1.Construction and Application of Whole Process Information Management for Clinical Trial Drugs
Yiqi FAN ; Shuai HE ; Shixiang ZHENG ; Yan WANG ; Hongbo GUO ; Yanjiao MA
Herald of Medicine 2025;44(6):1004-1009
Objective To sort out the management system of clinical trial drugs in our hospital,and analyze the construction and practical experience of the information system in the whole process management of clinical trial drugs,and to further improve the efficiency and quality of clinical trials.Methods Based on the original management of clinical trial drugs,an information system in line with the situation of our hospital was applied to manage the whole process of clinical trial drugs.Results Compared with the traditional management,the information system can automatically record the data of inbound and outbound storage,distribution,retrieval and return of trial drugs in real time,pre-review the prescriptions and randomized documents of clinical trial drugs,and realise paperless office.Conclusions The information system can ensure the safety,accuracy and traceability of the data of drugs used in clinical trial.The system can also save resources,improve the efficiency and quality of clinical trial management.
2.Effect of USP44 and NCOR1 expression on prognosis in non-small cell lung cancer
Yunguo LIAO ; Ziyu TANG ; Dan DENG ; Jingjing GUO ; Shixiang QIU ; Chao LI ; Zhipeng FENG
International Journal of Laboratory Medicine 2025;46(3):261-265
Objective To investigate the effect of ubiquitin-specific peptidase(USP)44 and nuclear receptor co-inhibitor 1(NCOR1)expression on prognosis in non-small cell lung cancer.Methods A total of 98 pa-tients with non-small cell lung cancer admitted to a hospital from May 2019 to May 2021 were selected as the study objects,and non-small cell lung cancer tissues and adjacent tissues were collected to detect the expres-sion levels of USP44 and NCOR1 in these tissues by immunohistochemical staining.The relationship between USP44 and NCOR1 expression and pathological features of non-small cell lung cancer patients was analyzed,and the prognostic factors of non-small cell lung cancer patients were analyzed by multivariate Cox regression.Results The positive expression rates of USP44 and NCOR1 in non-small cell lung cancer tissues were higher than those in adjacent tissues,the difference was statistically significant(P<0.05).The positive expression rates of USP44 and NCOR1 in patients with medium-low differentiation,lymph node metastasis,clinical stageⅢ to Ⅳ,and pleural metastasis were higher than those in patients with highly differentiated,no lymph node metastasis,clinical stage Ⅰ to Ⅱ,and no pleural metastasis,and the difference was statistically significant(P<0.05).The 3-year overall survival rate of USP44 and NCOR1 negative non-small cell lung cancer patients was higher than that of USP44 and NCOR1 positive non-small cell lung cancer patients,and the difference was statistically significant(all P<0.05).Multivariate Cox regression analysis showed that pleural metastasis,USP44 positive and NCOR1 positive were prognostic factors in non-small cell lung cancer patients(P<0.05).Conclusion The expression of USP44 and NCOR1 in patients with non-small cell lung cancer can be used as biomarkers for prognosis assessment,and provide evidence for progression assessment and clinical de-cision making of non-small cell lung cancer.
3.Advances in the development of novel pancreatic duct stent materials:from inert implantation to intelligent degradation through medical-engineering integration
Jingyang YIN ; Zhongchao YI ; Yanjun WANG ; Jia SHE ; Shixiang GUO
Chinese Journal of General Surgery 2025;34(9):1892-1901
Pancreatic duct stents are essential devices for managing chronic pancreatitis,ductal strictures,and postoperative fistula.Conventional plastic and metal stents effectively facilitate pancreatic drainage but often cause infection,restenosis,or migration upon long-term implantation.An ideal stent should provide excellent biocompatibility,efficient drainage,and controllable biodegradation.With advances in material science and medical-engineering integration,stent technology has evolved from inert implantation to intelligent degradation.Biodegradable polymers and metals,particularly magnesium alloys(Mg-Zn-Mn),offer tunable mechanical strength,corrosion resistance,and in vivo degradability.Mg-2Zn-1.0Mn alloy achieves balanced strength and corrosion control through compositional optimization and surface modification.Polymeric stents such as polylactic acid and polydioxanone demonstrate favorable drainage and avoid secondary removal.Composite biodegradable stents,exemplified by the multi-rate ARCHIMEDES model,have received international approval.Supported by 3D printing and smart functionalization-such as drug-eluting or shape-memory designs-next-generation pancreatic stents may achieve integrated functions of support,repair,and tumor inhibition.Future research should emphasize interdisciplinary material design,degradation kinetics under physiological conditions,and long-term biocompatibility to accelerate clinical translation.
4.Intervention effect of Bupiqiangli compound on experimental myasthenia gravis with subclinical hypothyroidism in rats
Qiang WANG ; Ruozhao LI ; Shixiang KUANG ; Hai ZHAO ; Yijia QIAN ; Bo YONG ; Jing GUO ; Yunquan LIU
Chinese Journal of Immunology 2025;41(8):1806-1811
Objective:To explore the therapeutic effect of Bupiqiangli compound on experimental myasthenia gravis with sub-clinical hypothyroidism in rats and the influence of hypothalamus-pituitary-thyroid-thymus(HPTT)axis.Methods:SPF Lewis rats were randomly divided into normal group,model group,Bupiqiangli compound low-dose,medium-dose and high-dose groups.Model rats were immunized with AchR-α subunit 97-116 peptide sequence to construct an experimental myasthenia gravis model,and then methimazole was used to prepare an experimental myasthenia gravis with subclinical hypothyroidism model.Bupiqiangli compound low-dose,medium-dose and high-dose groups were given 4.57 g/kg,7.12 g/kg and 9.49 g/kg of Bupiqiangli compound by gavage,nor-mal group and model group were given an equal volume of normal saline by gavage,once a day,for 4 weeks.After the last gavage,Lennon scores of rats in each group were recorded;HE staining was used to detect pathological changes of thymus and thyroid;ELISA was used to detect expression levels of acetylcholine receptor antibody(AchRab),thyroid stimulating hormone(TSH),thyrotropin releasing hormone(TRH),free thyroxine(FT4)and thyroxine(T4)in serum;mRNA level of TRH in hypothalamus and TSH in pituitary tissue were detected by qPCR;Western blot detected changes of protein expressions of Cleaved Caspase3,Bcl2 associated X protein(Bax)and B-cell lymphoma-2(Bcl2)in thymus.Results:Compared with normal group,model group showed obvious symp-toms of muscle weakness,Lennon score increased significantly(P<0.05),obvious pathological changes in thymus and thyroid tissues,while no significant changes in expressions of FT4 and T4 in serum(P>0.05),expressions of AchRab,TSH and TRH in serum were significantly increased(P<0.05),expressions of TRH in hypothalamus and TSH in pituitary were significantly increased(P<0.05),protein expressions of Cleaved Caspase3 and Bax in thymus were significantly decreased(P<0.05),while expression of Bcl2 protein in thymus increased significantly(P<0.05).Compared with model group,myasthenia symptoms of compound high-dose group were im-proved,Lennon score was significantly decreased(P<0.05),pathological changes of thymus and thyroid tissues were improved,ex-pressions of FT4 and T4 in serum had no significant changes(P>0.05),expressions of AchRab,TSH and TRH in serum were signifi-cantly decreased(P<0.05),expressions of TRH in hypothalamus and TSH in pituitary were significantly decreased(P<0.05),expres-sions of Cleaved Caspase3 and Bax in thymus were significantly increased(P<0.05),while expression of Bcl2 in thymus was signifi-cantly decreased(P<0.05).Conclusion:Bupiqiang compound can improve clinical symptoms of experimental myasthenia gravis with subclinical hypothyroidism in rats,and its mechanism may be related to the regulation of HPTT axis.
5.Advances in the development of novel pancreatic duct stent materials:from inert implantation to intelligent degradation through medical-engineering integration
Jingyang YIN ; Zhongchao YI ; Yanjun WANG ; Jia SHE ; Shixiang GUO
Chinese Journal of General Surgery 2025;34(9):1892-1901
Pancreatic duct stents are essential devices for managing chronic pancreatitis,ductal strictures,and postoperative fistula.Conventional plastic and metal stents effectively facilitate pancreatic drainage but often cause infection,restenosis,or migration upon long-term implantation.An ideal stent should provide excellent biocompatibility,efficient drainage,and controllable biodegradation.With advances in material science and medical-engineering integration,stent technology has evolved from inert implantation to intelligent degradation.Biodegradable polymers and metals,particularly magnesium alloys(Mg-Zn-Mn),offer tunable mechanical strength,corrosion resistance,and in vivo degradability.Mg-2Zn-1.0Mn alloy achieves balanced strength and corrosion control through compositional optimization and surface modification.Polymeric stents such as polylactic acid and polydioxanone demonstrate favorable drainage and avoid secondary removal.Composite biodegradable stents,exemplified by the multi-rate ARCHIMEDES model,have received international approval.Supported by 3D printing and smart functionalization-such as drug-eluting or shape-memory designs-next-generation pancreatic stents may achieve integrated functions of support,repair,and tumor inhibition.Future research should emphasize interdisciplinary material design,degradation kinetics under physiological conditions,and long-term biocompatibility to accelerate clinical translation.
6.Construction and Application of Whole Process Information Management for Clinical Trial Drugs
Yiqi FAN ; Shuai HE ; Shixiang ZHENG ; Yan WANG ; Hongbo GUO ; Yanjiao MA
Herald of Medicine 2025;44(6):1004-1009
Objective To sort out the management system of clinical trial drugs in our hospital,and analyze the construction and practical experience of the information system in the whole process management of clinical trial drugs,and to further improve the efficiency and quality of clinical trials.Methods Based on the original management of clinical trial drugs,an information system in line with the situation of our hospital was applied to manage the whole process of clinical trial drugs.Results Compared with the traditional management,the information system can automatically record the data of inbound and outbound storage,distribution,retrieval and return of trial drugs in real time,pre-review the prescriptions and randomized documents of clinical trial drugs,and realise paperless office.Conclusions The information system can ensure the safety,accuracy and traceability of the data of drugs used in clinical trial.The system can also save resources,improve the efficiency and quality of clinical trial management.
7.Intervention effect of Bupiqiangli compound on experimental myasthenia gravis with subclinical hypothyroidism in rats
Qiang WANG ; Ruozhao LI ; Shixiang KUANG ; Hai ZHAO ; Yijia QIAN ; Bo YONG ; Jing GUO ; Yunquan LIU
Chinese Journal of Immunology 2025;41(8):1806-1811
Objective:To explore the therapeutic effect of Bupiqiangli compound on experimental myasthenia gravis with sub-clinical hypothyroidism in rats and the influence of hypothalamus-pituitary-thyroid-thymus(HPTT)axis.Methods:SPF Lewis rats were randomly divided into normal group,model group,Bupiqiangli compound low-dose,medium-dose and high-dose groups.Model rats were immunized with AchR-α subunit 97-116 peptide sequence to construct an experimental myasthenia gravis model,and then methimazole was used to prepare an experimental myasthenia gravis with subclinical hypothyroidism model.Bupiqiangli compound low-dose,medium-dose and high-dose groups were given 4.57 g/kg,7.12 g/kg and 9.49 g/kg of Bupiqiangli compound by gavage,nor-mal group and model group were given an equal volume of normal saline by gavage,once a day,for 4 weeks.After the last gavage,Lennon scores of rats in each group were recorded;HE staining was used to detect pathological changes of thymus and thyroid;ELISA was used to detect expression levels of acetylcholine receptor antibody(AchRab),thyroid stimulating hormone(TSH),thyrotropin releasing hormone(TRH),free thyroxine(FT4)and thyroxine(T4)in serum;mRNA level of TRH in hypothalamus and TSH in pituitary tissue were detected by qPCR;Western blot detected changes of protein expressions of Cleaved Caspase3,Bcl2 associated X protein(Bax)and B-cell lymphoma-2(Bcl2)in thymus.Results:Compared with normal group,model group showed obvious symp-toms of muscle weakness,Lennon score increased significantly(P<0.05),obvious pathological changes in thymus and thyroid tissues,while no significant changes in expressions of FT4 and T4 in serum(P>0.05),expressions of AchRab,TSH and TRH in serum were significantly increased(P<0.05),expressions of TRH in hypothalamus and TSH in pituitary were significantly increased(P<0.05),protein expressions of Cleaved Caspase3 and Bax in thymus were significantly decreased(P<0.05),while expression of Bcl2 protein in thymus increased significantly(P<0.05).Compared with model group,myasthenia symptoms of compound high-dose group were im-proved,Lennon score was significantly decreased(P<0.05),pathological changes of thymus and thyroid tissues were improved,ex-pressions of FT4 and T4 in serum had no significant changes(P>0.05),expressions of AchRab,TSH and TRH in serum were signifi-cantly decreased(P<0.05),expressions of TRH in hypothalamus and TSH in pituitary were significantly decreased(P<0.05),expres-sions of Cleaved Caspase3 and Bax in thymus were significantly increased(P<0.05),while expression of Bcl2 in thymus was signifi-cantly decreased(P<0.05).Conclusion:Bupiqiang compound can improve clinical symptoms of experimental myasthenia gravis with subclinical hypothyroidism in rats,and its mechanism may be related to the regulation of HPTT axis.
8.Mendelian randomization analysis of the causal association between bronchial asthma and bone mineral density
Lianlian LIU ; Huiyong YU ; Lei LI ; Yufei GUO ; Tianyang NIE ; Tian MAN ; Shixiang WEI ; Chuxi XIE ; Tianyun CHEN ; Chengxiang WANG
Journal of Clinical Medicine in Practice 2024;28(14):24-29
Objective To investigate the causal association between bronchial asthma and bone mineral density at different sites using a two-sample Mendelian randomization (MR) approach. Methods Summary data for exposure factors and outcome were obtained from different genome-wide association studies.Single nucleotide polymorphisms strongly associated with bronchial asthma were selected as instrumental variables,and those in linkage disequilibrium were excluded.The inverse-variance weighted (IVW) method was used as the primary method for MR analysis,complemented by weighted median,simple mode,weighted mode,and MR-Egger regression methods.Sensitivity analyses were conducted to assess the stability of the results. Results The random-effects model of IVW analysis showed that heel bone mineral density (OR=0.986;95% CI,0.974 to 0.998;
9.Recent advances in the diagnosis and treatment of refractory epilepsy
Shuchao GUO ; Jianguo LI ; Shixiang CHENG ; Baohu LIU ; Tailong YI
Clinical Medicine of China 2017;33(8):765-768
The refractory epilepsy refers to the epilepsy whose seizures couldn't be cured after using two kinds of correctly selected antiepileptic drugs which can be tolerated and enough dosage and duration of monotherapy or combination therapy.The pathogenesis of intractable epilepsy is complex,and there is no established theory at home and abroad.Recently,more and more attention has been paid to the correlation between mitochondrial dysfunction caused by oxidative stress and intractable epilepsy.Based on the summary of common treatment of refractory epilepsy and by searching the related literature at home and abroad,further investigation would be made to explore the diagnosis and treatment of intractable epilepsy theory in order to provide new strategies for diagnosis and treatment of intractable epilepsy.
10.Effects of salvianolate lyophilized injection on neural functional recovery and the expression of microtubule associated protein-2 after focal cerebral ischemia-reperfusion injury in diabetic rats
Qiansong HE ; Shixiang KUANG ; Shaoxia WANG ; Pengwei ZHUANG ; Yanjun ZHANG ; Hong GUO ; Limin HU
Chinese Journal of Behavioral Medicine and Brain Science 2015;24(10):877-881
Objective To investigate the effects of salvianolate lyophilized injection(SLI) on neural functional recovery and the expression of microtubule associated protein-2(MAP2) after focal cerebral ischemia-reperfusion injury in the diabetic rats.Methods Diabetes model was made by intraperitoneal injection of streptozotocin (STZ) and cerebral ischemia-reperfusion model was developed by Longa suture occluded method in the middle cerebral artery of diabetic rats.The rats were randomly divided into five groups: sham operation group, model group, SLI (21.0 mg.kg-1,10.5 mg.kg-1) treatment groups, and edaravone (6 mg.kg-1) treatment group.3 hours after ischemia,rats were respectively given normal saline or drugs followed by the injection once a day for 14 days and the neurological impairment was assessed.2 h after the last injection,the rats were decapitated and the brains were collected.The expression of MAP2 protein and mRNA in the bilateral hippocampal ischemia and infarcted area was detected with immunohistochemistry and RT-PCR.Results Severe neurological dysfunction was found in diabetic rats that had been subjected to cerebral ischemic injury (1.850±0.457).A significant improvement on neurological function was found in the SLI treatment groups (1.581 ± 0.314, 1.345 ± 0.425) compared with model group(P<0.01, P<0.05).Moreover,the expression of MAP2 in ischemia bilateral hippocampal CA1 and penumbra was represented by the average optical density value respectively (0.743±0.250,0.561± 0.224).In the hippocampal CA1 region, the number of MAP2-positive cells (0.781 ± 0.420 , 0.851 ± 0.136) in the treatment group showed significant increase than those in model group (P<0.01, P<0.05).In the ischemic penumbra region,the number of MAP2-positive cells (0.753±0.235,1.203±0.326) in the treatment group showed significant increase than those in model group (P<0.01, P<0.05).Conclusion The SLI can promote the post-injury neurocognitive function in diabetic rats.The increase of MAP2 expression may be involved in the mechanisms.


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