1.Analysis on Clinical Trial Registration of TCM in the Treatment of Coronary Artery Microvascular Diseases
Zhao GE ; Silin REN ; Mengxue ZHOU ; Mohan LI ; Xujin NING ; Xianliang WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(3):64-68
Objective To review clinical trial registration status of TCM treatment for coronary microvascular disease;To analyze the effectiveness and safety of TCM in treating coronary microvascular disease.Methods The clinical trials of TCM in the treatment of coronary artery microvascular disease included in the Chinese Clinical Trials Registry and the US Clinical Trials Registry from the establishment of the database to January 31,2024 were retrieved,and the general characteristics(time,region,funding source),design type,intervention regimen and outcome indicators of the included clinical trials were extracted and analyzed using Excel 2019 software.Results A total of 17 clinical trials were included,including 16 pre-registrations.The registered units were distributed in 5 provinces across the country,involving 17 registration institutions.The two regions with the most distribution were Shanghai(6 studies,35.29%)and Beijing(5 studies,29.41%).The types of studies were mainly interventional studies,and most of the study designs were randomized parallel controlled studies(16 studies,94.12%).A total of 8 interventions were reported,including Chinese patent medicine,TCM decoction,TCM intravenous preparation,and acupuncture and moxibustion.A total of 143 outcome indicators were designed,including 10 first-level indicators,including coronary artery microcirculation,clinical efficacy,symptoms and signs,TCM syndromes,quality of life,exercise tolerance,cardiac function,physical and chemical testing,safety,and pharmacoeconomic evaluation.Conclusion The registration of clinical trials by TCM in the treatment of coronary microvascular diseases has been gradually receiving attention from researchers,but the overall number is still small.At present,the study needs to be optimized in terms of study design and index selection.
2.Influencing factors for delayed intracranial hemorrhage after ventriculo-peritoneal shunt and construction of its prediction model
Guanjiang LIN ; Xujin YING ; Hongcai WANG ; Shiwei LI
Chinese Journal of Neuromedicine 2025;24(8):790-798
Objective:To explore the clinical characteristics of hydrocephalus patients with delayed intracranial hemorrhage (DICH) after ventriculo-peritoneal shunt (VPS) and independent influencing factors for DICH after VPS, and construct a nomogram model for predicting the incidence of DICH after VPS.Methods:A retrospective analysis was performed; clinical data of 168 patients with hydrocephalus who underwent VPS at Department of Neurosurgery, Lihuili Hospital Affiliated to Ningbo University from January 2016 to December 2023 were collected. Based on the postoperative DICH occurrence, these patients were categorized into a non-DICH group and a DICH group. Clinical characteristics of patients from the DICH group were analyzed. Differences in clinical data between patients from the non-DICH group and DICH group were compared. Multivariate Logistic regression analysis was performed to screen the independent influencing factors for DICH after VPS, and a nomogram model for predicting DICH incidence after VPS was constructed. Receiver operating characteristic (ROC) curve, calibration curve, Hosmer-Lemeshow test and Bootstrap resampling method were used to evaluate the predictive efficiency and stability of the nomogram model.Results:(1) Among the 168 patients, 36 (21.43%) developed DICH, which occurred (6.06±2.77) days after VPS (ranged 2-13 days). Seven patients presented with symptoms as vomiting, epilepsy, and decreased consciousness, while 29 patients had no hemorrhage-related complication. The hemorrhage volume in these 36 DICH patients was 0.85(0.30, 3.54) mL. Regarding the hemorrhage sites, 12 patients had simple puncture tract hemorrhage, 14 had simple intraventricular hemorrhage, 7 had both puncture tract hemorrhage and intraventricular hemorrhage, and 3 had puncture tract hemorrhage combined with hemorrhage in other sites. At discharge, 8 patients had a good prognosis, and 28 had a poor prognosis. (2) Compared with the non-DICH group, the DICH group had statistically older age, higher proportion of patients with hypertension or craniotomy history, lower preoperative neutrophil-to-lymphocyte ratio (NLR), higher postoperative NLR, and higher ratio of postoperative to preoperative NLR (NLRR), with significant differences ( P<0.05). Results of multivariate Logistic regression analysis indicated that age ( OR=1.077, 95% CI: 1.022-1.135, P=0.005), history of craniotomy ( OR=3.547, 95% CI: 1.384-9.092, P=0.008), and NLRR ( OR=1.744, 95% CI: 1.179-2.581, P=0.005) were independent influencing factors for DICH in hydrocephalus patients after VPS ( P<0.05). (3) A nomogram model for predicting DICH in hydrocephalus patients after VPS was constructed based on age, history of craniotomy and NLRR. ROC curve analysis showed that area under the curve (AUC) of the nomogram model for predicting DICH in hydrocephalus patients after VPS was 0.812 (95% CI: 0.735-0.890, P<0.001); Hosmer-Lemeshow test indicated that the model had good calibration, and no significant difference was noted between the predicted probabilities and actual probabilities ( χ2=10.487, P=0.233); decision curve analysis results showed that the nomogram model could generate good clinical net benefits with risk threshold of 0%-60%; AUC of the internal validation ROC curve was 0.805 (95% CI: 0.785-0.816) and the C-index was 0.82 by Bootstrap resampling method, suggesting good stability of the model. Conclusion:Hydrocephalus patients with advanced age, history of craniotomy, and elevated NLRR trend to have DICH following VPS; the nomogram model constructed based on age, history of craniotomy and NLRR has good predictive performance and clinical practicability.
3.Analysis on Clinical Trial Registration of TCM in the Treatment of Coronary Artery Microvascular Diseases
Zhao GE ; Silin REN ; Mengxue ZHOU ; Mohan LI ; Xujin NING ; Xianliang WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(3):64-68
Objective To review clinical trial registration status of TCM treatment for coronary microvascular disease;To analyze the effectiveness and safety of TCM in treating coronary microvascular disease.Methods The clinical trials of TCM in the treatment of coronary artery microvascular disease included in the Chinese Clinical Trials Registry and the US Clinical Trials Registry from the establishment of the database to January 31,2024 were retrieved,and the general characteristics(time,region,funding source),design type,intervention regimen and outcome indicators of the included clinical trials were extracted and analyzed using Excel 2019 software.Results A total of 17 clinical trials were included,including 16 pre-registrations.The registered units were distributed in 5 provinces across the country,involving 17 registration institutions.The two regions with the most distribution were Shanghai(6 studies,35.29%)and Beijing(5 studies,29.41%).The types of studies were mainly interventional studies,and most of the study designs were randomized parallel controlled studies(16 studies,94.12%).A total of 8 interventions were reported,including Chinese patent medicine,TCM decoction,TCM intravenous preparation,and acupuncture and moxibustion.A total of 143 outcome indicators were designed,including 10 first-level indicators,including coronary artery microcirculation,clinical efficacy,symptoms and signs,TCM syndromes,quality of life,exercise tolerance,cardiac function,physical and chemical testing,safety,and pharmacoeconomic evaluation.Conclusion The registration of clinical trials by TCM in the treatment of coronary microvascular diseases has been gradually receiving attention from researchers,but the overall number is still small.At present,the study needs to be optimized in terms of study design and index selection.
4.Influencing factors for delayed intracranial hemorrhage after ventriculo-peritoneal shunt and construction of its prediction model
Guanjiang LIN ; Xujin YING ; Hongcai WANG ; Shiwei LI
Chinese Journal of Neuromedicine 2025;24(8):790-798
Objective:To explore the clinical characteristics of hydrocephalus patients with delayed intracranial hemorrhage (DICH) after ventriculo-peritoneal shunt (VPS) and independent influencing factors for DICH after VPS, and construct a nomogram model for predicting the incidence of DICH after VPS.Methods:A retrospective analysis was performed; clinical data of 168 patients with hydrocephalus who underwent VPS at Department of Neurosurgery, Lihuili Hospital Affiliated to Ningbo University from January 2016 to December 2023 were collected. Based on the postoperative DICH occurrence, these patients were categorized into a non-DICH group and a DICH group. Clinical characteristics of patients from the DICH group were analyzed. Differences in clinical data between patients from the non-DICH group and DICH group were compared. Multivariate Logistic regression analysis was performed to screen the independent influencing factors for DICH after VPS, and a nomogram model for predicting DICH incidence after VPS was constructed. Receiver operating characteristic (ROC) curve, calibration curve, Hosmer-Lemeshow test and Bootstrap resampling method were used to evaluate the predictive efficiency and stability of the nomogram model.Results:(1) Among the 168 patients, 36 (21.43%) developed DICH, which occurred (6.06±2.77) days after VPS (ranged 2-13 days). Seven patients presented with symptoms as vomiting, epilepsy, and decreased consciousness, while 29 patients had no hemorrhage-related complication. The hemorrhage volume in these 36 DICH patients was 0.85(0.30, 3.54) mL. Regarding the hemorrhage sites, 12 patients had simple puncture tract hemorrhage, 14 had simple intraventricular hemorrhage, 7 had both puncture tract hemorrhage and intraventricular hemorrhage, and 3 had puncture tract hemorrhage combined with hemorrhage in other sites. At discharge, 8 patients had a good prognosis, and 28 had a poor prognosis. (2) Compared with the non-DICH group, the DICH group had statistically older age, higher proportion of patients with hypertension or craniotomy history, lower preoperative neutrophil-to-lymphocyte ratio (NLR), higher postoperative NLR, and higher ratio of postoperative to preoperative NLR (NLRR), with significant differences ( P<0.05). Results of multivariate Logistic regression analysis indicated that age ( OR=1.077, 95% CI: 1.022-1.135, P=0.005), history of craniotomy ( OR=3.547, 95% CI: 1.384-9.092, P=0.008), and NLRR ( OR=1.744, 95% CI: 1.179-2.581, P=0.005) were independent influencing factors for DICH in hydrocephalus patients after VPS ( P<0.05). (3) A nomogram model for predicting DICH in hydrocephalus patients after VPS was constructed based on age, history of craniotomy and NLRR. ROC curve analysis showed that area under the curve (AUC) of the nomogram model for predicting DICH in hydrocephalus patients after VPS was 0.812 (95% CI: 0.735-0.890, P<0.001); Hosmer-Lemeshow test indicated that the model had good calibration, and no significant difference was noted between the predicted probabilities and actual probabilities ( χ2=10.487, P=0.233); decision curve analysis results showed that the nomogram model could generate good clinical net benefits with risk threshold of 0%-60%; AUC of the internal validation ROC curve was 0.805 (95% CI: 0.785-0.816) and the C-index was 0.82 by Bootstrap resampling method, suggesting good stability of the model. Conclusion:Hydrocephalus patients with advanced age, history of craniotomy, and elevated NLRR trend to have DICH following VPS; the nomogram model constructed based on age, history of craniotomy and NLRR has good predictive performance and clinical practicability.
5.Mechanism of NPY-Y1 signaling pathway regulation of eosinophilic inflammation in the nasal mucosa of rats with chronic sinusitis
Jiayan WANG ; Ming XU ; Wei WANG ; Xujin JIA
Chinese Archives of Otolaryngology-Head and Neck Surgery 2024;31(5):305-310
OBJECTIVE To investigate the mechanisms by which the NPY-Y1 signalling pathway regulates eosinophilic inflammation in the nasal mucosa of rats with eosinophilic chronic rhinosinusitis(ECRS).METHODS Seventy-two rats were divided into 6 groups according to the random grouping method of body weight.There were 12 rats in each group,including the control group,ECRS group,no-loading group,neuropeptide Y(NPY)interference group,low antagonist group and high antagonist group.Except for the control group,the ECRS rat model was constructed using the ovalbumin sensitisation+bacterial toxin method in the other five groups.The no-loading group and NPY-interfering group were intervened by tail vein injection of siNC and NPY siRNA plasmid,respectively,and the low and high antagonist groups were intervened by intraperitoneal injection of 20 and 50 μg of BIBO 3304,respectively.The rats were executed at the end of the final stimulation,and the nasal mucosal tissues were taken for HE staining and eosinophil(Eos)counting.NPY,IL-4,IL-5,IL-13 mRNA expression in nasal mucosa was detected by RT-PCT.Nuclear factor κB p65(NF-κB p65),NF-κB p50 protein expression was detected by Western blot method.NPY,NPY1 receptor(Y1R)expression was detected by immunohistochemistry.RESULTS HE staining results showed that the tissue structure of the nasal mucosa in the control group was complete and orderly.In the ECRS group and the airborne group,the cell arrangement was disordered and a large number of inflammatory cell infiltration appeared.In the low antagonist group,the cell structure was improved and the inflammatory cell infiltration was reduced.Compared with the low antagonist group,the improvement of cell structure and inflammatory cell infiltration was more significant in the NPY interference group and high antagonist group.Compared with the control group,the Eos count of nasal mucosa,NPY,IL-4,IL-5,IL-13 mRNA,NF-κB p65,NF-κB p50 protein and the relative intensity values of NPY and Y1R cell staining were significantly higher in both the ECRS group and the no-loading group(all P<0.05).Compared with the ECRS group and the no-loading group,the above indexes were reduced in the NPY interference group,the low antagonist group and the high antagonist group,and the NPY interference group and the high antagonist group were lower than that of the low antagonist group(all P<0.05).There was no statistically significant difference in the above indicators between the ECRS group and the no-loading group,the NPY interference group and the high antagonist group(all P>0.05).CONCLUSION ECRS rats have an abnormal infiltrative inflammatory response to Eos in the nasal mucosa,the mechanism of which may be related to the NPY-Y1 signalling pathway through activation of the NF-κB signalling pathway and effector protein expression.
6.Efficacy of micro-plate combined with tension-band wire fixation of comminuted inferior pole patellar fracture
Kai XIE ; Jiazhao YANG ; Wanbo ZHU ; Lei XU ; Wei XU ; Xujin WANG ; Shiyuan FANG ; Haiou HONG
Chinese Journal of Trauma 2022;38(2):136-141
Objective:To investigate the clinical effect of combined treatment of comminuted inferior pole patellar fracture with micro-plate and tension-band wire.Methods:A retrospective cohort study was conducted in 50 patients with comminuted inferior pole patellar fracture (AO classification of type 34-A1) admitted to First Affiliated Hospital of University of Science and Technology of China from October 2018 to October 2020, including 28 males and 22 females, aged 17-77 years[(51.4±11.5)years]. A total of 23 patients were treated with micro-plate combined with tension-band wire (Group A) and 27 patients were treated with cable wire looping combined with tension-band wire (Group B). Fracture union, union time and last follow-up evaluation of knee range of motion and Bostman score were compared between the two groups. Complications (infection, internal fixation failure, internal fixation irritation, etc.) were also observed.Results:All patients were followed up for 12-18 months[(14.1±2.1) months]. All patients had bone union, with no statistical difference between Group A[(9.9±1.8)weeks]and Group B[(10.3±1.4)weeks]in union time ( P>0.05). Knee range of motion was (129.2±9.7)° in Group A at the last follow-up, better than (122.3±11.0)° in Group B ( P<0.05). Knee Bostman score was (27.6±1.8)points in Group A, showing no statistical difference from that in Group B[(26.8±1.9)points]( P>0.05). There were no postoperative complications in Group A. Two patients with tension band shedding of Kirschner wire after fracture healing were found in Group B, with no special treatment given due to no obvious discomfort. Conclusions:For comminuted inferior pole patellar fracture, micro-plate combined with tension-band wire is more effective and provides better knee mobility with no complications of implant failure as compared with cable wire looping combined with tension-band wire. Therefore, the technique deserves clinical promotion.
7.Research Progress on Vector Flow Imaging of Cardiac Ultrasound.
Yigang DU ; Yongqiang DONG ; Dejie LIU ; Zhiwei SHI ; Yan WANG ; Xujin HE ; Lei ZHU
Chinese Journal of Medical Instrumentation 2022;46(2):176-180
Echocardiogram is vital for the diagnosis of cardiac disease. The heart has complex hemodynamics requiring an advanced ultrasound imaging mode. Cardiac ultrasound vector flow imaging is capable of measuring the actual magnitude and direction of the blood flow velocity, obtaining the quantitative parameters of hemodynamics, and then providing more information for clinical research and diagnosis. This study mainly reviewed several different vector flow imaging techniques for cardiac flow and presented the implementation difficulties, and proposed a diverging wave based high frame rate cardiac ultrasound vector flow imaging. The study discussed the limitation of current ultrasound technology used in the cardiac flow measurement, analyzed and demonstrated the specific reasons for these implementation difficulties and the potential future development.
Blood Flow Velocity
;
Heart/physiology*
;
Hemodynamics
;
Ultrasonography
8.Correlation between neonatal infectious diseases and brain injury
Xujin YANG ; Congle ZHOU ; Zezhong TANG ; Xinlin HOU ; Hongmei WANG ; Xiyong FAN ; Yi JIANG
Chinese Journal of Perinatal Medicine 2012;15(1):20-24
Objective To investigate the correlation between neonatal infectious disease and brain injury.MethodsClinical data of 1266 newborns with infectious diseases were collected from Peking University First Hospital from November 2005 to August 2010.The occurrence of brain injury was summarized.Related factors of brain injury caused by infection and the risk factors for severe brain injury were analyzed by Logistic regression model. Results Among the newborns with neonatal infectious diseases, the incidence of brain injury was 8.6%(108/1266), including 101 (8.0%)mild cases and seven (0.6%) severe cases. The incidence of brain injury for the newborns with severe infectious diseases was higher than those with mild infectious diseases [38.7%(29/75) vs 6.7%(79/1191),x2=92.787,P=0.000].The incidence of brain injury for the newborns withobviousinflammatoryreactionwassignificantlyhigherthanthosewithout [(13.0%(26/200) vs 7.5% (77/1025),x2=6.544,P=0.011].Severe infection was independent risk factor for severe brain injury by Logistic regression model analysis (OR =15.750,95% CI:1.756-141.281,P=0.014).ConclusionsIniectious diseases could cause injury on central nervous system,especially when there are severe infections or inflammatory reactions. The severer the infection,the severer the brain injury,especially when complicated by some factors such as asphyxia and hypoglycemia.

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