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Assessment of compatibility of rhlGF-1/rhlGFBP-3 with neonatal intravenous medications

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World Journal of Pediatrics 2023年第1期19卷 58-67页

作者： Nazila Salamat-Miller Mark A.Turner Amey Bandekar Nitin Dixit Emily Jochim Barry Mangum Christopher McPherson Srini Tenjarla Sukhjeet Singh You Seok Hwang Norman Barton Takeda 200 Shire WayLexingtonMA 02421USA Institute of Translational Medicine University of LiverpoolLiverpoolUK Paidion Research DurhamNCUSA Washington University St.LouisMOUSA

Background Recombinant human(rh)IGF-1/IGFBP-3 protein complex,administered as a continuous intravenous infusion in preterm infants,is being studied for the prevention of complications of prematurity.Methods We conducted in vitro studies to evaluate the physical and chemical compatibility of rhIGF-1/IGFBP-3 with medications routinely administered to preterm neonates.In vitro mixing of rhIGF-1/IGFBP-3 drug product with small-molecule test medications plus corresponding controls was performed.Physical compatibility was defined as no color change,precipitation,turbidity,gas evolution,no clinically relevant change in pH/osmolality or loss in medication content.Chemical compatibility of small molecules was assessed using liquid chromatography(e.g.,reverse-phase HPLC and ion chromatography),with incompatibility defined as loss of concentration of≥10%.A risk evaluation was conducted for each medication based on in vitro compatibility data and potential for chemical modification.Results In vitro physical compatibility was established for 11/19 medications:caffeine citrate,fentanyl,fluconazole,gen-tamicin,insulin,intravenous fat emulsion,midazolam,morphine sulfate,custom-mixed parenteral nutrition solution(with/without electrolytes),parenteral nutrition solution+intravenous fat emulsion,and vancomycin(dosed from a 5 mg/mL solu-tion),but not for 8/19 medications:amikacin,ampicillin,dopamine,dobutamine,furosemide,meropenem,norepinephrine,and penicillin G,largely owing to changes in pH after mixing.Small-molecule compatibility was unaffected post-mixing,with no loss of small-molecule content.For physically compatible medications,risk analyses confirmed low probability and severity of a risk event.Conclusion Co-administration of rhIGF-1/rhIGFBP-3 drug product with various medications was assessed by in vitro studies using case-by-case risk analyses to determine the suitability of the products for co-administration.

关键词： Chemical compatibility intravenous Neonatal Physical compatibility rhIGF-1/rhIGFBP-3

intravenous tirofiban therapy for patients with capsular warning syndrome

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Stroke & Vascular Neurology 2019年第1期4卷 22-27页

作者： Wei Li Ya Wu Xiao-Shu Li Cheng-Chun Liu Shu-Han Huang Chun-Rong Liang Huan Wang Li-Li Zhang Zhi-Qiang Xu Yan-Jiang Wang Meng Zhang Department of Neurology Daping Hospital&Research Institute of SurgeryThe Army Military Medical UniversityChongqingChina

Background Capsular warning syndrome(CWS)is defined as recurrent episodes of transient ischaemic attacks≥3 times during a short time frame.There is no effective therapy to stop these attacks.We,herein,report our experience of using intravenous tirofiban to treat CWS.Methods All patients with CWS in our hospital from January 2013 to September 2017 were reviewed.Patients in tirofiban group(T-group)were treated by intravenous tirofiban at 0.4μg/kg/min for 30 min followed by 0.1-0.15μg/kg/min infusion.Other treatments(non-T-group)included thrombolytic,oral antiplatelet agents and anticoagulant.Intracerebral haemorrhage(ICH),systematic bleeding,new attacks after treatment,National Institutes of Health Stroke Scale(NIHSS)scores at 24 hours and modified Rankin Scales(mRSs)at 3 months were recorded.Descriptive statistics were used for analysis.results Of 23 patients qualified(15 in T-group,8 in non-T-group),the duration of symptoms ranged from 2 to 100 min before treatments.After treatment,in T-group,four patients(26.7%)had recurrent attacks,and NIHSS scores were 0 in 11 patients(73.3%)at 24 hours.All patients reached a favourable outcome(mRS≤2) at 3 months.In non-T-group,five patients(62.5%)had new attacks.NIHSS scores were 0 in two patients(25%)at 24 hours.At 3 months,seven patients(87.5%)reached a favourable outcome.Neither ICH nor systematic bleeding or thrombocytopaenia occurred in both groups of patients.Conclusions intravenous tirofiban can be a potentially effective and safe therapy to stop early symptomatic fluctuations and shorten the duration of functional deficits in patients with CWS.

关键词： patients intravenous intravenous

Endovascular treatment with or without intravenous alteplase for acute ischaemic stroke due to basilar artery occlusion

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Stroke & Vascular Neurology 2022年第3期7卷 190-199页

作者： Ximing Nie David Wang Yuehua Pu Yufei Wei Qixuan Lu Hongyi Yan Xin Liu Lina Zheng Jingyi Liu Xinxuan Yang Yarong Ding Dacheng Liu Wanying Duan Zhe Zhang Zhonghua Yang Miao Wen Weibin Gu Xinyi Hou Xinyi Leng Yuesong Pan Zhongrong Miao Liping Liu Department of Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina China National Clinical Research Center for Neurological Diseases BeijingChina Neurovascular Division Department of NeurologyBarrow Neurological InstitutePhoenixArizonaUSA Department of Medicine and Therapeutics Prince of Wales HospitalHong KongChina Department of Radiology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina Department of Interventional Neurology Beijing Tiantan HospitalCapital Medical UniversityBeijingChina

Background and purpose It remains controversial if endovascular treatment(EVT)can improve the outcome of patients with acute basilar artery occlusion(BAO).This study aims to compare the functional outcomes between EVT with and without intravenous thrombolysis(IVT)first in patients who had acute ischaemic stroke(AIS)due to BAO.Methods Patients who had AIS with BAO who underwent EVT within 24 hours of onset were enrolled in this multicentre cohort study,and the efficacy and safety were compared between IVT+EVT and direct EVT.The primary outcome was 90-day functional independence.All outcomes were assessed with adjusted OR(aOR)from the multivariable logistic regression.In addition,a meta-analysis was performed on all recently published pivotal studies on functional independence after EVT in patients with BAO.Results Of 310 enrolled patients with BAO,241(78%)were treated with direct EVT and 69(22%)with IVT+EVT.Direct EVT was associated with a worse functional outcome(aOR,0.46(95%CI 0.24 to 0.85),p=0.01).IVT+EVT was associated with a lower percentage of patients who needed≥3 passes of stent retriever(10.14%vs 20.75%).The meta-analysis regression revealed a potential positive correlation between bridging with IVT first and functional independence(r=0.14(95%CI 0.05 to 0.24),p<0.01).Conclusions This study showed that compared with direct EVT,EVT with IVT first was associated with better functional outcomes in patients with BAO treated within 24 hours of onset.The meta-analysis demonstrated similar favourable efficacy of IVT first followed by EVT in patients with BAO.

关键词： acute intravenous occlusion

Mobile stroke care expedites intravenous thrombolysis and endovascular thrombectomy

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Stroke & Vascular Neurology 2022年第3期7卷 209-214页

作者： Matthew T Bender Thomas K Mattingly Redi Rahmani Diana Proper Walter A Burnett Jason L Burgett Joshua LEsperance Jeremy T Cushman Webster H Pilcher Curtis G Benesch Adam G Kelly Tarun Bhalla Department of Neurosurgery University of Rochester Medical CenterRochesterNew YorkUSA Department of Emergency Medicine University of Rochester Medical CenterRochesterNew YorkUSA Department of Neurology University of Rochester Medical CenterRochesterNew YorkUSA

Background The number of mobile stroke programmes has increased with evidence,showing they expedite intravenous thrombolysis.Outstanding questions include whether time savings extend to patients eligible for endovascular therapy and impact clinical outcomes.Objective Our mobile stroke unit(MSU),based at an academic medical centre in upstate New York,launched in October 2018.We reviewed prospective observational data sets over 26 months to identify MSU and non-MSU emergency medical service(EMS)patients who underwent intravenous thrombolysis or endovascular thrombectomy for comparison of angiographic and clinical outcomes.Results Over 568 days in service,the MSU was dispatched 1489 times(2.6/day)and transported 300 patients(20%of dispatches).intravenous tissue plasminogen activator(tPA)was administered to 57 MSU patients and the average time from 911 call-to tPA was 42.5 min(±9.2),while EMS transported 73 patients who received tPA at 99.4 min(±35.7)(pintravenous thrombolysis or endovascular thrombectomy,whether assessed as a dichotomous or ordinal variable.Conclusions Mobile stroke care expedited both intravenous thrombolysis and endovascular thrombectomy.There is an ongoing need to show improved functional outcomes with MSU care.

关键词： intravenous throm endovascular

Third-line therapies in patients with Kawasaki disease refractory to first-and second-line intravenous immunoglobulin therapy

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World Journal of Pediatrics 2022年第11期18卷 781-785页

作者： Takashi Furuta Hiroki Yasudo Seigo Okada Yuji Ohnishi Akiko Kawakami-Miyake Yasuo Suzuki Shouichi Ohga Shunji Hasegawa Department of Pediatrics Yamaguchi University Graduate School of Medicine1-1-1 MinamikogushiUbeYamaguchi755-8505Japan Department of Pediatrics Graduate School of Medical SciencesKyushu University3-1-1 MaidashiHigashi-kuFukuoka812-8582Japan

Kawasaki disease(KD)is an acute febrile ilness characterized by systemic vasculitis affecting the small-and mediumsized arteries in children [1,2].One of the most critical complications of KD is the development of coronary artery lesions(CALs)approximately after 12 days of ilness,which may lead to myocardial infarction[3].High-dose intravenous immunoglobulin(IVIG)and oral administration of aspirin have been established as the first-line therapy for KD[4,5].

关键词： intravenous acute immunoglobulin

Efficacy of live attenuated vaccines after two doses of intravenous immunoglobulin for Kawasaki disease

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World Journal of Pediatrics 2022年第10期18卷 706-709页

作者： Yoshihiko Morikawa Hiroshi Sakakibara Masaru Miura Clinical Research Support Center Tokyo Metropolitan Children’s Medical Center2-8-29 MusashidaiFuchuTokyo183-8561Japan Department of General Pediatrics Tokyo Metropolitan Children’s Medical CenterTokyoJapan Department of Cardiology Tokyo Metropolitan Children’s Medical CenterTokyoJapan

Kawasaki disease(KD)is a vasculitis of unknown etiology occurring predominantly in children under five years old[1].Coronary artery aneurysm,its most serious complica-tion,occurs in about 25%of untreated patients[2].High-dose intravenous immunoglobulin(IVIG)2 g/kg is used to prevent coronary artery aneurysms[1,3,4],but about 20%of patients are nonresponsive and require a second dose for a total of 4 g/kg.The appropriate timing of live attenuated vaccine(LAV)administration in such cases is unclear.

关键词： doses attenuated intravenous

GRP per capita and hospital characteristics associated with intravenous tissue plasminogen activator adherence rate:evidence from the Chinese Stroke Center Alliance

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Stroke & Vascular Neurology 2021年第3期6卷 337-343,I0001-I0005页

作者： Suxi Zheng Tian Jie Lyu Zixiao Li Hongqiu Gu Xin Yang Chunjuan Wang Hao Li Yong Jiang Haipeng Shen Yongjun Wang Innvotion and Information Management HKU Business SchoolThe University of Hong KongHong KongChina China National Clinical Research Center for Neurological Diseases Beijing Tiantan HospitalCapital Medical UniversityBeijingChina National Center for Healthcare Quality Management in Neurological Diseases Beijing Tiantan HospitalCapital Medical UniversityBeijingChina Chinese Institute for Brain Research BeijingChina Shenzhen Institute of Research and Innovation The University of Hong KongShenzhenChina

Background Timely delivery of intravenous tissue plasminogen activator(IV-rt PA)is pivotal to eligible patients who had a stroke while achieving higher rates of IV-rt PA has been problematic.This paper focuses on investigating influential factors associated with the administration of IV-rt PA,primarily per capita gross regional product(GRP)and healthcare system factors.Methods The study included 980 hospitals in the Chinese Stroke Center Alliance where 158003 patients who had an acute ischaemic stroke received IV-rt PA between August 2015 and August 2019.The adherence rate to IV-rt PA within 4.5 hours time window in each hospital was the primary outcome.Influential factors were grouped into two categories:macroeconomic status and hospital characteristics.The outcome was analysed using multivariable linear regression.Results GRP per capita(β=2.37,p<0.001),hospital stroke centre certification(β=3.77,p<0.001),number of neurologists(β=0.12,p<0.001),existence of emergency services for neurological treatment(β=7.43,p=0.014),presence of emergency department(β=10.03,p=0.019)and cooperating with emergency centre(β=4.65,p=0.029)were significantly positively associated with the adherence rate to IV-rt PA.Conclusions Higher GRP per capita,affluent neurological personnel,well-equipped emergency services for neurological treatment and routine cooperation with the emergency centre were important for enhancing the adherence rate to IV-rt PA among patients who had an acute ischaemic stroke in China.

关键词： intravenous routine Alliance

Association between fluid-attenuated inversion recovery vascular hyperintensity and outcome varies with different lesion patterns in patients with intravenous thrombolysis

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Stroke & Vascular Neurology 2021年第3期6卷 449-457,I0076页

作者： Erling Wang Chuanjie Wu Dandan Yang Xihai Zhao Jie Zhao Hong Chang Qi Yang Department of Radiology Beijing Chaoyang HospitalCapital Medical UniversityBeijingChina Department of Neurology Xuanwu HospitalCapital Medical UniversityBeijingChina Beijing Institute of Brain Disorders Laboratory of Brain DisordersMinistry of Science and TechnologyCollaborative Innovation Center for Brain DisordersCapital Medical UniversityBeijingChina Center for Biomedical Imaging Research Department of Biomedical EngineeringTsinghua UniversityBeijingChina Key Laboratory of Medical Engineering for Cardiovascular Disease Ministry of EducationBeijingChina

Background and purpose To evaluate relationship between fluid-attenuated inversion recovery vascular hyperintensity(FVH)after intravenous thrombolysis and outcomes in different lesion patterns on diffusion-weighted imaging(DWI).Methods Patients with severe internal carotid or intracranial artery stenosis who received intravenous thrombolysis from March 2012 to April 2019 were analysed.They were divided into four groups by DWI lesion patterns:border-zone infarct(BZ group),multiple lesions infarct(ML group),large territory infarct(LT group),and single cortical or subcortical lesion infarct(SL group).Logistic regression was performed to identify risk factors for outcome(unfavourable outcome,modified Rankin Scale(mRS)≥2;poor outcome,mRS≥3).Results Finally,203 participants(63.3±10.2 years old;BZ group,n=72;ML group,n=64;LT group,n=37;SL group,n=30)from 1190 patient cohorts were analysed.After adjusting for confounding factors,FVH(+)was associated with unfavourable outcome in total group(OR 3.02;95%CI 1.49 to 6.13;p=0.002),BZ group(OR 4.22;95%CI 1.25 to 14.25;p=0.021)and ML group(OR 5.44;95%CI 1.41 to 20.92;p=0.014)patients.FVH(+)was associated with poor outcome in total group(OR 2.25;95%CI 1.01 to 4.97;p=0.046),BZ group(OR 5.52;95%CI 0.98 to 31.07;p=0.053)and ML group(OR 4.09;95%CI 1.04 to 16.16;p=0.045)patients,which was marginal significance.FVH(+)was not associated with unfavourable or poor outcome in LT and SL groups.Conclusion This study suggests that association between FVH and outcome varies with different lesion patterns on DWI.The presence of FVH after intravenous thrombolysis may help to identify patients who require close observations in the hospitalisation in patients with border-zone and multiple lesion infarcts.

关键词： patients thrombolysis intravenous

Comparison of outcome of patients with acute minor ischaemic stroke treated with intravenous t-PA, DAPT or aspirin

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Stroke & Vascular Neurology 2021年第2期6卷 187-193页

作者： Peng Wang Mengyuan Zhou Yuesong Pan Xia Meng Xingquan Zhao Liping Liu Hao Li Yongjun Wang Zhimin Wang Yilong Wang Neurology Department Zhejiang Provincial People's HospitalHangzhouChina Neurology Department Beijing Tiantan HospitalBeijingChina China National Clinical Research Center for Neurological Diseases Beijing Tiantan HospitalBeijingChina Neurology Department The First people's Hospital of TaizhouTaizhouChina

Background Whether to treat minor stroke with intravenous tissue plasminogen activator(t-PA)treatment or antiplatelet therapy is a dilemma.Our study aimed to explore whether intravenous t-PA treatment,dual antiplatelet therapy(DAPT)and aspirin have different efficacies on outcomes in patients with minor stroke.Methods A post hoc analysis of patients with acute minor stroke treated with intravenous t-PA within 4.5 hours from a nationwide multicentric electronic medical record and patients with acute minor stroke treated with DAPT and aspirin from the Clopidogrel with Aspirin in Acute Minor Stroke or Transient Ischemic Attack Database.Minor stroke was defined by a score of 0-3 on the National Institutes of Health Stroke Scale at randomisation.Favourable functional outcome(defined as modified Rankin Scale(mRS)score of 0-1 or 0-2 at 3 months).Results Compared with those treated with intravenous t-PA,no significant association with 3-month favourable functional outcome(defined as mRS score of 0-1)was found neither in patients treated with aspirin(87.8%vs 89.4%;OR,0.83;95% CI,0.46 to 1.50;p=0.53)nor those treated with DAPT(87.4%vs 89.4%;OR,0.84;95% CI,0.46 to 1.52;p=0.56).Similar results were observed for the favourable functional outcome defined as mRS score of 0-2 at 3 months.Conclusions In our study,no significant advantage of intravenous t-PA over DAPT or aspirin was found.Due to insufficient sample size,our study is probably unable to draw such a conclusion that that intravenous t-PA was superior or non-superior to DAPT.

关键词： DAPT aspirin intravenous