1.Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study.
Wenyan KANG ; Chao GAO ; Xiaoyan LI ; Xiaoxue WANG ; Huizhu ZHONG ; Qiao WEI ; Yonghua TANG ; Peijian HUANG ; Ruinan SHEN ; Lingyun CHEN ; Jing ZHANG ; Rong FANG ; Wei WEI ; Fengjuan ZHANG ; Gaiyan ZHOU ; Weihong YUAN ; Xi CHEN ; Zhao YANG ; Ying WU ; Wenli XU ; Shuo ZHU ; Liwen ZHANG ; Naying HE ; Weihuan FANG ; Miao ZHANG ; Yu ZHANG ; Huijun JU ; Yaya BAI ; Jun LIU
Chinese Medical Journal 2025;138(22):2907-2916
INTRODUCTION:
Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD.
METHODS:
In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging.
RESULTS:
A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline.
CONCLUSIONS:
Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies.
REGISTRATION
ClinicalTrials.gov , NCT07034222.
Humans
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Alzheimer Disease/drug therapy*
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Male
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Female
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Aged
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Middle Aged
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Cognitive Dysfunction/drug therapy*
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Aged, 80 and over
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Amyloid beta-Peptides/metabolism*
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Biomarkers
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East Asian People
2.NAT10 inhibition alleviates astrocyte autophagy by impeding ac4C acetylation of Timp1 mRNA in ischemic stroke.
Li YANG ; Xiaotong LI ; Yaxuan ZHAO ; Hao CHEN ; Can WANG ; Angrong WU ; Xintong GUO ; Yue HUANG ; Qihui WANG ; Lingyun HAO ; Xiaowen LI ; Ying JI ; Jin BAN ; Guangtian WANG ; Junli CAO ; Zhiqiang PAN
Acta Pharmaceutica Sinica B 2025;15(5):2575-2592
Although a single nucleotide polymorphism for N-acetyltransferase 10 (NAT10) has been identified in patients with early-onset stroke, the role of NAT10 in ischemic injury and the related underlying mechanisms remains elusive. Here, we provide evidence that NAT10, the only known RNA N4-acetylcytidine (ac4C) modification "writer", is increased in the damaged cortex of patients with acute ischemic stroke and the peri-infarct cortex of mice subjected to photothrombotic (PT) stroke. Pharmacological inhibition of NAT10 with remodelin on Days 3-7 post-stroke or astrocytic depletion of NAT10 via targeted virus attenuates ischemia-induced infarction and improves functional recovery in PT mice. Mechanistically, NAT10 enhances ac4C acetylation of the inflammatory cytokine tissue inhibitor of metalloproteinase 1 (Timp1) mRNA transcript, which increases TIMP1 expression and results in the accumulation of microtubule-associated protein 1 light chain 3 (LC3) and progression of astrocyte autophagy. These findings demonstrate that NAT10 regulates astrocyte autophagy by targeting Timp1 ac4C after stroke. This study highlights the critical role of ac4C in the regulation of astrocyte autophagy and proposes a promising strategy to improve post-stroke outcomes via NAT10 inhibition.
3.Analysis of the efficacy and prognosis of radiotherapy in acute leukemia with extramedullary infiltration
Wenbin LEI ; Hui LIU ; Yan ZHANG ; Yinghao LU ; Yi HUANG ; Ying CHEN ; Rui GAO ; Xiao CHAI ; Yun ZHAN ; Jie XIONG ; Lingyun WANG ; Lei LIU ; Jishi WANG ; Peng ZHAO
Chongqing Medicine 2024;53(4):547-554
Objective To investigate the clinical characteristics,treatment methods,and prognosis of a-cute leukemia patients with extramedullary infiltration.Methods The clinical characteristics and treatment methods of 47 acute leukemia patients with extramedullary infiltration admitted to the Affiliated Hospital of Guizhou Medical University from April 2014 to April 2023 were retrospectively analyzed.Subgroup analysis was performed according to whether there was extramedullary infiltration before transplantation,and whether there was isolated extramedullary recurrence after transplantation.Based on this analysis,the patients were di-vided into the pre-transplantation radiotherapy group and pre-transplantation non-radiotherapy group,the post-transplantation radiotherapy group and post-transplantation non-radiotherapy group.According to the treatment methods of central nervous system leukemia(CNSL),the patients were divided into the intrathecal injection group(n=12)and combination of intrathecal injection and radiotherapy group(n=13).The local remission situation,survival duration,and toxic and side effects of radiotherapy and chemotherapy were com-pared.Results For acute leukemia patients with extramedullary infiltration,the overall survival time(OS)in the radiotherapy group was better than that in the non-radiotherapy group(median OS:706 d vs.151 d,P=0.015).Subgroup analysis showed that the OS of the pre-transplantation radiotherapy group was better than that of the pre-transplantation non-radiotherapy group(median OS:592 d vs.386 d,P=0.035).For CNSL,the combination of intrathecal injection and radiotherapy group had a better OS than the intrathecal injection group(median OS:547 d vs.388 d,P=0.045).The event-free survival time(EFS)of the radiotherapy group was better than that of the non-radiotherapy group(median EFS:175 d vs.50 d,P=0.005).The COX pro-portional-hazards model showed that treatment with or without radiotherapy had a significant impact on the OS of acute leukemia patients with extramedullary infiltration.The risk of death in the pre-transplantation non-radiotherapy group was 2.231 times higher than that in the pre-transplantation radiotherapy group(HR=3.231,95%CI:1.021-10.227,P=0.046).Compared with the non-radiotherapy group,the radiother-apy group had a higher local remission and a lower risk of haematological toxicity,infection,and haemorrhage.Conclusion Radiotherapy can rapidly alleviate the local symptoms of acute leukemia complicated with extr-amedullary infiltration,prolong the survival time of these patients,and reduce the risk of hematologic toxicity,infection,and haemorrhage.
4.Influencing factors for mild cognitive impairment among geriatric inpatients
ZHANG Yuan ; SHI Lingyun ; WU Ruikai ; HUANG Siying ; HAN Zhengfeng
Journal of Preventive Medicine 2024;36(4):299-303
Objective:
To investigate the influencing factors for mild cognitive impairment (MCI) among the elderly inpatients of the department of geriatrics, so as to provide the reference for early screening and prevention of MCI in the elderly population.
Methods:
Inpatients aged 60 years and older and admitted to the Department of Geriatrics at the First Affiliated Hospital of Xinjiang Medical University were selected as the study subjects. Demographic information, past medical history, activities of daily living (ADL), depressive symptoms were collected through questionnaire surveys. MCI was diagnosed with Montreal Cognitive Assessment in combination with medical history and physical examination. Factors affecting MCI were identified using a multivariable logistic regression model.
Results:
A total of 1 019 elderly patients were collected, including 472 males (46.32%) and 547 females (53.68%), and had a median age of 73.00 (interquartile range, 14.00) years. Among them, 746 patients had an educational level of junior high school or above, accounting for 73.21%, 446 patients had cerebrovascular disease, accounting for 43.77%, and 220 patients were diagnosed with MCI, with a detection rate of 21.59%. Multivariable logistic regression analysis showed that age (OR=1.354, 95%CI: 1.285-1.426), educational level (primary school, OR=0.345, 95%CI: 0.163-0.731; junior high school or above, OR=0.196, 95%CI: 0.096-0.402), ADL (moderate/severe dependence, OR=4.744, 95%CI: 2.044-11.012) and cerebrovascular disease (OR=2.335, 95%CI: 1.482-3.679) were the influencing factors for MCI among geriatric inpatients.
Conclusions
The MCI of the elderly inpatients of the department of geriatrics is related to age, educational level, ADL and cerebrovascular disease. Therefore, targeted health education and cognitive function training should be provided for elderly patients to prevent MCI.
5.Analysis of the epidemic characteristics and disease burden of hospitalized children with viral myocarditis in China from 2016 to 2021
Luci HUANG ; Wei SHAO ; Lingyun GUO ; Yiliang FU ; Fei LI ; Hui XU ; Guoshuang FENG ; Lu GAO ; Zhengde XIE ; Yue YUAN ; Gang LIU ; Xiangpeng CHEN
Chinese Journal of Experimental and Clinical Virology 2024;38(4):432-438
Objective:This study aimed to provide basic data for the prevention, diagnosis and treatment of pediatric viral myocarditis (VMC) in China through analyzing the epidemic characteristics and disease burden of pediatric inpatients with VMC from 2016 to 2021.Methods:We performed a descriptive statistical analysis to the age, genders, seasons, regions and hospitalization cost and days of pediatric VMC inpatients and the death. All of the information was obtained from 27 Children′s hospitals or Maternal and Child Health hospitals of 23 provinces of China from 2016 to 2021.Results:A total of 7 647 599 cases including 1 646 VMC inpatients were admitted into our study. The annual numbers of hospitalizations were 173, 227, 313, 301, 295 and 337, with the hospitalized constituent ratios being 14.9/100 000, 17.9/100 000, 23.0/100 000, 20.5/100 000, 26.5/100 000 and 26.4/100 000 from 2016 to 2021. In recent 6 years, the proportion of VMC hospitalizations had increased yearly ( P<0.001), and had associated with the onset age ( P<0.001). Aged 12-≤18 years owned the highest hospitalized constituent ratio. The Northeast of China owned the largest number of VMC inpatients, and the East second to it. Among the 1 646 VMC children, there were 68 deaths, with the hospitalized case fatality rate of 4.13%. There were no significant differences between genders, age, seasons, years and fatality rate of VMC inpatients. For the diseases burden, the median of hospitalization days of all VMC inpatients was 10 days (IQR 6, 21), and the median of hospitalization cost was 1 1 842.3 RMB (IQR 6 969.22, 19 714.78). The median of hospitalization days of deceased VMC children was only 1 day (IQR 1, 3), the median cost could be 8 874.03 RMB (IQR 5 277.94, 5 6 151.59). Conclusions:In this study, we found that proportion of hospitalization of VMC children increased year by year, adolescence might be a risk factor of VMC. The fatality of VMC inpatients could be up to 4.13%, and the death led to a huge economic burden of society, family and individuals.
6.Analysis of delayed cerebral ischemia and influencing factors after clipping surgery in anterior circulation aneurysm patients
Guangtao LÜ ; Lingyun SUN ; Xiaolong HUANG
Journal of Clinical Neurology 2024;37(5):366-371
Objective To explore the occurrence and influencing factors of delayed cerebral ischemia(DCI)after clipping surgery in patients with anterior circulation aneurysms.Methods A retrospective analysis was conducted on 248 patients with anterior circulation aneurysms who underwent clipping surgery in our hospital from May 2018 to May 2023.The patients were divided into the DCI group and the non-DCI group based on the occurrence of DCI after surgery.A1∶1 propensity score matching method was used to match 54 patients in the DCI group with 54 patients in the non-DCI group.The random forest algorithm was employed to rank the importance of factors influencing DCI.Multivariable Logistic regression analysis was performed to identify independent risk factors for DCI,and the E-value method was used to assess the sensitivity of model parameters.A DCI risk prediction model was constructed,and the discriminative ability and accuracy of the model were evaluated using ROC curve and Hosmer-Lemeshow test.Results After matching,no statistically significant differences were observed between the two groups in terms of gender,age,body mass index(BMI),smoking history,alcohol consumption,history of cerebral infarction,history of subarachnoid hemorrhage,aneurysm location,and maximum aneurysm diameter(all P>0.05).Compared to the non-DCI group,the DCI group had a higher proportion of modified Fisher grade 3-4 and Hunt-Hess grade IV patients,higher levels of D-dimer(D-D),total bilirubin(TBIL),TNF-α,high-sensitivity C-reactive protein(hs-CRP),IL-6,and glutamate,and lower levels of immunoglobulin(Ig)G,IgM,and IgA(all P<0.05).The random forest analysis showed that including Hunt-Hess grade,modified Fisher grade,D-D,glutamate,TB1L,IgA,and IL-6 in the multivariable regression analysis achieved the lowest out-of-bag error rate.Multivariable analysis revealed that Hunt-Hess grade Ⅳ,modified Fisher grade 3-4,D-D,glutamate,TBIL were independent risk factors for DCI,while IgA was a protective factor(all P<0.05).The risk prediction equation was as follows:P=1/[1+e(3.142+1.307 Hunt-Hess grade+1.086 modified Fisher grade+0.976 D-D+0.748 glutamate+0.552 TBIL-0.524 IgA+0.487 IL-6)].A patient with a risk probability P>0.65 was considered to have a postoperative occurrence of DCI.The ROC curve results showed that after internal validation,the AUC of the model was 0.869(95%CI:0.836-0.897),with sensitivity and specificity of 81.08%and 97.34%,respectively,indicating good discrimination of the model.The Hosmer-Lemeshow test results showed that after internal validation,the goodness of fit of the model wasx2=4.219,P=0.561,indicating good fit of the model.Conclusions Hunt-Hess grade Ⅳ,modified Fisher grade 3-4,D-D,glutamate,TBIL,and IL-6 are identified as independent risk factors for DCI,while IgA is a protective factor.The predictive model constructed using these factors demonstrates high accuracy and discriminative ability.A risk probability P>0.65 indicates a postoperative occurrence of DCI in patients.
7.Association of peripheral axial length, retinal curvature with refraction in school-aged children
Xi HE ; Ziyu HUA ; Shiming LI ; Xin YAN ; Yan JIANG ; Zhining CAI ; Nufei LIU ; Yuting KANG ; Shuang MA ; Lingyun HUANG ; Hanyue LI
Chinese Journal of Experimental Ophthalmology 2023;41(2):140-145
Objective:To investigate the association of peripheral axial lengths and retinal curvatures with refractive status.Methods:A cross-sectional study was conducted out.Two hundred and eighty-seven eyes of 287 consecutive children aged 6-15 years old who recieved eye examinations at Beijing Tongren Hospital from July to October 2021 were enrolled, including 154 males and 133 females.Uncorrected and best corrected visual acuity were tested with a standard logarithmic visual acuity chart.Spherical equivalent (SE) was measured via an auto refractometer after cycloplegia with tropicamide.The hyperopic, emmetropic and myopic groups were defined with a SE >+ 0.5 D, SE >-0.5 D to ≤+ 0.5 D and SE≤-0.5 D, respectively.Central and 30° peripheral eye lengths (nasal, temporal, superior, inferior) were obtained using the Lenstar LS900.Retinal coordinates were derived from partial coherence interferometry modeling and converted to retinal curvatures.According to the median horizontal peripheral eye length differences (absolute difference between nasal and temporal), participants were assigned to H1 group (absolute difference <0.35 mm) or H2 group (absolute difference ≥0.35 mm). According to the median vertical peripheral eye length differences (absolute difference between superior and inferior), participants were assigned to V1 group (absolute difference <0.32 mm) or V2 group (absolute difference ≥0.32 mm). Four groups of V1H1, V1H2, V2H1 and V2H2 were constructed according to the grouping methods in both directions above.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Beijing Tongren Hospital, Capital Medical University (No.TRECKY2021-162). Written informed consent was obtained from guardians of each subject prior to any medical examination.Results:The central axial length was 23.53(22.93, 24.10)mm.Peripheral eye lengths of temporal, nasal, superior and inferior were 22.75(22.11, 23.22)mm, 22.99(22.32, 23.45)mm, 23.24(22.58, 23.75)mm and 23.12(22.52, 23.56)mm, respectively.Temporal eye length was shorter than nasal, showing a statistically significant difference ( Z=-3.58, P<0.01). Compared with H2 group, H1 group had shorter central, nasal, superior and inferior eye lengths, showing statistically significant differences (all at P<0.05). Compared with V2 group, V1 group had shorter central, nasal and superior eye lengths, showing statistically significant differences (all at P<0.05). SE of H1 group was + 0.06 (-1.06, + 0.75) D, which was significantly greater than -0.32 (-1.64, + 0.56) D of H2 group ( Z=-2.10, P=0.04). SE of V1 group was + 0.13 (-0.81, + 0.80) D, which was significantly greater than -0.56 (-1.83, + 0.48) D of H2 group ( Z=-3.39, P<0.01). The myopia ratio of V1 group was 33.5% (58/173), which was significantly lower than 50.5% (53/105) of V2 group ( χ2=7.83, P<0.01). There was a significant overall difference in SE among VIH1, V1H2, V2H1 and V2H2 groups ( H=24.79, P<0.01). SE was greater in V1H1 group than V1H2, V2H1 and V2H2 groups (all at P<0.01). There was a significant difference in both horizontal and vertical retinal curvatures among different refractive groups ( H=22.34, 19.30; both at P<0.01). The retical curvature in both directions of hyperopic and emmetropic groups were significantly larger than those of myopic group (both at P<0.01). Conclusions:Peripheral eye lengths are asymmetric in school-aged children.Higher asymmetry is associated with myopic shifts.Myopic children have a steeper retina than the hyperopic and emmetropic children.
8.Expert consensus on clinical practice in perioperative nursing for elderly patients with hip fracture (version 2023)
Mi SONG ; Dan KONG ; Yuan GAO ; Yaping CHEN ; Xiaohua CHEN ; Yi CUI ; Junqin DING ; Leling FENG ; Lili FENG ; Jinli GUO ; Yun HAN ; Jing HU ; Sanlian HU ; Tianwen HUANG ; Yu JIA ; Yan JIN ; Xiangyan KONG ; Haiyan LI ; Hui LI ; Lunlan LI ; Shuixia LI ; Hua LIN ; Juan LIU ; Xuemei LU ; Ning NING ; Lingli PENG ; Lingyun SHI ; Changli WAN ; Jie WANG ; Qi WANG ; Yi WANG ; Ruifeng XU ; Ying YING ; Ping ZHANG ; Shijun ZHANG ; Wenjuan ZHOU
Chinese Journal of Trauma 2023;39(3):214-222
Hip fracture is considered as the most severe osteoporotic fracture characterized by high disability and mortality in the elderly. Improved surgical techniques and multidisciplinary team play an active role in alleviating prognosis, which places higher demands on perioperative nursing. Dysfunction, complications, and secondary impact of anaesthesia and surgery add more difficulties to clinical nursing. Besides, there still lack clinical practices in perioperative nursing for elderly patients with hip fracture in China. In this context, led by the Orthopedic Nursing Committee of Chinese Nursing Association, the Expert consensus on clinical practice in perioperative nursing for elderly patients with hip fracture ( version 2023) is developed based on the evidence-based medicine. This consensus provides 11 recommendations on elderly patients with hip fracture from aspects of perioperative health education, condition monitoring and inspection, complication risk assessment and prevention, and rehabilitation, in order to provide guiding advices for clinical practice, improve the quality of nursing and ameliorate the prognosis of elderly patients with hip fracture.
9.Expert consensus on perioperative nursing management of nutrition for elderly patients with hip fractures (version 2023)
Chunhua DENG ; Xiaohua CHEN ; Zhihua YIN ; Yao JIANG ; Xiaoju TAN ; Yaping CHEN ; Junqin DING ; Luo FAN ; Leling FENG ; Yuyun GAN ; Xiaoyan GAO ; Jinli GUO ; Jing HU ; Chen HUANG ; Guiling HUANG ; Tianwen HUANG ; Yingchun HUANG ; Hui JIN ; Yan JIN ; Fangfang LI ; Hui LI ; Hui LIU ; Ping LIU ; Ning NING ; Lingyun SHI ; Guomin SONG ; Yani SUN ; Guangling WANG ; Jie WANG ; Qi WANG ; Xia WANG ; Xiaoyun WANG ; Yi WANG ; Songmei WU ; Jian YANG ; Yumei ZHANG ; Yang ZHOU ; Xiaoyan WANG ; Yuan GAO
Chinese Journal of Trauma 2023;39(5):394-403
Hip fractures are among the most common fractures in the elderly, presenting to be a leading cause of disability and mortality. Surgical treatment is currently the main treatment method for hip fractures. The incidence of perioperative malnutrition is increased after hip fractures in the elderly due to the comorbidities, decreased basal metabolic rate, accelerated protein breakdown, weakened anabolism and surgical stress. However, malnutrition not only increases the incidence of postoperative complications, but also leads to increased mortality, indicating an important role of perioperative nursing management of nutrition for the elderly patients with hip fractures. At present, there still lacks scientific guidance and application standards on perioperative nursing management of nutrition for the elderly patients with hip fractures. Therefore, the Orthopedic Nursing Committee of Chinese Nursing Association and the Editorial Board of Chinese Journal of Trauma organized relevant experts to formulate the Expert consensus on perioperative nursing management of nutrition for elderly patients with hip fractures ( version 2023) according to evidence-based medical evidences and their clinical experiences. Fourteen recommendations were made from aspects of nutrition screening, nutrition assessment, nutrition diagnosis, nutrition intervention and nutrition monitoring to provide guidance for perioperative nursing management of nutrition in elderly patients with hip fractures.
10.Practice of a hemodialysis alliance in the context of closed-loop hospital management
Jing QIAN ; Mengjing WANG ; Chuhan LU ; Ping CHENG ; Li NI ; Wei LIU ; Bihong HUANG ; Zhibin YE ; Zhenwen YAN ; Qianqiu CHENG ; Chen YU ; Aili WANG ; Ai PENG ; Wei XU ; Chunlai LU ; Dandan CHEN ; Xiuzhi YU ; Liyan FEI ; Jun MA ; Jialan SHEN ; Junhui LI ; Ying LI ; Lingyun CHEN ; Weifeng WU ; Rongqiang YU ; Lihua XU ; Jing CHEN
Chinese Journal of Hospital Administration 2022;38(8):595-599
Closed-loop hospital management can effectivly cope with the COVID-19 pandemic. In order to ensure the continuity of treatments for hemodialysis patients under closed-loop management and minimize possible medical and infection risks, Huashan Hospital affiliated to Fudan University and 9 hospitals in Shanghai established a hemodialysis alliance in January 2021.The alliance optimized hemodialysis resources within the region through overall planning by preparing sites, materials and personnel shifts in advance, and establishing management systems and work processes to ensure that patients could be quickly and orderly diverted to other blood dialysis centers for uninterrupted high-quality hemodialysis services, in case that some hemodialysis centers in the alliance under closed-loop management.From November 2021 to April 2022, 317 of 1 459 hemodialysis patients in the alliance were diverted to other centers for treatment, accumulating 1 215 times/cases of treatments without obvious adverse reactions. The practice could provide a reference for medical institutions to quickly establish mutual support mode under major public health events.


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