1.A survey on Chinese physicians’cognition,attitudes,and practices regarding biosimilars and their clinical switching
Liyang GAO ; Lijuan ZUO ; Huiting PENG ; Weixin XU ; Li ZHANG ; Haisheng CHEN ; Jing SHI
China Pharmacy 2026;37(18):2363-2368
OBJECTIVE To investigate the cognition, attitudes, and current practices of Chinese physicians regarding biosimilars and their clinical switching, so as to provide a basis for the rational clinical application of biosimilars in China and the improvement of related policies.METHODS A national cross-sectional online questionnaire survey was conducted in 2025. Quota sampling was adopted, with quotas based on physicians’ sex, city tier, and specialty. Questionnaire invitations were distributed to licensed physicians, and physicians who had prescribed monoclonal antibody biosimilars were included for analysis. The questionnaire covered their familiarity with biosimilars, attitudes, clinical switching practices, and reasons. Data were processed using reliability and validity tests, dispersion analysis, and cross-tabulation analysis.RESULTS The questionnaire scale showed good reliability and validity, with Cronbach’s α coefficient >0.7 and KMO value >0.6. A total of 2 071 survey invitations were distributed, and 300 valid questionnaires were returned, with an effective response rate of 14.5%. Among the respondents, 75.3% had prescribed 3-5 types of monoclonal antibody biosimilars; only 35.3% were aware that China currently has no clear regulatory provisions on biosimilar switching; 46.3% and 47.3% of respondents believed that there was no difference in safety and efficacy, respectively, between biosimilars and originator products; 63.0% of respondents were concerned about the immunogenicity risk of long-term switching between originator drugs and biosimilars. A total of 92.3% of respondents had experience with biosimilar switching, 87.7% of which involved switching from originator products to biosimilars, and 28.2% of respondents had completed three or more switches in the same patient. Among the primary reasons for switching, non-medical factors accounted for 57.4%, higher than medical factors at 42.6%; “lower treatment cost after switching” was the most important reason for switching; 95.3% of respondents believed that informed consent should be obtained from patients before switching.CONCLUSIONS The surveyed physicians had basic knowledge of biosimilars, but their understanding of the relevant regulations of the national drug regulatory authority was insufficient. Although most physicians were concerned about the risks of non-medical switching, clinical switching was mostly driven by non-medical factors. It is recommended to strengthen policy education for medical professionals and standardize clinical switching behavior. The National Medical Products Administration should also promptly improve the interchangeability review standards and post-marketing surveillance system for biosimilars, so as to promote the rational use of biosimilars.
2.Establishment and application of rapid detection method based on MALDI-TOF MS platform for CRE drug resistance
Yeqiong LIU ; Wenxin TANG ; Honglin ZHANG ; Feng YAN ; Weixin XU
China Medical Equipment 2025;22(11):56-60
Objective:To establish a rapid detection method based on matrix-assisted laser desorption ionization time-of-flight mass spectrometry(MALDI-TOF MS)for drug resistance of Carbapenem-resistant Enterobacteriaceae(CRE),so as to provide basis for enhancing clinically diagnostic effect.Methods:A total of 120 suspected CRE strains that were isolated from the clinical laboratory of Jiading District Central Hospital Affiliated to Shanghai University of Medicine&Health Sciences during October 2023 and September 2024 were collected,and the experimental detection of 44 strains was finally completed.The 44 suspected CRE bacterial strains were all from hospitalized patients.A rapid detection protocol based on the MALDI-TOF MS platform was initially established and improved,and experimental detection was carried out using the fully automatic rapid microbial mass spectrometry detection system(VITEK MS).The results of identification review and antimicrobial susceptibility test(AST)for VitEK-2 Compact strain was used as the reference standard.The screening results and detection efficacy of two kinds of detection methods were compared.Results:In the 44 suspected CRE strains,31 CRE strains were screened out by MALDI-TOF MS detection,and 31 CRE stains were screened out by VITEK-2 Compact recheck detection.In them,one strain of Enterobacter cloacae was confirmed as negativity by the MALDI-TOF MS test,but it was confirmed as CRE by the VITEK-2 Compact test.One strain of Klebsiella pneumoniae was confirmed as positivity by the MALDI-TOF MS test,but it was confirmed as mediator for carbapenem drugs by the VITEK-2 Compact test.The tested results of VITEK-2 Compact was used as standard,the results of four-grid table(2×2 contingency table)statistical method indicated that the sensitivity,specificity,accuracy rate and Youden index(R)of MALDI-TOF MS were respectively 96.7%,92.3%,100%and 89.1%.Conclusion:The rapid detection method based on the MALDI-TOF MS platform for CRE drug resistance has simple operation process and high accuracy rate,which can provide a basis for the application of targeted antibacterial drugs at early stage.
3.Improve self-management behaviour of the patients with glaucoma after day surgery:an online-to-offline health education based on timing theory
Chunyan YANG ; Weixin ZHENG ; Wenmin HUANG ; Huiming XIAO ; Bomin LIN ; Xiaoye XU ; Xinyan LI ; Yu ZHANG
Modern Clinical Nursing 2025;24(8):46-53
Objective To evaluate the efficacy of an online-to-offline(O2O)health education guided by the'Timing Theory'in improving self-management behaviours among the patients with glaucoma after day surgery.Methods In this randomised controlled study conducted between July and December 2022,70 patients with glaucoma after day surgery in our hospital were assigned to a control group and an experimental group,with 35 patients per group.Patients in control group received routine nursing care,while those in experimental group received O2O health education based on timing theory in addition to the routine nursing care.Outcomes were evaluated using the glaucoma awareness and knowledge questionnaire(GAKQ),self-efficacy to manage chronic disease scale(SEMCD)and glaucoma self-management questionnaire(GSMQ)at baseline,at 1 month and 3 months after surgery.Results A total of 32 patients in the experimental group and 27 in the control group completed the study.The generalised estimating equation(GEE)analysis showed a significant difference,respectively,in total score of GSMQ in interaction effect(F=8.408,P=0.015)and SEMC in time main effect(F=54.660,P<0.001).There were significant differences in total scores of GAKQ in time main effect,inter-group main effect and interaction effect(F=128.483,P<0.001;F=7.991,P<0.05;F=32.652,P<0.001,respectively).At one-month after intervention,the experimental group showed significantly higher GAKQ and SEMCD scores than the control group(Z=-2.004,P<0.05;Z=-2.029,P<0.05,respectively).At 1-and 3-months after intervention,the experimental group demonstrated significantly higher GAKQ scores(Z=-3.987,P<0.001;Z=-4.505,P<0.001,respectively).Conclusion The timing theory based O2O health education significantly improves knowledge of glaucoma,self-efficacy and self-management behaviours among day surgery patients and helps patients better cope with perioperative self-management over day surgery.
4.Effects of acupuncture on the hypothalamic-pituitary-ovarian axis and FSH/cAMP signaling pathway in aged rats.
Yaoyao ZHU ; Yaqian YIN ; Huanfang XU ; Li YANG ; Weixin LI ; Chenchen SU ; Rong ZHANG ; Yigong FANG
Chinese Acupuncture & Moxibustion 2025;45(2):200-208
OBJECTIVE:
To explore the mechanism of acupuncture on improving ovarian hypofunction in aged rats from two perspectives: the overall regulation of the hypothalamic-pituitary-ovarian (HPO) axis and the local ovarian follicle stimulating hormone (FSH)/cyclic adenosine monophosphate (cAMP) signaling pathway.
METHODS:
Six 3-month-old female SPF-grade Sprague-Dawley (SD) rats were selected as the blank group. Another twelve 9-month-old female SD rats were randomly divided into a model group and an acupuncture group, with six rats in each. The acupuncture group received acupuncture at "Baihui" (GV20), "Guanyuan" (CV4), and bilateral "Ciliao" (BL32) for 20 min per session, once every other day, for a total of 10 sessions. Vaginal smear tests were performed daily to observe the estrous cycle of the rats. Ovarian morphology was observed using HE staining, and follicles at various stages were counted. ELISA was used to detect levels of serum FSH, luteinizing hormone (LH), estradiol (E2), anti-müllerian hormone (AMH), hypothalamic gonadotropin-releasing hormone (GnRH), pituitary FSH and LH, and ovarian cAMP. Immunohistochemistry and Western blot were used to detect the protein expression of ovarian cAMP protein kinase catalytic subunit, FSH receptor (FSHR), and P450. Real-time quantitative PCR was used to measure mRNA expression levels of FSHR and P450 in ovarian tissue.
RESULTS:
Compared with the blank group, the model group showed an increased rate of estrous cycle disorder (P<0.01), reduced granulosa cell layers with blurred boundaries and disordered arrangement, decreased numbers of developing follicles at all stages, and increased numbers of atretic follicles (P<0.01); the serum levels of FSH and LH were increased (P<0.01), while E2 and AMH levels were decreased (P<0.01); the hypothalamic GnRH and pituitary FSH and LH levels were elevated (P<0.01), and ovarian cAMP level was decreased (P<0.01); the positive expression and protein expression of ovarian P450, cAMP protein kinase catalytic subunit, and FSHR were reduced (P<0.01), and ovarian FSHR and P450 mRNA expression was decreased (P<0.01). Compared with the model group, the acupuncture group showed a reduced rate of estrous cycle disorder (P<0.01), clear granulosa cell margins, increased numbers of primordial and secondary follicles, and decreased numbers of atretic follicles (P<0.01); the serum FSH and LH levels were decreased (P<0.01, P<0.05), while E2 and AMH levels were increased (P<0.05, P<0.01); the hypothalamic GnRH and pituitary FSH and LH levels were decreased (P<0.01, P<0.05), and ovarian cAMP level was increased (P<0.01); the positive expression and protein expression of ovarian P450, cAMP protein kinase catalytic subunit, and FSHR were elevated (P<0.01), and ovarian FSHR and P450 mRNA expression was increased (P<0.01).
CONCLUSION
Acupuncture could delay ovarian hypofunction in aged rats, possibly through regulating the HPO axis and the FSH/cAMP signaling pathway.
Animals
;
Female
;
Rats
;
Rats, Sprague-Dawley
;
Follicle Stimulating Hormone/genetics*
;
Acupuncture Therapy
;
Ovary/metabolism*
;
Signal Transduction
;
Humans
;
Cyclic AMP/metabolism*
;
Hypothalamo-Hypophyseal System/metabolism*
;
Aging/metabolism*
;
Hypothalamus/metabolism*
;
Pituitary Gland/metabolism*
;
Gonadotropin-Releasing Hormone/metabolism*
5.Improve self-management behaviour of the patients with glaucoma after day surgery:an online-to-offline health education based on timing theory
Chunyan YANG ; Weixin ZHENG ; Wenmin HUANG ; Huiming XIAO ; Bomin LIN ; Xiaoye XU ; Xinyan LI ; Yu ZHANG
Modern Clinical Nursing 2025;24(8):46-53
Objective To evaluate the efficacy of an online-to-offline(O2O)health education guided by the'Timing Theory'in improving self-management behaviours among the patients with glaucoma after day surgery.Methods In this randomised controlled study conducted between July and December 2022,70 patients with glaucoma after day surgery in our hospital were assigned to a control group and an experimental group,with 35 patients per group.Patients in control group received routine nursing care,while those in experimental group received O2O health education based on timing theory in addition to the routine nursing care.Outcomes were evaluated using the glaucoma awareness and knowledge questionnaire(GAKQ),self-efficacy to manage chronic disease scale(SEMCD)and glaucoma self-management questionnaire(GSMQ)at baseline,at 1 month and 3 months after surgery.Results A total of 32 patients in the experimental group and 27 in the control group completed the study.The generalised estimating equation(GEE)analysis showed a significant difference,respectively,in total score of GSMQ in interaction effect(F=8.408,P=0.015)and SEMC in time main effect(F=54.660,P<0.001).There were significant differences in total scores of GAKQ in time main effect,inter-group main effect and interaction effect(F=128.483,P<0.001;F=7.991,P<0.05;F=32.652,P<0.001,respectively).At one-month after intervention,the experimental group showed significantly higher GAKQ and SEMCD scores than the control group(Z=-2.004,P<0.05;Z=-2.029,P<0.05,respectively).At 1-and 3-months after intervention,the experimental group demonstrated significantly higher GAKQ scores(Z=-3.987,P<0.001;Z=-4.505,P<0.001,respectively).Conclusion The timing theory based O2O health education significantly improves knowledge of glaucoma,self-efficacy and self-management behaviours among day surgery patients and helps patients better cope with perioperative self-management over day surgery.
6.Establishment and application of rapid detection method based on MALDI-TOF MS platform for CRE drug resistance
Yeqiong LIU ; Wenxin TANG ; Honglin ZHANG ; Feng YAN ; Weixin XU
China Medical Equipment 2025;22(11):56-60
Objective:To establish a rapid detection method based on matrix-assisted laser desorption ionization time-of-flight mass spectrometry(MALDI-TOF MS)for drug resistance of Carbapenem-resistant Enterobacteriaceae(CRE),so as to provide basis for enhancing clinically diagnostic effect.Methods:A total of 120 suspected CRE strains that were isolated from the clinical laboratory of Jiading District Central Hospital Affiliated to Shanghai University of Medicine&Health Sciences during October 2023 and September 2024 were collected,and the experimental detection of 44 strains was finally completed.The 44 suspected CRE bacterial strains were all from hospitalized patients.A rapid detection protocol based on the MALDI-TOF MS platform was initially established and improved,and experimental detection was carried out using the fully automatic rapid microbial mass spectrometry detection system(VITEK MS).The results of identification review and antimicrobial susceptibility test(AST)for VitEK-2 Compact strain was used as the reference standard.The screening results and detection efficacy of two kinds of detection methods were compared.Results:In the 44 suspected CRE strains,31 CRE strains were screened out by MALDI-TOF MS detection,and 31 CRE stains were screened out by VITEK-2 Compact recheck detection.In them,one strain of Enterobacter cloacae was confirmed as negativity by the MALDI-TOF MS test,but it was confirmed as CRE by the VITEK-2 Compact test.One strain of Klebsiella pneumoniae was confirmed as positivity by the MALDI-TOF MS test,but it was confirmed as mediator for carbapenem drugs by the VITEK-2 Compact test.The tested results of VITEK-2 Compact was used as standard,the results of four-grid table(2×2 contingency table)statistical method indicated that the sensitivity,specificity,accuracy rate and Youden index(R)of MALDI-TOF MS were respectively 96.7%,92.3%,100%and 89.1%.Conclusion:The rapid detection method based on the MALDI-TOF MS platform for CRE drug resistance has simple operation process and high accuracy rate,which can provide a basis for the application of targeted antibacterial drugs at early stage.
7.Current status and influencing factors of decision conflicts among family members of Neurosurgical Intensive Care Unit patients
Miao LI ; Yiming ZHAN ; Weixin CAI ; Lijie XU ; Yuan YUAN ; Ran ZHANG
Chinese Journal of Modern Nursing 2025;31(6):718-723
Objective:To explore the current status of decision conflicts among family members of Neurosurgical Intensive Care Unit patients and its influencing factors, so as to provide a reference for meeting the decision needs of family members of Neurosurgical Intensive Care Unit patients.Methods:Convenience sampling was used to select 150 family members of Neurosurgical Intensive Care Unit patients from Beijing Tiantan Hospital affiliated with Capital Medical University from March to May 2024 for the study. General Information Questionnaire, Decisional Conflict Scale, Control Preference Scale, Preparation Decision Making, and Impact of Event Scale were used to survey the study participants. Multiple linear regression was used to analyze the factors influencing decision conflicts among family members of Neurosurgical Intensive Care Unit patients.Results:A total of 150 questionnaires were distributed, six questionnaires whose answers showed obvious patterns were excluded, 144 valid questionnaires were recovered, and the effective recovery rate of the questionnaires was 96.0% (144/150) . The total score of the Decisional Conflict Scale of family members of Neurosurgical Intensive Care Unit patients was (34.95±9.99) . Multiple linear regression analysis showed that decision readiness and impact of events were influencing factors of decision conflicts among family members of Neurosurgical Intensive Care Unit patients, and the difference was statistically significant ( P<0.05) . Conclusions:There are certain decision conflicts among family members of Neurosurgical Intensive Care Unit patients. Healthcare professionals should pay attention to family members' decision readiness and the impact of events, and develop targeted decision interventions to reduce decision conflicts of family members in order to promote a smooth medical decision process.
8.Current status and influencing factors of decision conflicts among family members of Neurosurgical Intensive Care Unit patients
Miao LI ; Yiming ZHAN ; Weixin CAI ; Lijie XU ; Yuan YUAN ; Ran ZHANG
Chinese Journal of Modern Nursing 2025;31(6):718-723
Objective:To explore the current status of decision conflicts among family members of Neurosurgical Intensive Care Unit patients and its influencing factors, so as to provide a reference for meeting the decision needs of family members of Neurosurgical Intensive Care Unit patients.Methods:Convenience sampling was used to select 150 family members of Neurosurgical Intensive Care Unit patients from Beijing Tiantan Hospital affiliated with Capital Medical University from March to May 2024 for the study. General Information Questionnaire, Decisional Conflict Scale, Control Preference Scale, Preparation Decision Making, and Impact of Event Scale were used to survey the study participants. Multiple linear regression was used to analyze the factors influencing decision conflicts among family members of Neurosurgical Intensive Care Unit patients.Results:A total of 150 questionnaires were distributed, six questionnaires whose answers showed obvious patterns were excluded, 144 valid questionnaires were recovered, and the effective recovery rate of the questionnaires was 96.0% (144/150) . The total score of the Decisional Conflict Scale of family members of Neurosurgical Intensive Care Unit patients was (34.95±9.99) . Multiple linear regression analysis showed that decision readiness and impact of events were influencing factors of decision conflicts among family members of Neurosurgical Intensive Care Unit patients, and the difference was statistically significant ( P<0.05) . Conclusions:There are certain decision conflicts among family members of Neurosurgical Intensive Care Unit patients. Healthcare professionals should pay attention to family members' decision readiness and the impact of events, and develop targeted decision interventions to reduce decision conflicts of family members in order to promote a smooth medical decision process.
9.Dosage of 4-Vinylcyclohexene Diepoxide in Induction of Premature Ovarian Insufficiency in Rats
Weixin LI ; Pengfei DU ; Yaoyao ZHU ; Chenchen SU ; Huanfang XU ; Li YANG ; Xiaojing SONG ; Yigong FANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(18):72-79
ObjectiveTo compare the effects of different doses and withdrawal time of 4-vinylcyclohexene diepoxide (VCD) on the reproductive endocrine levels of female rats, and to explore the effective, stable, and safe dosage of VCD for constructing a premature ovarian insufficiency (POI) rat model. MethodSD rats with regular estrous cycles were randomly divided into three groups: blank group, low-dose VCD group (80 mg·kg-1·d-1), and high-dose VCD group (160 mg·kg-1·d-1), with 24 rats in each group. After drug intervention, samples were collected on the 15th day (D15) and the 45th day (D45) after intervention. The general condition, rate of estrous cycle disturbance, serum hormone levels, ovarian histomorphology, follicle count, pregnancy outcome, and the protein and mRNA expression of transforming growth factor (TGF)-β and Smad2/3 were assessed. ResultCompared with the blank group, the low-dose VCD group showed no significant differences in the rate of estrous cycle disturbance or serum follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E2) levels. Ovarian tissue was damaged. Specifically, the number of primordial and primary follicles decreased on D15 (P<0.01), and the number of secondary follicles (P<0.01) and antral follicles (P<0.05) further decreased on D45. The litter number decreased on D15 (P<0.05), but there was no significant difference on D45. Furthermore, TGF-β protein levels increased on D15 (P<0.05) and D45 (P<0.01). The Smad2/3 levels increased on D45 (P<0.01), and TGF-β and Smad2/3 mRNA levels increased on D45 (P<0.05). Compared with the results in the blank group, the disturbance rate of the estrous cycle increased on D45 in the high-dose VCD group (P<0.01). The serum of FSH and LH increased (P<0.01), while E2 decreased (P<0.05). Ovarian tissue was damaged, and the downward trend of follicles at all levels was similar to that in the low-dose VCD group. The litter number significantly decreased on D15 and D45. TGF-β and Smad2/3 protein levels increased (P<0.05,P<0.01), and TGF-β mRNA increased on D45 (P<0.05). ConclusionHigh-dose VCD is an ideal method for constructing a POI rat model, being effective, stable, and safe.
10.Investigation and analysis of the current status of transjugular intrahepatic portosystemic shunt treatment for portal hypertension in China
Haozhuo GUO ; Meng NIU ; Haibo SHAO ; Xinwei HAN ; Jianbo ZHAO ; Junhui SUN ; Zhuting FANG ; Bin XIONG ; Xiaoli ZHU ; Weixin REN ; Min YUAN ; Shiping YU ; Weifu LYU ; Xueqiang ZHANG ; Chunqing ZHANG ; Lei LI ; Xuefeng LUO ; Yusheng SONG ; Yilong MA ; Tong DANG ; Hua XIANG ; Yun JIN ; Hui XUE ; Guiyun JIN ; Xiao LI ; Jiarui LI ; Shi ZHOU ; Changlu YU ; Song HE ; Lei YU ; Hongmei ZU ; Jun MA ; Yanming LEI ; Ke XU ; Xiaolong QI
Chinese Journal of Radiology 2024;58(4):437-443
Objective:To investigate the current situation of the use of transjugular intrahepatic portosystemic shunt (TIPS) for portal hypertension, which should aid the development of TIPS in China.Methods:The China Portal Hypertension Alliance (CHESS) initiated this study that comprehensively investigated the basic situation of TIPS for portal hypertension in China through network research. The survey included the following: the number of surgical cases, main indications, the development of Early-TIPS, TIPS for portal vein cavernous transformation, collateral circulation embolization, intraoperative portal pressure gradient measurement, commonly used stent types, conventional anticoagulation and time, postoperative follow-up, obstacles, and the application of domestic instruments.Results:According to the survey, a total of 13 527 TIPS operations were carried out in 545 hospitals participating in the survey in 2021, and 94.1% of the hospital had the habit of routine follow-up after TIPS. Most hospitals believed that the main indications of TIPS were the control of acute bleeding (42.6%) and the prevention of rebleeding (40.7%). 48.1% of the teams carried out early or priority TIPS, 53.0% of the teams carried out TIPS for the cavernous transformation of the portal vein, and 81.0% chose routine embolization of collateral circulation during operation. Most of them used coils and biological glue as embolic materials, and 78.5% of the team routinely performed intraoperative portal pressure gradient measurements. In selecting TIPS stents, 57.1% of the hospitals woulel choose Viator-specific stents, 57.2% woulel choose conventional anticoagulation after TIPS, and the duration of anticoagulation was between 3-6 months (55.4%). The limitation of TIPS surgery was mainly due to cost (72.3%) and insufficient understanding of doctors in related departments (77.4%). Most teams accepted the domestic instruments used in TIPS (92.7%).Conclusions:This survey shows that TIPS treatment is an essential part of treating portal hypertension in China. The total number of TIPS cases is far from that of patients with portal hypertension. In the future, it is still necessary to popularize TIPS technology and further standardize surgical indications, routine operations, and instrument application.

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