1.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.
2.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.
3.The current status of continuing medical education among obstetricians and gynecologists in hospitals at secondary level or above in Beijing, China
Jiajia ZHANG ; Pengyun HU ; Huamao LIANG
Chinese Journal of Medical Education Research 2024;23(2):211-215
Objective:To investigate the situation of continuing medical education (CME) among obstetricians and gynecologists from Beijing's general hospitals at the secondary level or above in 2018 and 2023, and to provide a reference for standardizing CME for obstetricians and gynecologists in the future.Methods:We performed questionnaire surveys and interviews with 164 obstetricians and gynecologists in Beijing to investigate the status of completion of CME, the reasons for incompletion, the preferred modes to complete CME, and the preferred contents and forms of CME. SPSS 26.0 software was used for data analysis. The rate was compared using the chi-squared test.Results:Due to the impact of coronavirus disease 2019, the 2023 survey showed that 79 (48.17%) participants completed CME in an online mode, and 76 (46.34%) participants completed CME in an mostly online mode, with a significantly increased degree of satisfaction with CME compared with the 2018 survey ( P<0.05); 49 (29.88%) participants believe that online education is superior to traditional CME, and 69 (42.07%) participants believe that online education is comparable to traditional CME. The main advantages of the online education mode are flexible time and location and cost savings. "Hoping to improve my professional level" is the main purpose to participate in CME in both 2018 and 2023 surveys [124 (75.61%) vs. 127 (77.44%)]. "Professional skills and techniques" and "New advances in the specialty" are the contents of most interest. Conclusions:Obstetricians and gynecologists should raise the awareness to participant in CME. Relevant departments should establish a standardized system and an effective supervision and management mechanism, and take flexible education modes with the use of the Internet. Online education can achieve similar teaching effects and also improve learners' satisfaction.
4.Genetic diagnosis and analysis of eight cases with central 22q11.2 deletion syndrome
Jing GUO ; Pengyun LI ; Jia CHE ; Shanshan ZHAI ; Weifang TIAN ; Ying LI ; Hua ZHANG ; Ling LIU
Chinese Journal of Medical Genetics 2024;41(2):145-149
Objective:To explore the pregnancy outcome and postpartum clinical phenotype of LCR22B/C~D central 22q11.2 deletion syndrome.Methods:For fetuses diagnosed with central 22q11.2 deletion by chromosomal microarray analysis (CMA) at the Prenatal Diagnosis Center of the Third Affiliated Hospital of Zhengzhou University from January 2019 to April 2022, their prenatal imaging, parental CMA verification, pregnancy outcomes and postpartum clinical phenotype were analyzed.Results:Eight cases of central 22q11.2 deletion syndrome were included, including six cases with LCR22B~D 22q11.2 deletions and two with LCR22C~D 22q11.2 deletions. Among the six cases with LCR22B~D type 22q11.2 deletions, three had shown cardiovascular malformations (right aortic arch, ventricular septal defect, mild tricuspid regurgitation), one had shown urinary defect (right kidney heterotopia). Two cases with LCR22C~D 22q11.2 deletions showed nonspecific ultrasonographic findings, including oligohydramnios with growth restriction and nuchal skin thickening. The CMA verification showed that six cases were inherited from their parents, and five couples had chosen to continue with the pregnancy. Postpartum follow-up showed that the physical and intellectual development of all children were normal. One couple had opted to terminate the pregnancy considering the ectopic fetal right kidney. Two remaining cases had decided to terminate their pregnancies without parental verification.Conclusion:The central 22q11.2 deletion syndrome of the LCR22B/C~D type is different from the classical types. Its genetic information mainly comes from parents. Prenatal imaging has mainly shown cardiovascular and urinary abnormalities. Postnatal growth and intellectual development have been normal. Therefore, the couples should be provided with suffice prenatal genetic counseling.
5.Prenatal ultrasonographic manifestations and genetic diagnosis of nine fetuses with 7q11.23 duplication syndrome
Pengyun LI ; Jing GUO ; Jia CHE ; Fangying CUI ; Yuexia LYU ; Hua ZHANG ; Ying LI ; Ling LIU
Chinese Journal of Medical Genetics 2024;41(3):266-270
Objective:To analyze ultrasonographic manifestations and genetic etiology of nine fetuses with 7q11.23 duplication syndrome.Methods:Ultrasonographic finding, pregnancy outcome and follow-up of nine fetuses detected at the Prenatal Diagnosis Center of the Third Affiliated Hospital of Zhengzhou University from January 2017 to December 2021 were retrospectively analyzed.Results:The fetuses were found to harbor a duplication in the 7q11.23 region by chromosomal microarray analysis (CMA). Among these, five had shown ventriculomegaly, including four syndromic and one non-syndromic. For the remainders, one had ventricular septal defect and mild tricuspid regurgitation, one had echogenic intracardiac focus, whilst another two were normal. Five couples had accepted parental verification, and the results confirmed that the 7q11.23 duplication carried by their fetuses were de novo in origin. Following genetic counseling, seven couples had opted to terminate their pregnancies. Two fetuses were delivered at full term, and follow-up had found no abnormalities. Conclusion:Prenatal ultrasonographic manifestations of fetuses with 7q11.23 duplication syndrome are variable. CMA can provide assistance for their diagnosis and genetic counseling.
6.Short term clinical efficacy and influencing factors of ustekinumab monoclonal antibody in the treatment of Crohn's disease
Rui WANG ; Changqin LIU ; Cui ZHANG ; Qinglu YANG ; Jiaolan YANG ; Pengyun YIN ; Xiaohui LI ; Yongshun SUN ; Zhanju LIU ; Xiaomin SUN
The Journal of Practical Medicine 2024;40(7):989-995
Objective To analyze the short-term clinical efficacy and influencing factors of ustekinumab monoclonal antibody(UST)in the treatment of Crohn′s disease(CD).Methods Retrospective cohort study was used to collect the clinical data of CD patients treated with UST in the 10th People′s Hospital affiliated to Tongji University from December 2020 to October 2022.The main analysis is the short-term clinical efficacy and influencing factors of UST treatment for CD at weeks 8 and 16,And analyze the endoscopic response rate of some patients.Results A total of 91 CD patients who first used UST were included.The 8-week clinical response rate of UST treat-ment for CD was 61.5%,and the clinical response rate was 45%;The clinical response rate at 16 weeks was 71.4%,and the clinical response rate was 54.9%.56 cases underwent endoscopic re-examination in our hospital,and the endoscopic response rate at 16 weeks was 41.1%.Univariate analysis showed that fistula(including anal fistula,personal history of anal fistula,and intestinal skin fistula)is associated with clinical remission in Crohn′s disease patients at 8/16 weeks.Further multivariate COX regression analysis showed that the presence of a history of anal fistula surgery was an independent protective factor affecting clinical remission in CD patients treated with UST at 8 weeks(HR = 0.04,95%CI:0.00~0.38;P = 0.005)and 16 weeks(HR = 0.04,95%CI:0.01~0.34;P = 0.003)compared to those without fistula;Narrow lesions are an independent risk factor for 16 week clinical remission in CD patients compared to non-narrow and non-penetrating lesions(HR = 1.75,95%CI:1.08~2.84;P = 0.023).No patients were found to have stopped medication due to serious adverse reactions.Conclusions UST can improve the clinical remission and response of CD patients at 8/16 weeks,and has good short-term clinical efficacy.CD patients with a personal history of anal fistula are recommended to use UST monoclonal antibodies,while patients with stenotic lesions should be cautious in using UST monoclonal antibodies.Whether the patient has undergone surgical treatment in the past,as well as whether UST has been used on the first or non-first line,has no significant impact on clinical remission.
7.Topology Optimization Design of Bone Plate Structure Based on Load Path
Jun CAI ; Xiaohong DING ; Pengyun DUAN ; Min XIONG ; Heng ZHANG
Journal of Medical Biomechanics 2024;39(3):442-449
Objective To propose a topology-optimized design method for bone plates that effectively reduces stress concentration and improves bone healing compared with traditional topology-optimized method.Methods Based on the load constraints of a bone plate in a broken bone-splint system,an improved topology optimization method based on the load path was used to optimize the design of the bone plate structure.Subsequently,a bone regeneration simulation model based on bias strain was used to simulate the transverse fracture of the tibial tuberosity,and the force state,fixation stability,and healing performance of the optimized plate were evaluated based on data from the bone regeneration process.Results Using the optimized bone plate based on the load path optimization method,the maximum stresses of the bone plate were 55.68 MPa and 42.23 MPa at volume fractions f=0.55 and 0.65,respectively,which were reduced by 32.96%and 29.95%,respectively,compared with the optimized bone plate using the traditional topology optimization method.The average elastic moduli of the callus after the bone-healing process were 1 439.47 MPa and 1 355.71 MPa,respectively.These values were 145.86%and 131.06%higher than those of traditional bone plates,respectively.Conclusions In this study,the proposed improved topology optimization method based on the load path was used to optimize bone-plate structures.Compared to the bone plate obtained using the traditional topology optimization method,the optimized bone plate was more uniformly loaded and safer.The bone-healing performance was significantly improved compared to the traditional bone plate.These results provide a new method for the optimal design of internal fixation implants for fractures.
8.Advances in the study of human sperm metabolism and epigenetic regulation causing male infertility by influencing sperm motility
Feifan SUN ; Maoxiang ZHANG ; Yu JIANG ; Na WANG ; Fa REN ; Pengyun QIAO
Chinese Journal of Reproduction and Contraception 2024;44(5):548-555
As a highly differentiated haploid germ cell in male body, sperm is an important carrier of life genetic information transmission, and its structural integrity is the condition of normal insemination, and also the basis of normal metabolism to produce energy and complete epigenetic inheritance. Sperm metabolism is considered to be the "energy supply station" of sperm movement, which ensures the normal life activities such as spermatogenesis, maturation, over-activation and sperm-egg union. Abnormal metabolism will directly affect the sperm vitality and cause male infertility. Sperm epigenetic inheritance is a process that affects the embryonic development and reproduction of offspring through paternal inheritance, including DNA methylation, chromatin remodeling and small RNA carried by sperm and other regulatory modes, which can also affect energy production to a certain extent, thereby leading to the decline of sperm motility and male fertility. Therefore, sperm metabolism and epigenetics are inextricably related to the maintenance of sperm motility. In this paper, the structure, metabolism and epigenetic regulation of human sperm are reviewed in order to provide theoretical reference for the research on male infertility caused by abnormal sperm motility.
9.Advances in the study of human sperm metabolism and epigenetic regulation causing male infertility by influencing sperm motility
Feifan SUN ; Maoxiang ZHANG ; Yu JIANG ; Na WANG ; Fa REN ; Pengyun QIAO
Chinese Journal of Reproduction and Contraception 2024;44(5):548-555
As a highly differentiated haploid germ cell in male body, sperm is an important carrier of life genetic information transmission, and its structural integrity is the condition of normal insemination, and also the basis of normal metabolism to produce energy and complete epigenetic inheritance. Sperm metabolism is considered to be the "energy supply station" of sperm movement, which ensures the normal life activities such as spermatogenesis, maturation, over-activation and sperm-egg union. Abnormal metabolism will directly affect the sperm vitality and cause male infertility. Sperm epigenetic inheritance is a process that affects the embryonic development and reproduction of offspring through paternal inheritance, including DNA methylation, chromatin remodeling and small RNA carried by sperm and other regulatory modes, which can also affect energy production to a certain extent, thereby leading to the decline of sperm motility and male fertility. Therefore, sperm metabolism and epigenetics are inextricably related to the maintenance of sperm motility. In this paper, the structure, metabolism and epigenetic regulation of human sperm are reviewed in order to provide theoretical reference for the research on male infertility caused by abnormal sperm motility.
10.Growth and intelligence development among a cohort of low birth weight infants
ZHANG Yuerong, SUN Yu, LI Peipei, WANG Yan, CHEN Zhenzhen, SHAO Ziyu, JI Pengyun
Chinese Journal of School Health 2023;44(10):1555-1559
Objective:
To explore growth and intelligence development of low birth weight infants (LBWI) at 24 and 36 months of age, so as to provide reference for early monitoring and intervention of the development of LBWI.
Methods:
A total of 100 LBWI born and managed in Hefei Maternal and Child Health Care Institution were selected from 2012 October 1 to 2015 December 30, and 99 normal birth weight infants (NBWI) under child health management in the same sitinstitution were selected as controls. According a prospective cohort study method, and based on the establishment of a cohort and monitoring of childhood growth and development, a unified method was used to longitudinally follow up and observe the physical fitness of two groups of infants at the determined time points. The development of LBWI and NBWI at 24 and 36 months of age was surveyed using the Gesell Development Scale.
Results:
Weight, length and head circumference of LBWI children at the age of 15-36 months were significantly lower than those of NBWI children ( P <0.05). In addition, 117 children (43.98%) completed the full assessment of intelligent development scale, including 62 LBWI and 55 NBWI. The scores of Gesell in NBWI group was higher than that in LBWI group at 24 and 36 months of age, including adaptability, gross motor, fine metor skills, language and personal social functions ( t =-4.17, -3.82, -3.21 , -3.03, -2.61; -4.23, -3.16, -3.07, -3.13, -3.99, P <0.05). Multivariate linear regression analysis found that birth weight was positively correlated with adaptability, gross motor, fine motor skills, language functions at 24 and 36 months of age and personal social function at 36 months of age ( β =0.004, 0.010; 0.003, 0.008; 0.003, 0.007; 0.004, 0.009; 0.011, P <0.05).
Conclusion
The growth and development of LBWI children are significantly delayed compared to NBWI children. The scores of LBWI children are lower than those of NBWI children in all functional areas. Weight is the main factor affecting children s intellectual development. Early monitoring and intervention of low birth weight infants should be carried out to avoid or mitigate adverse consequences.


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