1.Current Status and Optimization Strategies for Setting Objective Performance Criteria in Clinical Trials of Traditional Chinese Medicine
Jiaqi LAI ; Qian HUANG ; Xueyin CHEN ; Shaonan LIU ; Lihong YANG ; MIMAZHUOGA ; DAWA ; Zhijian LI ; Tuerxun WUFUER ; Xinfeng GUO
Journal of Traditional Chinese Medicine 2026;67(13):1461-1464
Current formulation of objective performance criteria (OPC) in traditional Chinese medicine (TCM) faces methodological challenges, including poor reporting quality, insufficient standardization of methods, limited comparability of study populations, and inadequate consideration of the genetic and environment particularities of ethnic minority populations. In response to these issues, this paper proposes optimization strategies for setting OPC in TCM, with particular attention to ethnic minority medicine. These include improving methodological techniques and statistical descriptions, ensuring transparency in meta-analyses and data sources; standardizing the estimation of point estimates and confidence intervals, and incorporating multidisciplinary expert consensus for value determination; introducing local real-world data from the same period, especially cohort study evidence, to compensate for the lack of high-quality randomized controlled trial data. Through process transparency and dynamic updating mechanisms, the credibility of OPC method can be enhanced, thereby providing methodological support for strengthening evidence-based research capacity in this field.
2.Efficacy and safety of pegylated interferon α-2b in treatment of patients with hepatitis B virus-related compensated liver cirrhosis: A real-world study
Yan WANG ; Lihong LI ; Anna WANG ; Jing WEN ; Jie YANG ; Yinong FENG ; Ye ZHANG ; Qianhui WANG
Journal of Clinical Hepatology 2026;42(7):1597-1606
ObjectiveTo investigate the antiviral efficacy of pegylated interferon α-2b (PEG-IFN-α-2b) in patients with HBV-related liver cirrhosis, to assess the safety and tolerability of this regimen, and to provide evidence-based medical evidence for optimizing the treatment strategies for patients with HBV-related compensated liver cirrhosis. MethodsA prospective study was conducted among 115 patients with HBV-related compensated liver cirrhosis and 114 patients with CHB who attended Third People’s Hospital of Taiyuan from January 2023 to March 2024. Treatment-naïve patients received PEG-IFN-α-2b monotherapy, while the patients once treated with nucleos(t)ide analogues (NAs) received PEG-IFN-α-2b add-on therapy. The patients with HBV-related compensated liver cirrhosis were followed up at baseline and at 12, 24, 36, and 48 weeks of treatment. Samples were collected from CHB patients at baseline and at the end of follow-up to assess virological indicators, routine blood test results, and liver function. The chi-square test was used for comparison of categorical data between groups; the independent samples t-test was used for comparison of normally distributed continuous data between two groups, and the one-way repeated measures analysis of variance was used for comparison among different time ponts within the same group,and the Bonferroni was applied for post-hoc pairwise comparisons; the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups, and the Friedman test was used for comparison across different time points within the same group, and the Nemenyi test was utilized for subsequent pairwise comparisons. The multivariate stepwise Logistic regression analysis was used to investigate the influencing factors for clinical cure. ResultsCompared with the CHB group, the HBV-related compensated liver cirrhosis group had a significantly higher mean age (43.50±9.97 years vs 40.90±8.16 years, t=2.160, P=0.032), a significantly higher proportion of patients with hepatitis B e antigen at baseline (28.70% vs 15.79%, χ2=4.788, P=0.029), and a significantly lower platelet level [(178.67±55.07)×109/L vs (194.93±55.79)×109/L, t=2.217, P=0.028]. Compared with the CHB group at the end of follow-up, the HBV-related compensated liver cirrhosis group had significantly lower HBV surface antigen (HBsAg) clearance rate (10.38% vs 33.04%, χ2=14.988, P<0.001) and HBV surface antibody positive rate (0.00% vs 19.64%, χ2=21.041, P<0.001). Compared with the CHB group at the end of follow-up,the HBV-related compensated liver cirrhosis group had significantly lower aminotransferase levels [ALT: 31.00(19.00~47.50) U/L vs 40.00(27.00~57.00) U/L, Z=2.433, P<0.05; AST: 31.00(23.00~45.50) U/L vs 37.00(25.00~52.00) U/L, Z=1.963, P<0.05], but significantly higher level of white blood cells (WBC) [(4.02±1.56)×109/L vs (3.59±1.24)×109/L, t=2.272, P<0.05], neutrophils [(2.39±1.17)×109/L vs (1.87±0.94)×109/L, t=3.284, P<0.05], and platelets [(143.93±68.10)×109/L vs (121.88±49.72)×109/L, t=2.588, P<0.05]. A lower level of HBsAg (OR=0.997, 95%CI: 0.996 — 0.999, P<0.001) and previous treatment with NAs (OR=5.889, 95%CI: 2.195 — 17.330, P<0.001) were positive predictive factors for clinical cure, while liver cirrhosis (OR=0.177, 95%CI: 0.063 — 0.470, P<0.001) was a negative predictive factor for clinical cure. During follow-up, no patients experienced acute decompensation or progression to hepatocellular carcinoma, and the main adverse events included fever, fatigue, reductions in WBC and platelets, weight loss, alopecia, and thyroid dysfunction. In the subgroup analysis of HBV-related compensated liver cirrhosis, in both the treatment-naïve patients and the patients previously treated with NAs, there was a significant reduction in HBsAg level from baseline to week 36 of treatment [treatment-naïve: 99.25 (5.87 — 1 212.35) IU/mL vs 403.47 (36.94 — 2 569.02) IU/mL, P<0.05; previously treated with NAs: 205.94 (14.00 — 737.80) IU/mL vs 427.03 (65.64 — 1 552.65) IU/mL, P<0.05] and week 48 of treatment [treatment-naïve: 85.45 (0.58 — 827.56) IU/mL vs 403.47 (36.94 — 2 569.02) IU/mL, P<0.05; previously treated with NAs: 45.28 (0.16 — 267.27) IU/mL vs 427.03 (65.64 — 1 552.65) IU/mL, P<0.05]. There were significant increases in the levels of aminotransferases during treatment, as well as significant reductions in the levels of WBC, neutrophils, platelets, and hemoglobin (all P<0.05). ConclusionAlthough a finite course of PEG-IFN-α-2b therapy has achieved a relatively low rate of clinical cure in the treatment of HBV-related compensated liver cirrhosis, it can still significantly reduce the level of HBsAg, and this treatment regimen has good safety and tolerability, without accelerating disease progression.
3.Influencing factors for delay in healthcare-seeking, definitive diagnosis, identification in patients with pulmonary tuberculosis in Minhang District
MA Qiongjin ; YAN Huiqin ; WU Yunhua ; GUO Xu ; YANG Lijia ; TANG Lihong ; YANG Shengyuan
Journal of Preventive Medicine 2025;37(1):59-64
Objective:
To investigate the influencing factors for delay in healthcare-seeking, definitive diagnosis and identification in patients with pulmonary tuberculosis (PTB) in Minhang District, Shanghai Municipality, so as to provide the basis for effectively reducing delay in PTB patients.
Methods:
Data of PTB patients in Minhang District from 2017 to 2022 were collected from the Infectious Disease Reporting Information System of Chinese Disease Prevention and Control Information System. The prevalence rates of delay in healthcare-seeking, definitive diagnosis and identification were analyzed, and factors affecting delay in healthcare-seeking, definitive diagnosis and identification were identified using multivariable logistic regression models.
Results:
A total of 4 214 PTB patients were reported in Minhang District from 2017 to 2022, including 2 802 males and 1 412 females, with a male-to-female ratio of 1.98∶1. The majority of patients were aged 25 to <45 years (1 664 cases, 39.49%). The prevalence rates of delay in healthcare-seeking, definitive diagnosis and identification were 36.81%, 30.21% and 38.09%, respectively. Delay in healthcare-seeking was associated with the year (2018, OR=0.708; 2019, OR=0.549; 2020, OR=0.670; 2021, OR=0.682), gender (female, OR=1.199), occupation (worker, OR=1.379; housekeeping service/housework/unemployed, OR=1.481), case identification route (symptom-based consultation, OR=11.159), and level of the first-diagnosed hospital (city-level, OR=1.528). Delay in definitive diagnosis was associated with age (45 to <65 years, OR=1.476), occupation (commercial service, OR=0.687; housekeeping service/housework/unemployed, OR=0.672), household registration (non-local, OR=0.820), case identification route (symptom-based consultation, OR=0.616), pathogen test result (negative/not tested, OR=1.903), and the level of the first-diagnosed hospital (city-level, OR=0.311). Delay in identification was associated with the year (2018, OR=0.785; 2019, OR=0.647; 2020, OR=0.790; 2021, OR=0.710), occupation (commercial service, OR=0.687), household registration (non-local, OR=0.848) and level of the first-diagnosed hospital (city-level, OR=0.560)
Conclusions
Year, gender, occupation, case identification route and level of the first-diagnosed hospital are influencing factors for delay in healthcare-seeking in PTB patients. Age, occupation, household registration, case identification route, pathogen test result and level of the first-diagnosed hospital are influencing factors for delay in definitive diagnosis. Year, occupation, household registration and level of the first-diagnosed hospital are influencing factors for delay in identification.
4.Epidemiological characteristics of human brucellosis in Jiande City from 2005 to 2024
YANG Xianqing ; FANG Lihong ; FANG Lian ; ZHONG Rongwan ; WANG Fei ; LIANG Jie ; HUANG Yanyin ; XU Xiaoping
Journal of Preventive Medicine 2025;37(3):304-307,311
Objective:
To investigate the epidemiological characteristics of human brucellosis in Jiande City, Zhejiang Province from 2005 to 2024, so as to provide the evidence for strengthening the prevention and control of brucellosis.
Methods:
Data on brucellosis cases and surveillance in Jiande City from 2005 to 2024 were collected through the Chinese Disease Prevention and Control Information System, the annual brucellosis surveillance reports from the Jiande Center for Disease Control and Prevention, and the annual summaries of brucellosis prevention and control efforts. The epidemiological characteristics of human brucellosis were analyzed using a descriptive epidemiological method.
Results:
A total of 1 125 individuals were monitored in Jiande City from 2005 to 2024, with 18 seropositive cases identified and the seropositivity rate of 1.60%. The average annual seropositivity rate from 2015 to 2024 was 3.35%, which was significantly higher than that of 0.57% from 2005 to 2014 (P<0.05). There were 10 confirmed brucellosis cases and 8 asymptomatic infections, with no reported deaths. The peak incidence occurred between March and August. Among the 16 towns (streets) in Jiande City, 8 reported brucellosis cases. Of the brucellosis cases, 14 were male and 4 were female, with a male-to-female ratio of 3.5∶1. The majority of cases (13 cases) were aged between 40 and 60 years. Occupational exposure was identified in 16 cases, all of whom were infected through direct hand contact with the excreta, secretions, or animal products of infected sheep or cattle. The primary source of infection was sheep, followed by cattle. Five strains of Brucella were isolated and cultured, all identified as Brucella melitensis biovar 3.
Conclusions
The brucellosis epidemic in Jiande City remained at a sporadic and low prevalence level from 2005 to 2024, with an increasing trend observed from 2015 to 2024. Male occupational groups aged 40 to 60 years were the key population for brucellosis prevention and control, and sheep were the primary source of infection.
5.A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants.
Shuang LIU ; Hongsheng CHEN ; Zaiwei SONG ; Qi GUO ; Xianglin ZHANG ; Bingyi SHI ; Suodi ZHAI ; Lingli ZHANG ; Liyan MIAO ; Liyan CUI ; Xiao CHEN ; Yalin DONG ; Weihong GE ; Xiaofei HOU ; Ling JIANG ; Long LIU ; Lihong LIU ; Maobai LIU ; Tao LIN ; Xiaoyang LU ; Lulin MA ; Changxi WANG ; Jianyong WU ; Wei WANG ; Zhuo WANG ; Ting XU ; Wujun XUE ; Bikui ZHANG ; Guanren ZHAO ; Jun ZHANG ; Limei ZHAO ; Qingchun ZHAO ; Xiaojian ZHANG ; Yi ZHANG ; Yu ZHANG ; Rongsheng ZHAO
Journal of Zhejiang University. Science. B 2025;26(9):897-914
Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C0), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug-drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage*
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Drug Monitoring/methods*
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Humans
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Organ Transplantation
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Immunosuppressive Agents/administration & dosage*
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Delphi Technique
6.Expert consensus on apical microsurgery.
Hanguo WANG ; Xin XU ; Zhuan BIAN ; Jingping LIANG ; Zhi CHEN ; Benxiang HOU ; Lihong QIU ; Wenxia CHEN ; Xi WEI ; Kaijin HU ; Qintao WANG ; Zuhua WANG ; Jiyao LI ; Dingming HUANG ; Xiaoyan WANG ; Zhengwei HUANG ; Liuyan MENG ; Chen ZHANG ; Fangfang XIE ; Di YANG ; Jinhua YU ; Jin ZHAO ; Yihuai PAN ; Shuang PAN ; Deqin YANG ; Weidong NIU ; Qi ZHANG ; Shuli DENG ; Jingzhi MA ; Xiuping MENG ; Jian YANG ; Jiayuan WU ; Yi DU ; Junqi LING ; Lin YUE ; Xuedong ZHOU ; Qing YU
International Journal of Oral Science 2025;17(1):2-2
Apical microsurgery is accurate and minimally invasive, produces few complications, and has a success rate of more than 90%. However, due to the lack of awareness and understanding of apical microsurgery by dental general practitioners and even endodontists, many clinical problems remain to be overcome. The consensus has gathered well-known domestic experts to hold a series of special discussions and reached the consensus. This document specifies the indications, contraindications, preoperative preparations, operational procedures, complication prevention measures, and efficacy evaluation of apical microsurgery and is applicable to dentists who perform apical microsurgery after systematic training.
Microsurgery/standards*
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Humans
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Apicoectomy
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Contraindications, Procedure
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Tooth Apex/diagnostic imaging*
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Postoperative Complications/prevention & control*
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Consensus
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Treatment Outcome
7.Expert consensus on pulpotomy in the management of mature permanent teeth with pulpitis.
Lu ZHANG ; Chen LIN ; Zhuo CHEN ; Lin YUE ; Qing YU ; Benxiang HOU ; Junqi LING ; Jingping LIANG ; Xi WEI ; Wenxia CHEN ; Lihong QIU ; Jiyao LI ; Yumei NIU ; Zhengmei LIN ; Lei CHENG ; Wenxi HE ; Xiaoyan WANG ; Dingming HUANG ; Zhengwei HUANG ; Weidong NIU ; Qi ZHANG ; Chen ZHANG ; Deqin YANG ; Jinhua YU ; Jin ZHAO ; Yihuai PAN ; Jingzhi MA ; Shuli DENG ; Xiaoli XIE ; Xiuping MENG ; Jian YANG ; Xuedong ZHOU ; Zhi CHEN
International Journal of Oral Science 2025;17(1):4-4
Pulpotomy, which belongs to vital pulp therapy, has become a strategy for managing pulpitis in recent decades. This minimally invasive treatment reflects the recognition of preserving healthy dental pulp and optimizing long-term patient-centered outcomes. Pulpotomy is categorized into partial pulpotomy (PP), the removal of a partial segment of the coronal pulp tissue, and full pulpotomy (FP), the removal of whole coronal pulp, which is followed by applying the biomaterials onto the remaining pulp tissue and ultimately restoring the tooth. Procedural decisions for the amount of pulp tissue removal or retention depend on the diagnostic of pulp vitality, the overall treatment plan, the patient's general health status, and pulp inflammation reassessment during operation. This statement represents the consensus of an expert committee convened by the Society of Cariology and Endodontics, Chinese Stomatological Association. It addresses the current evidence to support the application of pulpotomy as a potential alternative to root canal treatment (RCT) on mature permanent teeth with pulpitis from a biological basis, the development of capping biomaterial, and the diagnostic considerations to evidence-based medicine. This expert statement intends to provide a clinical protocol of pulpotomy, which facilitates practitioners in choosing the optimal procedure and increasing their confidence in this rapidly evolving field.
Humans
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Calcium Compounds/therapeutic use*
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Consensus
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Dental Pulp
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Dentition, Permanent
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Oxides/therapeutic use*
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Pulpitis/therapy*
;
Pulpotomy/standards*
8.Expert consensus on intentional tooth replantation.
Zhengmei LIN ; Dingming HUANG ; Shuheng HUANG ; Zhi CHEN ; Qing YU ; Benxiang HOU ; Lihong QIU ; Wenxia CHEN ; Jiyao LI ; Xiaoyan WANG ; Zhengwei HUANG ; Jinhua YU ; Jin ZHAO ; Yihuai PAN ; Shuang PAN ; Deqin YANG ; Weidong NIU ; Qi ZHANG ; Shuli DENG ; Jingzhi MA ; Xiuping MENG ; Jian YANG ; Jiayuan WU ; Lan ZHANG ; Jin ZHANG ; Xiaoli XIE ; Jinpu CHU ; Kehua QUE ; Xuejun GE ; Xiaojing HUANG ; Zhe MA ; Lin YUE ; Xuedong ZHOU ; Junqi LING
International Journal of Oral Science 2025;17(1):16-16
Intentional tooth replantation (ITR) is an advanced treatment modality and the procedure of last resort for preserving teeth with inaccessible endodontic or resorptive lesions. ITR is defined as the deliberate extraction of a tooth; evaluation of the root surface, endodontic manipulation, and repair; and placement of the tooth back into its original socket. Case reports, case series, cohort studies, and randomized controlled trials have demonstrated the efficacy of ITR in the retention of natural teeth that are untreatable or difficult to manage with root canal treatment or endodontic microsurgery. However, variations in clinical protocols for ITR exist due to the empirical nature of the original protocols and rapid advancements in the field of oral biology and dental materials. This heterogeneity in protocols may cause confusion among dental practitioners; therefore, guidelines and considerations for ITR should be explicated. This expert consensus discusses the biological foundation of ITR, the available clinical protocols and current status of ITR in treating teeth with refractory apical periodontitis or anatomical aberration, and the main complications of this treatment, aiming to refine the clinical management of ITR in accordance with the progress of basic research and clinical studies; the findings suggest that ITR may become a more consistent evidence-based option in dental treatment.
Humans
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Tooth Replantation/methods*
;
Consensus
;
Periapical Periodontitis/surgery*
9.Expert consensus on the diagnosis and treatment of cemental tear.
Ye LIANG ; Hongrui LIU ; Chengjia XIE ; Yang YU ; Jinlong SHAO ; Chunxu LV ; Wenyan KANG ; Fuhua YAN ; Yaping PAN ; Faming CHEN ; Yan XU ; Zuomin WANG ; Yao SUN ; Ang LI ; Lili CHEN ; Qingxian LUAN ; Chuanjiang ZHAO ; Zhengguo CAO ; Yi LIU ; Jiang SUN ; Zhongchen SONG ; Lei ZHAO ; Li LIN ; Peihui DING ; Weilian SUN ; Jun WANG ; Jiang LIN ; Guangxun ZHU ; Qi ZHANG ; Lijun LUO ; Jiayin DENG ; Yihuai PAN ; Jin ZHAO ; Aimei SONG ; Hongmei GUO ; Jin ZHANG ; Pingping CUI ; Song GE ; Rui ZHANG ; Xiuyun REN ; Shengbin HUANG ; Xi WEI ; Lihong QIU ; Jing DENG ; Keqing PAN ; Dandan MA ; Hongyu ZHAO ; Dong CHEN ; Liangjun ZHONG ; Gang DING ; Wu CHEN ; Quanchen XU ; Xiaoyu SUN ; Lingqian DU ; Ling LI ; Yijia WANG ; Xiaoyuan LI ; Qiang CHEN ; Hui WANG ; Zheng ZHANG ; Mengmeng LIU ; Chengfei ZHANG ; Xuedong ZHOU ; Shaohua GE
International Journal of Oral Science 2025;17(1):61-61
Cemental tear is a rare and indetectable condition unless obvious clinical signs present with the involvement of surrounding periodontal and periapical tissues. Due to its clinical manifestations similar to common dental issues, such as vertical root fracture, primary endodontic diseases, and periodontal diseases, as well as the low awareness of cemental tear for clinicians, misdiagnosis often occurs. The critical principle for cemental tear treatment is to remove torn fragments, and overlooking fragments leads to futile therapy, which could deteriorate the conditions of the affected teeth. Therefore, accurate diagnosis and subsequent appropriate interventions are vital for managing cemental tear. Novel diagnostic tools, including cone-beam computed tomography (CBCT), microscopes, and enamel matrix derivatives, have improved early detection and management, enhancing tooth retention. The implementation of standardized diagnostic criteria and treatment protocols, combined with improved clinical awareness among dental professionals, serves to mitigate risks of diagnostic errors and suboptimal therapeutic interventions. This expert consensus reviewed the epidemiology, pathogenesis, potential predisposing factors, clinical manifestations, diagnosis, differential diagnosis, treatment, and prognosis of cemental tear, aiming to provide a clinical guideline and facilitate clinicians to have a better understanding of cemental tear.
Humans
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Dental Cementum/injuries*
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Consensus
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Diagnosis, Differential
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Cone-Beam Computed Tomography
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Tooth Fractures/therapy*
10.Application of f-wave to QRS complex amplitude ratio in PICC tip positioning for patients with atrial fibrillation
Lihua SHI ; Rongrong YANG ; Lihong LIAO ; Jing GUO ; Qiu SUN ; Yuanyuan GONG ; Jiabao YE ; Jianfang ZHANG
Chinese Journal of Nursing 2025;60(13):1553-1557
Objective To evaluate the clinical utility of the f-wave to QRS complex amplitude ratio(f/R ratio)in intracardiac electrogram(IC-ECG)-guided positioning of peripherally inserted central catheter(PICC)tips in patients with atrial fibrillation(AF),providing evidence to enhance clinical practice.Methods This study employed a conve-nience sampling method to enroll eligible AF patients admitted to a tertiary hospital in Suzhou from July 2023 to July 2024.During PICC placement,IC-ECG was utilized to monitor f-wave and QRS complex amplitude variations.Following successful catheterization,the f/R ratio was measured,and chest X-ray was performed to confirm the catheter tip position.The accuracy of PICC tip positioning across different f/R ratio ranges was analyzed,and the incidence of arrhythmias was recorded.A receiver operating characteristic curve was constructed to assess the diag-nostic performance of the f/R ratio in PICC tip localization.Results A total of 68 AF patients were included,with f/R ratios ranging from 20.63%to 91.24%.PICC tip positioning accuracy varied significantly across different f/R ratio ranges(P=0.006).The area under the ROC curve(AUC)for f/R ratio in PICC tip positioning was 0.784(P=0.009),with a maximum Youden index of 0.567,an optimal diagnostic threshold of 40.00%,a sensitivity of 81.7%,a speci-ficity of 75.0%,a positive predictive value of 96.1%,and a negative predictive value of 35.3%.No arrhythmias other than AF occurred during the procedure.Conclusion The f/R ratio provides reliable and safe guidance for PICC tip positioning in AF patients.An f/R ratio ≥40%is associated with higher accuracy in identifying the optimal catheter tip position.


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