1.Influenza surveillance results in Ordos City in 2017 - 2023
Xiaomin ZHANG ; Hongtao XIAO ; Sheng WANG ; Rong SUN ; Shangwu JIN ; Di ZHANG ; Jiming HAO ; Jialin LYU ; Chunyan YANG
Journal of Public Health and Preventive Medicine 2026;37(2):54-58
Objective To analyze the influenza-like illness (ILI) data in Ordos City from 2017 to 2023 and conduct nucleic acid detection of the virus to understand the local influenza epidemic situation, and to provide a reliable basis for influenza prevention and control in the city. Methods Real-time quantitative polymerase chain reaction (qPCR) was used to identify virus subtypes in ILI throat swab samples. Comparisons of positive rates were conducted using the chi-square test, with a significance level of α=0.05. Results From 2017 to 2023, a total of 3,283,434 outpatient and emergency visits were recorded at the Ordos City Central Hospital, including 74,159 ILI cases, with an ILI proportion of 2.26%. The majority of ILI cases (74.43%) occurred in children aged 0~14 years old. The overall positive rate of influenza virus nucleic acid detection was 10.87%, with the highest proportion being subtype A (seasonal H3) at 43.03%. The highest detection rate was observed in the 5~14 years age group, with statistically significant differences in positive rates across age groups (χ2=155.638, P<0.001). Influenza peaks occurred mainly from November to March of the following year. From January to April, three types of influenza were prevalent alternately or mixed, while from October to December, subtype A (seasonal H3) predominated. Positive rates varied significantly across months (χ2=250.923, P<0.001). The temporal trends of ILI proportions and PCR-positive rates were consistent. Conclusion Influenza in Ordos City exhibits distinct seasonal and age distribution characteristics, with alternating or mixed circulation of three virus types. Continued efforts are needed to strengthen influenza surveillance, especially the prevention and control of influenza in infants and adolescents.
2.Efficacy and safety of lenvatinib combined with sintilimab versus atezolizumab combined with bevacizumab in treatment of unresectable hepatocellular carcinoma
Jianying WEI ; Wei SUN ; Xiaomin LIU ; Minghua YU ; Wendong LI ; Jinglong CHEN
Journal of Clinical Hepatology 2026;42(6):1335-1341
ObjectiveTo investigate the efficacy and safety of lenvatinib combined with sintilimab versus atezolizumab combined with bevacizumab in patients with unresectable hepatocellular carcinoma (uHCC), aims to provide real-world evidence for clinical personalized treatment. MethodsA retrospective analysis was performed for 78 patients with uHCC who were admitted to Beijing Ditan Hospital, Capital Medical University, from January 1, 2023, to May 31, 2025, and according to the treatment modality, they were divided into lenvatinib+sintilimab group (L+S group with 49 patients) and atezolizumab+bevacizumab group (A+T group with 29 patients). The primary endpoints were progression-free survival (PFS) and overall survival (OS), and the secondary endpoints included objective response rate (ORR), disease control rate (DCR), and the incidence rate of adverse events. The independent-samples t test was used for comparison of normally distributed continuous data between groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups; the chi-square test was used for comparison of categorical data between groups. The Kaplan-Meier method was used for survival analysis, and the log-rank test was used for comparison between groups. ResultsThe 78 patients had a median PFS of 9 months and a median OS of 15 months. The median PFS was 11 months in the L+S group and 7 months in the A+T group, with no significant difference between the two groups (χ2=0.247, P=0.619); the median OS was 19 months in the L+S group and 12 months in the A+T group, with a significant difference between the two groups (χ2=6.565, P=0.010). There were no significant differences between the two groups in complete remission, partial remission, stable disease, disease progression, DCR, and ORR (all P>0.05). The L+S group had a significantly higher incidence rate of adverse events than the A+T group (95.9% vs 75.9%, P=0.007), and there was a significant difference in the incidence rate of grade ≥3 adverse events between the L+S group and the A+T group (65.3% vs 34.5%, P=0.008). ConclusionCompared with atezolizumab combined with bevacizumab, lenvatinib combined with sintilimab can improve the OS of patients with uHCC, while atezolizumab combined with bevacizumab has a better safety profile.
3.Si Junzitang Ameliorates Alzheimer's Disease by Regulating Keap1/Nrf2/HO-1 Signaling Pathway
Minyan SUN ; Shaofeng WEI ; Xiaomin WANG ; Kehan GAO ; Jianhao YANG ; Ziran XIE ; Yu ZHANG ; Qin ZHENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(17):23-37
ObjectiveTo explore the mechanisms through which Si Junzitang (SJZD) ameliorates Alzheimer's disease (AD) induced by scopolamine (SCOP) in mice and the PC12 cell model induced by H2O2 based on the Kelch-like ECH-associated protein 1 (Keap1)/nuclear factor erythroid 2-related factor 2 (Nrf2)/heme oxygenase-1 (HO-1) signaling pathway. MethodsIn the animal experiments, an AD model was established in mice by intraperitoneal injection of SCOP (3 mg·kg-1). Morris water maze and open field tests (OFT) were conducted to assess learning and memory abilities. Hematoxylin-eosin (HE) staining and Nissl staining were performed to observe pathological changes in neurons. Immunofluorescence was used to detect amyloid β-protein1-42 (Aβ1-42) expression, and immunohistochemistry was employed to detect phosphorylated (p)-Tau expression. Transmission electron microscopy (TEM) was employed to observe ultrastructural changes in hippocampal neurons and synapses. Biochemical methods were used to measure the levels of acetylcholine (ACh), acetylcholinesterase (AChE), superoxide dismutase (SOD), malondialdehyde (MDA), catalase (CAT), and lactate dehydrogenase (LDH). Real-time PCR and Western blot were employed to measure the mRNA and protein levels of molecules in the Keap1/Nrf2/HO-1 pathway in the hippocampus. In the cell experiments, a PC12 cell model of oxidative damage model was established with H2O2. Cell count kit-8 (CCK-8) assays and flow cytometry were adopted to measure cell viability and apoptosis rates, and Western blot was employed to quantify the expression levels of proteins in the Keap1/Nrf2/HO-1 pathway. ResultsThe animal experiments showed that compared with the model group, the SJZD and donepezil groups showed shortened escape latency (P<0.01), increased time in the target quadrant and platform crossings, and increased movement distance and duration in the central area of the open field (P<0.05, P<0.01). HE and Nissl staining showed more organized neurons and increased Nissl bodies in the drug intervention groups (P<0.05, P<0.01), and the Aβ1-42 and p-Tau expression levels were downregulated (P<0.05, P<0.01). TEM revealed reduced ultrastructural damage in hippocampal neurons and synapses in the drug intervention groups. In addition, the drug intervention groups showed declined levels of MDA, LDH, and AChE (P<0.05, P<0.01), elevated levels of SOD, CAT, and ACh (P<0.05, P<0.01), reduced Keap1 expression and increased Nrf2, HO-1, and NQO1 expression in the hippocampus (P<0.05, P<0.01). The cell experiments showed that compared with the model group, the SJZD-containing serum increased the cell viability (P<0.05, P<0.01), and decreased total apoptosis rates (P<0.05, P<0.01). The drug intervention groups showed upregulated protein levels of Nrf2 and HO-1 and downregulated protein level of Keap1 (P<0.05, P<0.01). ConclusionSJZD demonstrates protective effects against SCOP-induced AD in mice and H2O2-induced damage in PC12 cells through antioxidant mechanisms mediated by the Keap1/Nrf2/HO-1 pathway.
4.Efficacy of atezolizumab combined with bevacizumab versus sintilimab combined with bevacizumab biosimilar in treatment of unresectable hepatocellular carcinoma
Xiaomin LIU ; Qingfang ZHAO ; Wei SUN ; Wendong LI
Journal of Clinical Hepatology 2026;42(7):1632-1637
ObjectiveTo investigate the efficacy and safety of atezolizumab combined with bevacizumab versus sintilimab combined with bevacizumab biosimilar in the treatment of patients with unresectable hepatocellular carcinoma (HCC) in a real-world setting, and to provide a reference for clinical practice. MethodsA retrospective analysis was performed for 130 patients with unresectable HCC who were treated in Beijing Ditan Hospital, Capital Medical University, from January 2020 to January 2026, and all patients received the first-line systemic therapy with immune checkpoint inhibitors combined with bevacizumab or its biosimilar. According to the treatment regimen, the patients were divided into atezolizumab+bevacizumab group (T+A group with 51 patients) and sintilimab+bevacizumab biosimilar group (Shuangda group with 79 patients). The primary endpoint was progression-free survival (PFS), and secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety profile. The independent-samples t test or the Wilcoxon rank-sum test was used for comparison of continuous data between the two groups, and the chi-square test was used for comparison of categorical data between groups. The Kaplan-Meier method was used for survival analysis, and the Log-rank test was used for comparison between groups. ResultsThe T+A group had a median PFS of 297.00 days (95% confidence interval [CI]: 195.44 — 398.56), and the Shuangda group had a median PFS of 236.00 days (95%CI: 165.10 — 306.90), with no significant difference between the two groups (P=0.668). There were no significant differences between the T+A group and the Shuangda group in ORR (56.9% vs 45.6%, χ2=1.581, P=0.209), DCR (76.5% vs 77.2%, χ2=0.010, P=0.922), and the incidence of adverse events (96.08% vs 94.94%, P>0.05). ConclusionFor unresectable HCC patients without prior systemic treatment, atezolizumab combined with bevacizumab can achieve a comparable PFS to sintilimab combined with bevacizumab biosimilar.
5.Effect of standardized rehabilitation unit on traumatic brain injury
Qianqian CHI ; Xiaonian ZHANG ; Xiaomin ZHU ; Wanyue SUN ; Xin ZHANG ; Jin ZHOU ; Hongwei BU ; Lei ZHAI ; Xin ZHANG ; Zirui LING ; Hongyu CHEN
Chinese Journal of Rehabilitation Theory and Practice 2026;32(9):1033-1040
ObjectiveTo establish three standardized rehabilitation unit models covering acute, critical and comprehensive recovery stages for traumatic brain injury (TBI) that fit the whole-course characteristics, clarify their multidisciplinary collaborative framework, standardized procedures, and information management system, and verify the clinical effectiveness of this staged rehabilitation unit on long-term functional prognosis and in-hospital complications of TBI patients. MethodsThis study was conducted at two stages: model construction and efficacy verification. At the first stage, TBI rehabilitation units for acute, critical and recovery stages were established in the Department of Neurosurgery, Intensive Care Unit and Department of Rehabilitation Medicine, respectively, with unified multidisciplinary team configuration, standardized assessment and treatment protocols, collaborative workflows, and a dedicated information management system. At the second stage, 324 TBI patients admitted to the newly built rehabilitation units from July, 2023 to July, 2025 were enrolled as the observation group, and 167 TBI patients receiving traditional management from January, 2018 to December, 2022 were retrospectively selected as the control group. The primary outcomes were 1-year post-injury Glasgow Outcome Scale (GOS) and Disability Rating Scale (DRS) scores. Secondary outcomes included the incidence of in-hospital complications and the mean indwelling time of tracheal intubation, gastric tube and urinary catheter. ResultsThe 1-year GOS score was significantly higher (t = -7.836, P < 0.001), and the DRS score was significantly lower (t = -6.742, P < 0.001) in the observation group than in the control group. The overall incidence of complications was significantly lower in the observation group than in the control group (χ2 = 18.762, P < 0.001). The incidences of pulmonary infection, urinary tract infection, pressure ulcer, lower extremity venous thrombosis and joint contracture deformity were all significantly reduced (χ2 > 4.328, P < 0.05). The indwelling time of tracheal intubation, gastric tube and urinary catheter was significantly shorter in the observation group than in the control group (t > 10.276, P < 0.001). ConclusionThe acute-critical-comprehensive three-stage standardized TBI rehabilitation unit could significantly improve the long-term functional outcomes of TBI patients, reduce the incidence of complications, and shorten the indwelling time of invasive tubes through multidisciplinary collaboration, whole-course standardized management and information-based quality control. This model conforms to the pathological and functional laws of TBI, realizes seamless whole-course connection from acute treatment to recovery rehabilitation, and has good clinical feasibility and promotion value. It can provide evidence-based evidence and practical reference for the homogenized and standardized development of TBI rehabilitation in China.
6.Integrating O-RADS,Contrast-enhanced Ultrasound and ROMA z-score for Three-category Prediction of Ovarian Epithelial Tumors
Kun YUAN ; Xiaomin ZHU ; Huanyu ZHANG ; Yujun HUANG ; Qingying LI ; Yan OU ; Yunxiao ZHU
Journal of Sun Yat-sen University(Medical Sciences) 2026;47(2):336-345
ObjectiveTo develop and evaluate an O-RADSbased multiparametric model integratingcontrast-enhanced US (CEUS) and the z-score standardized risk of ovarian malignancy algorithm (ROMA z-score) to improve the diagnostic accuracy for differentiating benign, borderline, and malignant ovarian epithelial tumors (OETs). MethodsThis retrospective study included 129 patients with pathologically confirmed OETs between May 2018 and December 2024. Clinical variables (age, menopausal status, BMI, HE4, CA125) and sonographic features (conventional US and CEUS) were collected. Tumors were classified as benign, borderline, or malignant according to pathological findings. A random forest algorithm was used to contruct the predictive model. Receiver operating characteristic (ROC) curves were generated tocompare the diagnostic performance of O-RADS, O-RADS+CEUS, O-RADS+ROMA z-score, and O-RADS+ CEUS+ROMA z-score. ResultsAmong the 129 patients, 63 had benign tumors, 25 had borderline tumors, and 41 had malignant tumors. Compared with O-RADS alone, the combined O-RADS+CEUS+ROMA z-score model demonstrated superior diagnostic performance, with an AUC of 0.87 (95% CI: 0.79-0.95) vs. 0.64 (95% CI: 0.51-0.76), P<0.001, for differentiating benign from borderline tumors, and 0.90 (95% CI: 0.83-0.97) vs. 0.64 (95% CI: 0.50-0.78), P<0.001, for differentiating borderline from malignant tumors. The random forest analysis identified HE4, CA125 and CEUS features as the most important predictors,contributing 11.02, 8.82, 18.1 points, respectively, to the total importance score of 51.94. In the test cohort, the model achieved an overall diagnostic accuracy of 72.97%, with an AUC of 0.89(95%CI:0.77-1.00), sensitivity of 67.06%, and specificity of 85.01%. ConclusionsO-RADS+CEUS+ROMA z-score multiparametric model demonstrated the highest diagnostic performance for in differentiating benign from borderline and borderline from malignant OETs. HE4, CA125 and CEUS features were identified as key predictive risk factors, supporting the role of this model in improving preoperative risk stratification of OETs.
7.Association between dietary patterns and overweight and obesity among primary and middle school students
JIANG Nan ; TANG Xiaomin ; SUN Wentao
Journal of Preventive Medicine 2025;37(3):228-232
Objective:
To explore the association between dietary patterns and overweight and obesity among primary and middle school students, so as to provide the guidance of diet balance and obesity prevention for students.
Methods:
Students from 11 primary and middle schools in Tongzhou District, Beijing Municipality, were selected using the stratified cluster sampling method. Demographic information was collected through a general questionnaire, and dietary intake types and frequencies over the past week were assessed using a food frequency questionnaire. Dietary patterns were determined using factor analysis, and the dietary pattern factor scores were divided into Q1, Q2, Q3, and Q4 groups based on quartiles. Height and weight were collected through physical examinations, and Z-scores of body mass index adjusted for gender and age were calculated to assess overweight and obesity. The association between dietary patterns and overweight and obesity was analyzed using a multivariable logistic regression model.
Results:
A total of 1 485 students were surveyed, including 745 males (50.17%) and 740 females (49.83%). The mean age was (12.87±2.86) years. Three dietary patterns were identified: animal and plant protein dietary pattern, high-fat and high-sugar dietary pattern, and vegetable-fruit-dairy dietary pattern. The detection rates of overweight and obesity were 42.57%, 48.42%, and 34.75%, respectively, with statistically significant differences (P<0.05). Multivariable logistic regression analysis showed that compared with the vegetable-fruit-dairy dietary pattern, the animal and plant protein dietary pattern (OR=1.406, 95%CI: 1.084-1.823) and the high-fat and high-sugar dietary pattern (OR=2.137, 95%CI: 1.643-2.779) were associated with a higher risk of overweight and obesity among primary and middle school students. Compared with the Q1 group of dietary pattern factor scores, the Q3 group (OR=1.631, 95%CI: 1.206-2.208) and Q4 group (OR=1.965, 95%CI: 1.446-2.671) of the high-fat and high-sugar dietary pattern had an increased risk of overweight and obesity, while the Q4 group of the vegetable-fruit-dairy dietary pattern (OR=0.551, 95%CI: 0.406-0.747) had a reduced risk of overweight and obesity. There was no statistical association between factor scores of animal and plant protein dietary pattern and overweight and obesity (all P>0.05).
Conclusions
The animal and plant protein dietary pattern and the high-fat and high-sugar dietary pattern are associated with a higher risk of overweight and obesity among primary and middle school students. Within the same dietary pattern, the more inclined students are to the high-fat and high-sugar dietary pattern, the higher their risk of overweight and obesity, while the more inclined they are to the vegetable-fruit-dairy dietary pattern, the lower their risk of overweight and obesity.
8.Prognostic value of serum Mrp 8/14 in patients with acute respiratory distress syndrome induced by pulmonary sepsis and extrapulmonary sepsis
Caizhi SUN ; Yongpeng XIE ; Chenchen ZHU ; Haidong QIN ; Xiaomin LI
Chinese Journal of Emergency Medicine 2025;34(1):78-83
Objective:To investigate the differences and prognostic value of serum myeloid-related proteins 8 and 14 (Mrp 8/14) in patients with acute respiratory distress syndrome (ARDS) induced by pulmonary and extrapulmonary sepsis.Methods:A retrospective cohort study was conducted to collect the general clinical data of septic ARDS patients admitted to the intensive care unit (ICU) of Nanjing Hospital of Nanjing Medical University from August 2021 to February 2024. The serum levels of Mrp 8/14 were detected within 24 hours after admission. According to whether the patients died during ICU stay, the patients with pulmonary ARDS and extrapulmonary ARDS induced by sepsis were divided into survival and death groups, respectively. The differences of Mrp 8/14 and other clinical data between the two groups were compared. Logistic regression analysis was used to analyze the prognostic factors of septic patients with pulmonary ARDS and extrapulmonary ARDS. The receiver operating characteristic (ROC) curve was plotted to evaluate the predictive value of serum Mrp 8/14 for the prognosis of patients with pulmonary ARDS and extrapulmonary ARDS.Results:A total of 138 patients with sepsis-induced ARDS were enrolled in this study, including 79 patients with pulmonary ARDS and 59 patients with extrapulmonary ARDS. Compared to the death group, the level of serum Mrp 8/14 was significantly lower [Mrp 8/14: 22.90 (17.91, 30.88) μg/mL vs. 10.73 (7.15, 17.20) μg/mL, P<0.05]. Multivariate logistic regression analysis demonstrated that the serum Mrp 8/14 level was an independent risk factor for the prognosis of pulmonary ARDS patients only during the ICU stay ( OR=1.253, 95% CI: 1.110-1.414, P<0.05). ROC curve analysis showed that the area under the curve of serum Mrp 8/14 for the prediction of death in ARDS patients with pulmonary sepsis during ICU stay was 0.855 (95% CI: 0.773-0.938, P<0.05), the cut-off value was 19.230 μg/mL, the sensitivity was 0.718, the specificity was 0.925, and the Yonden index was 0.405. Conclusion:Serum Mrp 8/14 is an effective prognostic indicator for the mortality of ARDS patients with pulmonary sepsis during ICU hospitalization.
9.Comparison of the efficacy of ustekinumab and vedolizumab in achieving transmural healing in active Crohn′s disease
Long JU ; Yujie ZHAO ; Changqin LIU ; Yanhong SHI ; Xiaomin SUN ; Zhanju LIU ; Xiaolei WANG
Chinese Journal of Digestion 2025;45(2):107-116
Objective:To compare the efficacy of ustekinumab (UST) and vedolizumab (VDZ) in achieving transmural healing in active Crohn′s disease (CD).Methods:From March 1, 2020 to November 30, 2024, 112 patients with active CD treated with UST or VDZ at the Department of Gastroenterology, Tenth People′s Hospital of Tongji University were retrospectively enrolled. According to the medication regimen, the 112 patients were divided into UST group (61 cases) and VDZ group (51 cases). Collected the data at baseline, such as the disease phenotype, other medication history, and clinical indicators including C-creative protein (CRP), etc. Clinical disease activity and endoscopic disease activity were assessed by Harvey-Bradshaw index (HBI) and simplified endoscopic score for Crohn′s disease (SES-CD), respectively. Transmural healing was evaluated according to the intestinal wall thickness measured by intestinal imaging examination of the affected intestinal segment. Transmural healing was defined as bowel wall thickness <0.3 cm and 110 obvious signs of inflammation, clinical remission was defined as HBI≤4, and endoscopic remission was defined as a reduction in SES-CD ≥50% or a score of ≤2. The primary endpoint was transmural healing rate within one year after treatment. The secondary endpoints were endoscopic healing rate and clinical remission rate at 13 to 24th week and 30 to 52nd week after treatment. Chi-square test or Fisher′s exact test was used to compare the efficacy of the 2 medications.Results:There was no significant difference in transmural healing rate between UST group and VDZ group within 1 year after treatment (16.4% (10/61) vs. 23.5% (12/51), χ2=0.90, P=0.344). There were no significant differences in the healing rate between UST group and VDZ group in patients with specific baseline characteristics before treatment, including CD with stenosis, with perianal disease, no history of glucocorticoid use, secondary loss of response to anti-tumor necrosis factor (TNF)-α, SES-CD 7 to 15, decreased body mass index, and increased CRP (18.2%(6/33) vs. 19.4%(7/36), 17.9%(7/39) vs. 19.4%(6/31), 17.1%(6/35) vs. 24.2%(8/33), 20.0%(8/40) vs. 3/18, 14.3%(5/35) vs. 19.2%(5/26), 15.0%(3/20) vs. 3/10, 21.4%(6/28) vs. 5/16), all P>0.05). There was no significant difference in the clinical remission rate or endoscopic remission rate between the UST group and the VDZ group from 13 to 24th week (7/14 vs. 9/18, 3/14 vs. 7/18, RR=1.000 and 0.551, 95% confidence interval: 0.497to 2.011, 0.173to 1.755, χ2=<0.01, Fisher′s exact test, both P>0.05). There was no significant difference in clinical remission rate or endoscopic remission rate between UST group and VDZ group from week 30 to week 52 after treatment (68.5% (37/54) vs. 74.4% (32/43), 27.8% (15/54) vs. 32.6% (14/43), RR=0.921 and 0.853, 95% confidence interval: 0.716 to 1.184, 0.464 to 1.568, χ2=0.41 and 0.26, both P>0.05). In UST group, the proportion of patients with normal hemoglobin after transmural healing was higher than that of patients without transmural healing (9/10 vs. 45.1% (23/51), and the difference was statistically significant ( χ2=5.08, P=0.024). However, there were no significant differences in the proportion of patients with normal body mass index, CRP, platelet count, prealbumin, albumin, interleukin-6 or TNF-α levels after treatment between those who achieved transmural healing and those who did not in either UST group or VDZ group (all P>0.05). And in VDZ group there was no significant difference in the proportion of patients with normal hemoglobin between those who achieved transmural healing and who did not (all P>0.05). Conclusion:UST and VDZ exhibit similar efficacy in transmural healing within one year of treatment in patients with active CD.
10.Efficacy and safety of adalimumab originator and biosimilars in the treatment of Crohn′s disease
Xiaohui LI ; Jingyi JU ; Qinglu YANG ; Pengyun YIN ; Jiaolan YANG ; Cui ZHANG ; Changqin LIU ; Zhanju LIU ; Xiaomin SUN
Chinese Journal of Digestion 2025;45(3):177-181
Objective:To evaluate the efficacy and safety of adalimumab (ADA) originator and biosimilars in the treatment of Crohn′s disease (CD).Methods:From January 2020 to January 2023, the clinical data of 73 patients who were diagnosed as CD and received ADA treatment at the Department of Gastroenterology, the Tenth People′s Hospital of Tongji University were retrospectively analyzed. Among them, 30 patients received ADA originator treatment (National Medicine Approval Number SJ20181019; originator group), 23 patients received biosimilar A treatment (Medicine Medicine Approval Number S20190038; biosimilar A group), and 20 patients received biosimilar B (Medicine Medicine Approval Number S20190043; biosimilar B group). At 12 and 48 weeks after treatment, the clinical data of clinical remission (Crohn′s disease activity index(CDAI) score <150), clinical response (CDAI score decreased ≥ 70 from baseline), endoscopic remission (simple endoscopic score for Crohn′s disease (SES-CD) ≤ 2 or Rutgeerts score ≤ 1), endoscopic response (SES-CD decreased > 50% from baseline), and adverse drug reaction (ADR) were collected. Chi-square test or Fisher′s exact test was used for statistical analysis.Results:After 12 weeks of ADA treatment, the overall clinical remission rate was 69.9% (51/73), which of the biosimilar A group was 69.6% (16/23), the biosimilar B group was 75.0% (15/20), and the originator group was 66.7% (20/30). The overall clinical response rate was 83.6% (61/73), which of the biosimilar A group was 82.6% (19/23), the biosimilar B group was 80.0% (16/20), and the originator group was 86.7% (26/30). The overall endoscopic remission rate was 42.5% (31/73), which of the biosimilar A group was 52.2% (12/23), the biosimilar B group was 45.0% (9/20), and the originator group was 33.3% (10/30). The overall endoscopic response rate was 63.0% (46/73), which of the biosimilar A group was 73.9% (17/23), the biosimilar B group was 70.0% (14/20), and the originator group was 50.0% (15/30). And in the above data, there were no statistically significant differences among the 3 groups (all P>0.05). After 48 weeks of treatment, the overall clinical remission rate was 54.2% (32/59), which of the biosimilar A group was 8/18, the biosimilar B group was 9/15, and the originator group was 57.7% (15/26). The overall clinical response rate was 71.2% (42/59), which of the biosimilar A group was 10/18, the biosimilar B group was 12/15, and the originator group was 76.9% (20/26). The overall endoscopic remission rate was 25.4% (15/59), which of the biosimilar A group was 5/18, the biosimilar B group was 3/15, and the originator group was 26.9% (7/26). The overall endoscopic response rate was 40.7% (24/59), which of the biosimilar A group was 7/18, the biosimilar B group was 5/15, and the originator group was 46.2% (12/26). And in the above data, there were no statistically significant differences among the 3 groups (all P>0.05). The overall incidence of ADR was 32.9% (24/73), which of the biosimilar A group was 30.4% (7/23), the biosimilar B group was 30.0% (6/20), and the originator group was 36.7% (11/30); and there was no statistically significant difference among the 3 groups ( P=0.847). Conclusion:ADA biosimilars A and B demonstrate comparable efficacy and safety to the originator medication in the treatment of CD.


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