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A functional tacrolimus-releasing nerve wrap for enhancing nerve regeneration following surgical nerve repair

Neural Regeneration Research 2025年第1期20卷 291-304页

作者： Simeon C.Daeschler Katelyn J.W.So Konstantin Feinberg Marina Manoraj Jenny Cheung Jennifer Zhang Kaveh Mirmoeini JPaul Santerre Tessa Gordon Gregory HBorschel SickKids Research Institute Neuroscience and Mental Health ProgramTorontoONCanada Institute of Biomaterials and Biomedical Engineering University of TorontoTorontoONCanada Indiana University School of Medicine IndianapolisINUSA Division of Plastic and Reconstructive Surgery the Hospital for Sick ChildrenTorontoONCanada Translational Biology and Engineering Program Ted Rogers Centre for Heart ResearchInstitute of Biomedical EngineeringFaculty of DentistryUniversity of TorontoTorontoONCanada

Axonal regeneration following surgical nerve repair is slow and often incomplete,resulting in poor functional recovery which sometimes contributes to lifelong ***,there are no FDA-approved therapies available to promote nerve *** accelerates axonal regeneration,but systemic side effects presently outweigh its potential benefits for peripheral nerve *** authors describe herein a biodegradable polyurethane-based drug delivery system for the sustained local release of tacrolimus at the nerve repair site,with suitable properties for scalable production and clinical application,aiming to promote nerve regeneration and functional recovery with minimal systemic drug *** is encapsulated into co-axially electrospun polycarbonate-urethane nanofibers to generate an implantable nerve wrap that releases therapeutic doses of bioactive tacrolimus over 31 *** and drug loading are adjustable for applications in small and large caliber nerves,and the wrap degrades within 120 days into biocompatible *** released from the nerve wrap promotes axon elongation in vitro and accelerates nerve regeneration and functional recovery in preclinical nerve repair models while off-target systemic drug exposure is reduced by 80%compared with systemic *** its surgical suitability and preclinical efficacy and safety,this system may provide a readily translatable approach to support axonal regeneration and recovery in patients undergoing nerve surgery.

关键词： biodegradable local drug delivery nerve injury nerve regeneration nerve wrap tacrolimus

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tacrolimus treatment for relapsing-remitting chronic inflammatory demyelinating polyradiculoneuropathy:Two case reports

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World Journal of Clinical Cases 2022年第5期10卷 1709-1715页

作者： Wen-Jia Zhu Yu-Wei Da Hai Chen Min Xu Yan Lu Li Di Jian-Ying Duo Department of Neurology Xuanwu HospitalCapital Medical UniversityBeijing 100053China

BACKGROUND This study describes the efficacy of a tacrolimus treatment regimen used to treat two patients with relapsing-remitting chronic inflammatory demyelinating polyradiculoneuropathy(CIDP).CASE SUMMARY Two patients(17-year-old female and 27-year-old male)were enrolled in the current study and were followed up for 12 *** first patient was administered tacrolimus(2 mg/d)for 12 mo and prednisolone(40 mg/d)for six *** second patient was administered tacrolimus(3 mg/d)for six *** patients were followed up for 12 mo and the degree of recurrent weakness or normalized motor function was *** addition,nerve conduction studies and tacrolimus levels were *** tacrolimus treatment,both patients showed marked improvement in clinical *** the first patient,prednisolone treatment was successfully withdrawn after six *** as well as motor nerve conduction velocities showed evident recovery following ***,conduction velocities did not completely return to normal,suggesting that electrophysiological recovery can be slower than clinical *** Neither patient exhibited any adverse effects due to the tacrolimus ***,tacrolimus can be effective for the treatment of patients with steroidresistant CIDP.

关键词： Chronic inflammatory demyelinating polyradiculoneuropathy Prednisolone tacrolimus Relapsing-remitting Treatment Case report

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tacrolimus for children with refractory nephrotic syndrome:a one-year prospective,multicenter,and open-label study of Tacrobell®,a generic formula

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World Journal of Pediatrics 2016年第1期12卷 60-65页

作者： Eun Mi Yang Sang Taek Lee Hyun Jin Choi Hee Yeon Cho Joo Hoon Lee Hee Gyung Kang Young Seo Park Hae Il Cheong Il-Soo Ha Department of Pediatrics Chonnam National University HospitalGawngjuKorea Department of Pediatrics Seoul National University Children's HospitalSeoulKorea Department of Pediatrics Samsung Medical CenterSungkynkwan University School of MedicineSeoulKorea Department of Pediatrics Asan Medical Center Children's HospitalUniversity of Ulsan College of MedicineSeoulKorea Research Coordination Center for Rare Diseases Seoul National University HospitalSeoulKorea Kidney Research Institute Medical Research CenterSeoul National University College of MedicineSeoulKorea

Background:Cyclosporine A and tacrolimus(TAC)are often used as a second-line treatment for children with refractory nephrotic syndrome(NS).This study was undertaken to investigate the efficacy and safety of Tacrobell®,a locally produced generic form of ***:This study was a one-year prospective,open-label,single-arm,multicenter ***-four children with steroid-dependent NS(SDNS)and 33 children with steroid-resistant NS(SRNS)were *** primary endpoints were defined as the remission rates,whereas the secondary endpoints were recognized as the duration of remission and adverse effects of ***:After one-year treatment,34(77.3%)of the 44 patients with SDNS were in complete remission,and 6(13.6%)were in partial ***(43.2%)patients did not relapse during the study;for those who did relapse,the mean duration of remission was 4.6±2.9 *** number of relapse episodes during the study period(0.90 per patient-year)was significantly lower than that in the preceding year(2.8 per patientyear).After treatment for 3 and 6 months,12(36.4%)of the 33 patients with SRNS were in remission,and after treatment for 12 months,the number of patients had increased to 13(39.4%).The mean time to achieve remission was 4.0±3.2 *** remission(duration,3.7±2.7 months),12(54.5%)of 22 patients *** fasting blood glucose and blood pressure levels during the therapy were similar to those at the time of study ***:Treatment with Tacrobell®was effective and safe for children with refractory *** efficacy of this generic form of TAC was better than that of the original TAC formula.

关键词： generic drugs nephrotic syndrome tacrolimus

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Helper T Cell(CD4^(+))Targeted tacrolimus Delivery Mediates Precise Suppression of Allogeneic Humoral Immunity

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Research 2022年第3期2022卷 189-203页

作者： Jia Shen Chang Liu Pengpeng Yan Meifang Wang Luying Guo Shuaihui Liu Jianghua Chen Jessica MRosenholm Hongfeng Huang Rending Wang Hongbo Zhang Kidney Disease Center The First Affiliated HospitalCollege of MedicineZhejiang UniversityKey Laboratory of Kidney Disease Prevention and Control TechnologyZhejiang ProvinceChina Pharmaceutical Sciences Laboratory Faculty of Science and EngineeringÅbo Akademi UniversityTurku 20520Finland Turku Bioscience Centre University of Turku andÅbo Akademi UniversityTurku 20520Finland Organ Donation and Coordination Office The First Affiliated HospitalSchool of MedicineZhejiang UniversityHangzhou 310003China Department of Orthopaedics Shanghai Key Laboratory for Prevention and Treatment of Bone and Joint DiseasesShanghai Institute of Traumatology and OrthopaedicsRuijin HospitalShanghai Jiao Tong University School of MedicineShanghai 200025China

Antibody-mediated rejection(ABMR)is a major cause of dysfunction and loss of transplanted *** current treatments for ABMR involve nonspecific inhibition and clearance of T/B cells or plasma ***,the prognosis of patients following current treatment is poor.T follicular helper cells(Tfh)play an important role in allograft-specific antibodies secreting plasma cell(PC)*** cells are therefore considered to be important therapeutic targets for the treatment of antibody hypersecretion disorders,such as transplant rejection and autoimmune ***(Tac),the primary immunosuppressant,prevents rejection by reducing T cell ***,its administration should be closely monitored to avoid serious side *** this study,we investigated whether Tac delivery to helper T(CD4^(+))cells using functionalized mesoporous nanoparticles can block Tfh cell differentiation after alloantigen *** showed that Tac delivery ameliorated humoral rejection injury in rodent kidney graft by suppressing Tfh cell development,PC,and donor-specific antibody(DSA)generation without causing severe side effects compared with delivery through the drug administration *** study provides a promising therapeutic strategy for preventing humoral rejection in solid organ *** specific and controllable drug delivery avoids multiple disorder risks and side effects observed in currently used clinical approaches.

关键词： tacrolimus treatment donor

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Effects of tacrolimus on infection of Friend murine leukemia virus to Fυ-4 gene heterozygous mice

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Acta Pharmacologica Sinica 2004年第2期25卷 82-86页

作者： Feng-min ZHANG2, Bao-feng YANG3, Hong-xi GU, Xiao-bei CHEN, Zhao-hua ZHONG, Zhi CHENG Department of Microbiology Department of Pharmacology, Harbin Medical University, Harbin 150086, China 3 Department of Microbiology Harbin Medical University Harbin 150086 Department of Pharmacology Harbin Medical University Harbin 150086

AIM: To investigate the effect of tacrolimus (FK506) on the infection of Friend murine leukemia virus (Friend MuLV) in vivo. METHODS: Three kinds of mice were used including Friend MuLV-sensitive BALB/c mice, Friend MuLV-resistant Fv-4 gene-homozygous mice (Fv-4 mice), and Friend MuLV-resistant Fv-4 gene-heterozygous mice (F1 mice). tacrolimus was administrated ip to those mice in every 2 d. Those treated mice were inoculated ip with Friend MuLV once on d 3. The symptoms and viral proliferations in those mice were observed to recognize the Friend MuLV infection. The expression and genotype of Fv-4 gene that resistant against the infection of Friend MuLV were analyzed to confirm the genomic background and related mechanism of the resistance. RESULTS: BALB/c mice and F1 mice, but not Fv-4 mice, appeared obvious early death, spleenomegaly, and viral proliferation after both treatments of viral inoculation and tacrolimus administration, whereas the expression and genotype of Fv-4 gene was not changed in F1 mice and Fv-4 mice with treatment of tacrolimus. Compared to the virus- inoculated control, the Friend MuLV-sensitivity of tacrolimus-treated BALB/c mice and the Friend MuLV-resistance of tacrolimus-treated Fv-4 mice were the same as the controls, but only F1 mice became the symptoms and viral proliferation after both treatments. It suggested the Friend MuLV-resistant F1 mice could be converted to be Friend MuLV-sensitive by treatment of tacrolimus, and this conversion was not depended on the expression and genotype of Fv-4 gene. CONCLUSION: tacrolimus could not inhibit the infection of Friend MuLV in all mice, furthermore, it could enhance the infection of Friend MuLV in F1 mice. The enhancement may be related to the immunosuppres- sive effect of tacrolimus.

关键词： tacrolimus murine leukemia virus transgenic mice

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tacrolimus may play a role in dermatitis and radiation-induced skin injury through cellular senescence

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Radiation Medicine and Protection 2024年第3期5卷 161-164页

作者： Jie Chen Ling Gao China CDC Key Laboratory of Radiological Protection and Nuclear Emergency National Institute for Radiological ProtectionChinese Center for Disease Control and PreventionBeijing 100088China

Skin Exposure of skin to ionizing radiation can induce acute or chronic biological effects,resulting in radiation-induced skin injury(RSI).Premature cellular senescence,caused by oxidative stress and/or DNA damage from chemical or physical agents,leads to the decrease of cellular proliferation and physiological *** DNA damage and accumulation of senescent cells are associated with the progression of radiation-induced *** dermatitis and RSI have similar inflammatory *** treatment of tacrolimus(TAC)in atopic dermatitis may be associated with premature cellular *** can prevent the onset of cellular senes-cence by inactivating the p38 mitogen-activated protein kinase(p38 MAPK).The activation of p38 MAPK can induce the senescence-associated secretory phenotype(SASP)by enhancing the transcriptional activity of nuclear factor kappa-B(NF-κB),which ultimately leads to premature cellular ***506 binding protein 51(FKBP51)exhibits resistance to ionizing radiation,but the mechanism of TAC regulation of ionizing radiation-induced premature senescence still needs further *** review discusses the mechanism of cellular senes-cence in RSI and the role of TAC in both dermatitis and RSI.

关键词： tacrolimus Premature cellular senescence Radiation-induced skin injury p38 MAPK NF-κB

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Efficacy and safety of tacrolimus and low-dose prednisone in Chinese children with steroid-resistant nephrotic syndrome

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World Journal of Pediatrics 2020年第2期16卷 159-167页

作者： Hai-Xia Chen Qia Cheng Fang Li Qing-Nan He Yan Cao Zhu-Wen Yi Xiao-Chuan Wu Department of Pediatrics The Second Xiangya HospitalCentral South UniversityChangsha 410011China

Background tacrolimus,a calcineurin inhibitor,is recommended by the recent guidelines from the Kidney Disease Improving Global Outcomes Group as the first-line treatment for steroid-resistant nephrotic syndrome(SRNS),but its clinical application in China is still *** investigated the efficacy and safety of tacrolimus combined with low-dose corticosteroids in a population of Chinese children with *** In this prospective non-randomized,non-controlled study,Chinese children with SRNS who failed the previous full-dose prednisone treatment were given tacrolimus(0.1 mg/kg/day)and low-dose prednisone(0.25-0.50 mg/kg/day).We compared the overall remission rate(ORR)and adverse events in the follow-up period with this therapeutic *** A total of 76 children were enrolled into the study with an average follow-up period of 18±6 months(maximum 36 months).ORR achieved by the first,third,and sixth months was 94.7%,94.7%,and 96.0%,*** patients who attained an initial tacrolimus trough concentration(FK506C0)>6 ng/mL(60.3%)achieved *** relative risk of relapse at FK506C0tacrolimus and low-dose prednisone was safe and effective for the treatment of children with SRNS,with high remission rates observed as early as the first *** were infrequent,but tended to increase significantly with decreases in FK506C0.

关键词： Children Low-dose prednisone Steroid-resistant nephrotic syndrome tacrolimus

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Antibiotics-mediated intestinal microbiome perturbation aggravates tacrolimus-induced glucose disorders in mice

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Frontiers of Medicine 2019年第4期13卷 471-481页

作者： Yuqiu Han Xiangyang Jiang Qi Ling Li Wu Pin Wu Ruiqi Tang Xiaowei Xu Meifang Yang Lijiang Zhang Weiwei Zhu Baohong Wang Lanjuan Li National Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases State Key Laboratory for Diagnosis and Treatment of Infectious Diseases the First Affiliated Hospital Zhejiang University School of Medicine Hangzhou 310003 China Division of Hepatobiliary and Pancreatic Surgery Department of Surgery the First Affiliated Hospital Zhejiang University School of Medicine Hangzhou 310003 China Division of Throat Surgery the Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou 310003 China Center of Safety Evaluation Zhejiang Academy of Medical Sciences Hangzhou 310053 China

Both immunosuppressants and antibiotics (ABX) are indispensable for transplant patients. However, the former increases the risk of new-onset diabetes, whereas the latter impacts intestinal microbiota (IM). It is still unclear whether and how the interaction between immunosuppressants and ABX alters the IM and thus leads to glucose metabolism disorders. This study examined the alterations of glucose and lipid metabolism and IM in mice exposed to tacrolimus (TAC) with or without ABX. We found that ABX further aggravated TAC-induced glucose tolerance and increased insulin secretion. Combined treatment resulted in exacerbated lipid accumulation in the liver. TAC-altered microbial community was further amplified by ABX administration, as characterized by reductions in phylum Firmicutes, family Lachnospiraceae, and genus Copyococcus. Analyses based on the metagenomic profiles revealed that ABX augmented the effect of TAC on microbial metabolic function mostly related to lipid metabolism. The altered components of gut microbiome and predicted microbial functional profiles showed significant correlation with hepatic lipid accumulation and glucose disorders. In conclusion, ABX aggravated the effect of TAC on the microbiome and its metabolic capacities, which might contribute to hepatic lipid accumulation and glucose disorders. These findings suggest that the ABX-altered microbiome can amplify the diabetogenic effect of TAC and could be a novel therapeutic target for patients.

关键词： antibiotics tacrolimus glucose disorders microbiome

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Mycophenolate mofetil or tacrolimus compared with azathioprine in long-term maintenance treatment for active lupus nephritis

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Frontiers of Medicine 2022年第5期16卷 799-807页

作者： Qianying Zhang Peng Xing Hong Ren Xiaonong Chen Jingyuan Xie Wen Zhang Pingyan Shen Xiao Li Nan Chen Department of Nephrology Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai 200025China

This study aimed to evaluate the efficacy and safety of mycophenolate mofetil(MMF)or tacrolimus(TAC)compared with azathioprine(AZA)as maintenance therapy for active lupus nephritis(ALN).Patients with ALN who responded to 24 weeks of induction treatment were *** who received MMF or TAC as induction therapy continued MMF or TAC treatment during the maintenance period,whereas those who received intravenous cyclophosphamide were subjected to AZA *** primary endpoint was the incidence of renal *** endpoints included extrarenal flares and composite endpoints(deaths,end-stage renal disease,or doubling of serum creatinine levels).A total of 123 ALN patients(47 in the MMF group,37 in the TAC group,and 39 in the AZA group)were *** median follow-up time was 60 *** MMF-treated patients,ten TAC-treated patients,and eight AZA-treated patients experienced renal relapses(P=0.844).The cumulative renal relapse rates in the MMF group(P=0.934)and TAC group(P=0.673)were similar to the renal relapse rate in the AZA *** significant difference in the incidence of severe adverse event was observed among the ***-term maintenance therapies with MMF or TAC might have similarly low rates of renal relapse and similar safety profiles compared with AZA.

关键词： lupus nephritis mycophenolate mofetil tacrolimus maintenance therapy

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Performance of tacrolimus in hospitalized patients with steroid-refractory acute severe ulcerative colitis

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World Journal of Gastroenterology 2019年第13期25卷 1603-1617页

作者： Peter Hoffmann Cyrill Wehling Johannes Krisam Jan Pfeiffenberger Nina Belling Annika Gauss Department of Gastroenterology and Hepatology Heidelberg University Hospital Institute of Medical Biometry and Informatics University of Heidelberg

BACKGROUND Acute severe ulcerative colitis unresponsive to systemic steroid treatment is a lifethreatening medical condition requiring hospitalization and often *** the increasing choice of medical therapy options for ulcerative colitis, the condition remains a great challenge in the field of inflammatory bowel diseases(IBD). The performance of the calcineurin inhibitor tacrolimus in this clinical setting is insufficiently *** To evaluate the short and long-term outcomes of tacrolimus therapy in adult inpatients with steroid-refractory acute severe ulcerative *** We conducted a retrospective monocentric study enrolling 22 patients at a tertiary care center for the treatment of IBD. All patients who were admitted to one of the wards of the Department of Gastroenterology and Hepatology of the Heidelberg University Hospital with acute severe ulcerative colitis between 2007 and 2018, and who received oral or intravenous tacrolimus for steroid-refractory disease were included. Baseline characteristics and data on the disease courses were retrieved from entirely computerized patient charts. The primary study endpoint was clinical response to tacrolimus therapy, resulting in discharge from the hospital. Secondary study endpoints were colectomy rate and time to colectomy, achievement of clinical remission under tacrolimus therapy, and the occurrence of side *** the majority of the 22 included patients(68.2%), tacrolimus therapy was initiated intravenously and subsequently converted to oral administration. The treatment duration was 128 ± 28.5 d(mean ± SEM), and the patients were followed up for 705 ± 110 d after treatment initiation. Among all patients, 86.4%were discharged from the hospital under continued oral tacrolimus therapy. In36.4% of the patients, the administration of tacrolimus resulted in clinical remission at some point during the treatment. Thirty-two percent of the patients underwent colectomy between 5 and 1

关键词： Acute severe ulcerative colitis Steroid-refractory tacrolimus Rescue therapy Calcineurin inhibitor Inflammatory bowel disease Hospitalized

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