intravenous

静脉注射
  • 文章类型: Journal Article
    本项目旨在比较不同法莫替丁给药途径的非创伤性脑出血(ICH)患者的生存结果,并探讨影响患者临床结局的危险因素。
    从2008年至2019年入住ICU并接受法莫替丁治疗的患者数据收集自医学信息集市重症监护IV(MIMIC-IV)数据库。选择ICU入院>1天且用法莫替丁治疗的患者被分为通过静脉内(IV)给药组和通过非静脉内(非IV)给药组。Cox分析和双侧逐步回归分析用于确定影响患者生存的独立预后因素。使用Kaplan-Meier(K-M)存活曲线比较倾向评分匹配(PSM)前后不同给药途径患者的存活率。
    这项调查包括351名患者。PSM以1:2的比例匹配后,109例患者聚集在IV组中,84例患者聚集在非IV组中。Cox多变量结果显示,接受法莫替丁治疗的ICH患者的生存预后与年龄相关(HR=1.031,95CI:1.011-1.050,p=0.002),氯离子水平(HR=1.061,95CI:1.027-1.096,p<0.001),血尿素氮(BUN)(HR=1.034,95CI:1.007-1.062,p=0.012),颅内压(ICP)(HR=1.059,95CI:1.027-1.092,p<0.001),红细胞分布宽度(RDW)(HR=1.156,95CI:1.030-1.299,p=0.014),机械通气(HR=2.526,95CI:1.341-4.760,p=0.004),抗生素使用(HR=0.331,95CI:0.144-0.759,p=0.009),和非静脉途径(HR=0.518,95CI:0.283-0.948,p=0.033)。K-M曲线结果表明,非IV组ICH患者的30天生存率明显高于IV组患者(PSM前,p=0.036;PSM后,p=0.011)。在年龄的亚组分析中,ICP,机械通气,和抗生素的使用,法莫替丁的给药与30天死亡率之间存在很大的异质性相互作用(P<0.05)。非静脉途径大大降低了ICP正常(7-15mmHg)患者的死亡风险(HR=0.518,95CI:0.283-0.948,p=0.033)。
    在接受法莫替丁的ICH患者中,那些通过非静脉注射接受法莫替丁的人比接受静脉注射的人有更好的30天生存率,尤其是ICP正常(7-15mmHg)的患者。
    UNASSIGNED: This project aims to compare the survival outcomes of non-traumatic intracerebral hemorrhage (ICH) patients with different famotidine administration routes, and explore the risk factors influencing patients\' clinical outcomes.
    UNASSIGNED: Data of patients admitted to the ICU from 2008 to 2019 and receiving famotidine therapy were collected from the Medical Information Mart for Intensive Care IV (MIMIC-IV) database. Patients selected for ICU admission > 1 day and treated with famotidine were divided into the group via intravenous (IV) dosing and the group via non-intravenous (Non-IV) dosing. Cox analysis and bilateral stepwise regression were utilized to determine independent prognostic factors affecting patient survival. Survival of patients on different routes of administration before and after propensity score matching (PSM) was compared using Kaplan - Meier (K-M) survival curves.
    UNASSIGNED: This investigation included 351 patients. After PSM was matched with a 1:2 ratio, 109 patients were clustered in the IV group and 84 patients in the Non-IV group. Cox multivariate results uncovered that survival prognosis in ICH patients receiving famotidine was associated with age (HR = 1.031, 95%CI:1.011-1.050, p = 0.002), chloride ion levels (HR = 1.061, 95%CI:1.027-1.096, p < 0.001), blood urea nitrogen (BUN) (HR = 1.034, 95%CI:1.007-1.062, p = 0.012), intracranial pressure (ICP) (HR = 1.059, 95%CI:1.027-1.092, p < 0.001), red blood cell distribution width (RDW) (HR = 1.156, 95%CI:1.030-1.299, p = 0.014), mechanical ventilation (HR = 2.526, 95%CI:1.341-4.760, p = 0.004), antibiotic use (HR = 0.331, 95%CI:0.144-0.759, p = 0.009), and Non-IV route (HR = 0.518, 95%CI:0.283-0.948, p = 0.033). The K-M curve results indicated that the 30-day survival rate of Non-IV group ICH patients was substantially higher than that of IV group patients (before PSM, p = 0.036; after PSM, p = 0.011). In the subgroup analysis of age, ICP, mechanical ventilation, and antibiotic use, there was a great heterogeneity interaction between the administration of famotidine and the 30-day mortality rate (P for interaction < 0.05). The Non-IV route considerably reduced the risk of death in patients with normal ICP (7-15 mmHg) (HR = 0.518, 95%CI:0.283-0.948, p = 0.033).
    UNASSIGNED: Among ICH patients receiving famotidine, those receiving famotidine via Non-IV have a better 30-day survival rate compared to those receiving IV, especially in patients with normal ICP (7-15 mmHg).
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  • 文章类型: Journal Article
    目的:确定口服和静脉(IV)给药加巴喷丁在山羊体内的药代动力学和生理效应。
    方法:前瞻性,交叉研究,治疗之间有3周的洗脱期。
    方法:总共八种健康,客户拥有的,雌性山羊.
    方法:加巴喷丁(10mgkg-1)口服或静脉注射给山羊。使用液相色谱-四极杆飞行时间质谱法测量给药后0-96小时收集的血清样品中的加巴喷丁浓度。心率,呼吸频率,在研究前和整个研究过程中记录血压和体温.使用Pearson方法确定加巴喷丁的平均血清浓度与每个生理参数的相关性。
    结果:加巴喷丁口服生物利用度的平均值和标准偏差为60.9±11.2%。口服加巴喷丁的最大血清浓度(1.19±0.29μgmL-1)低于静脉给药后(59.76±14.38μgmL-1,p<0.0001)。PO后的半衰期(8.18±0.57小时)比IV后(1.79±0.06小时,p<0.0001)。口服后达到最大浓度的时间为6.86±2.27小时。心率与血清加巴喷丁浓度呈负相关。在三只动物中观察到轻微的共济失调,一个人在静脉注射加巴喷丁后变得平卧。
    结论:加巴喷丁口服给山羊后吸收良好,但血清浓度明显低于静脉途径。口服加巴喷丁后比IV给药后更长的半衰期可能是由于整个山羊胃肠道的长期吸收所致。静脉注射加巴喷丁可能会导致一些山羊轻微的共济失调。
    OBJECTIVE: To determine the pharmacokinetics and physiological effects following oral and intravenous (IV) administration of gabapentin in goats.
    METHODS: Prospective, crossover study with a 3 week washout period between treatments.
    METHODS: A total of eight healthy, client-owned, female goats.
    METHODS: Gabapentin (10 mg kg-1) was administered to goats either orally or IV. Gabapentin concentrations were measured in serum samples collected 0-96 hours post-administration using liquid chromatography-quadrupole time-of-flight mass spectrometry. Heart rate, respiratory rate, blood pressure and temperature were recorded before and throughout the study. Correlations of the mean serum concentrations of gabapentin to those of each physiological parameter were determined using the Pearson method.
    RESULTS: The mean and standard deviation of oral bioavailability for gabapentin was 60.9 ± 11.2%. Maximum serum concentration of gabapentin was lower following oral (1.19 ± 0.29 μg mL-1) than after IV administration (59.76 ± 14.38 μg mL-1, p < 0.0001). Half-lives were longer following PO (8.18 ± 0.57 hours) than after IV administration (1.79 ± 0.06 hours, p < 0.0001). Time to maximum concentration was 6.86 ± 2.27 hours following oral administration. Heart rate was inversely correlated with serum gabapentin concentrations. Slight ataxia was observed in three animals, and one became recumbent following IV gabapentin.
    CONCLUSIONS: Gabapentin is well-absorbed following oral administration to goats but yielded significantly lower serum concentrations than the IV route. The longer half-life of gabapentin following oral than after IV administration may result from prolonged absorption throughout the caprine gastrointestinal tract. IV gabapentin may cause slight ataxia in some goats.
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  • 文章类型: Journal Article
    (1)背景:作为质量保证计划的一部分,我们旨在通过检查在引入24小时时限之前和之后接受正常或较高血清磷酸盐浓度的磷酸盐患者比例的变化来检查和改善磷酸盐处方默认磷酸盐处方。(2)方法:这是一项在三个澳大利亚成人重症监护病房(ICU)进行的质量保证研究。包括所有ICU住院时间大于或等于48小时且已测量血清磷酸盐浓度的成年患者。在参与的ICU的肠内和静脉内磷酸盐电子临床信息系统中,将24小时的时间限制引入到promocolised处方中。患者特征,磷酸盐给药,并比较引入该时限前后的结局。主要结果是在测量正常或高血清磷酸盐水平后,开具磷酸盐的患者比例。次要结果是ICU住院时间,死亡率,和排放目的地。(3)结果:在两个时期内,共有1192例患者从三个ICU中纳入。在第二个研究期间,磷酸盐水平正常或较高的患者接受磷酸盐补充的比例显着降低(30.3%vs.9.9%;p<0.001)。在混合效应逻辑回归模型中对潜在的混杂因素进行校正后,这种差异仍然存在(接受正常或高血清浓度磷酸盐的校正比值比0.214,95%置信区间为0.132-0.347;p<0.001)。在典型的ICU住院时间中没有发现显着差异,住院病死率,以及这些群体之间的出院目的地。(4)结论:这项多中心前后研究表明,对电子磷酸盐处方进行24小时限制后,当他们的血清磷酸盐浓度正常或较高时,接受磷酸盐治疗的患者显着减少,对患者预后无任何不利影响。
    (1) Background: We aim to examine and improve phosphate prescribing as part of a quality assurance program by examining the change in the proportion of patients receiving phosphate with normal or high preceding serum phosphate concentrations before and after the introduction of the 24 h time limit to default phosphate prescription. (2) Methods: This was a quality assurance study conducted across three Australian adult intensive care units (ICUs). All adult patients with ICU lengths of stay greater than or equal to 48 h who had their serum phosphate concentrations measured were included. A 24 h time limit was introduced to the protocolised prescription in the electronic clinical information system for enteral and intravenous phosphate at participating ICUs. Patient characteristics, phosphate administration, and outcomes were compared before and after this time limit was introduced. The primary outcome was the proportion of patients to whom phosphate was prescribed after measurement of a normal or high serum phosphate level. Secondary outcomes were ICU length of stay, mortality, and discharge destination. (3) Results: A total of 1192 patients were included from three ICUs over the two periods. The proportion of patients with a normal or high measured phosphate level who then received phosphate supplementation was significantly lower in the second study period (30.3% vs. 9.9%; p < 0.001). This difference persisted when adjusted for potential confounders in a mixed-effects logistic regression model (an adjusted odds ratio for receiving phosphate with normal or high serum concentration 0.214, 95% confidence interval of 0.132-0.347; p < 0.001). No significant difference was seen in the typical ICU length of stay, in-hospital case-fatality rate, and hospital discharge destination between these groups. (4) Conclusions: This multicentre before-after study has demonstrated that the introduction of a 24 h limit on electronic phosphate prescriptions resulted in significantly fewer patients receiving phosphate when their serum phosphate concentration was normal or high, without any adverse impact on patient outcomes.
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  • 文章类型: Journal Article
    目的:几项研究发现皮下(SC)和静脉内(IV)给药类似的药物治疗长期免疫和自身免疫性疾病具有相似的临床效果,这意味着患者报告他们更喜欢的是,或者应该是,治疗选择的主要因素。因此,系统地收集有关患者偏好的证据很重要,使用SC或IV给药相同药物的治疗满意度和健康相关生活质量(HRQL)。材料与方法:PubMed数据库搜索于2021年10月15日进行。包括具有基于家庭的SC和基于医院的IV施用免疫球蛋白或用于治疗任何自身免疫性疾病或原发性免疫缺陷(PID)的生物疗法的经验的患者的研究。评估的结果是患者的偏好,治疗满意度和HRQL。使用随机效应模型对偏好数据进行荟萃分析。结果:总的来说,筛选了3504篇引文,46篇出版物描述了37项研究被纳入审查.总体上对SC的偏好高于IV给药,与PID和自身免疫性疾病的结果相似:PID,80%(95%置信区间[CI],64-94%)首选SC;自身免疫性疾病,83%(95%CI:73-92%);总体而言,82%(95%CI:75-89%)。荟萃分析还发现,84%(95%CI:75-92%)的患者更喜欢在家给药,而不是在医院治疗。使用生活质量指数对治疗满意度的分析发现,SC给药的治疗干扰和治疗设置评分始终优于IV给药。结论:与医院静脉输液相比,患者往往更喜欢,更满意,并报告更好的HRQL与SC在家里给药相同的药物,主要是由于更大的便利性。这项研究有助于对患有自身免疫性疾病或PID的患者进行循证护理。
    Aim: Several studies have found subcutaneous (SC) and intravenous (IV) administration of similar drugs for long-lasting immunological and autoimmune diseases to have similar clinical effectiveness, meaning that what patients report they prefer is, or should be, a major factor in treatment choices. Therefore, it is important to systematically compile evidence regarding patient preferences, treatment satisfaction and health-related quality of life (HRQL) using SC or IV administration of the same drug. Materials & methods: PubMed database searches were run on 15 October 2021. Studies involving patients with experience of both home-based SC and hospital-based IV administration of immunoglobulins or biological therapies for the treatment of any autoimmune disease or primary immunodeficiencies (PIDs) were included. The outcomes assessed were patient preferences, treatment satisfaction and HRQL. Preference data were meta-analyzed using a random-effects model. Results: In total, 3504 citations were screened, and 46 publications describing 37 studies were included in the review. There was a strong overall preference for SC over IV administration, with similar results seen for PIDs and autoimmune diseases: PID, 80% (95% confidence interval [CI], 64-94%) preferred SC; autoimmune diseases, 83% (95% CI: 73-92%); overall, 82% (95% CI: 75-89%). The meta-analysis also found that 84% (95% CI: 75-92%) of patients preferred administration at home to treatment in hospital. Analysis of treatment satisfaction using the life quality index found consistently better treatment interference and treatment setting scores with SC administration than with IV administration. Conclusion: Compared with IV infusions in hospital, patients tend to prefer, to be more satisfied with and to report better HRQL with SC administration of the same drug at home, primarily due to the greater convenience. This study contributes to evidence-based care of patients with autoimmune diseases or PIDs.
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  • 文章类型: Journal Article
    这项研究旨在评估当天混合冠状动脉计算机断层扫描血管造影(CCTA)和13N氨正电子发射断层扫描(PET)心肌灌注显像(MPI)期间急性静脉β受体阻滞剂给药对心肌血流量(MBF)的影响。先前关于在MPI之前停用口服β受体阻滞剂的研究显示出不同的结果,目前还没有研究在当天混合成像的背景下探索急性静脉给药。这项回顾性研究包括疑似慢性冠状动脉综合征患者,接受当天混合CCTA/13N-氨PETMPI。排除标准包括冠状动脉狭窄≥50%或PET局部灌注异常,和基线口服β受体阻滞剂药物。在CCTA之前,根据需要静脉注射美托洛尔(最多30mg)以控制心率。MBF测量值在休息时(rMBF)和应力期间(sMBF)获得,计算心肌血流储备(MFR)。排除281名患者后,154人符合倾向评分匹配的条件,根据β受体阻滞剂的给药,将108例患者分为两组。各组在基线特征方面没有显着差异。在那些接受β受体阻滞剂的人中,sMBF(2.21[IQR1.72-2.78]对2.46[2.08-2.99]ml•min-1•g-1,p=0.027)和MFR(3.46[2.70-4.05]对3.79[3.22-4.46],p=0.030),分别,与未接受β受体阻滞剂的患者相比。相比之下,rMBF未受影响(0.65[0.54-0.78]对0.64[0.55-0.76]ml·min-1·g-1,p=0.931)。急性静脉注射β受体阻滞剂显著影响MBF,导致sMBF和MFR略有降低。相比之下,rMBF似乎未受影响,提示β受体阻滞剂主要影响冠状动脉对血管扩张剂的反应能力。
    This study aimed to evaluate the impact of acute intravenous beta-blocker administration on myocardial blood flow (MBF) during same-day hybrid coronary computed tomography angiography (CCTA) and 13N-ammonia positron emission tomography (PET) myocardial perfusion imaging (MPI). Previous research on the discontinuation of oral beta-blockers before MPI has shown mixed results, with no studies yet exploring the acute intravenous administration in the context of same-day hybrid imaging. This retrospective study included patients with suspected chronic coronary syndromes undergoing same-day hybrid CCTA/13N-ammonia PET MPI. Exclusion criteria comprised coronary artery stenosis ≥ 50% or regional perfusion abnormalities on PET, and baseline oral beta-blocker medication. Intravenous metoprolol (up to 30 mg) was administered as needed for heart rate control before CCTA. MBF measurements were obtained at rest (rMBF) and during stress (sMBF), and myocardial flow reserve (MFR) was calculated. After excluding 281 patients, 154 were eligible for propensity-score matching, resulting in 108 patients divided into two equal groups based on beta-blocker administration. The groups showed no significant differences in baseline characteristics. Among those who received beta-blockers, there was a significant decrease in sMBF (2.21 [IQR 1.72-2.78] versus 2.46 [2.08-2.99] ml∙min-1∙g-1, p = 0.027) and MFR (3.46 [2.70-4.05] versus 3.79 [3.22-4.46], p = 0.030), respectively, compared to those who did not receive beta-blockers. In contrast, rMBF remained unaffected (0.65 [0.54-0.78] versus 0.64 [0.55-0.76] ml∙min-1∙g-1, p = 0.931). Acute intravenous beta-blocker administration significantly impacts MBF, leading to a slight reduction in sMBF and MFR. In contrast, rMBF appears unaffected, suggesting that beta-blockers primarily affect the coronary capacity to respond to vasodilators.
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  • 文章类型: Case Reports
    实体器官移植受者发生严重带状疱疹相关神经痛的风险很高,对于这些器官功能有限的患者,疼痛管理的药物疗法具有挑战性。静脉输注利多卡因显示出积极的镇痛作用,并用于治疗神经性疼痛。本病例系列报告了静脉输注利多卡因治疗实体器官移植受者顽固性带状疱疹相关神经痛的安全性和有效性。
    纳入了5名患有难治性带状疱疹相关神经痛的实体器官移植受者(数字评定量表8-10,尽管使用了高剂量的抗癫痫药物或与阿片类药物联合使用)。静脉注射利多卡因(5mg/kg理想体重)超过1.5h,并监测生命体征。疼痛强度,患者满意度,不良事件,典型的肝脏,并评估肾功能。所有受试者在6个月的随访中报告了对他们的治疗和有效疼痛缓解的高满意度。一名患者在治疗后出现短暂和轻度的口腔麻木和头晕,但未报告重大不良反应.
    本病例系列提供证据表明,静脉输注利多卡因可有效缓解疼痛,作为难治性带状疱疹相关神经痛的移植患者的镇痛治疗选择。
    UNASSIGNED: Solid organ transplant recipients are at high risk for developing severe zoster-associated neuralgia, and the pharmaceutic therapies of pain management for these patients with limited organ function are challenging. Intravenous lidocaine infusion showed positive analgesic effects and is used for the management of neuropathic pain. This case series reports the safety and effectiveness of intravenous lidocaine infusion in the treatment of intractable zoster-associated neuralgia in solid organ transplant recipients.
    UNASSIGNED: Five solid organ transplant recipients suffering from refractory zoster-associated neuralgia (numeric rating scale 8-10, despite using high doses of antiepileptic drugs or combined with opioids) were enrolled. Intravenous lidocaine (5 mg/kg ideal bodyweight) was administered over 1.5 h with the monitoring of vital signs. Pain intensity, patient satisfaction, adverse events, typical liver, and kidney function were evaluated. All subjects reported high satisfaction with their treatment and effective pain relief at the 6-month follow-up. One patient experienced short and mild numbness in the mouth and dizziness after the therapy, but no major adverse reactions were reported.
    UNASSIGNED: This case series provides evidence that intravenous lidocaine infusion provided effective pain relief as an analgesic treatment option for transplant patients with intractable zoster-associated neuralgia.
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  • 文章类型: Case Reports
    静脉内平滑肌瘤病(IVL)是一种特殊类型的子宫平滑肌瘤,很少见。静脉内脂平滑肌瘤病(LPL)是一种罕见的IVL亚型,以脂肪组织的存在为特征。尽管组织学上是良性的,这种疾病表现出侵袭性的生物学行为,如局部侵袭和高复发率。该疾病最初没有明显的临床特征,心脏症状可能只出现在后期。诊断主要依靠影像学检查,由于其罕见和不典型的临床表现,影像诊断可能具有挑战性,导致误诊和漏诊。以前,没有关于这种疾病的影像学发现的报告.
    本文报道一例52岁患者,因IVL而出现下腹部不适,接受了手术切除并恢复得很好。
    这是我们首次报道下腔静脉(IVC)延伸的静脉LPL疾病的影像学特征,及其特征成像特征[超声显示具有高回声性的肿块,计算机断层扫描(CT)显示类似脂肪的低密度信号,磁共振成像(MRI)在T1加权(T1W)图像上显示高信号,在具有脂肪抑制(T1FS)的T1W上显示低信号]可以导致准确的术前诊断并指导临床治疗。
    UNASSIGNED: Intravenous leiomyomatosis (IVL) is a special type of uterine leiomyoma and is rare. Intravenous lipoleiomyomatosis (LPL) is a rare subtype of IVL, distinguished by the presence of adipose tissue. Although histologically benign, this disease exhibits aggressive biological behavior such as local invasion and high recurrence rate. The disease initially presents with no obvious clinical features, and cardiac symptoms may only appear in the later stages. Diagnosis primarily relies on imaging studies, and due to its rarity and atypical clinical presentation, imaging diagnosis can be challenging, leading to misdiagnosis and missed diagnosis. Previously, there was no report on the imaging findings of this disease.
    UNASSIGNED: This article reports a case of a 52-year-old patient who presented with lower abdominal discomfort due to IVL, and who underwent surgical resection and had a good recovery.
    UNASSIGNED: This is the first time we report the imaging features of a disease of intravenous LPL with an extension of the inferior vena cava (IVC), and its characteristic imaging features [ultrasound shows a mass with high echogenicity, computed tomography (CT) shows low-density signal similar to fat, magnetic resonance imaging (MRI) shows high signal on T1-weighted (T1W) image and low signal on T1W with fat-suppression (T1FS)] can lead to an accurate preoperative diagnosis and guide clinical treatment.
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  • 文章类型: Journal Article
    这项首次在人体中的研究评估了安全性,耐受性,和药代动力学(PK)的顺帕加明(静脉注射)在健康成人。它包括第1部分,单次递增剂量[SAD:10.5mg-210mg;n=8(活性:6,安慰剂:2)],和第2部分,多次递增剂量[MAD:每天60和120mg,持续5天;n=9(活性:6,安慰剂:3)]。最后一次剂量随访是SAD的第3、4和6天,MAD的第7、8和10天。在每个队列完成时进行安全性和PK审查。我们探讨了顺帕加明在重症疟疾患者临床发展中的应用。在SAD部分,单次静脉给药后,全身暴露量(最大测量浓度和曲线下面积)随剂量增加(10.5mg-210mg)而增加.Cipargamin被消除,平均T1/2为21.9-38.9h。分布体积(92.9L-154L)和清除率(2.43L/h-4.33L/h)中等和低,分别,在剂量范围内。在MAD部分,每日一次服用顺帕加明5天后,平均积累比分别为1.51(60mg)和2.43(120mg).第5天后,平均T1/2为35.5(60mg)和31.9h(120mg),剂量增加两倍(60-120mg),导致暴露增加约2倍。Cipargamin对通常报道的轻度胃肠道具有良好的耐受性,神经学,和泌尿生殖系统事件。顺帕加明暴露量增加显示较高的基线校正QTcF,和模型预测的ΔΔQTcF表明,对ΔΔQTcF≥10ms的影响可以排除到6470ng/mL。然而,由于Fridericia的QT校正不足,这些结果应谨慎解释。
    结果:本研究在ClinicalTrials.gov注册为NCT04321252。
    This first-in-human study assessed safety, tolerability, and pharmacokinetics (PK) of cipargamin (intravenous) in healthy adults. It included part 1, single ascending dose [SAD: 10.5 mg-210 mg; n = 8 (active: 6, placebo: 2)], and part 2, multiple ascending dose [MAD: 60 and 120 mg daily for 5 days; n = 9 (active: 6, placebo: 3)]. Last dose follow-ups were on days 3, 4, and 6 for SAD and 7, 8, and 10 for MAD. Safety and PK review was done at completion of each cohort. We explored the cipargamin use for clinical development in patients with severe malaria. In SAD part, systemic exposure (maximum measured concentration and area under the curve) increased with increasing dose (10.5 mg-210 mg) following single intravenous dose. Cipargamin was eliminated with a mean T1/2 of 21.9-38.9 h. Volume of distribution (92.9 L-154 L) and clearance (2.43 L/h-4.33 L/h) was moderate and low, respectively, across the dose range. In MAD part, the mean accumulation ratio was 1.51 (60 mg) and 2.43 (120 mg) after once-daily cipargamin administration for 5 days. After day 5, the mean T1/2 was 35.5 (60 mg) and 31.9 h (120 mg) with twofold dose increase (60-120 mg) resulting in ~2-fold increased exposure. Cipargamin was well tolerated with commonly reported mild gastrointestinal, neurological, and genitourinary events. Increasing exposure to cipargamin showed higher baseline-corrected QTcF, and model-predicted ΔΔQTcF indicated that an effect on ΔΔQTcF ≥10 ms can be excluded up to 6470 ng/mL. However, these results should be interpreted with caution due to inadequate Fridericia\'s QT correction.
    RESULTS: This study is registered with ClinicalTrials.gov as NCT04321252.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    背景:在NOVA(第1部分)和欧洲药品管理局批准了那他珠单抗的皮下(SC)给药途径之后,在接受那他珠单抗每6周(Q6W)给药的患者中,开始了NOVAIIIb期研究(第2部分)的延长阶段,以收集SC与静脉内(IV)给药的患者偏好数据.这项研究是为了评估患者对SC与IV那他珠单抗给药的偏好,并探讨疗效。安全,和两种给药途径的药理学特征。
    方法:在第2部分中,参与者通过静脉输注Q6W接受纳他珠单抗(Tysabri®)300mg,持续36周,然后随机分配至48周交叉治疗(24周SCQ6W和24周IVQ6W,反之亦然)。主要终点是在患者偏好问卷中表示偏爱那他珠单抗SC给药的参与者比例。
    结果:在NOVA第2部分中,共有153名参与者被随机分配。在123名患者偏好数据中,108(87.8%)更喜欢SC给药途径,而不是IV途径;102(82.9%)指定“在临床上需要更少的时间”作为SC偏好的原因。
    结论:在NOVA(第2部分)中,Q6W给药那他珠单抗的大多数参与者首选SC给药而不是IV给药.
    结果:GOV:NCT03689972。不清楚.
    BACKGROUND: Following NOVA (part 1) and the approval of the subcutaneous (SC) route of administration of natalizumab by the European Medicines Agency, an extension phase of the NOVA phase IIIb study (part 2) was initiated to collect patient preference data for SC versus intravenous (IV) dosing in patients receiving every-6-week (Q6W) dosing of natalizumab. This study was performed to evaluate patient preference for SC versus IV natalizumab administration and explore the efficacy, safety, and pharmacology characteristics of both routes of administration.
    METHODS: In part 2, participants received natalizumab (Tysabri®) 300 mg via IV infusion Q6W for 36 weeks and then were randomized to 48 weeks of crossover treatment (24 weeks SC Q6W and 24 weeks IV Q6W, or vice versa). The primary endpoint was the proportion of participants who indicated a preference for natalizumab SC administration on the Patient Preference Questionnaire.
    RESULTS: A total of 153 participants were randomized in NOVA part 2. Of 123 with patient preference data, 108 (87.8%) preferred the SC route of administration for natalizumab over the IV route; 102 (82.9%) specified \"requires less time in the clinic\" as the reason for the SC preference.
    CONCLUSIONS: In NOVA (part 2), most participants on Q6W dosing of natalizumab preferred SC administration versus IV administration.
    RESULTS: GOV: NCT03689972. INFOGRAPHIC.
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