1.The Current Status and Prospects of the Application of Digital Technology in the Field of Pharmacovigilance of Rare Diseases
Ying CAO ; Xinru LIU ; Shengfeng WANG ; Lin ZHUO
JOURNAL OF RARE DISEASES 2025;4(1):22-29
To summarize the current status in the application of digital and intelligent technologies in the field of pharmacovigilance and to provide reference to the selection and development of methods for pharmacovigilance of rare diseases. Searched five major databases-CNKI, WANFANG, VIP, PubMed, and Embase, selected and the data of application of digital technology in the field of drug vigilance for rare diseases, extracted relevant information and conducted a systematic review. The application of digital technology in drug surveillance has not yet been used in the special field of rare diseases. Relevant case studies are insufficient. Two major challenges need to be addressed. One is the insufficient data sources and the other is technical limitations. Based on the characteristics of drugs for rare diseases, this paper identifies data sources and intelligent technologies suitable for the field of drug vigilance for rare disease, proposes direction for potential development in the future, and makes targeted suggestions.
2.Comparison of three methods for removing microglial cells from primary astrocytes
Hongyan CHEN ; Zhen LEI ; Chunting WANG ; Xinru WEN ; Xuemei LIN ; Yuqiang JI ; Songdi WU
Chinese Journal of Neuroanatomy 2024;40(5):565-571
Objective:In this study,three methods of removing microglial cells from primary astrocyte culture were compared and analyzed to explore the characteristics of different purification methods.It provides the basis for research-ers to select the appropriate primary astrocyte culture method.Methods:The cerebral cortex cells of SD neonatal rats were isolated and platted and divided into an unpurified group(control group),a traditional oscillation purification group(TO group),a cytosine β-D-arabinofuranoside(AraC)+TO group,and an AraC+L-leucine methyl ester(LME)group according to different purification methods.Cell counts were used to calculate the cell production after different purification treatments.The cell morphology of each group was observed under an optical microscope,and the proportion of glial fibrillary acidic protein(GFAP)positive cells was calculated by immunofluorescence staining.AlamarBlue HS was used to detect cell viability after passage.Results:Compared with the control group,the cell purity(P<0.0001)and cell viability(P<0.0001)of purified cells in the TO group were significantly increased after pas-sage,while the total number of purified cells was significantly decreased(P<0.001).These trends were more obvious in the AraC+TO and AraC+LME group,and the cell purity(P<0.0001 or P<0.0001)and cell viability(P<0.01 or P<0.001)of purified cells in the AraC+TO and AraC+LME group after passage were significantly higher than those in the TO group.The total amount of cells obtained was significantly decreased compared with the TO group(P<0.01 orP<0.01).There was no significant difference between the AraC+TO and AraC+LME group.Conclusion:The culture rich in astrocytes(cell purity>90%)was obtained by the TO method,and the cell yield was high,which could be applied to routine cell research.The highly enriched astrocyte cultures(cell purity>99%)obtained by the AraC+TO and AraC+LME purification methods can be applied to study the precise role of astrocytes in the context of neuroinflammation.
3.Predictive value of FLAIR vascular hyperintensity in patients with acute ischemic stroke underwent endovascular treatment
Yaoyao YAN ; Jianxun SONG ; Guohui LIN ; Tengda HUANG ; Xinru WEN
International Journal of Cerebrovascular Diseases 2024;32(1):62-66
Endovascular treatment has become the standard treatment method for acute ischemic stroke caused by large vessel occlusion. The application of neuroimaging techniques for appropriate patient selection and prognosis prediction is of great significance for successful endovascular treatment. This article reviews the application progress of fluid-attenuated inversion recovery sequence vascular hyperintensity in patients with acute ischemic stroke underwent endovascular treatment.
4.Antibiotic-loaded bone cement enhances ability of tibial cortex transverse transport for treating infected wounds
Junpeng LIU ; Xingchen YAO ; Hui ZHAO ; Ziyu XU ; Yue WU ; Fuchun PEI ; Lin ZHANG ; Xinru DU
Chinese Journal of Tissue Engineering Research 2024;28(29):4599-4604
BACKGROUND:Diabetic foot patients with wound infections constitute a large patient population,and there is currently no satisfactory treatment approach. OBJECTIVE:To investigate the clinical efficacy of a modified tibial cortex transverse transport combined with antibiotic-loaded bone cement for treating refractory diabetic foot ulcers. METHODS:A total of 46 diabetic foot ulcers patients,27 males and 19 females,with an average age of 64.37 years,were selected from Beijing Chaoyang Hospital,Capital Medical University and Beijing Chaoyang Integrative Medicine Rescue and First Aid Hospital from January 2020 to January 2023.All of them underwent the modified tibial cortex transverse transport combined with antibiotic-loaded bone cement treatment.Ankle-brachial index,WIFi(Wound/Ischemia/Foot infection)classification,pain visual analog scale score,and ulcer area were recorded before and 3 months after surgery. RESULTS AND CONCLUSION:(1)The mean ulcer healing time for the 46 patients was(58.07±24.82)days.At 3 months postoperatively,there were significant improvements in ankle-brachial index,pain visual analog scale score,ulcer area,and WIFi classification in 46 patients,as compared to the preoperative values,with statistically significant differences(P<0.05).Two patients experienced pin-tract infections,without infection or ulcer recurrence during the follow-up period.(2)These findings indicate that the modified tibial cortex transverse transport combined with antibiotic-loaded bone cement effectively alleviates patients'pain,improves lower limb circulation,controls infections,and promotes ulcer healing.
5.Sub-chronic aluminum exposure induces cognitive impairment through ALKBH5/PTEN/AKT signaling pathway in rats
Yan LIU ; Xiaoyu ZHANG ; Weitao ZHANG ; Feifan XIAO ; Ping CUI ; Binhong WANG ; Xinru CHEN ; Bin JIANG ; Huan CHEN ; Li LIN ; Jing ZHANG ; Huan LI
China Occupational Medicine 2024;51(2):144-149
ObjectiveTo investigate the effects of maltol aluminum exposure on miR-193a-3p, demethylase AlkB homolog 5 (ALKBH5), phosphatase and tensin homolog deleted on chromosome ten (PTEN) and protein kinase B (AKT), and whether miR-193a-3p is involved in aluminum-induced cognitive impairment by regulating ALKBH5/PTEN/AKT signaling pathway. Methods Specific pathogen-free male SD rats were randomly divided into control group and low-, medium- and high- dose groups according to their body weight, with eight rats in each group. Rats in the low-, medium-, and high- dose groups were intraperitoneally injected with maltol aluminum solution at concentrations of 10.00, 20.00, and 40.00 μmol/kg body weight, respectively, while the rats in control group were given an equal volume of 0.9% sodium chloride solution. Rats were injected for five days every week for three months. After injection, the novel object recognized test was used to assess the learning and memory ability of the rats. The relative expression of miR-193a-3p and B-cell lymphocytoma-2 (Bcl-2), Bcl-2 associated X protein (Bax) and cysteine aspartate protease-3 (Caspase-3) mRNA in rat hippocampus was detected using the real-time quantitative polymerase chain reaction. The relative protein expression of ALKBH5, PTEN, and AKT2 in the rat hippocampus was detected using Western blot. Results The discrimination index and the preference index of the new object recognition test of the rats in high-dose group were lower than those in control group and low-dose group (all P<0.05). The relative expression of miR-193a-3p and Bcl-2 mRNA in the hippocampus of the rats in high-dose group was lower than those in control group and low-dose group (all P<0.05). The relative mRNA expression of Bax in the high-dose group was higher than those in the control group and low-dose group (both P<0.05). The relative mRNA expression of Caspase-3 of the rats in the high-dose group was higher than that in the other three groups (both P<0.05). The relative protein expression of ALKBH5 in the hippocampus of the rats in the high-dose group was lower than that in the control group (P<0.05). The relative expression of PTEN protein was higher than those in the control group and low-dose group (both P<0.05). The relative protein expression of AKT2 was lower than those in the control group and low-dose group (both P<0.05). Conclusion Sub-chronic aluminum exposure can inhibit the expression of miR-193a-3p in the hippocampus of rats, which may disrupt the ALKBH5/PTEN/AKT pathway and affect normal neuronal homeostasis and cellular function. This pathway may play an important role in aluminum-induced cognitive impairment.
6.Micro-osteotomy bone transport combined with vacuum sealing drainage for the treatment of diabetic foot:A retrospective cohort study of 128 patients from two centers
Junpeng LIU ; Xinru DU ; Xingchen YAO ; Ziyu XU ; Fuchun PEI ; Lin ZHANG ; Hui ZHAO
The Journal of Practical Medicine 2024;40(18):2590-2596
Objective To assess the effectiveness of enhanced tibial transverse transport(TTT)in con-junction with vacuum-assisted closure(VAC)therapy for managing recalcitrant diabetic foot ulcers.Methods A retrospective analysis was conducted on data from diabetic foot patients with Wagner grade≥2 who were treated at Beijing Chaoyang Hospital and Beijing Chaoyang Hospital of Integrated Traditional Chinese and Western Medicine between July 2020 and December 2022.The patients were categorized into three groups based on their treatment regimen:VSD treatment(VSD group),modified TTT treatment(TTT group),and combined application of TTT and VSD(combined group).A one-year follow-up was performed to assess general data,ulcer area before and three months after surgery,ankle brachial index,visual analog pain score,as well as adverse events within one year post-surgery among the three groups.Results The VSD group consisted of 43 patients,while the TTT group consisted of 43 patients,and the combined group consisted of 42 patients.There were no statistically significant differences in baseline characteristics among the three groups(P>0.05).Patients in the VSD group had longer ulcer healing time,higher pain scores,lower ankle brachial index(P<0.05),larger ulcer area(P=0.029),and higher one-year ulcer recurrence rate compared to those in the TTT group.On the other hand,patients in the combined group had shorter ulcer healing time compared to those in the TTT group(P=0.046).However,there were no significant differences observed between these two groups regarding ulcer area(P=0.362),pain scores(P=0.932),ankle brachial index(P=0.671),and one-year ulcer recurrence rate(P=0.710).Conclusions The efficacy of modified TTT surpasses that of VSD in promoting ulcer healing,alleviating pain,and enhancing lower limb circulation.Furthermore,the combination of VSD with modified TTT demonstrates a potential to further expedite wound healing time.
7.Evidence-based clinical guideline for the diagnosis and treatment of surgical site infection in spinal trauma (version 2024)
Zhu GUO ; Chao WANG ; Hongfei XIANG ; Zhongqiang CHEN ; Liang CHEN ; Tongwei CHU ; Shucai DENG ; Jian DONG ; Xinru DU ; Shiqing FENG ; Baorong HE ; Xijing HE ; Jianzhong HU ; Yong HAI ; Qingquan KONG ; Guiqing LIANG ; Qi LIAO ; Zhongjun LIU ; Shaoyu LIU ; Baoge LIU ; Xiaoguang LIU ; Weishi LI ; Li LI ; Fang LI ; Bin LIN ; Shibao LU ; Tao NIU ; Zhenli QIAO ; Dike RUAN ; Yueming SONG ; Haipeng SI ; Jun SHU ; Zhongyi SUN ; Qing WANG ; Zili WANG ; Huan WANG ; Hongli WANG ; Yan WANG ; Xiaolin WU ; Zhanyong WU ; Jinglong YAN ; Tengbo YU ; Qiang ZHANG ; Guoqing ZHANG ; Xuesong ZHANG ; Fengdong ZHAO ; Jie ZHAO ; Zhaomin ZHENG ; Qingsan ZHU ; Dingjun HAO ; Bohua CHEN
Chinese Journal of Trauma 2024;40(12):1057-1070
Spinal surgical site infection (SSI), especially deep SSI after internal fixation is difficult in treatment, with long course of disease and poor prognosis. At present, there are many controversies in the diagnosis and treatment of spinal SSI, with unsatisfactory overall efficacy of its diagnosis and treatment. Besides, no diagnosis and treatment guideline based on evidence-based medicine has been in existence. To this end, the Spinal Infection Group of the Orthopedic Branch of the Chinese Medical Doctor Association and the Spinal Infection Group of the Spinal Surgery Branch of the Chinese Rehabilitation Medicine Association jointly organized relevant experts to formulate Evidence-based clinical guideline for the diagnosis and treatment of surgical site infection in spinal trauma ( version 2024) based on an evidence-based approach. A total of 10 recommendations were proposed on the diagnosis and treatment of spinal SSI, so as to provide a clinical reference for the diagnosis and treatment of spinal SSI.
8.Evidence-based clinical guideline for the diagnosis and treatment of surgical site infection in spinal trauma (version 2024)
Zhu GUO ; Chao WANG ; Hongfei XIANG ; Zhongqiang CHEN ; Liang CHEN ; Tongwei CHU ; Shucai DENG ; Jian DONG ; Xinru DU ; Shiqing FENG ; Baorong HE ; Xijing HE ; Jianzhong HU ; Yong HAI ; Qingquan KONG ; Guiqing LIANG ; Qi LIAO ; Zhongjun LIU ; Shaoyu LIU ; Baoge LIU ; Xiaoguang LIU ; Weishi LI ; Li LI ; Fang LI ; Bin LIN ; Shibao LU ; Tao NIU ; Zhenli QIAO ; Dike RUAN ; Yueming SONG ; Haipeng SI ; Jun SHU ; Zhongyi SUN ; Qing WANG ; Zili WANG ; Huan WANG ; Hongli WANG ; Yan WANG ; Xiaolin WU ; Zhanyong WU ; Jinglong YAN ; Tengbo YU ; Qiang ZHANG ; Guoqing ZHANG ; Xuesong ZHANG ; Fengdong ZHAO ; Jie ZHAO ; Zhaomin ZHENG ; Qingsan ZHU ; Dingjun HAO ; Bohua CHEN
Chinese Journal of Trauma 2024;40(12):1057-1070
Spinal surgical site infection (SSI), especially deep SSI after internal fixation is difficult in treatment, with long course of disease and poor prognosis. At present, there are many controversies in the diagnosis and treatment of spinal SSI, with unsatisfactory overall efficacy of its diagnosis and treatment. Besides, no diagnosis and treatment guideline based on evidence-based medicine has been in existence. To this end, the Spinal Infection Group of the Orthopedic Branch of the Chinese Medical Doctor Association and the Spinal Infection Group of the Spinal Surgery Branch of the Chinese Rehabilitation Medicine Association jointly organized relevant experts to formulate Evidence-based clinical guideline for the diagnosis and treatment of surgical site infection in spinal trauma ( version 2024) based on an evidence-based approach. A total of 10 recommendations were proposed on the diagnosis and treatment of spinal SSI, so as to provide a clinical reference for the diagnosis and treatment of spinal SSI.
9.Comparison of three methods for removing microglial cells from primary astrocytes
Hongyan CHEN ; Zhen LEI ; Chunting WANG ; Xinru WEN ; Xuemei LIN ; Yuqiang JI ; Songdi WU
Chinese Journal of Neuroanatomy 2024;40(5):565-571
Objective:In this study,three methods of removing microglial cells from primary astrocyte culture were compared and analyzed to explore the characteristics of different purification methods.It provides the basis for research-ers to select the appropriate primary astrocyte culture method.Methods:The cerebral cortex cells of SD neonatal rats were isolated and platted and divided into an unpurified group(control group),a traditional oscillation purification group(TO group),a cytosine β-D-arabinofuranoside(AraC)+TO group,and an AraC+L-leucine methyl ester(LME)group according to different purification methods.Cell counts were used to calculate the cell production after different purification treatments.The cell morphology of each group was observed under an optical microscope,and the proportion of glial fibrillary acidic protein(GFAP)positive cells was calculated by immunofluorescence staining.AlamarBlue HS was used to detect cell viability after passage.Results:Compared with the control group,the cell purity(P<0.0001)and cell viability(P<0.0001)of purified cells in the TO group were significantly increased after pas-sage,while the total number of purified cells was significantly decreased(P<0.001).These trends were more obvious in the AraC+TO and AraC+LME group,and the cell purity(P<0.0001 or P<0.0001)and cell viability(P<0.01 or P<0.001)of purified cells in the AraC+TO and AraC+LME group after passage were significantly higher than those in the TO group.The total amount of cells obtained was significantly decreased compared with the TO group(P<0.01 orP<0.01).There was no significant difference between the AraC+TO and AraC+LME group.Conclusion:The culture rich in astrocytes(cell purity>90%)was obtained by the TO method,and the cell yield was high,which could be applied to routine cell research.The highly enriched astrocyte cultures(cell purity>99%)obtained by the AraC+TO and AraC+LME purification methods can be applied to study the precise role of astrocytes in the context of neuroinflammation.
10.The research on the efficiency of single-port plus-one robot-assisted pyeloplasty for children with UPJO
Xinru XU ; Jianglong CHEN ; Shan LIN ; Yufeng HE ; Di XU
Chinese Journal of Urology 2023;44(7):524-528
Objective:To investigate the effect of Da Vinci robot-assisted single-port plus-one laparoscopic pyeloplasty (RSPY) in children with ureteropelvic junction obstruction (UPJO).Methods:The clinical data of 13 children with UPJO diagnosed by robot-assisted single-port plus-one laparoscopic pyeloplasty in Fujian Provincial Hospital from September 2021 to August 2022 were retrospectively analyzed. The mean age of the children was 60.0 (1.3, 108.0) months. The lesions of 10 patients were on the left, and 3 were on the right. The clinical manifestations were abdominal pain in 3 cases, urinary tract infection in 2 cases, and no symptoms in 10 cases. Preoperative isotope renogram showed affected renal function (28.32±1.82)%, and bilateral renal function difference > 10% in 7 cases. Mechanical obstruction existed in 5 cases. Preoperative ultrasound showed the affected side's renal cortex thickness of (1.98 ± 0.23) cm. During the operation, a single-port multi-channel trocar was placed in the umbilicus with another single port in the epigastrium, and a robotic system was placed to explore the subperitoneal dilated renal pelvis. The renal pelvis was suspended and pulled through the abdominal wall. The visual field was exposed, and the dilated renal pelvis was incised. The dilated renal pelvis was cut, a ureteral stent was placed, and the ureteropelvic duct was anastomosed.Results:The operation of 13 cases was successfully completed, without conversion to open surgery. The operation time was 180.0(165.0, 190.2)min. The intraoperative blood loss was < 5 ml. The postoperative hospital stay was 7.0(7.0, 7.0)d, and hospitalization costs were 56.3(52.1, 56.5)thousand yuan. The ureteral stent was removed 2 months after the operation, and no obvious complications such as urinary tract infection or low back pain occurred. The median postoperative follow-up was 12 months, ranged from 6 to 18 months. Urinary color ultrasound showed that the renal cortex was (4.95±0.57) cm, which was thicker than before. Isotope renogram showed that the renal function was (38.02±1.76)%, which was higher than before. Mechanical obstruction was transformed into incomplete obstruction.Conclusions:Da Vinci robot-assisted single-port plus-one laparoscopic pyeloplasty is precise and could achieve good surgical results on the basis of the effective restoration of lesion kidney function.

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