Infusions, Parenteral

输液,肠胃外
  • 文章类型: Journal Article
    目的:恶性肿瘤腹膜转移和癌性腹水的预后普遍较差,有限的治疗选择。PRaG方案,其中包括大分割放射治疗,程序性细胞死亡-1(PD-1)抑制剂,和粒细胞-巨噬细胞集落刺激因子(GM-CSF),在至少一线标准全身治疗失败的晚期实体瘤患者中显示出生存优势。腹膜内输注PD-1抑制剂可能是控制恶性腹水的新治疗策略。将PRaG方案与PD-1抑制剂的腹膜内灌注相结合可能会控制恶性腹水并在这些患者中提供进一步的生存益处。这项拟议的研究旨在研究腹膜内输注serplulimab联合PRaG方案在同时患有晚期实体瘤和癌性腹水且至少一线治疗失败的患者中的安全性和有效性。方法:本研究是一项前瞻性研究,单臂,开放标签,多中心临床试验。所有符合条件的患者将接受2个周期的强化治疗,PRaG方案与腹膜内输注PD-1抑制剂的组合。接受强化治疗的患者将每2周接受一次巩固治疗,直到腹水消失,疾病进展发生,发生无法忍受的毒性,或长达1年。本研究的第一阶段将使用改进的3+3设计进行。对于II期PD-1抑制剂的腹膜内输注的剂量将根据I期研究中的剂量限制性毒性评估来确定。结论:这一前瞻性,开放标签,多中心研究可能导致腹膜内灌注PD-1抑制剂成为恶性腹水患者的新策略,并为这些患者PRaG方案联合腹膜内输注PD-1抑制剂提供有意义的疗效和安全性.
    Objective: The prognosis of malignant tumors with peritoneal metastases and cancerous ascites has generally been poor, with limited treatment options. The PRaG regimen, which comprised of hypofractionated radiotherapy, programmed cell death-1 (PD-1) inhibitor, and granulocyte-macrophage colony-stimulating factor (GM-CSF), showed a survival advantage in patients with advanced solid tumors who failed at least the first line of standard systemic treatment. Intraperitoneal infusion of PD-1 inhibitors may be a novel therapeutic strategy for managing malignant ascites. Integrating the PRaG regimen with intraperitoneal perfusion of a PD-1 inhibitor might control malignant ascites and provide further survival benefits in these patients. This proposed study aims to investigate the safety and efficacy of intraperitoneal infusion of serplulimab in combination with the PRaG regimen in patients with simultaneous advanced solid tumors and cancerous ascites who fail at least the first-line treatment. Methods: This proposed study is a prospective, single-arm, open-label, multicenter clinical trial. All eligible patients will receive 2 cycles of intensive treatment, a combination of PRaG regimen with an intraperitoneal infusion of PD-1 inhibitor. The patients who are beneficially treated with intensive treatment will receive consolidation treatment every 2 weeks until ascites disappear, disease progression occurs, intolerable toxicity occurs, or for up to 1 year. Phase I of this study will be conducted using a modified 3 + 3 design. The dose of intraperitoneal infusion of PD-1 inhibitor for phase II will be determined according to dose-limiting toxicity evaluation in the phase I study. Conclusion: This prospective, open-label, multicenter study will potentially lead to intraperitoneal perfusion of a PD-1 inhibitor being a new strategy for malignant ascites patients and provide a meaningful efficacy and safety of the combination of PRaG regimen with an intraperitoneal infusion of PD-1 inhibitor for these patients.
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  • 文章类型: Letter
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  • 文章类型: Journal Article
    因感染管理而延长住院时间会增加住院护理成本和医疗相关不良事件的风险,包括感染。全球对医疗保健的需求不断增长,医院床位的减少和患者对自己家中护理的偏好日益增加,这是扩大家庭医院方案的主要驱动因素。这些方案包括在门诊环境中使用IV抗菌药物,被称为门诊肠胃外抗菌治疗(OPAT)。然而,OPAT实践在全球范围内各不相同。本文旨在描述当前的OPAT实践和全球挑战。OPAT实践从使用资格标准进行患者评估和选择开始,这需要跨学科的OPAT团队之间的合作,患者和护理人员。根据护理要求,符合条件的患者可以参加各种护理模式,在门诊输液中心接受医疗保健专业人员的药物治疗,医院诊所,家访或通过自我管理。OPAT可用于管理许多缺乏有效口服治疗选择的感染。各类肠胃外抗菌药物,包括β-内酰胺,氨基糖苷类,糖肽,氟喹诺酮类药物和杀真菌药,如棘白菌素,在OPAT实践中在全球范围内使用。尽管有好处,OPAT有许多挑战,包括药物管理装置的并发症,抗菌副作用,监测要求,抗菌不稳定性,患者不遵守,患者OPAT排斥反应,以及与OPAT团队结构和管理相关的挑战,所有这些都会影响其结果。负面结果可能包括计划外的住院再入院。未来的研究应专注于缓解这些挑战,以实现OPAT服务的优化,从而最大限度地提高医疗保健系统的成文效益。患者和医疗保健提供者。
    Extended hospitalization for infection management increases inpatient care costs and the risk of healthcare-associated adverse events, including infections. The growing global demand for healthcare, the diminishing availability of hospital beds and an increasing patient preference for care within their own home have been the primary drivers of the expansion of hospital-in-the-home programmes. Such programmes include the use of IV antimicrobials in outpatient settings, known as outpatient parenteral antimicrobial therapy (OPAT). However, OPAT practices vary globally. This review article aims to describe the current OPAT practices and challenges worldwide. OPAT practice begins with patient evaluation and selection using eligibility criteria, which requires collaboration between the interdisciplinary OPAT team, patients and caregivers. Depending on care requirements, eligible patients may be enrolled to various models of care, receiving medication by healthcare professionals at outpatient infusion centres, hospital clinics, home visits or through self-administration. OPAT can be used for the management of many infections where an effective oral treatment option is lacking. Various classes of parenteral antimicrobials, including β-lactams, aminoglycosides, glycopeptides, fluoroquinolones and antifungals such as echinocandins, are used globally in OPAT practice. Despite its benefits, OPAT has numerous challenges, including complications from medication administration devices, antimicrobial side effects, monitoring requirements, antimicrobial instability, patient non-adherence, patient OPAT rejection, and challenges related to OPAT team structure and administration, all of which impact its outcome. A negative outcome could include unplanned hospital readmission. Future research should focus on mitigating these challenges to enable optimization of the OPAT service and thereby maximize the documented benefits for the healthcare system, patients and healthcare providers.
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  • 文章类型: Journal Article
    为了加快文章的发表,AJHP在接受后尽快在线发布手稿。接受的手稿经过同行评审和复制编辑,但在技术格式化和作者打样之前在线发布。这些手稿不是记录的最终版本,将在以后替换为最终文章(按照AJHP样式格式化并由作者证明)。
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  • 文章类型: Journal Article
    门诊肠胃外抗菌治疗(OPAT)依赖于大量的无补偿的提供者时间。在这项大型学术OPAT计划的研究中,OPAT管理时间的中位数为每周27分钟,每个OPAT课程。这些数据应该为OPAT寻求新的支付方法提供基准。
    Outpatient parenteral antimicrobial therapy (OPAT) relies on substantial uncompensated provider time. In this study of a large academic OPAT program, the median amount of unbilled OPAT management time was 27 minutes per week, per OPAT course. These data should inform benchmarks in pursuing novel payment approaches for OPAT.
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  • 文章类型: Journal Article
    背景:胃癌腹膜转移与预后不良相关。基于常温导管的腹膜内化疗和常温加压腹膜内气溶胶化疗(PIPAC)是腹膜内化疗的方法,与静脉内给药相比,导致腹膜内细胞毒性药物浓度更高。我们综述了不同姑息性腹腔化疗方法的有效性和安全性。
    方法:Embase,MEDLINE,在WebofScience和Cochrane中搜索了研究在胃癌和腹膜转移患者中反复使用姑息性腹膜内化疗的文章,公布至2024年1月。主要结果是总生存率。
    结果:纳入了23项研究,共999名患者。合并的中位总生存期为14.5个月。使用腹膜内紫杉醇和多西他赛的两种RCT的合并风险比有利于腹膜内化疗。腹膜内紫杉醇的中位总生存期,多西他赛和PIPAC联合顺铂和阿霉素分别为18.4个月,13.2个月和9.0个月。所有治疗方法都具有相对安全的毒性特征。16%的患者在完成腹膜内治疗后进行了转换手术。
    结论:反复腹腔化疗,不管管理方法如何,对于胃癌和腹膜转移患者是安全的。在一部分患者中,完成腹膜内化疗后的转换手术是可能的。
    BACKGROUND: Gastric cancer with peritoneal metastases is associated with a dismal prognosis. Normothermic catheter-based intraperitoneal chemotherapy and normothermic pressurized intraperitoneal aerosol chemotherapy (PIPAC) are methods to deliver chemotherapy intraperitoneally leading to higher intraperitoneal concentrations of cytotoxic drugs compared to intravenous administration. We reviewed the effectiveness and safety of different methods of palliative intraperitoneal chemotherapy.
    METHODS: Embase, MEDLINE, Web of Science and Cochrane were searched for articles studying the use of repeated administration of palliative intraperitoneal chemotherapy in patients with gastric cancer and peritoneal metastases, published up to January 2024. The primary outcome was overall survival.
    RESULTS: Twenty-three studies were included, representing a total of 999 patients. The pooled median overall survival was 14.5 months. The pooled hazard ratio of the two RCTs using intraperitoneal paclitaxel and docetaxel favoured the intraperitoneal chemotherapy arm. The median overall survival of intraperitoneal paclitaxel, intraperitoneal docetaxel and PIPAC with cisplatin and doxorubicin were respectively 18.4 months, 13.2 months and 9.0 months. All treatment methods had a relatively safe toxicity profile. Conversion surgery after completion of intraperitoneal therapy was performed in 16% of the patients.
    CONCLUSIONS: Repeated intraperitoneal chemotherapy, regardless of method of administration, is safe for patients with gastric cancer and peritoneal metastases. Conversion surgery after completion of the intraperitoneal chemotherapy is possible in a subset of patients.
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  • 文章类型: Journal Article
    背景:门诊肠外抗菌治疗(OPAT),住院静脉抗生素治疗的替代方案,在国际研究中显示出益处,例如增加患者满意度。由于到目前为止,OPAT仅在德国零星使用,目前还没有关于OPAT患者经验和担忧的结构化结果。因此,本研究旨在探索德国试点地区OPAT患者的经验。
    方法:这是德国试点地区的一项观察性研究,包括对58名患者的OPAT经历的调查,并对12例患者进行了深入访谈(解释性序贯混合方法设计)。
    结果:患者报告他们对OPAT感到满意。可以出院并且可以在家庭环境中继续进行抗感染治疗被认为是特别积极的。一开始,在访谈中,许多患者不确定是否能够自己在家进行抗生素治疗。然而,医疗保健提供者(医生和药房服务提供者工作人员)能够缓解这些担忧.患者赞赏与护理提供者的定期联系。有改进的建议,特别是关于每周检查预约的组织和提供关于OPAT的信息。
    结论:患者对OPAT普遍满意。然而,德国的治疗结构仍然需要扩大,以确保全面和高质量的OPAT护理。
    背景:NCT04002453,https://www.
    结果:gov/,(注册日期:2019-06-21)。
    BACKGROUND: Outpatient Parenteral Antimicrobial Therapy (OPAT), an alternative to inpatient intravenous antibiotic therapy, has shown benefits in international studies such as increased patient satisfaction. Because OPAT has been used only sporadically in Germany so far, no structured results on patients\' experiences and concerns regarding OPAT have yet been available. This study therefore aims to explore the experiences of OPAT patients in a pilot region in Germany.
    METHODS: This is an observational study in a German pilot region, including a survey of 58 patients on their experiences with OPAT, and in-depth interviews with 12 patients (explanatory-sequential mixed-methods design).
    RESULTS: Patients reported that they were satisfied with OPAT. That a hospital discharge was possible and anti-infective therapy could be continued in the home environment was rated as being particularly positive. In the beginning, many patients in the interviews were unsure about being able to administer the antibiotic therapy at home on their own. However, healthcare providers (doctors and pharmacy service provider staff) were able to allay these concerns. Patients appreciated regular contact with care providers. There were suggestions for improvement, particularly concerning the organization of the weekly check-up appointments and the provision of information about OPAT.
    CONCLUSIONS: Patients were generally satisfied with OPAT. However, the treatment structures in Germany still need to be expanded to ensure comprehensive and high-quality OPAT care.
    BACKGROUND: NCT04002453, https://www.
    RESULTS: gov/ , (registration date: 2019-06-21).
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  • 文章类型: Journal Article
    住院患者术后少肌症与不良预后相关。然而,很少有研究关注术后短期肌少症。此外,使用包含外周肠外营养(PPN)溶液的氨基酸(AAs)及其与运动(Exc)联合使用的营养管理的影响尚不清楚.因此,我们建立了大鼠术后肌肉萎缩模型,以评估胃肠外输注AA联合Exc对骨骼肌的影响,并研究其改善肌肉萎缩的潜在机制。雄性F344大鼠接受手术,然后进行后肢悬吊(HS)5天。将大鼠分为AA(-),AA(+),AA(-)-Exc,和AA(+)-Exc组。以98kcal/kg/天连续给药含或不含AA的PPN溶液。Exc组每天间歇加载1小时。术后肌少症大鼠肌肉力量和质量下降,泛素-蛋白酶体系统上调,自噬-溶酶体系统,和快速抽搐纤维相关基因,尤其是AA(-)组。AA(+)-Exc组肌肉力量减弱,腓肠肌质量增加,和抑制肌肉失步和快速抽搐纤维相关基因的上调。因此,肠外AA输注联合Exc可能有效预防住院患者术后肌少症。
    Postoperative sarcopenia is associated with poor outcomes in hospitalized patients. However, few studies have focused on short-term postoperative sarcopenia. Furthermore, the influence of nutritional management using amino acids (AAs) comprising a peripheral parenteral nutrition (PPN) solution and its combination with exercise (Exc) is unclear. Hence, we established a postoperative sarcopenic rat model to evaluate the effects of parenteral AA infusion combined with Exc on skeletal muscles and investigate the underlying mechanisms involved in the amelioration of muscle atrophy. Male F344 rats underwent surgery followed by hindlimb suspension (HS) for 5 days. The rats were divided into AA (-), AA (+), AA (-)-Exc, and AA (+)-Exc groups. They were continuously administered a PPN solution with or without AA at 98 kcal/kg/day. The Exc groups were subjected to intermittent loading for 1 h per day. Postoperative sarcopenic rats exhibited decreased muscle strength and mass and an upregulated ubiquitin-proteasome system, autophagy-lysosome system, and fast-twitch fiber-related genes, especially in the AA (-) group. The AA (+)-Exc group exhibited attenuated decreased muscle strength, increased gastrocnemius mass, and a suppressed upregulation of muscle atrophy- and fast-twitch fiber-related genes. Therefore, parenteral AA infusion combined with Exc may be effective in preventing postoperative sarcopenia in hospitalized patients.
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  • 文章类型: Journal Article
    背景:感染性心内膜炎(IE)需要长期静脉(IV)抗生素治疗。门诊肠外抗生素治疗(OPAT)节省了资源,改善患者体验,并允许在他们喜欢的地方进行护理;然而,在治疗IE患者时,仍然存在有关安全性的问题。本研究评估了2006年至2019年间本地区IE患者的OPAT管理。
    方法:这是一项回顾性观察性评估,并描述了结果和对适合性标准的遵守情况。根据英国抗菌化疗协会(BSAC)指南。
    结果:我们确定了OPAT交付的五种模型。随着时间的推移,接受治疗的患者数量显着增加。101名患者中,6(6%)结果不佳,但每位患者都有原发感染以外的因素.OPAT的中位持续时间为12天,节省了1489个住院天数。
    结论:在符合BSAC标准的情况下,使用OPAT服务治疗IE患者是安全的。观察到的并发症可能与治疗位置无关。节省了大量的卧床时间。
    BACKGROUND: Infective endocarditis (IE) requires long courses of intravenous (IV) antibiotics. Outpatient parenteral antibiotic therapy (OPAT) saves resources, improves the patient experience and allows care in their preferred place; however, questions remain about safety when treating IE patients. This study evaluates OPAT management of IE patients in our region between 2006 and 2019.
    METHODS: This is a retrospective observational evaluation and description of outcomes and adherence to suitability criteria, according to British Society for Antimicrobial Chemotherapy (BSAC) guidelines.
    RESULTS: We identified five models of OPAT delivery. The number of patients treated expanded significantly over time. Of 101 patients, six (6%) suffered poor outcomes, but each patient had contributing factors outside of the primary infection. Median OPAT duration was 12 days and 1,489 hospital bed days were saved.
    CONCLUSIONS: In a setting where there was good adherence to BSAC criteria, treating IE patients using OPAT services was safe. Complications observed were likely independent of treatment location. Significant bed days were saved.
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  • 文章类型: Journal Article
    目的:门诊肠胃外抗菌治疗(OPAT)具有几个关键优势,包括提高患者的生活质量,降低医疗成本,并有可能减少医院感染。它的安全性和有效性是公认的。这项研究为德国提供了第一个系统的临床数据,OPAT尚未被广泛采用。目的是为进一步研究OPAT并将其整合到德国医疗保健系统中建立基础参考点。
    方法:这项前瞻性观察性研究描述性分析了从接受OPAT的患者队列中获得的数据。可以招募来自所有医学专业的住院病人和门诊病人。患者在家中使用弹性泵自行施用抗感染药物。
    结果:77名患者接受了OPAT,中位持续时间为15天,节省了1782个住院天数。最常治疗的实体是骨科感染(n=20,26%),金黄色葡萄球菌血流感染(n=16,21%)和感染性心内膜炎(n=11,14%)。最常用的药物是氟氯西林(n=18,23%),青霉素G(n=13,17%)和头孢曲松(n=10;13%)。只有5%的患者(n=4)报告错过了一次以上的门诊剂量(最大。每位患者3人)。只有1例导管相关不良事件需要医疗干预,并且没有导管相关感染。
    结论:该研究表明OPAT可以在德国安全进行。为其更广泛的实施做准备,关键的下一步包括制定医疗指南,促进跨学科和部门间的交流,以及制定促进和鼓励采用OPAT的财务和结构性法规。
    背景:NCT04002453。
    OBJECTIVE: Outpatient parenteral antimicrobial therapy (OPAT) offers several key advantages, including enhanced patient quality of life, reduced healthcare costs, and a potential reduction of nosocomial infections. It is acknowledged for its safety and effectiveness. This study provides the first systematic clinical data for Germany, where OPAT has not yet been widely adopted. The aim is to establish a foundational reference point for further research and integration of OPAT into the German healthcare system.
    METHODS: This prospective observational study descriptively analyses data obtained from a cohort of patients receiving OPAT. Both in- and outpatients from all medical specialties could be recruited. Patients administered the anti-infective medications themselves at home using elastomeric pumps.
    RESULTS: 77 patients received OPAT, with a median duration of 15 days and saving 1782 inpatient days. The most frequently treated entities were orthopaedic infections (n = 20, 26%), S. aureus bloodstream infection (n = 16, 21%) and infectious endocarditis (n = 11, 14%). The most frequently applied drugs were flucloxacillin (n = 18, 23%), penicillin G (n = 13, 17%) and ceftriaxone (n = 10; 13%). Only 5% of patients (n = 4) reported to have missed more than one outpatient dose (max. 3 per patient). Only one catheter-related adverse event required medical intervention, and there were no catheter-related infections.
    CONCLUSIONS: The study demonstrates that OPAT can be safely conducted in Germany. In preparation for its broader implementation, crucial next steps include creating medical guidelines, fostering interdisciplinary and inter-sectoral communication, as well as creating financial and structural regulations that facilitate and encourage the adoption of OPAT.
    BACKGROUND: NCT04002453.
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