no significant differences between RIPC and non-RIPC in terms of perioperative mortality and other clinical endpoint outcomes.

Objective : To explore the value of combined indicators of prognostic nutritional index ( PNI) ，nutri- tional risk screening 2002 scale ( NRS2002 ) ，body mass index ( BMI) ，monocyte / lymphocyte ratio ( MLR) ， platelet / lymphocyte ratio ( PLR) ，and neutrophil / lymphocyte ratio ( NLR) in evaluating the severity of pulmonary tuberculosis ( PTB) ． Methods : A total of 175 patients with pulmonary tuberculosis were selected as the study group，and 175 healthy subjects who underwent physical examination during the same period were selected as the control group．According to the range of lung lesions，the patients were divided into mild to moderate group ( ＜3 lung fields，n = 110) and severe group ( ≥3 lung fields，n = 65) ，PNI，NRS2002，BMI and peripheral blood MLR , PLR and NLR levels were compared between the two groups．Spearman rank correlation was used to analyze their correlation with the severity of the disease．A multivariate logistic regression model was established．A nomo- gram was drawn，and the efficiency of the model was evaluated by receiver operating characteristic ( ROC) curve， calibration curve，decision curve． Results: The PNI，BMI，peripheral blood lymphocyte and albumin levels in the study group were lower than those in the control group ( P＜0. 05) ，while the MLR , PLR and NLR levels were sig- nificantly higher than those in the control group ( P＜0. 05) ．The NRS2002，MLR , PLR and NLR levels in the se- vere group were higher than those in the mild and moderate group ( P＜0. 05) ，while the PNI and BMI levels were lower than those in the mild and moderate group ( P＜0. 05) ．NRS2002 and peripheral blood MLR , PLR and NLR levels in patients with pulmonary tuberculosis were positively correlated with the severity of the disease ( r = 0. 250， 0. 509，0. 431 and 0. 488) ．PNI and BMI were negatively correlated with the severity of the disease ( r = －0. 516， - 0. 231) ．Multivariate Logistic regression showed that NRS2002 and NLR were independent risk factors for severe disease，while PNI was a protective factor．The areas under the curve ( AUC) of NRS2002，NLR , PNI，and com- bined detection for evaluating the severity of pulmonary tuberculosis were 0. 692，0. 777，0. 786，and 0. 860，re- spectively，the sensitivity of the combined prediction was 81. 54% and the specificity was 76. 36%．The combined detection had better evaluation efficiency for severe pulmonary tuberculosis than the single indicator ( P ＜0. 05) ． Conclusion NRS2002 and NLR are independent risk factors for severe disease，while PNI is a protective factor． The combined detection model has a good fit，which can improve the evaluation efficiency and has potential for clin- ical application．

Objective:To investigate the medication law of TCM compound patents for treating primary dilated cardiomyopathy (DCM) based on data mining.Methods:TCM compound patents for the treatment of DCM were retrieved from State Intellectual Property Office of China-Chinese Patent Publication Notice webpage from the establishment of the database to November 18, 2024. After extracting information, statistics were conducted on patent publication time, indications, drug frequency, etc. The association rules of drugs were analyzed using SPSS Modeler 18.0 software based on the Apriori algorithm, and the core drug co-occurrence relationship was visualized using Cytascape 3.9.1 software. SPSS 27.0 software was used to cluster the high-frequency drugs and core co-occurrence drugs. The MCODE plug-in of Cytascape 3.9.1 software was used for graphic clustering analysis.Results:A total of 52 patents were included in this study, with high-frequency syndromes of qi deficiency and blood stasis (16 times), qi and yin deficiency (13 times), blood stasis and water stagnation syndrome (5 times), etc. A total of 236 kinds of Chinese materia medica were involved, with high-frequency herbal medicines such as Astmgali Radix (34 times), Salvia Miltiorrhiza (24 times), Poria (22 times), Ophiopogonis Radix (19 times), etc.; common pairs were Poria → Astmgali Radix (rule support 34.62%, confidence 81.82%), Atractylodes Macrocephala → Poria (rule support 25.0%, confidence 100%), etc.; common medicinal combinations were Atractylodes Macrocephala - Astmgali Radix → Poria (rule support 21.15%, confidence 100%), Astmgali Radix-Schisandrae Chinensis Fructus → Ophiopogonis Radix (rule support 21.15%, confidence 91.67%), etc.; new prescriptions included "Poria, Atractylodes Macrocephala, Ginseng Radix et Rhizoma, Cmnamomi Mmulus, Descurainiae Semen, Aconiti Lateralis Radix Praeparaka, Polyporus", etc.; potential Chinese medicine combinations included "Aconitum Bullatifolium-Eupolyphaga Steleophaga-Myrrh-Os Costaziae-Os Draconis-Olibanum-Moschus-Pyritum", etc.Conclusion:TCM compound patents for treating DCM mainly include qi deficiency and blood stasis, qi-yin deficiency , blood stasis and water stagnation, etc. The basic treatment method is to tonify qi and nourish yin, invigorate blood circulation and eliminate blood stasis, promote water circulation and reduce swelling, and cooperate with the method of softening and dispersing knots.