1.Signals mining and analysis of adverse drug events of anifrolumab based on FAERS database
Fanbin YAN ; Jia WANG ; Lujie XU ; Chang LIU
Chinese Journal of Pharmacoepidemiology 2025;34(6):650-656
Objective To explore the adverse drug event(ADE)signals of anifrolumab,and to provide references for clinical safe medication.Methods The ADE reports related to anifrolumab from the third quarter of 2021 to the third quarter of 2024 in the U.S.Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)were collected.The report odds ratio(ROR)method,the comprehensive standard method of the U.K.Medicines and Healthcare Products Regulatory Agency(MHRA),and the Bayesian Confidence Interval Progressive Neural Network(BCPNN)method were employed to identify ADE signals related to anifrolumab.System-organ class(SOC)and preferred term in the Medical Dictionary for Regulatory Activities were used for data classification and statistics.Results A total of 1,186 ADE reports with anifrolumab as the primary suspected drug were collected,and 49 signals were identified,involving 14 SOCs.The top 3 SOCs in terms of report frequency ranking were general disorders and administration site reactions,infections and infestations,and nervous system disorders.The top 3 ADEs in terms of report frequency ranking were headache,joint pain,and herpes zoster.Vasculitis,pericarditis,proteinuria,and blood pressure abnormalities were suspected ADEs not documented in the specification and were also ADE signals with a high signal strength ranking.Conclusion The common ADE signals of anifrolumab are consistent with its drug instructions.However,when using anifrolumab in clinical practice,it is also necessary to be vigilant against the increase of various infectious diseases such as herpes zoster and new ADEs not included in the instructions such as pericarditis,to ensure the safety of patients'medication.
2.Clinical study on diagnosis and treatment of calculous small intestinal obstruction by single-balloon enteroscope
Mei WANG ; Ting SHEN ; Lujie MIAO ; Jiao HE ; Fu XU ; Yuan LU ; Kewen SUN
China Journal of Endoscopy 2025;31(3):85-88
Objective To explore the feasibility and efficacy of single-balloon enteroscope in the diagnosis and treatment of calculous small intestinal obstruction.Methods A retrospective analysis was performed on the clinical data of 16 patients who underwent endoscopic enterolith removal for small intestinal obstruction from July 2013 to December 2023.The outcomes of stone removal and therapeutic efficacy were evaluated.Results All the 16 patients successfully underwent single-balloon enteroscope.Among them,15 cases achieved successful stone extraction,while 1 case failed due to an oversized stone that could not pass through the pharyngoesophageal junction.The stone was subsequently pushed to the stomach and removed through surgical operation finally.Conclusion Single-balloon enteroscope has excellent efficacy in enterolith removal,with rapid postoperative recovery and less complications.It is worthy of widespread clinical application.
3.Clinical study on diagnosis and treatment of calculous small intestinal obstruction by single-balloon enteroscope
Mei WANG ; Ting SHEN ; Lujie MIAO ; Jiao HE ; Fu XU ; Yuan LU ; Kewen SUN
China Journal of Endoscopy 2025;31(3):85-88
Objective To explore the feasibility and efficacy of single-balloon enteroscope in the diagnosis and treatment of calculous small intestinal obstruction.Methods A retrospective analysis was performed on the clinical data of 16 patients who underwent endoscopic enterolith removal for small intestinal obstruction from July 2013 to December 2023.The outcomes of stone removal and therapeutic efficacy were evaluated.Results All the 16 patients successfully underwent single-balloon enteroscope.Among them,15 cases achieved successful stone extraction,while 1 case failed due to an oversized stone that could not pass through the pharyngoesophageal junction.The stone was subsequently pushed to the stomach and removed through surgical operation finally.Conclusion Single-balloon enteroscope has excellent efficacy in enterolith removal,with rapid postoperative recovery and less complications.It is worthy of widespread clinical application.
4.Recent advances in platelet lipid rafts
Diyang WU ; Lujie ZHOU ; Zhicheng WANG
Chinese Journal of Blood Transfusion 2025;38(10):1421-1426
Platelet lipid rafts are dynamic nanodomains enriched in cholesterol and sphingolipids within the plasma membrane. As pivotal hubs for signal transduction, membrane trafficking, and intercellular interactions, they have garnered significant attention in recent years for their roles in regulating platelet function and related disease mechanisms. This article reviews the structural characteristics and molecular composition of platelet lipid rafts, as well as their central roles in signal transduction and cytoskeletal reorganization. It particularly focuses on the functional abnormalities and pathological contributions of lipid rafts in diseases such as atherosclerosis, antiphospholipid antibody syndrome, and ANCA-associated vasculitis. Research indicates that lipid rafts coordinate platelet activation, inflammatory responses, and immunomodulatory processes by integrating receptor clustering, enrichment of signaling proteins, and regulation of metabolites. Finally, the article discusses the future prospects of lipid raft-targeted nanotherapeutic strategies and addresses challenges in translational research, providing a theoretical foundation and novel perspectives for understanding platelet biology and intervening in thrombo-inflammatory diseases.
5.Signals mining and analysis of adverse drug events of anifrolumab based on FAERS database
Fanbin YAN ; Jia WANG ; Lujie XU ; Chang LIU
Chinese Journal of Pharmacoepidemiology 2025;34(6):650-656
Objective To explore the adverse drug event(ADE)signals of anifrolumab,and to provide references for clinical safe medication.Methods The ADE reports related to anifrolumab from the third quarter of 2021 to the third quarter of 2024 in the U.S.Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)were collected.The report odds ratio(ROR)method,the comprehensive standard method of the U.K.Medicines and Healthcare Products Regulatory Agency(MHRA),and the Bayesian Confidence Interval Progressive Neural Network(BCPNN)method were employed to identify ADE signals related to anifrolumab.System-organ class(SOC)and preferred term in the Medical Dictionary for Regulatory Activities were used for data classification and statistics.Results A total of 1,186 ADE reports with anifrolumab as the primary suspected drug were collected,and 49 signals were identified,involving 14 SOCs.The top 3 SOCs in terms of report frequency ranking were general disorders and administration site reactions,infections and infestations,and nervous system disorders.The top 3 ADEs in terms of report frequency ranking were headache,joint pain,and herpes zoster.Vasculitis,pericarditis,proteinuria,and blood pressure abnormalities were suspected ADEs not documented in the specification and were also ADE signals with a high signal strength ranking.Conclusion The common ADE signals of anifrolumab are consistent with its drug instructions.However,when using anifrolumab in clinical practice,it is also necessary to be vigilant against the increase of various infectious diseases such as herpes zoster and new ADEs not included in the instructions such as pericarditis,to ensure the safety of patients'medication.
6.Analysis of learning curve for robot-assisted laparoscopic radical prostatectomy: a single operator’s initial experience in 65 cases
Ruihang ZHANG ; Jianwen HUANG ; Ying WANG ; Xinru ZHANG ; Lujie SONG ; Qiang FU ; Yinglong SA
Journal of Modern Urology 2024;29(3):219-223
【Objective】 To explore the learning curve of single-surgeon robot-assisted laparoscopic radical prostatectomy (RARP), which provides a reference for physicians who intend to carry out RARP. 【Methods】 The clinical data of 65 prostate cancer patients who underwent RARP in our hospital during Sep.2022 and Dec.2023 were retrospectively analyzed.The patients’ median age was 67.5(58.1-82.4) years, median total prostate-specific antigen (PSA) was 15.6 (6.7-98.4) ng/mL, median body mass index (BMI) was 20.8(17.4-27.3) and preoperative clinical stage of tumor was T2aN0M0-T3bN1M0.The cumulative sum (CUSUM) method was used to fit the learning curves of machine installation time and operation time.According to the inflection points, the learning curves were divided into different learning stages, and the clinical data of patients at different learning stages were compared. 【Results】 The learning curve of RARP was 12 cases.The 65 cases were divided into three stages: 1st-12th cases in the learning stage, 13rd-43rd cases in the mastery stage, and 44th-65th cases in the proficiency stage.With the increase of the number of surgical cases, the median operation time [191(100-360) min vs. 116(83-165) min vs. 90(75-105) min] and median intraoperative blood loss [403(180-900) mL vs. 236(180-305) mL vs. 94(30-200) mL] in the three stages showed a gradual downward trend (P<0.05).The median machines installation time of the learning stage was significantly longer than that in the mastery stage and the proficiency stage [25(21-28) min vs. 12(11-15) min vs. 12(11-14) min] (P<0.05).The positive surgical marginrate (PSM) in the learning stage was significantly higher than that in the mastery stage and proficiency stage (41.7% vs.22.6% vs.22.7%) (P<0.05). 【Conclusion】 For surgeons with rich experience in traditional laparoscopic surgery, the learning curve of RARP is about 12 cases, and after 43 cases, the operation time and intraoperative blood loss can be further reduced.
7.Establishment of reference intervals for thromboelastography in Shaanxi healthy population
Lujie HUANG ; Jie MA ; Mi WANG ; Fang YAN
Journal of Xi'an Jiaotong University(Medical Sciences) 2024;45(4):663-668
Objective To establish the reference interval of thromboelastography(TEG)for healthy adults in Shaanxi province so as to serve clinical precision blood transfusion.Methods According to the standard method of"Establishment of Reference Interval for Clinical Laboratory Test Items"(WS/T 402-2012),peripheral venous blood was collected from 386 selected patients in Shaanxi.The conventional coagulation and fibrinolysis indexes(PT,APTT,TT,FiB,FDP,and DD)were detected by hemagglutinometer,and the following parameters(R,K,Angle,MA,LY30,CI)were determined by thrombolysis graph.The 95%confidence interval was used to determine the reference interval of each parameter of thrombolysis diagram.Results The routine coagulation and fibrinolysis indexes of the 386 healthy volunteers were normal.Compared with the reference intervals of various TEG indicators provided by the manufacturer of TEG,7.2%(28/386)were diagnosed with coagulopathy,and the test specificity was only 44%(170/386).Furthermore,there was decreased R in 188 subjects(48.7%),increased K in 28 subjects(7.3%),and decreased Angle in 12 subjects(3.1%).The significant differences in R,MA and CI were found between males and females(P<0.05).The significantly different R and CI were revealed in different age ranges(P<0.05).Finally,the normal reference range of each parameter of thrombus elastigram in 386 cases was set for males(R:2.7-8.6,K:1.3-3.6,Angle:46.2-72.5,MA:49.5-69.3,LY30:0-8.0,CI:-3.2-3.6)and females(R:2.7-9.2,K:1.2-3.4,Angle:46.2-72.5,MA:49.5-69.3,LY30:0-8.0,CI:-3.2-3.6).Conclusion The reference interval of thrombolysis map of healthy people in Shaanxi is significantly different from that provided by the manufacturer.The thrombolysis map reference interval established in this study is more suitable for the clinical coagulation characteristics of the local population and can be better applied in clinical diagnosis and treatment services.
8.Robot-assisted modified bladder neck reconstruction for the treatment of female acquired urinary incontinence: a case report
Jianwen HUANG ; Ying WANG ; Xinru ZHANG ; Lujie SONG ; Qiang FU
Chinese Journal of Urology 2024;45(3):227-228
Female acquired urinary incontinence is a clinical challenge. This article reported a female patient who had urinary incontinence after excessive urethral caruncle resection. Urodynamics showed effective urethral length was 1.6 cm and maximal urethral pressure was 41 cm cmH 2O(1 cmH 2O=0.133 kPa). Urethroscopy showed urethral length was about 2 cm, urethral sphincter function was good, and urethral stricture was absent. The patient has undergone robot-assisted modified Leadbetter bladder neck reconstruction. The surgery was successfully completed without intraoperative complications. Urinary catheter was removed at 4 weeks after surgery, and the patient has complete urinary continence with unobstructed voiding. After 3 months of follow-up, the patient still has unobstructed voiding and urinary continence.
9.Comparison of robot-assisted Y-V plasty and laparoscopic Y-V plasty in the treatment of refractory bladder neck contracture after BPH surgery
Jianwen HUANG ; Xiaoyong HU ; Ying WANG ; Xinru ZHANG ; Lujie SONG ; Qiang FU
Chinese Journal of Urology 2024;45(4):320-324
Objective:To evaluate the efficacy of robot-assisted Y-V plasty (RAYV) and laparoscopic Y-V plasty (LYV) in the treatment of refractory bladder neck contracture (BNC) after BPH surgery.Methods:A retrospective analysis was performed for the clinical data of 42 patients with refractory BNC after BPH surgery from January 2020 to July 2023, including 18 RAYV and 24 LYV. There were no significant differences between both groups( P>0.05) in term of median age [68(62, 81) years vs. 70(61, 76) years], median body mass index [20.7(17.6, 26.1) kg/m 2 vs. 19.8(16.3, 25.3) kg/m 2], median Q max [9.4(5.6, 13.2) ml/s vs. 8.9(6.2, 12.2)ml/s], median IPSS [20.5(15, 23) vs. 21.1(17, 23)], median QOL score [4.6 (4, 6) points vs. 4.8 (4, 6) points] and median postvoid residual volume [84.7(58, 125)ml vs. 78.3(50, 120)ml]. Preoperative examination of one patient in the RAYV group showed no contractile function of the external urethral sphincter.The surgical procedure was basically the same for both groups: entering into the retropubic space, and incision of the anterior wall of bladder and prostate urethra was performed in an inverted Y-shaped. After excising the scar around the anterior wall of bladder neck, the apex of inverted V-shaped bladder wall flap is brought to the base of the Y-shaped incision using two 3-0 running suture. The catheter was removed 2 weeks after surgery. Perioperative and follow-up data were compared between the two groups. Results:All surgeries were successfully completed without complications. The difference between RAYV and the LYV group in operation time [71.8(50, 98)min vs. 105.9(71, 143)min] and postoperative drainage removal time [2.7(2, 4)d vs. 4.5(3, 7)d] was statistically significant ( P<0.05). There was no significant difference between both groups in term of intraoperative blood loss [50.4(20, 100) ml vs. 60.8(40, 150) ml] and postoperative hospital stay [4.1(3, 5)d vs. 4.6(3, 7)d]( P>0.05). All patients were followed up with a median follow-up of 16.5(2, 41) months. There was no significant difference between RAYV and LYV in term of postoperative Q max [27.9(11.7, 37.6) ml/s vs. 22.4(12.3, 31.5)ml/s], IPSS[5.1(4, 9) points vs. 4.8(4, 10) points], QOL[1.6(1, 3) points vs. 1.5(1, 3) points] and postvoid residual volume [5.6(0, 15) ml vs. 7.2(5, 20) ml] ( P>0.05). The postoperative bladder neck patency rates in the RAYV group and the LYV group were 94.4%(17/18) and 95.8%(23/24), respectively, with no significant difference( P>0.05). In terms of urinary continence, 1 patient in the RAYV group had no contractile function of the external urethral sphincter before surgery, and none of the 41 patients with good preoperative continence had urinary incontinence after surgery. Conclusions:The effect of RAYV in the treatment of refractory BNC after BPH surgery is comparable to that of LYV, but RAYV can shorten the operation time and postoperative drainage time.
10.Efficacy of Thulium laser enucleation-resection of prostate with bladder neck preservation for the treatment of BPH with a history of pelvic fracture urethral injury reconstruction
Jianwen HUANG ; Nailong CAO ; Ying WANG ; Xinru ZHANG ; Lujie SONG ; Qiang FU
Chinese Journal of Urology 2024;45(5):391-392
Pelvic fracture urethral injury (PFUI) may result in loss of external urethral sphincter function, and traditional transurethral resection of the prostate may increase risk of permanent urinary incontinence after surgery in patients with benign prostatic hyperplasia (BPH) with a history of PFUI reconstruction. In the study, hulium laser enucleation-resection of prostate(ThuLERP) with bladder neck preservation was used to treat 4 patients with BPH with a history of PFUI reconstruction. All operations were conducted smoothly, and all patients had unobstructed voiding and no permanent urinary incontinence at 3 months after surgery. ThuLERP with bladder neck preservation was safe and effective treatment of BPH with a history of PFUI reconstruction, and avoided the risk of permanent urinary incontinence.

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