1.Quality evaluation of Abri Mollis Herba
Xingmei LIN ; Huiping LI ; Ting WANG ; Chengzhong ZHANG ; Baokang HUANG
Journal of Pharmaceutical Practice and Service 2025;43(5):251-258
		                        		
		                        			
		                        			Objective To establish a quality evaluation method for Abri Mollis Herba based on its morphological characteristics, microscopic features, and the determination of principal component contents. Methods The morphological characteristics of Abri Mollis Herba were identified by morphological authentication methods. Microscopic techniques were employed to observe the microscopic features of both the powdered form and cross-sectional tissue of Abri Mollis Herba. Additionally, a high-performance liquid chromatography (HPLC) method was developed to establish the quantify the main components, abrine and soyasaponin Bb, in Abri Mollis Herba. Results The morphological characteristics of Abri Mollis Herba were defined by numerous long pubescence on both the upper and lower surfaces of the leaflets, with indistinct veins and vein islands. The microscopic features mainly included non-glandular hairs, prismatic crystals, and crystal-sheathed fibers in the powdered form. In the root cross-section, xylem bundles, rays, vessels, and stone cells were visible. The stem cross-section displayed rays, vessels, and a hollow pith, while the leaf cross-section revealed collateral vascular bundles, vessels, and prismatic crystals. Conclusion The quality of Abri Mollis Herba could be effectively evaluated by the combination of morphological identification, microscopic authentication, and the quantification of main components abrine and soyasaponin Bb .
		                        		
		                        		
		                        		
		                        	
2.Research progress in regulating intestinal flora structure and repairing intestinal mucosal barrier damage through Tongfu method
Yiheng WU ; Zhiwei XU ; Huiping ZHU ; Song YU ; Chuan ZHANG ; Hengyue DING ; Hongwen SUN
International Journal of Traditional Chinese Medicine 2024;46(4):536-540
		                        		
		                        			
		                        			The intestinal flora and gut barrier function are of great significance for gut function and human health. When the intestinal flora is disrupted and the gut barrier structure is disrupted, it can lead to bacterial translocation, endotoxin influx into the bloodstream, and the production of pro-inflammatory factors, leading to various tissue damage in the body. Tongfu method in TCM can affect the intestinal environment by regulating intestinal permeability and immune response, restoring normal intestinal movement, and regulating the structure and metabolites of intestinal flora, thereby maintaining intestinal homeostasis and body health. The research on regulating intestinal flora and improving intestinal barrier function by Tongfu method can provide reference for further research on the relationship between TCM and intestinal microecology, and provide ideas for clinical treatment.
		                        		
		                        		
		                        		
		                        	
3.Clinical and imaging features of extralobar pulmonary sequestration with torsion in children
Huiping BAI ; Yuewen HAO ; Siwen WEI ; Peng ZHANG ; Aihui ZHANG
Journal of Practical Radiology 2024;40(1):100-102
		                        		
		                        			
		                        			Objective To investigate the clinical and imaging features of extralobar pulmonary sequestration(ELS)with torsion.Methods The clinical and imaging data,surgical records and pathological results of four ELS children with torsion were analyzed ret-rospectively.Results All four children presented with abdominal pain,and all CT scans showed soft tissue masses on the medial side of the lower lobe,and there were 2 masses with long fusculine-shaped in the right pleural cavity,2 round masses in the left pleural cavity,all of which were accompanied by pleural effusion and poor ventilation of adjacent lung lobes.There were 1 case without enhance-ment,1 case with mild enhancement,and 2 cases with simple marginal linear enhancement.There were no patients with definitive supplying artery and 3 cases with peripheral post-intercostal dilated veins.Intraoperative ELS combined with torsion was shown,and the nutrient artery were derived from the thoracic aorta.All ELS showed bleeding and necrosis according to the pathological results,and 1 case was complicated with congenital pulmonary airway malformation(type 2).Conclusion ELS combined with torsion is mostly abdominal pain as the first symptom,and there are soft tissue mass adjacent to the lower lobe with pleural effusion on the affected side as the imaging features with no,mild or marginal linear enhancement,with no supplying artery,and with intracostal posterior venous expansion.
		                        		
		                        		
		                        		
		                        	
4.Efficacy,metabolic characteristics,safety and immunogenicity of AK-HER2 compared with reference trastuzumab in patients with metastatic HER2-positive breast cancer:a multicenter,randomized,double-blind phase Ⅲ equivalence trial
Yang LUO ; Tao SUN ; Zhimin SHAO ; Jiuwei CUI ; Yueyin PAN ; Qingyuan ZHANG ; Ying CHENG ; Huiping LI ; Yan YANG ; Changsheng YE ; Guohua YU ; Jingfen WANG ; Yunjiang LIU ; Xinlan LIU ; Yuhong ZHOU ; Yuju BAI ; Yuanting GU ; Xiaojia WANG ; Binghe XU ; Lihua SONG
China Oncology 2024;34(2):161-175
		                        		
		                        			
		                        			Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.
		                        		
		                        		
		                        		
		                        	
5.Accuracy of sacroiliac screw placement in robot-assisted navigation
Wenhui ZHANG ; Chunli WANG ; Lizhen FAN ; Yuping YANG ; Jinlong ZHANG ; Hui ZHANG ; Jie LIU ; Huiping TAI
Chinese Journal of Tissue Engineering Research 2024;28(24):3845-3849
		                        		
		                        			
		                        			BACKGROUND:Orthopedic robots have been widely used in clinical practice,and relevant reports have shown that they have many advantages such as minimal trauma and short surgical time.However,there is currently no clear report on how accurate they are. OBJECTIVE:To evaluate the accuracy of robot-assisted sacroiliac screw insertion. METHODS:A total of 131 patients with sacroiliac joint fracture and dislocation and sacral fracture admitted to the Department of Trauma Surgery,Gansu Provincial Hospital from January 2020 to April 2023 were retrospectively collected,including 131 S1 screws and 46 S2 screws,totaling 177 screws.They were divided into two groups based on whether robot-assisted navigation was performed.There were 63 cases of sacroiliac screws inserted under robot-assisted navigation(observation group),with 36 males and 27 females,aged 19-72 years,with a mean age of(45.3±17.6)years.Among them,39 cases were fixed with only S1 screws,while 24 cases were fixed with S1S2 screws,resulting in a total of 87 sacroiliac screws.Under C-arm fluoroscopy,68 cases of sacroiliac screws were inserted with bare hands(control group),including 41 males and 27 females,aged 23-67 years,with a mean age of(42.6±21.3)years.Among them,46 cases were fixed with simple S1 screws,while 22 cases were fixed with S1S2 screws,resulting in a total of 90 sacroiliac screws.A postoperative CT scan was performed to evaluate the number of S1 screws,S2 screws,total screw level,and calculate accuracy based on the method introduced by SMITH et al. RESULTS AND CONCLUSION:(1)In the observation group,62 S1 screws were accurately placed(62/63),with an accuracy rate of 98%.24 S2 screws were accurately placed(24/24),with an accuracy rate of 100%.The total number of screws accurately placed was 86(86/87),with an accuracy rate of 99%.(2)In the control group,58 S1 screws were accurately inserted(58/68),with an accuracy rate of 85%.19 S2 screws were accurately inserted(19/22),with an accuracy rate of 86%.The total number of screws accurately inserted was 77(77/90),with an accuracy rate of 86%.(3)There was a statistically significant difference in the accuracy of the S1 screw,S2 screw,and total screw between the two groups(P<0.05).It is suggested that the placement of sacroiliac screws under robot navigation has higher accuracy compared to manual placement under C-arm fluoroscopy,but still has a lower error rate in placement.
		                        		
		                        		
		                        		
		                        	
6.Early motor development in small for gestational age infants at high risk of brain injury
Ru JIAN ; Huiping ZHANG ; Jingyu BU ; Sa YUAN ; Yanni CHEN
Chinese Journal of Perinatal Medicine 2024;27(2):126-132
		                        		
		                        			
		                        			Objective:To investigate the characteristics of early motor development in small for gestational age (SGA) infants at high risk of brain injury.Methods:This study retrospectively enrolled a total of 81 SGA infants and appropriate for gestational age (AGA) infants who were at high risk of brain injury and attended outpatient follow-up visits in Xi'an Children's Hospital from February to October 2022. Seventeen SGA infants (SGA group) and 24 AGA infants (AGA group) were assessed for motor development using the Test of Infant Motor Performance (TIMP) at 2-5 weeks of corrected age (CA) and 20 SGA infants (SGA group) and 20 AGA infants (AGA group) were assessed at 14-17 weeks of CA. Independent samples t-test, rank-sum test, and Chi-square test were used to compare the demographic characteristics, high-risk factors of brain injury, and TIMP scores between the two groups. Results:At 2-5 weeks and 14-17 weeks of CA, the birth weights of SGA group were both less than those of AGA group [(1 817.1±440.3) vs. (2 630.0±560.9) g, t=-4.98; (1 752.0±434.4) vs. (2 226.3±699.8) g, t=-2.58; both P<0.05], but there were no significant differences in gestational age at birth or high-risk factors of brain injury between the two groups (all P>0.05). (1) At 2-5 weeks of CA: SGA group had lower total TIMP score [(71.6±13.7) vs. (80.5±11.5) scores, t=-2.26, P=0.029], elicited item score [61.0 scores (41.0-85.0 scores) vs. 69.1 scores (49.0-96.0 scores), Z=-2.15, P=0.037], sitting position score [8.8 scores (3.0-19.0 scores) vs. 11.2 scores (5.0-22.0 scores), Z=-2.07, P=0.038], and prone position score [(9.8±3.1) vs. (12.3±3.1) scores, t=-2.19, P=0.034] when compared with AGA group. (2) At 14-17 weeks of CA: The standing position score of the SGA group was lower than that of the AGA group [6.5 scores (4.0-11.0 scores) vs. 7.7 scores (2.0-11.0 scores), Z=-2.05, P=0.040], but no statistical difference was observed in the total TIMP score or the scores of sitting, supine, prone, turning, and lateral positions between the two groups (all P>0.05). Conclusion:Early motor performance of SGA infants is inferior to AGA infants before five months of age, which is embodied in the poor head control at 2-5 weeks of CA that further affects the stability of standing posture in them at 14-17 weeks of CA.
		                        		
		                        		
		                        		
		                        	
7.Effect of miR-15a-5p on autophagy of placental trophoblasts in preeclampsia
Sumei YU ; Yuyue ZHANG ; Liwen MA ; Yuanjun KUANG ; Qingning CHANG ; Min KONG ; Huiping ZHANG
The Journal of Practical Medicine 2024;40(12):1631-1636
		                        		
		                        			
		                        			Objective Investigating the impact of miR-15a-5p on autophagy in trophoblast cells of pre-eclamptic placenta.Methods Collect 20 cases of normal placental tissue and 20 cases of preeclamptic placental tissue from December 2020 to December 2022.Use fluorescence quantitative PCR to detect the expression of miR-15a-5p in placental tissue and trophoblast cells,and study its correlation with patient blood pressure.The HTR8-S/Vneo cells are divided into normal group(control)and hypoxia group,and the effect of hypoxia on the expression of miR-15a-5p is observed.Additionally,mimic-NC group,mimic-NC+hypoxia group,miR-15a-5p mimic group,miR-15a-5p mimic+hypoxia group,inhibitor-NC group,inhibitor-NC+hypoxia group,miR-15a-5p inhibitor group,and miR-15a-5p inhibitor+hypoxia groups are set up to observe the effect of miR-15a-5p on hypoxia-induced autophagy-related proteins LC3B and p62 protein in trophoblast cells.Western blot is used to detect the expression levels of autophagy-related proteins LC3B and p62 protein in each group;TargetScan website predicts the target genes of miR-15a-5p,and detects their expression levels in placental tissue and trophoblast cells.Results Compared with the control group,the expression levels of miR-15a-5p were significantly increased in the placentas and hypoxic trophoblasts of preeclampsia,and they were positively correlated with the blood pressure of the patients.Under hypoxic conditions,the overexpressed miR-15a-5p promoted the protein expression of LC3BII/I,while the relative expression of P62 was decreased.But after interference with miR-15a-5p,LC3BII/I expression was down-regulated and P62 expression was up-regulated.The results of quantitative PCR and Western blot showed that the expression levels of YAP1 in the preeclampsia placental tissues and hypoxic trophoblasts were significantly reduced.Conclusion The upregulation of miR-15a-5p in trophoblast cells of the placenta in individuals with preeclampsia could enhance autophagy in preeclampsia by forming a complex with YAP1.
		                        		
		                        		
		                        		
		                        	
8.Contemporary Evidence Summary of Strategies for Weaning From Extracorporeal Membrane Oxygenation in Adult Patients
Chaonan WO ; Shuai ZHANG ; Weifang FAN ; Huiping YAO ; Lili GE ; Ruoyu LUO ; Dechuan DENG ; Juanhong CHEN
Chinese Circulation Journal 2024;39(9):896-902
		                        		
		                        			
		                        			Objectives:To retrieve,evaluate and summarize the contemporary evidence of strategies for weaning from extracorporeal membrane oxygenation(ECMO)of adult patients,and to provide evidence-based reference for clinical practice. Methods:The Web of Science,Embase,Cochrane Library,PubMed,Wanfang Database,CNKI,VIP website,SinoMed,BMJ Best Practice,National Institute for Health and Care Excellence,Joanna Briggs Institute Library,UpToDate and the website of Agency for Healthcare Research and Quality,Society of Critical Care Medicine,American Association of Critical-Care Nurses,European Society of Intensive Care Medicine and Extracorporeal Life Support Organization were researched to collect the literature related to randomized controlled trials,systematic reviews,guidelines,evidence summaries,expert consensuses and clinical decisions in this field.The time limit for the retrieval is from the inception of databases until July 2023. Results:A total of 13 related literature were retrieved,including 4 guidelines,4 expert consensuses,3 clinical decisions and 2 system reviews.Totally 42 evidences were formulated based on retrieved literature,including adequately accessing the ability of gas exchange before weaning from veno-venous ECMO(V-V ECMO)and withdrawing from veno-arterial ECMO(V-A ECMO)as soon as possible when patients's heart function has recovered,involving six aspects such as team composition,anticoagulation measures,assessment before weaning,weaning implementation,cannula and wound management and quality measures. Conclusions:It is suggested to build a professional ECMO team based on the actual hospital situation,to follow the contemporary evidence to standardize the weaning process of patients from ECMO to ensure the patients'safety and improve the outcomes.
		                        		
		                        		
		                        		
		                        	
9.Research Progress on Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement
Nan CHEN ; Xi PENG ; Junpeng LIU ; Huiping ZHANG
Chinese Circulation Journal 2024;39(9):924-930
		                        		
		                        			
		                        			Indications of transcatheter aortic valve replacement(TAVR)are extending to lower risk population.High atrioventricular block is one of the common complication of TAVR,permanent pacemaker implantation is receiving high recognition now.This review summarizes research progress on the anatomy,indicators,predictors and prognosis of permanent pacemaker implantation after TAVR.
		                        		
		                        		
		                        		
		                        	
10.Association between cerebral small vessel disease and mild cognitive impairment in the elderly
Journal of Apoplexy and Nervous Diseases 2024;41(4):329-335
		                        		
		                        			
		                        			Objective To investigate the association between cerebral small vessel disease (CSVD) and mild cognitive impairment (MCI) in the elderly. Methods A total of 109 elderly patients who were diagnosed with MCI from March 2022 to February 2023 were enrolled as experimental group, and 89 healthy controls with normal cognitive function were enrolled as control group. Demographic data and general clinical data were collected from all subjects, and the onset of CSVD was evaluated based on cranial MRI findings. The two groups were compared in terms of baseline data, general clinical data, and CSVD manifestations. The ordered multi-classification logistic regression model was used to identify the independent influencing factors for MCI in the elderly. Results There were 109 patients with MCI and 89 controls in this study. Compared with the experimental group, the control group had significantly longer education years, a significantly better economic status, a significantly higher degree of participation in social activities, and a significantly lower alcohol consumption rate (P<0.05). There were 90 subjects (82.57%) in the experimental group and 62 (69.66%) in the control group who had different CSVD phenotypes. The experimental group had significantly higher detection rates of LI and moderate-to-severe WMH than the control group (P<0.05), while there were no significant differences between the two groups in the detection rates of moderate-to-severe EPVS and CMB (P>0.05). There were significant differences between the two groups in the total load score of CSVD and the total load degree of CSVD (P<0.05). The logistic regression analysis showed that education years, participation in social activities, detection rate of CSVD, moderate-to-severe WMH, total load score of CSVD, and total load degree of CSVD were independent influencing factors for MCI in the elderly. Conclusion There is an increase in the detection rate of CSVD in the elderly patients with MCI, especially LI and moderate-to-severe WMH. The total load score of CSVD and the total load degree of CSVD are independently associated with MCI in the elderly.
		                        		
		                        		
		                        		
		                        	
            
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