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.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.
6.Analysis of a Chinese pedigree with Hereditary coagulation factor Ⅻ deficiency due to compound heterozygous variants of Ⅻ gene
Haixiao XIE ; Huanhuan WANG ; Meina LIU ; Huinan XIA ; Yuan CHEN ; Kaiqi JIA ; Lihong YANG ; Mingshan WANG
Chinese Journal of Medical Genetics 2025;42(3):282-285
Objective:To analyze a Chinese pedigree with Hereditary coagulation factor Ⅻ (FⅫ) deficiency duo to variants of F12 gene and explore its molecular pathogenesis. Methods:A patient who underwent laparoscopic cystectomy at the Department of Gynecology of the First Affiliated Hospital of Wenzhou Medical University in June 2012 was selected as the study subject. Coagulation factor indexes of the proband and her family members (5 individuals from three generations) were determined. All exons, flanking sequences, 5′ and 3′ untranslated regions of the F12 gene of the proband and her family members were analyzed by direct sequencing. Three bioinformatics software was used to analyze the conservation, pathogenicity and protein model of the variant. This study was approved by the Medical Ethics Committee of the Hospital (Ethics No. 2012-17). Results:The activated partial thromboplastin time (APTT), FⅫ activity (FⅫ: C) and FⅫ antigen (FⅫ: Ag) of the proband was 180.0 s, 1.0% and 2.1%, respectively. DNA sequencing revealed that she has harbored compound heterozygous variants of the F12 gene, namely c. 712_713insT (p.Cys238Leufs *73) in exon 8 and c. 1561G>A (p.Glu521Lys) in exon 13. Her mother and younger son were heterozygous for the p. Cys238Leufs*73 variant, while her older son was heterozygous for the p. Glu521Lys variant. Bioinformatic analysis suggested that Cys238 is highly conserved and p. Cys238Leufs*73 is a pathogenic variant, which eventually resulted in a truncated protein. Conclusion:The c. 712_713insT and c. 1561G>A compound heterozygous variants of the F12 gene probably underlay the decreased FⅫ level in this pedigree, among which c. 712_713insT (NM_000505) was unreported previously.
7.Analysis of two cases of hereditary protein C deficiency causing venous thrombosis
Mengzhen WEN ; Yifan LU ; Meina LIU ; Langyi QIN ; Yanhui JIN ; Mingshan WANG ; Lihong YANG
Chinese Journal of Hematology 2025;46(3):244-251
Objective:To investigate the molecular pathogenic mechanism of venous thrombosis caused by heterozygous missense mutations in two protein C (PROC) genes through laboratory phenotype analysis, genetic mutation analysis, and in vitro expression experiments.Methods:Two probands presented with venous thromboembolism at the First Affiliated Hospital of Wenzhou Medical University. Clinical data and blood samples were collected from the probands and their family members to evaluate the plasma protein C (PC) activity (PC∶A), PC antigen (PC∶Ag) levels, and other relevant coagulation parameters. The anticoagulant capacity was assessed using the thrombin generation test (TGT). The mutation sites of the PROC gene were identified using direct DNA sequencing. Bioinformatics software was used to analyze the conservation and pathogenicity of the mutated gene. PyMOL software was used for the analysis of the protein three-dimensional models and interactions between mutated amino acids. Wild-type and two mutant expression vectors were constructed and HEK293T cells were transiently transfected. Total cellular RNA was extracted from positively transfected cells to investigate the transcriptional levels of the mutant PROC gene. Enzyme-linked immunosorbent assay, Western blot, and cellular immunofluorescence assays were used to investigate the translation levels of the mutant PROC protein.Results:Probands 1 and 2 exhibited PC∶A levels of 35% and 40% and PC∶Ag levels of 44% and 39%, with increasing D-dimer levels to 4.42 mg/L and 0.83 mg/L, respectively. Meanwhile, other coagulation parameters revealed no significant abnormalities. TGT demonstrated impaired anticoagulant function in both proband witnesses and their familial PC carriers. Sequencing analysis revealed heterozygous missense mutations c. 833T>C (p. Leu278Pro) in proband 1 and c. 1330T>C (p. Trp444Arg) in proband 2 within exon 9 of the PROC gene. Conservation analysis revealed that Leu278 and Trp444 were highly conserved across homologous species. Pathogenicity analysis indicated that both p. Leu278Pro and p. Trp444Arg mutations are deleterious. Protein modeling analysis demonstrated that both mutations induce structural alterations in the protein. In vitro expression experiments revealed that compared with the wild-type, both p. Leu278Pro and p. Trp444Arg mutations showed no significant differences in the mRNA expression level of the PC protein. However, both mutations caused significantly lower PC∶Ag content and protein expression levels in the cell culture supernatant compared with the wild-type, whereas higher levels were observed in the cell culture lysate. This indicates the association of both mutations with the secretion function of the PC protein.Conclusion:The heterozygous missense mutations p. Leu278Pro and p. Trp444Arg in exon 9 of the PROC gene in both probands are associated with decreased PC levels.
8.Implementation of a "hospital-community general practitioner co-management" model for multimorbidity via a mobile-based digital platform
Meng GUO ; Huicui ZHAO ; Huiqi YANG ; Fuqun GUO ; Yuqi ZHANG ; Qiujun WANG ; Lihong JIANG ; Jia MENG
Chinese Journal of General Practitioners 2025;24(7):883-887
Multimorbidity has emerged as a critical global public health challenge, necessitating effective management strategies. In Heilongjiang Province, a cold north region in China with a high prevalence of multimorbidity, healthcare disparities, uneven resource distribution, and inadequate chronic disease control remain pressing issues. Driven by national policies on family physician contracting and regional demands for chronic disease management, this study established a "hospital-community general practitioner co-management" model utilizing a mobile-based digital platform. This model integrates hospital-based general practitioners into primary care teams to optimize resource allocation and enhance multimorbidity management. The initiative aims to explore pathways for improving healthcare system reform and strengthening the chronic disease prevention framework in the region.
9.Efficacy and safety of dupilumab in the treatment of atopic dermatitis in the elderly
Zijing YANG ; Lihong CHEN ; Yeping RUAN ; Wanting WEN ; Jiayi ZHANG ; Hailun WANG ; Meng PAN ; Xiaoqing ZHAO
Chinese Journal of Dermatology 2025;58(1):65-69
Objective:To investigate the efficacy and safety of dupilumab in the treatment of elderly patients (≥ 60 years old) with atopic dermatitis (AD), with particular attention paid to rare adverse reactions.Methods:A single-center retrospective analysis was conducted on data collected from 281 elderly AD patients who received the standard regimen of dupilumab at the Department of Dermatology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine from January 2020 to May 2024. Clinical characteristics such as gender, disease duration, skin lesion manifestations, and itch severity were analyzed. Changes in skin lesions and itch severity, as well as related adverse events were recorded during the follow-up period of 0 - 16 weeks. The efficacy and safety of dupilumab in the treatment of elderly AD patients were evaluated.Results:Among the 281 elderly AD patients, 214 were males (76.16%) and 67 were females (23.84%), with the age being 71.13 ± 7.91 years and the age at onset being 59.92 ± 15.72 years. The disease duration ( M[ IQR]) was 5.00 (13.00) years. After standard-regimen dupilumab treatment, the improvement rates of clinical outcome indicators SCORing Atopic Dermatitis (SCORAD) and pruritus numerical rating scale (NRS) scores gradually increased. At week 16, the improvement rates of SCORAD and NRS scores ( M[ IQR]) reached the maxima of 72.37% (23.89%) and 75.00% (29.72%), respectively. The overall incidence of adverse events was relatively low, with only 16 patients (6.05%) reporting adverse events. Common adverse reactions such as conjunctivitis (2 cases, 0.71%) and facial erythema (1 case, 0.36%) were mild and well-tolerated. Phenotype switching occurred in 10 cases (3.56%) . Conclusion:Dupilumab was an effective and safe treatment for elderly AD, but phenotype switching may occur.
10.Correlation between type 2 diabetes and hepatitis B virus infection
Wu LIU ; Tianshuo ZHAO ; Liguo YANG ; Genxia GAO ; Wenli MIAO ; Tongxia ZENG ; Yonglan CHEN ; Lina ZHANG ; Xiaoyan CHE ; Lihong WANG ; Junhan ZHANG ; Bingfeng HAN ; Fuqiang CUI
Chinese Journal of Epidemiology 2025;46(5):833-839
Objective:To analyze the latent prevalence of hepatitis B and type 2 diabetes and their correlation through an observational study.Methods:This study used a case-control design. The cases with diabetes were recruited through the diabetes management system and village doctors, while the controls without diabetes were screened from volunteers recruited by village health clinics. Capillary blood samples were collected from the study participants for the measurement of real-time blood glucose level, and venous blood samples were taken from them for the detections of HBV serological markers. Firth logistic regression model was used to fit the relationship between HBsAg positive status and diabetes status.Results:The study included 1 218 diabetes patients, 62 patients with impaired fasting glucose and 491 cases without diabetes. In the cases without diagnosis of diabetes, 11.15% had impaired fasting blood glucose and 4.43% had diabetes. Among those who reported no or unknown diagnosis of hepatitis B, 1.73% were positive for HBsAg, while 18.80% were positive for both HBV core antibody and surface antibody, indicating latent infection of hepatitis B virus. In the non-diabetes group, 0.81% reported hepatitis B history, and in the diabetes group, 2.76% reported hepatitis B history. After adjustment, the HBsAg positive rate was higher in the diabetes group ( OR=2.90, 95% CI: 1.21-6.91). Conclusions:Both diabetes and hepatitis B exhibited a high degree of latent prevalence. The HBsAg positive rate was significantly higher in those with diabetes than in those without diabetes, indicating a potential correlation. These findings highlighted the importance of strengthened screening and management of comorbidities.


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