1.Quality Evaluation of Fengshiding Capsules Based on National Drug Sampling and Testing
Lumei GUO ; Tao CHENG ; Donglan LIU ; Xingpeng LIU ; Ming YANG ; Fangfang SI ; Min ZOU ; Jialiang ZHU
Herald of Medicine 2025;44(9):1423-1430
Objective To systematically evaluate the quality of Fengshiding capsules,to analyze existing problems based on national drug sampling and testing,and to offer references and suggestions for improving quality control and regulatory supervision of this product.Methods A total of 136 batches of Fengshiding capsules were subjected to standard quality tests and exploratory analyses.HPLC was used to establish the content determination of Angelica dahurica,Cynanchum paniculatum,and Glycyrrhizae Radix,as well as the limit test for anabasine in the preparation.Additionally,an UPLC method was also employed to establish the characteristic chromatogram of Fengshiding capsules.A screening method for artificial pigments was developed,and UPLC-MS/MS was used to detect the illegal addition of chemical drugs in Fengshiding capsules.Results All 136 batches of samples passed inspection according to the current quality standards.However,based on exploratory study evaluations,the content determination results of Cynanchum paniculatum,Angelica dahurica,and Glycyrrhiza Radix were below the proposed limits.The limit test for anabasine did not exceed the proposed threshold.Furthermore,the characteristic chromatograms revealed missing peaks in several samples,and some batches contained artificial pigments and residues of acetaminophen.Conclusions The overall quality of Fengshiding capsules is rated as"average"based on national drug sampling and testing.To enhance product quality,it is recommended to improve quality standards,ensure the use of high-quality raw herbal materials,promote stronger internal oversight by manufacturers,and intensify regulatory supervision.
2.Quality Evaluation of Fengshiding Capsules Based on National Drug Sampling and Testing
Lumei GUO ; Tao CHENG ; Donglan LIU ; Xingpeng LIU ; Ming YANG ; Fangfang SI ; Min ZOU ; Jialiang ZHU
Herald of Medicine 2025;44(9):1423-1430
Objective To systematically evaluate the quality of Fengshiding capsules,to analyze existing problems based on national drug sampling and testing,and to offer references and suggestions for improving quality control and regulatory supervision of this product.Methods A total of 136 batches of Fengshiding capsules were subjected to standard quality tests and exploratory analyses.HPLC was used to establish the content determination of Angelica dahurica,Cynanchum paniculatum,and Glycyrrhizae Radix,as well as the limit test for anabasine in the preparation.Additionally,an UPLC method was also employed to establish the characteristic chromatogram of Fengshiding capsules.A screening method for artificial pigments was developed,and UPLC-MS/MS was used to detect the illegal addition of chemical drugs in Fengshiding capsules.Results All 136 batches of samples passed inspection according to the current quality standards.However,based on exploratory study evaluations,the content determination results of Cynanchum paniculatum,Angelica dahurica,and Glycyrrhiza Radix were below the proposed limits.The limit test for anabasine did not exceed the proposed threshold.Furthermore,the characteristic chromatograms revealed missing peaks in several samples,and some batches contained artificial pigments and residues of acetaminophen.Conclusions The overall quality of Fengshiding capsules is rated as"average"based on national drug sampling and testing.To enhance product quality,it is recommended to improve quality standards,ensure the use of high-quality raw herbal materials,promote stronger internal oversight by manufacturers,and intensify regulatory supervision.
3.MR lymphangiography radiomics for evaluating central conducting lymphatic anomaly
Yimeng ZHANG ; Jixue FENG ; Xiaojie ZHANG ; Haoyue LIU ; Mengke LIU ; Xingpeng LI ; Mingxia ZHANG ; Rengui WANG
Chinese Journal of Medical Imaging Technology 2024;40(11):1677-1681
Objective To observe the value of MR lymphangiography(MRL)radiomics for evaluating central conducting lymphatic anomaly(CCLA).Methods Sixty-one patients with complex lymphatic anomaly,including 41 CCLA(group A),20 non-CCLA(generalized lymphatic anomaly and Gorham-Stout disease)and 20 subjects with normal thoracic duct(group B,n=38)were retrospectively enrolled.Cervical and thoracic(combined with abdominal if necessary)MRL was acquired using three-dimensional heavily T2W fast spin echo sequence.ROI was delineated along overall thoracic duct,and radiomics features were extracted.Data sets of group A and B were divided into K subsets using 5-fold cross-validation.The union of(K-1)subset was always used as training set,while the other subsets were used as validation set.Radiomics model was constructed based on support vector machine(SVM)algorithm.Receiver operating characteristic curve was drawn,the area under the curve(AUC)was calculated to evaluate the efficacy of SVM model for assessing CCLA.Results The proportions of bifurcation,cystoid change and extension of main thoracic duct,and extension of terminal thoracic duct in group A were all higher,while of normal main and terminal thoracic duct in group A were both lower than those in group B(all P<0.05).No significant difference of proportions of multiple thoracic ducts,dextral thoracic duct,part of thoracic duct invisible,multiple terminal thoracic ducts,cystoid change of terminal thoracic duct nor terminal thoracic duct pampiniform was found between groups(all P>0.05).The sensitivity,specificity,accuracy,positive predictive,negative predictive and AUC of SVM model for evaluating CCLA in training set was 78.95%,97.56%,88.61%,96.77%,83.33%and 0.920,respectively,which in validation set was 78.95%,83.57%,82.28%,83.33%,81.40%and 0.833,respectively.Conclusion MRL radiomics could be used to effectively evaluate CCLA.
4.Incidence and related factors of pericardial tamponade after left atrial appendage closure in patients with non-valvular atrial fibrillation
Binbin WANG ; Xiang XU ; Xingpeng WANG ; Huakang LI ; Qing YAO ; Haiyun HUANG ; Wenting WANG ; Chen WAN ; Feng LIU ; Yanli GUO ; Zhiyuan SONG
Journal of Army Medical University 2024;46(7):768-774
Objective To observe the incidence of pericardial tamponade(PT)after left atrial appendage closure(LAAC)in patients with non-valvular atrial fibrillation(NVAF),and to explore its related factors and outcomes.Methods NVAF patients who were hospitalized and treated with LAAC in Department of Cardiology of our hospital from August 2014 to March 2023 were selected for the study.The general clinical data,preoperative transthoracic echocardiography and transesophageal echocardiography data,results of routine preoperative laboratory tests,intraoperative data and follow-up data of the patients were collected through the hospital medical record management system.The enrolled patients were classified into the non-PT group(n=8)and the PT group(n =1184)according to whether PT occurred after LAAC or not.The incidence of PT,related risk factors and outcomes were statistically analyzed.Results This study included 639 males(53.6%)and 553 females(46.4%),with an average age of 68.1±9.65 years.The CHA2 DS2-VASc score was 4.51±1.72,and the HAS-BLED score was 3.36±1.09.PT occurred in 8 cases(0.67%),among them,6 cases occurred 1 to 33 h after LAAC,and 2 cases occurred on day 19 and day 27 after LAAC.As for the results of transesophageal echocardiography(TEE)and LAA angiography,compared with the non-PT group,the PT group had the significantly larger maximum caliber of the LAA(P=0.025,P=0.015),smaller maximum depth of the LAA(P=0.028,P=0.031),and lower success rate of one-time placement of the occluder(P=0.031);The occluder compression rate of the PT group was significantly greater than that of the non-PT group(P=0.046).Multivariate analysis showed that larger maximum diameter of LAA,smaller average effective depth of LAA and larger compression rate of occluder were the main risk factors for PT.All the 8 PT patients were cured by stopping antithrombotic drugs,pericardiocentesis or surgical drainage.During a mean follow-up of 39±27 months,there were no device-related thrombosis(DRT),ischemic stroke,systemic embolism and other complications in the PT group.Conclusion The incidence of PT after LAAC is low,which is related to the large diameter of LAA,the relatively insufficient depth of the LAA and the large compression rate of the occlude.PT can be cured by stopping antithrombotic drugs and pericardiocentesis/surgical drainage.
5.Surgical Treatment Strategy for Acute Type A Aortic Dissection Complicated With Neri Type C Coronary Artery Involvement on the Basis of Detailed Classification
Guijun ZHU ; Zhe YAN ; Yang LIU ; Zhiliang SONG ; Bin LI ; Xingpeng CHEN
Chinese Journal of Minimally Invasive Surgery 2024;24(11):731-736
Objective To explore the surgical treatment strategy of acute type A aortic dissection (ATAAD) complicated with Neri type C coronary artery involvement on the basis of detailed classification.Methods Clinical data of 21 cases of ATAAD complicated with Neri type C coronary artery involvement in our hospital from November 2020 to February 2024 were retrospectively analyzed.The dissection involved the coronary artery,and the onset time was less than 1 week.Total aortic arch replacement,descending aorta stent and elephant trunk artificial vessel placement,ascending aorta replacement,and coronary artery management were performed.The treatment of detailed classification and coronary artery was as follows.Seven cases with type C1 ( local damage and rupture of coronary artery opening,partial connection with pseudolumen,and no proximal coronary involvement) were repaired with artificial material"copper coin sample";3 cases with type C2 ( severe avulsion of coronary artery opening,complete connection with pseudolumen,slight proximal involvement of coronary artery,and no sleeve formation) were replaced with 8 mm artificial vessels;11 cases with type C3 ( severe avulsion of coronary artery opening,complete connection with pseudolumen,severe proximal involvement of coronary artery,and sleeve formation) were transplanted by great saphenous vein bypass.Results Two patients died in hospital (all type C3),all of whom had difficulty in cardioversion and were given extracorporeal membrane oxygenation (ECMO) assisted circulation,and passed away on the same day and the second day after surgery,respectively.Aortic and coronary CTA were re-examined in the remaining 19 patients before discharge,and no coronary artery opening stenosis or bridge stenosis was found.Aortic and coronary CTA were re-examined at 6,12,and 18 months after surgery,respectively.The 19 patients were followed up for 6-36 months ( mean,21 months),and there were no cases of coronary artery opening stenosis or bridge stenosis.According to the New York Heart Association (NYHA) functional classification,there were 15 patients with grade Ⅰ and 4 patients with grade Ⅱ.Conclusion The detailed classification of ATAAD combined with Neri type C coronary artery involvement has guiding significance for surgical precision treatment.
6.Surgical Treatment Strategy for Acute Type A Aortic Dissection Complicated With Neri Type C Coronary Artery Involvement on the Basis of Detailed Classification
Guijun ZHU ; Zhe YAN ; Yang LIU ; Zhiliang SONG ; Bin LI ; Xingpeng CHEN
Chinese Journal of Minimally Invasive Surgery 2024;24(11):731-736
Objective To explore the surgical treatment strategy of acute type A aortic dissection (ATAAD) complicated with Neri type C coronary artery involvement on the basis of detailed classification.Methods Clinical data of 21 cases of ATAAD complicated with Neri type C coronary artery involvement in our hospital from November 2020 to February 2024 were retrospectively analyzed.The dissection involved the coronary artery,and the onset time was less than 1 week.Total aortic arch replacement,descending aorta stent and elephant trunk artificial vessel placement,ascending aorta replacement,and coronary artery management were performed.The treatment of detailed classification and coronary artery was as follows.Seven cases with type C1 ( local damage and rupture of coronary artery opening,partial connection with pseudolumen,and no proximal coronary involvement) were repaired with artificial material"copper coin sample";3 cases with type C2 ( severe avulsion of coronary artery opening,complete connection with pseudolumen,slight proximal involvement of coronary artery,and no sleeve formation) were replaced with 8 mm artificial vessels;11 cases with type C3 ( severe avulsion of coronary artery opening,complete connection with pseudolumen,severe proximal involvement of coronary artery,and sleeve formation) were transplanted by great saphenous vein bypass.Results Two patients died in hospital (all type C3),all of whom had difficulty in cardioversion and were given extracorporeal membrane oxygenation (ECMO) assisted circulation,and passed away on the same day and the second day after surgery,respectively.Aortic and coronary CTA were re-examined in the remaining 19 patients before discharge,and no coronary artery opening stenosis or bridge stenosis was found.Aortic and coronary CTA were re-examined at 6,12,and 18 months after surgery,respectively.The 19 patients were followed up for 6-36 months ( mean,21 months),and there were no cases of coronary artery opening stenosis or bridge stenosis.According to the New York Heart Association (NYHA) functional classification,there were 15 patients with grade Ⅰ and 4 patients with grade Ⅱ.Conclusion The detailed classification of ATAAD combined with Neri type C coronary artery involvement has guiding significance for surgical precision treatment.
7.Survivin ( BIRC5 ) regulates bladder fibrosis in a rat model of partial bladder outlet obstruction.
Xingpeng DI ; Xi JIN ; Liyuan XIANG ; Xiaoshuai GAO ; Liao PENG ; Wei WANG ; Kaiwen XIAO ; Yu LIU ; Guo CHEN ; Chi YUAN ; Deyi LUO ; Hong LI ; Kunjie WANG
Chinese Medical Journal 2023;136(1):117-119
8.Macrophage-mediated tumor-targeted delivery of engineered Salmonella typhi murium VNP20009 in anti-PD1 therapy against melanoma.
Leyang WU ; Lin LI ; Shufeng LI ; Lina LIU ; Wenjie XIN ; Chenyang LI ; Xingpeng YIN ; Xuebo XU ; Feifei BAO ; Zichun HUA
Acta Pharmaceutica Sinica B 2022;12(10):3952-3971
Bacterial antitumor therapy has great application potential given its unique characteristics, including genetic manipulation, tumor targeting specificity and immune system modulation. However, the nonnegligible side effects and limited efficacy of clinical treatment limit their biomedical applications. Engineered bacteria for therapeutic applications ideally need to avoid their accumulation in normal organs and possess potent antitumor activity. Here, we show that macrophage-mediated tumor-targeted delivery of Salmonella typhimurium VNP20009 can effectively reduce the toxicity caused by administrating VNP20009 alone in a melanoma mouse model. This benefits from tumor-induced chemotaxis for macrophages combined with their slow release of loaded strains. Inspired by changes in the tumor microenvironment, including a decrease in intratumoral dysfunctional CD8+ T cells and an increase in PDL1 on the tumor cell surface, macrophages were loaded with the engineered strain VNP-PD1nb, which can express and secrete anti-PD1 nanoantibodies after they are released from macrophages. This novel triple-combined immunotherapy significantly inhibited melanoma tumors by reactivating the tumor microenvironment by increasing immune cell infiltration, inhibiting tumor cell proliferation, remodeling TAMs to an M1-like phenotype and prominently activating CD8+ T cells. These data suggest that novel combination immunotherapy is expected to be a breakthrough relative to single immunotherapy.
9.Application of gel adsorption tank in large-scale production of human prothrombin complex
Xiao LIU ; Xiangdong HAN ; Yijie LI ; Xingpeng WEI ; Guizhen CHEN ; Chenyao LEI ; Anshan ZHANG ; Xiaoyu LIU
Chinese Journal of Blood Transfusion 2021;34(12):1382-1384
【Objective】 To study the application effect of gel adsorbent tank in the production of human prothrombin complex concentrate(PCC). 【Methods】 Six batches of PCC were produced from 1000 L cryoprecipitated plasma, using the same gel twice for adsorption within the tank.The number of gel repeated application was examined by retrospective confirmation, and the adsorption rate, specific activity and residue of finished virus inactivation reagent were determined before and after adsorption. 【Results】 All 6 batches of PPC, produced by the same gel, satisfied quality criteria. Both PPC solution and the gel presented good color. The average activities of coagulation Factors Ⅱ, Ⅶ, Ⅸ and Ⅹ of six batches of PCC were 118.2%, 157.0%, 140.5% and 176.8%, respectively. The The adsorption capacity of coagulation factor Ⅱ, Ⅸ and Ⅹ were both 100% in the first and second adsorption, while coagulation factor Ⅶ were 75% and 81%, respectively. The average specific activity of coagulation factor Ⅸ was 0.7 IU/mg. The average residues of polysorbate 80 and tributyl phosphate products were 0 μg/mL and 33 μg/mL, respectively. The same batch of gel can be repeatedly used up to 6 times during the PCC process. 【Conclusion】 The gel adsorption tank presents good application value in the production of PCC, which can realize process amplification and automatic control.
10.Rationale and Study Design for Evaluating the Efficacy and Safety of Intracardiac Echocardiography-Guided Minimal-Fluoroscopy Ablation in Patients with Paroxysmal Atrial Fibrillation: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial (PAF-ICE Trial)
Jiang RUHONG ; Liu XINGPENG ; Zhang JIDONG ; Chen YU ; Wang RUI ; Wu MENGZUO ; Long DEYONG ; Li JIA ; Wang HAIXIONG ; Fan JIE ; Ju WEIZHU ; Ge WEILI ; Liu XU ; Deng HAI ; Wang WEIJIAN ; Yang PINGZHEN ; Li DING ; Huang XIAOBO ; Liu XIONGTAO ; Tao HAILONG ; Paul C. ZEI ; Tung RODERICK ; Wang XUNZHANG ; Jiang CHENYANG
Cardiology Discovery 2021;01(4):228-232
The feasibility and safety of intracardiac echocardiography (ICE)-guided catheter ablation for atrial fibrillation (AF) using a minimal/zero-fluoroscopy approach have recently been reported. This approach helps to reduce ionizing radiation exposure and orthopedic complications resulting from using lead aprons. The objectives of this planned prospective, multicenter randomized controlled trial (RCT) (paroxysmal AF (PAF)-ICE trial; ChiCTR2000033624) are to evaluate the efficacy and safety of ICE-guided minimal-fluoroscopy ablation in patients with PAF and the impact on occupational hazards among lab staff.Patients will be randomized in a 1:1 ratio to 2 groups: minimal fluoroscopy group ( n = 216) and traditional approach group ( n = 216). In the minimal fluoroscopy group, an ICE catheter will be used for geometry/anatomic construction, transseptal puncture, catheter tracking, and effusion monitoring. Pulmonary vein isolation (PVI) will be performed using an open-irrigated radiofrequency SmartTouch Surround Flow or SmartTouch catheter (Biosense Webster, Diamond Bar, California, USA), and confirmed by a multipolar Lasso or PentaRay catheter (Biosense Webster). In the traditional approach group, an ICE catheter will not be used. Transseptal puncture will be performed under fluoroscopic guidance, with all geometries constructed by mapping the catheters. The primary efficacy endpoint is freedom from AF recurrence (without antiarrhythmic medications) at 12 months after ablation. Other endpoints include duration of lead apron use, measures of intra-procedural efficiency, and peri-procedural complications. This RCT will evaluate the efficacy and safety of ICE-guided minimal-fluoroscopy ablation in patients with PAF, also evaluate the benefits to lab staff (regarding reducing occupational hazards) related to this "minimal/zero-fluoroscopy" and "leadless" mode.

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