1.Clinical Safety Monitoring of 3 035 Cases of Juvenile Feilike Mixture After Marketing in Hospital
Jian ZHU ; Zhong WANG ; Jing LIU ; Jun LIU ; Wei YANG ; Yanan YU ; Hongli WU ; Sha ZHOU ; Zhiyu PAN ; Guang WU ; Mengmeng WU ; Zhiwei JING
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):194-200
ObjectiveTo explore the clinical safety of Feilike Mixture (FLK) in the real world. MethodsThe safety of all children who received FLK from 29 institutions in 12 provinces between January 21,2021 and December 25,2021 was evaluated through prospective centralized surveillance and a nested case control study. ResultsA total of 3 035 juveniles were included. There were 29 research centers involved,which are distributed across 12 provinces,including one traditional Chinese medicine (TCM) hospital and 28 general hospitals. The average age among the juveniles was (4.77±3.56) years old,and the average weight was (21.81±12.97) kg. Among them,119 cases (3.92%) of juveniles had a history of allergies. Acute bronchitis was the main diagnosis for juveniles,with 1 656 cases (54.46%). FLK was first used in 2 016 cases (66.43%),and 142 juvenile patients had special dosages,accounting for 4.68%. Among them,92 adverse drug reactions (ADRs) occurred,including 73 cases of gastrointestinal system disorders,10 cases of metabolic and nutritional disorders,eight cases of skin and subcutaneous tissue diseases,two cases of vascular and lymphatic disorders,and one case of systemic diseases and various reactions at the administration site. The manifestations of ADRs were mainly diarrhea,stool discoloration,and vomiting,and no serious ADRs occurred. The results of multi-factor analysis indicated that special dosages (the use of FLK)[odds ratio (OR) of 2.642, 95% confidence interval (CI) of 1.105-6.323],combined administration: spleen aminopeptide (OR of 4.978, 95%CI of 1.200-20.655),and reason for combined administration: anti-infection (OR of 1.814, 95%CI of 1.071-3.075) were the risk factors for ADRs caused by FLK. Conclusion92 ADRs occurred among 3 035 juveniles using FLK. The incidence of ADRs caused by FLK was 3.03%,and the severity was mainly mild or moderate. Generally,the prognosis was favorable after symptomatic treatment such as drug withdrawal or dosage reduction,suggesting that FLK has good clinical safety.
2.Efficacy and safety of recombinant human anti-SARS-CoV-2 monoclonal antibody injection(F61 injection)in the treatment of patients with COVID-19 combined with renal damage:a randomized controlled exploratory clinical study
Ding-Hua CHEN ; Chao-Fan LI ; Yue NIU ; Li ZHANG ; Yong WANG ; Zhe FENG ; Han-Yu ZHU ; Jian-Hui ZHOU ; Zhe-Yi DONG ; Shu-Wei DUAN ; Hong WANG ; Meng-Jie HUANG ; Yuan-Da WANG ; Shuo-Yuan CONG ; Sai PAN ; Jing ZHOU ; Xue-Feng SUN ; Guang-Yan CAI ; Ping LI ; Xiang-Mei CHEN
Chinese Journal of Infection Control 2024;23(3):257-264
Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome coronavirus 2(anti-SARS-CoV-2)monoclonal antibody injection(F61 injection)in the treatment of patients with coronavirus disease 2019(COVID-19)combined with renal damage.Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected.Subjects were randomly divided into two groups.Control group was treated with conventional anti-COVID-19 therapy,while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection.A 15-day follow-up was conducted after drug administration.Clinical symptoms,laboratory tests,electrocardiogram,and chest CT of pa-tients were performed to analyze the efficacy and safety of F61 injection.Results Twelve subjects(7 in trial group and 5 in control group)were included in study.Neither group had any clinical progression or death cases.The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days(P=0.046),respectively.The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group(both P<0.05).According to the clinical staging and World Health Organization 10-point graded disease progression scale,both groups of subjects improved but didn't show statistical differences(P>0.05).For safety,trial group didn't present any infusion-re-lated adverse event.Subjects in both groups demonstrated varying degrees of elevated blood glucose,elevated urine glucose,elevated urobilinogen,positive urine casts,and cardiac arrhythmia,but the differences were not statistica-lly significant(all P>0.05).Conclusion F61 injection has initially demonstrated safety and clinical benefit in trea-ting patients with COVID-19 combined with renal damage.As the domestically produced drug,it has good clinical accessibility and may provide more options for clinical practice.
3.Chinese expert consensus on transcatheter tricuspid valve intervention therapy
Chinese College of Cardiovascular Physicians Structural Cardiology Group ; House Heart CHINA ; Wen-Zhi PAN ; Guang-Yuan SONG ; Da-Xin ZHOU ; Yong-Jian WU
Chinese Journal of Interventional Cardiology 2024;32(10):551-561
Tricuspid regurgitation(TR)is a common heart valve disease traditionally treated with surgery,which is invasive and high-risk.Recently,transcatheter tricuspid valve intervention(TTVI)technology has achieved major breakthroughs.It is being promoted internationally and several expert consensus documents have been launched abroad.However,in China,there is still a lack of consensus documents in this regard.In order to promote the safe,standardized and healthy development of this technology,this expert consensus is specially compiled.This consensus will introduce anatomy,epidemiology,classification and pathogenesis of TR,the traditional treatment and TTVI,preoperative evaluation and clinical efficacy endpoints.We sort out ten core viewpoints so that readers can quickly grasp the essence of the consensus.
4.2024 expert consensus on clinical pathway for transcatheter aortic valve replacement in China
Structural Cardiology Committee of Cardiovascular Physicians Branch,Chinese Medical Doctor Association ; Asia Pacific Structural Heart Disease Club ; Guang-Yuan SONG ; Wen-Zhi PAN ; Da-Xin ZHOU ; Yong-Jian WU
Chinese Journal of Interventional Cardiology 2024;32(11):601-617
Transcatheter aortic valve replacement(TAVR)has reached maturity and has entered a stage of steady and stable development in China.From 2017 to 2023,the number of centers conducting TAVR in China has increased from less than 10 to over 600,and the annual implantation volume has increased from hundreds to over 10 000.The 2018 and 2021 editions of the"Expert Consensus on Clinical Pathway for Transcatheter Aortic Valve Replacement in China"played a crucial guiding role during the golden period of TAVR development in China.With significant progress in evidence-based practice,clinical experience,guideline updates,device development,and procedure technique improvements in the TAVR field,especially the important advances in technologies developed from China,protocol optimization based on Chinese clinical practices,it is necessary to update the previous clinical pathway consensus.The new version of the clinical pathway expert consensus has updated the standard procedures for preoperative clinical assessment,perioperative imaging evaluation,standardized procedural processes,comprehensive perioperative management,and postoperative rehabilitation follow-up for TAVR patients.This update aims to further promote the healthy and standardized development of TAVR technology in China and to steadily enhance the medical and scientific research capabilities with this therapeutic technology.
5.Drug-coated balloons for the treatment of ostial left anterior descending or ostial left circumflex artery lesions: a patient-level propensity score-matched analysis.
Liang PAN ; Wen-Jie LU ; Zhan-Ying HAN ; San-Cong PAN ; Xi WANG ; Ying-Guang SHAN ; Meng PENG ; Xiao-Fei QIN ; Guo-Ju SUN ; Pei-Sheng ZHANG ; Jian-Zeng DONG ; Chun-Guang QIU
Journal of Geriatric Cardiology 2023;20(10):716-727
BACKGROUND:
Controversy exists as to the optimal treatment approach for ostial left anterior descending (LAD) or ostial left circumflex artery (LCx) lesions. Drug-coated balloons (DCB) may overcome some of the limitations of drug-eluting stents (DES). Therefore, we investigated the security and feasibility of the DCB policy in patients with ostial LAD or ostial LCx lesions, and compared it with the conventional DES-only strategy.
METHODS:
We retrospectively enrolled patients with de novo ostial lesions in the LAD or LCx who underwent interventional treatment. They were categorized into two groups based on their treatment approach: the DCB group and the DES group. The treatment strategies in the DCB group involved the use of either DCB-only or hybrid strategies, whereas the DES group utilized crossover or precise stenting techniques. Two-year target lesion revascularization was the primary endpoint, while the rates of major adverse cardiovascular events, cardiac death, target vessel myocardial infarction, and vessel thrombosis were the secondary endpoints. Using propensity score matching, we assembled a cohort with comparable baseline characteristics. To ensure result analysis reliability, we conducted sensitivity analyses, including interaction, and stratified analyses.
RESULTS:
Among the 397 eligible patients, 6.25% of patients who were planned to undergo DCB underwent DES. A total of 108 patients in each group had comparable propensity scores and were included in the analysis. Two-year target lesion revascularization occurred in 5 patients (4.90%) and 16 patients (16.33%) in the DCB group and the DES group, respectively (odds ratio = 0.264, 95% CI: 0.093-0.752, P = 0.008). Compared with the DES group, the DCB group demonstrated a lower major adverse cardiovascular events rate (7.84% vs. 19.39%, P = 0.017). However, differences with regard to cardiac death, non-periprocedural target vessel myocardial infarction, and definite or probable vessel thrombosis between the groups were non-significant.
CONCLUSIONS
The utilization of the DCB approach signifies an innovative and discretionary strategy for managing isolated ostial lesions in the LAD or LCx. Nevertheless, a future randomized trial investigating the feasibility and safety of DCB compared to the DES-only strategy specifically for de novo ostial lesions in the LAD or LCx is highly warranted.
6.Preliminary evaluation on the efficacy of emergency transcatheter aortic valve replacement: a multicenter study.
Zheng ZHOU ; Long Yan ZHANG ; Jian YANG ; Xiao Ke SHANG ; Jie LI ; Wen Zhi PAN ; Zheng Ming JIANG ; Zhen Fei FANG ; Fei LI ; Yong Jian WU ; Guang Yuan SONG
Chinese Journal of Cardiology 2022;50(7):698-704
Objectives: To explore the efficacy and safety of emergency transcatheter aortic valve replacement (TAVR). Methods: Data of patients who underwent emergency TAVR in eight centers, namely Fuwai Hospital, Wuhan Asia Heart Hospital, Xijing Hospital, Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Guangdong Provincial People's Hospital, Zhongshan Hospital Affiliated to Fudan University, the First Affiliated Hospital of Zhengzhou University, the Second Xiangya Hospital of Central South University, between May 2017 and December 2020 were retrospectively analyzed. The use of mechanical circulatory support system (MCS) and the results of laboratory tests (N-terminal B-type natriuretic peptide (NT-proBNP)) and echocardiography (mean aortic valve cross valve pressure difference and left ventricular ejection fraction) before and after operation were collected. The primary endpoint was all-cause death, and the secondary endpoints were stroke, major bleeding, major vascular complications, myocardial infarction, permanent pacemaker implantation, and acute renal injury. Device success was caculated, which refered to absence of procedural mortality and correct positioning of a single prosthetic heart valve into the proper anatomical location and intended performance of the prosthetic heart valve (mean aortic valve gradient<20 mmHg(1 mmHg=0.133 kPa) or peak velocity<3 m/s, with no moderate or severe prosthetic valve regurgitation). Kaplan-Meier survival curve was used to estimate the survival rate of patients during follow-up. Results: This study included 48 patients. The age was (72.5±8.1) years, and 34 patients were males (70.8%). Device success rate was 91.7% (44/48). The mean aortic valve transvalvular pressure was significantly decreased after operation ((12.3±6.4)mmHg vs. (60.2±23.8)mmHg, P<0.000 1). Left ventricular ejection fraction was significantly increased ((41.5±11.7)% vs. (31.0±11.3)%, P<0.000 1). NT-proBNP significantly decreased (3 492.0 (1 638.8, 7 165.5) ng/L vs. 12 418.5 (6 693.8, 35 000.0) ng/L, P<0.000 1). In-hospital all-cause mortality was 8.3% (4/48). During hospitalization, the rate of stroke was 2.1% (1/48), major bleeding was 6.3% (3/48), major vascular complications was 10.4% (5/48), myocardial infarction was 4.2% (2/48), permanent pacemaker implantation was 6.3% (3/48), and the rate of acute renal injury was 12.5% (6/48). MCS was used in 20 patients (41.7%). The median follow-up time was 196 days. During the follow-up, one patient died (due to systemic metastasis of pancreatic cancer), two cases suffered new myocardial infarction and one case received permanent pacemaker implantation. The survival rate of 30 days, 1 year and 2 years after the operation were 91.7% (44/48), 89.6% (43/48), 89.6% (43/48), respectively. Conclusion: Emergency TAVR may be a safe and effective treatment for patients with severe decompensated aortic valve stenosis.
Acute Kidney Injury
;
Aged
;
Aged, 80 and over
;
Aortic Valve/surgery*
;
Aortic Valve Stenosis/surgery*
;
Female
;
Heart Valve Prosthesis
;
Humans
;
Male
;
Middle Aged
;
Myocardial Infarction/surgery*
;
Retrospective Studies
;
Risk Factors
;
Stroke
;
Stroke Volume
;
Transcatheter Aortic Valve Replacement/methods*
;
Treatment Outcome
;
Ventricular Function, Left
7.Strike Velocity Prediction of Stick Blunt Instruments Based on Backpropagation Neural Network.
Hai-Yan LI ; Hai-Fang LI ; Jian-Yu PAN ; Shi-Hai CUI ; Guang-Long HE ; Li-Juan HE ; Wen-le LÜ
Journal of Forensic Medicine 2022;38(5):573-578
OBJECTIVES:
To analyze and predict the striking velocity range of stick blunt instruments in different populations, and to provide basic data for the biomechanical analysis of blunt force injuries in forensic identification.
METHODS:
Based on the Photron FASTCAM SA3 high-speed camera, Photron FASTCAM Viewer 4.0 and SPSS 26.0 software, the tester's maximum striking velocity of stick blunt instruments and related factors were calculated and analyzed, and inputed to the backpropagation (BP) neural network for training. The trained and verified BP neural network was used as the prediction model.
RESULTS:
A total of 180 cases were tested and 470 pieces of data were measured. The maximum striking velocity range was 11.30-35.99 m/s. Among them, there were 122 female data, the maximum striking velocity range was 11.63-29.14 m/s; there were 348 male data, the maximum striking velocity range was 20.11-35.99 m/s. The maximum striking velocity of stick blunt instruments increased with the increase of weight and height, but there was no obvious increase trend in the male group; the maximum striking velocity decreased with age, but there was no obvious downward trend in the female group. The maximum striking velocity of stick blunt instruments has no significant correlation with the material and strike posture. The root mean square error (RMSE), the mean absolute error (MAE) and the coefficient of determination (R2) of the prediction results by using BP neural network were 2.16, 1.63 and 0.92, respectively.
CONCLUSIONS
The prediction model of BP neural network can meet the demand of predicting the maximum striking velocity of different populations.
Male
;
Humans
;
Female
;
Neural Networks, Computer
;
Software
;
Wounds, Nonpenetrating
;
Forensic Medicine
8.Usage of Chinese Herbs in Cancer Patients in Southern China: A Survey.
Shao-Quan XIONG ; Yu CHEN ; Li-Juan WANG ; Pan-Pan LYU ; Wan LIAO ; Cui WANG ; Jian-Long KE ; Xi ZHU ; Jin-Yang WANG ; Xian-Ying SHEN ; Guang-Ping LI ; Li-Zhu LIN
Chinese journal of integrative medicine 2021;27(7):502-508
OBJECTIVE:
To study the use of Chinese medicine (CM) in cancer patients in southern China.
METHODS:
A total of 1,950 cancer patients finished questionnaires in four provinces in southern China. The survey included socio-demographic and clinical characteristics of participants, dosage forms, efficacy, and side effects.
RESULTS:
The study results showed that cancer patients with higher education (>12 years) were more likely to accept the treatment of Chinese herbs. There were 54.61% (1,065 cases) of patients chose Chinese herbs for the initial treatment and 14.46% (282 cases) chose Chinese herbs as monotherapy. Most patients (54.51%, 1,063 cases) continuously used CM for more than 6 months, and a few of them (212 cases) used CM for up to 3 years. All kinds of dosage forms of CM had been used, including CM decoction, CM patent prescription and CM injection. Concerning the efficacy in the view of patients, 40.31% (786 cases) believed that it would be effective to take Chinese herbs before they starting the anti-cancer treatment, and the percentage increased to 81.08% after 1-month CM treatment. The effect of Chinese herbs was mainly demonstrated by symptom relief and improvement of quality of life, and 8.31% (162 cases) of patients experienced control of tumor growth and decreased tumor markers. Furthermore, only 14.31% (279 cases) participants reported that they experienced side effects during CM treatment.
CONCLUSION
This large scale investigation reflects the current situation of domestic CM usage objectively and comprehensively, which might provide new ways for cancer treatment.
9. Morphology of the fifth metacarpal bone based on three-dimensional computed tomography image and its clinical significance
Jiu-Zheng DENG ; Zhe ZHAO ; Jian-Jin ZHU ; Yong-Wei PAN ; Xiao-Guang CHENG ; Yi-Min MA
Acta Anatomica Sinica 2020;51(3):411-415
Objective To discuss the morphological features of the fifth metacarpal bone and clinical significance by measuring the three-dimensional (3-D) reconstruction model, and to improve the clinical technique and surgical instruments. Methods A total of 114 3-D reconstruction models based on computed tomography data of fifth metacarpal bone were created. The length, the radius of head, the radius of arc, the 1/ 2 central angle of arc, the distance of head offset, the ratio of head offset, the inner diameter of the isthmus of medullary space were measured based on 3-D models. Results The fifth metacarpal bone length was(51. 55±3. 01) mm. The radius of the fifth metacarpal head was (6. 59± 0. 49)mm. The radius of the fifth metacarpal bone arc was(99. 58±26. 83)mm. The 1/ 2 central angle of fifth metacarpal bone arc was(15. 90±3. 36)°. The distance of the fifth metacarpal head offset was(0. 49±0. 26) mm. The ratio of head offset was(7. 4±3. 9)%. The inner diameter of the isthmus of medullary space was (2. 28±0. 77)mm. Conclusion The length, the radius of head, the distance of head offset, the inner diameter of the isthmus of medullary space are different between male and female, and the other parameters are not different. There is no significant difference between left and right hand.
10. Changes of vascular endothelial growth factor and neuropilin-1 in rats with early blast lung injury and its correlation with lung injury
Medical Journal of Chinese People's Liberation Army 2019;44(1):63-69
[Abstract] Objective To explore the regular pattern of the changes of vascular endothelial growth factor (VEGF) and neuropilin-1 (NRP-1) of rat model in early (<48h) blast lung injury (BLI) and the correlation of such changes to the degree of lung injury. Methods The rat model of lung blast injury was established with reducing three-way pipe and fixed pressure pneumatic simulation device. Forty SD rats were randomly divided into 5 groups: control group (C), 1h after blast (B1h), 6h after blast (B6h), 24h after blast (B24h) and 48h after blast (B48h) group. The data were collected of concentrations of VEGF and NRP-1 in serum and lung tissue. The degree of lung injury was estimated. Results The levels of NRP-1 increased in both serum and lung tissue (P<0.01) and the level of VEGF decreased in lung tissue (P<0.05) in control group than in B groups. The concentrations of NRP-1 in serum and lung tissue were highest, and of VEGF in lung tissue were lowest in the group B6h. The lung injury score was positively correlated with the levels of NRP-1 in lung tissue (r=0.429, P=0.014). In group B6h, the lung injury score was negatively correlated with the levels of VEGF in lung tissue (r=–0.769, P=0.013). In group B48h, both the lung injury score and the wet and dry ratios (W/D) of lung tissue were positively correlated with the concentrations of VEGF in serum (r=0.777, P=0.012 and r=0.687, P=0.030, respectively). Pulmonary interstitial vascular rupture, alveolar hemorrhage, alveolar epithelial cell and capillary injuries, and accompanied by inflammatory cell infiltration were the basic pathological changes of BLI. Conclusion The levels of NRP-1 and VEGF in serum and lung tissue may vary with time and are correlated with the degree of lung injury in early BLI.

Result Analysis
Print
Save
E-mail