OBJECTIVE: To evaluate the clinical efficacy and safety of Yangxue Qingnao Pills (YXQNP) combined with amlodipine in treating patients with grade 1 hypertension. METHODS: This is a multicenter, randomized, double-blind, and placebo-controlled study. Adult patients with grade 1 hypertension of blood deficiency and Gan (Liver)-yang hyperactivity syndrome were randomly divided into the treatment or the control groups at a 1:1 ratio. The treatment group received YXQNP and amlodipine besylate, while the control group received YXQNP's placebo and amlodipine besylate. The treatment duration lasted for 180 days. Outcomes assessed included changes in blood pressure, Chinese medicine (CM) syndrome scores, symptoms and target organ functions before and after treatment in both groups. Additionally, adverse events, such as nausea, vomiting, rash, itching, and diarrhea, were recorded in both groups. RESULTS: A total of 662 subjects were enrolled, of whom 608 (91.8%) completed the trial (306 in the treatment and 302 in the control groups). After 180 days of treatment, the standard deviations and coefficients of variation of systolic and diastolic blood pressure levels were lower in the treatment group compared with the control group. The improvement rates of dizziness, headache, insomnia, and waist soreness were significantly higher in the treatment group compared with the control group (P<0.05). After 30 days of treatment, the overall therapeutic effects on CM clinical syndromes were significantly increased in the treatment group as compared with the control group (P<0.05). After 180 days of treatment, brachial-ankle pulse wave velocity, ankle brachial index and albumin-to-creatinine ratio were improved in both groups, with no statistically significant differences (P>0.05). No serious treatment-related adverse events occurred during the study period. CONCLUSIONS Combination therapy of YXQNP with amlodipine significantly improved symptoms such as dizziness and headache, reduced blood pressure variability, and showed a trend toward lowering urinary microalbumin in hypertensive patients. These findings suggest that this regimen has good clinical efficacy and safety. (Registration No. ChiCTR1900022470).
Humans ; Amlodipine/adverse effects* ; Drugs, Chinese Herbal/adverse effects* ; Male ; Female ; Hypertension/complications* ; Middle Aged ; Treatment Outcome ; Drug Therapy, Combination ; Adult ; Blood Pressure/drug effects* ; Double-Blind Method ; Aged ; Antihypertensive Agents/adverse effects*

Objective:To evaluate the clinical efficacy of a novel reduction device in the treatment of A3N0/1 thoracolumbar fracture using navigation-assisted techniques.Methods:A retrospective analysis was conducted on 45 patients (29 males, 16 females; mean age 40.67±16.11 years, range 24-57) with thoracolumbar fractures who underwent fracture reduction and pedicle screw fixation via the Wiltse approach at Zhengzhou Orthopaedic Hospital between January 2022 and January 2023. Injury levels included: T 10 in 2 cases, T 11 in 5 cases, T 12 in 13 cases, L 1 in 20 cases, L 2 in 3 cases, L 3 in 2 cases. All patients underwent fracture reduction via the Wiltse approach using the spinal fracture reduction instrument for vertebral body reduction. Among them, 20 patients received O-arm navigation-assisted internal fixation and vertebral reduction (O-arm group), while 25 received C-arm fluoroscopy-guided internal fixation and vertebral reduction (C-arm group). Operative time, intraoperative blood loss, vertebral reduction time using the instrument, first-time screw placement success rate, screw placement accuracy, and complications were compared. Mid-vertebral body height ratio (MVBHr), local Cobb angle of the fractured vertebra, visual analogue scale (VAS) score, and Oswestry disability index (ODI) were compared preoperatively, at 1 week postoperatively, 3 months postoperatively, and final follow-up. Results:All surgeries were successfully completed in both groups. Operative time was significantly shorter in the O-arm group (106.8±14.4 min) than in the C-arm group (119.1±16.4 min, P<0.05). All patients were followed up for a mean duration of 15.9±3.9 months (range 12-20 months). Vertebral reduction time was significantly shorter in the O-arm group (11.0±2.2 min) than in the C-arm group (20.4±5.7 min, P<0.05). The first-time screw placement success rate was significantly higher in the O-arm group (100%) than in the C-arm group (95.3%, P<0.05). Screw placement accuracy (Grade I) was significantly higher in the O-arm group (117 screws, 97.5%) than in the C-arm group (136 screws, 90.7%, P<0.05). No cases of wrong-level surgery, infection, or spinal cord/nerve injury occurred. Both groups showed significant improvements in MVBHr, Cobb angle, VAS, and ODI at all postoperative time points compared to preoperative values ( P<0.05). At final follow-up, the O-arm group demonstrated significantly better outcomes than the C-arm group in MVBHr (90.6%±4.5% vs. 86.4%±6.9%, P<0.05), Cobb angle (7.6°±1.8° vs. 10.1°±3.2°, P<0.05), VAS (1.3±0.4 vs. 1.7±0.6, P<0.05), and ODI (4.6%±1.9% vs. 7.7%±2.0%, P<0.01). Conclusion:O-arm navigation-assisted intrasegmental push reduction for A3N0/1 type thoracolumbar fractures demonstrates advantages including faster and more accurate screw placement, precise reduction with improved outcomes, and significant postoperative pain relief.

Traditional Chinese medicine(TCM) resources are the essential material foundation for the development of TCM. The national survey of TCM resources serves as a periodic summary of these resources, ensuring the continuity, prosperity, and development of TCM in China. Since 1949, four national surveys of TCM resources have been conducted. The fourth survey incorporated an investigation into traditional knowledge related to TCM resources, including the traditional medicinal knowledge of Chinese ethnic minorities, with the goal of systematically exploring, preserving, and inheriting this knowledge. This manuscript provides an overview of the basic findings from the first three national surveys of TCM resources, while also clarifying the concepts, categories, forms, carriers, and acquisition pathways of traditional knowledge related to TCM resources. A preliminary summary of the findings from traditional knowledge investigations reported in current literature is also presented. Based on the fourth survey, this manuscript emphasizes the urgency of developing public medical knowledge through empirically-based investigations, the excavation, and compilation of traditional knowledge. It also outlines the potential for conducting "precise" investigations based on first-hand data obtained from the survey, as well as facilitating the discovery and evaluation of new medicines using traditional knowledge related to ethnic minority medicinal practices. This manuscript is expected to provide valuable insights for promoting the health and industrial development of ethnic minority populations in the post-"survey" phase.
Humans ; Medicine, Chinese Traditional ; China/ethnology* ; Minority Groups ; Ethnicity ; Drugs, Chinese Herbal/therapeutic use* ; Health Knowledge, Attitudes, Practice/ethnology* ; Surveys and Questionnaires

OBJECTIVE: To investigate the accuracy and safety of pedicle screw placement using 3D-printed auxiliary guides in scoliosis correction surgery for adolescents. METHODS: A retrospective analysis was conducted on the clinical data of 51 patients who underwent posterior scoliosis correction surgery from January 2020 to March 2023. Among them, there were 35 cases of adolescent idiopathic scoliosis and 16 cases of congenital scoliosis. The patients were divided into two groups based on the auxiliary tool used:the 3D-printed auxiliary guide screw placement group (3D printing group) and the free-hand screw placement group (free-hand group, without auxiliary tools). The 3D printing group included 32 patients (12 males and 20 females) with an average age of (12.59±2.60) years;the free-hand group included 19 patients (7 males and 12 females) with an average age of (14.58±3.53) years. The two groups were compared in terms of screw placement accuracy and safety, spinal correction rate, intraoperative blood loss, number of intraoperative fluoroscopies, operation time, hospital stay, and preoperative and last follow-up scores of the Scoliosis Research Society-22 (SRS-22) questionnaire. RESULTS: A total of 707 pedicle screws were placed in the two groups, with 441 screws in the 3D printing group and 266 screws in the free-hand group. All patients in both groups successfully completed the surgery. There was a statistically significant difference in operation time between the two groups (P<0.05). The screw placement accuracy rate of the 3D printing group was 95.46% (421/441), among which the Grade A placement rate was 89.34% (394/441);the screw placement accuracy rate of the free-hand group was 86.47% (230/266), with a Grade A placement rate of 73.31% (195/266). There were statistically significant differences in the accuracy of Grade A, B, and C screw placements between the two groups (P<0.05), while no statistically significant differences were observed in intraoperative blood loss, number of fluoroscopies, correction rate, or hospital stay (P>0.05). In the SRS-22 questionnaire scores, the scores of functional status and activity ability, self-image, mental status, and pain of patients in each group at the last follow-up were significantly improved compared with those before surgery (P<0.05), but there were no statistically significant differences in all scores between the two groups (P>0.05). CONCLUSION In scoliosis correction surgery, compared with traditional free-hand screw placement, the use of 3D-printed auxiliary guides for screw placement significantly improves the accuracy and safety of screw placement and shortens the operation time.
Humans ; Male ; Scoliosis/surgery* ; Female ; Adolescent ; Printing, Three-Dimensional ; Retrospective Studies ; Pedicle Screws ; Child

PURPOSE: To analyze risk factors for severe trauma and establish a nomogram for early risk prediction, to improve the early identification of severe trauma. METHODS: This study was conducted on the patients treated in 81 trauma treatment institutions in Gansu province from 2020 to 2022. Patients were grouped by year, with 5364 patients from 2020 to 2021 as the training set and 1094 newly admitted patients in 2020 as the external validation set. Based on the injury severity score (ISS), patients in the training set were classified into 2 subgroups of the severe trauma group (n = 478, ISS scores ≥25) and the non-severe trauma group (n = 4886, ISS scores <25). Univariate and binary logistic regression analyses were employed to identify independent risk factors for severe trauma. Subsequently, a predictive model was developed using the R software environment. Furthermore, the model was subjected to internal and external validation via the Hosmer-Lemeshow test and receiver operating characteristic curve analysis. RESULTS: In total, 6458 trauma patients were included in this study. Initially, this study identified several independent risk factors for severe trauma, including multiple traumatic injuries (polytrauma), external hemorrhage, elevated shock index, elevated respiratory rate, decreased peripheral oxygen saturation, and decreased Glasgow coma scale score (all p < 0.05). For internal validation, the area under the receiver operating characteristic curve was 0.914, with the sensitivity and specificity of 88.4% and 87.6%, respectively; while for external validation, the area under the receiver operating characteristic curve was 0.936, with the sensitivity and specificity of 84.6% and 93.7%, respectively. In addition, a good model fitting was observed through the Hosmer-Lemeshow test and calibration curve analysis (p > 0.05). CONCLUSION This study establishes a nomogram for early risk prediction of severe trauma, which is suitable for primary healthcare institutions in underdeveloped western China. It facilitates early triage and quantitative assessment of trauma severity by clinicians prior to clinical interventions.
Humans ; Nomograms ; Male ; Female ; Wounds and Injuries/diagnosis* ; Risk Factors ; Middle Aged ; Adult ; Injury Severity Score ; Risk Assessment ; ROC Curve ; Aged ; Logistic Models ; China ; Glasgow Coma Scale

Objective:To investigate the the differential expression of EIF5A2 in intrahepatic cholangiocarcinoma cell lines RBE,HCCC9810,and HUCCT1,and its effects on HCCC9810 cell migration and invasion,epithelial mesenchymal transition,and PI3K/AKT signaling pathway.Methods:The differential expression of EIF5A2 in RBE,HCCC9810,and HUCCT1 cell lines was detected using WB method.The HCCC9810 cell line,with the highest expression of EIF5A2,was selected for this experiment.The expression of EIF5A2 in HCCC9810 cell line was silenced by transient transfection of small interfering RNA.The best silencing effect of small interfering RNA was screened by WB.Scratch assay and Tran-swell migration invasion assay were used to detect the effect of silencing EIF5A2 on the migration and invasion ability of HCCC9810 cells.WB was used to detect the effect of silencing EIF5A2 on PI3K/AKT signaling pathway and epithelial mesenchymal transition in HCCC9810 cells.Results:The WB results showed that EIF5A2 had the highest expression in the HCCC9810 cell line,and siRNA1 had the best silencing effect on EIF5A2 in the HCCC9810 cell line.Scratch assay and Transwell migration invasion assay results showed that silencing EIF5A2 in the HCCC9810 cell line resulted in a decrease in cell invasion and metastasis ability(P＜0.05).At the same time,the expression of p-PI3K and p-AKT in the PI3K/AKT signaling pathway was significantly decreased(P＜0.05),while the epithelial cell marker E-cadherin expression increased(P＜0.05)and the stromal cell marker N-cadherin expression decreased(P＜0.05).Conclusion:EIF5A2 may promote epi-thelial mesenchymal transition and enhance the migration and invasion ability of intrahepatic cholangiocarcinoma cells through the PI3K/AKT signaling pathway.

Objective:To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia(ChP)2025 Edition,and explore its novel requirements in risk-based pharmaceutical product lifecycle management.Methods:A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview,international harmonization of microbiological standards,risk-based quality man-agement system,and novel tools and methods with Chinese characteristics.Results:The ChP 2025 edition demon-strates three prominent features in microbiological-related standards:enhanced international harmonization,intro-duced emerging molecular biological technologies,and established a risk-based microbiological quality control sys-tem.Conclusion:The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system,which significantly improves the scientificity,standardization and applicability of the standards,providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

Objective To understand the clinical applicability and implementation of expert consensus on the implementation and removal of protective restraints in psychiatry,and to provide references for promoting the standardized practice of psychiatric protective restraints and updating the consensus.Methods By the convenience sampling method,a questionnaire survey was conducted among nurses from 480 hospitals in 30 provinces from June 15 to July 15,2024.The survey was conducted using the instrument for evaluating clinical applicability of guide-lines(version 2.0)and a self-compiled questionnaire on the clinical implementation of the restraint consensus.Results A total of 7,844 valid questionnaires were collected,with a valid questionnaire recovery rate of 93.78％.The results of clinical applicability scoring showed that the consensus had the lowest availability score(64.72％)and the highest acceptability score(76.74％).The results showed that nurses' receiving training and the level of their hospitals were the main influencing factors for scores in various dimensions(P＜0.05).4,774 participants(87.42％)believed that the application of consensus could enhance the standardization of nurses' restraint operations.The safety rate of the restraint consensus was 79.51％,and the economic ratio was 76.87％.Among the evaluators,1,739(22.17％)believed that there were implementation obstacles in the consensus.Conclusion The clinical applicability of the consensus is relatively good,and the application of the consensus helps to improve the standardization of clinical operations.In the future,efforts should be made to strengthen the promotion and training of the consensus,develop hierarchical promotion strategies according to the characteristics of medical institutions,and improve the quality of evidence for the consensus,so as to further enhance the clinical application effect of the consensus.

Objective:To evaluate the clinical efficacy of a novel reduction device in the treatment of A3N0/1 thoracolumbar fracture using navigation-assisted techniques.Methods:A retrospective analysis was conducted on 45 patients (29 males, 16 females; mean age 40.67±16.11 years, range 24-57) with thoracolumbar fractures who underwent fracture reduction and pedicle screw fixation via the Wiltse approach at Zhengzhou Orthopaedic Hospital between January 2022 and January 2023. Injury levels included: T 10 in 2 cases, T 11 in 5 cases, T 12 in 13 cases, L 1 in 20 cases, L 2 in 3 cases, L 3 in 2 cases. All patients underwent fracture reduction via the Wiltse approach using the spinal fracture reduction instrument for vertebral body reduction. Among them, 20 patients received O-arm navigation-assisted internal fixation and vertebral reduction (O-arm group), while 25 received C-arm fluoroscopy-guided internal fixation and vertebral reduction (C-arm group). Operative time, intraoperative blood loss, vertebral reduction time using the instrument, first-time screw placement success rate, screw placement accuracy, and complications were compared. Mid-vertebral body height ratio (MVBHr), local Cobb angle of the fractured vertebra, visual analogue scale (VAS) score, and Oswestry disability index (ODI) were compared preoperatively, at 1 week postoperatively, 3 months postoperatively, and final follow-up. Results:All surgeries were successfully completed in both groups. Operative time was significantly shorter in the O-arm group (106.8±14.4 min) than in the C-arm group (119.1±16.4 min, P<0.05). All patients were followed up for a mean duration of 15.9±3.9 months (range 12-20 months). Vertebral reduction time was significantly shorter in the O-arm group (11.0±2.2 min) than in the C-arm group (20.4±5.7 min, P<0.05). The first-time screw placement success rate was significantly higher in the O-arm group (100%) than in the C-arm group (95.3%, P<0.05). Screw placement accuracy (Grade I) was significantly higher in the O-arm group (117 screws, 97.5%) than in the C-arm group (136 screws, 90.7%, P<0.05). No cases of wrong-level surgery, infection, or spinal cord/nerve injury occurred. Both groups showed significant improvements in MVBHr, Cobb angle, VAS, and ODI at all postoperative time points compared to preoperative values ( P<0.05). At final follow-up, the O-arm group demonstrated significantly better outcomes than the C-arm group in MVBHr (90.6%±4.5% vs. 86.4%±6.9%, P<0.05), Cobb angle (7.6°±1.8° vs. 10.1°±3.2°, P<0.05), VAS (1.3±0.4 vs. 1.7±0.6, P<0.05), and ODI (4.6%±1.9% vs. 7.7%±2.0%, P<0.01). Conclusion:O-arm navigation-assisted intrasegmental push reduction for A3N0/1 type thoracolumbar fractures demonstrates advantages including faster and more accurate screw placement, precise reduction with improved outcomes, and significant postoperative pain relief.