RESUMEN
Infiltration of a vesicant, called extravasation, can result in severe patient injuries. Recognition of vesicants and their relative risk of injury is essential to extravasation prevention, early recognition, and appropriate treatment. In this article, the Vesicant Task Force (VTF) updates the previously published Infusion Nurses Society (INS) vesicant list from 2017. The 2024 INS list diverges from earlier vesicant lists, such as the 2017 VTF list, by adopting a risk stratification approach based upon documented patient outcomes, in contrast to the reliance on expert consensus or only surrogate risk indicators, such as pH and osmolarity. The methodology used to create the updated list is explained, and the criteria for high- and moderate-risk vesicants and cautionary vesicants are defined.
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Extravasación de Materiales Terapéuticos y Diagnósticos , Humanos , Irritantes/efectos adversos , Infusiones Intravenosas , Enfermería Basada en la Evidencia , Sociedades de EnfermeríaRESUMEN
BACKGROUND: Intravenous thrombolysis is a standard treatment of acute ischemic stroke. The efficacy and safety of combining intravenous thrombolysis with argatroban (an anticoagulant agent) or eptifibatide (an antiplatelet agent) are unclear. METHODS: We conducted a phase 3, three-group, adaptive, single-blind, randomized, controlled clinical trial at 57 sites in the United States. Patients with acute ischemic stroke who had received intravenous thrombolysis within 3 hours after symptom onset were assigned to receive intravenous argatroban, eptifibatide, or placebo within 75 minutes after the initiation of thrombolysis. The primary efficacy outcome, the utility-weighted 90-day modified Rankin scale score (range, 0 to 10, with higher scores reflecting better outcomes), was assessed by means of centralized adjudication. The primary safety outcome was symptomatic intracranial hemorrhage within 36 hours after randomization. RESULTS: A total of 514 patients were assigned to receive argatroban (59 patients), eptifibatide (227 patients), or placebo (228 patients). All the patients received intravenous thrombolysis (70% received alteplase, and 30% received tenecteplase), and 225 patients (44%) underwent endovascular thrombectomy. At 90 days, the mean (±SD) utility-weighted modified Rankin scale scores were 5.2±3.7 with argatroban, 6.3±3.2 with eptifibatide, and 6.8±3.0 with placebo. The posterior probability that argatroban was better than placebo was 0.002 (posterior mean difference in utility-weighted modified Rankin scale score, -1.51±0.51) and that eptifibatide was better than placebo was 0.041 (posterior mean difference, -0.50±0.29). The incidence of symptomatic intracranial hemorrhage was similar in the three groups (4% with argatroban, 3% with eptifibatide, and 2% with placebo). Mortality at 90 days was higher in the argatroban group (24%) and the eptifibatide group (12%) than in the placebo group (8%). CONCLUSIONS: In patients with acute ischemic stroke treated with intravenous thrombolysis within 3 hours after symptom onset, adjunctive treatment with intravenous argatroban or eptifibatide did not reduce poststroke disability and was associated with increased mortality. (Funded by the National Institute of Neurological Disorders and Stroke; MOST ClinicalTrials.gov number, NCT03735979.).
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Eptifibatida , Hemorragias Intracraneales , Accidente Cerebrovascular Isquémico , Péptidos , Ácidos Pipecólicos , Sulfonamidas , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Arginina/administración & dosificación , Arginina/efectos adversos , Arginina/análogos & derivados , Quimioterapia Combinada/efectos adversos , Quimioterapia Combinada/métodos , Eptifibatida/administración & dosificación , Eptifibatida/efectos adversos , Fibrinolíticos/administración & dosificación , Fibrinolíticos/efectos adversos , Infusiones Intravenosas , Hemorragias Intracraneales/inducido químicamente , Hemorragias Intracraneales/epidemiología , Accidente Cerebrovascular Isquémico/mortalidad , Accidente Cerebrovascular Isquémico/terapia , Péptidos/administración & dosificación , Péptidos/efectos adversos , Péptidos/uso terapéutico , Ácidos Pipecólicos/administración & dosificación , Ácidos Pipecólicos/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/efectos adversos , Método Simple Ciego , Sulfonamidas/administración & dosificación , Sulfonamidas/efectos adversos , Terapia Trombolítica/efectos adversos , Terapia Combinada/efectos adversos , Terapia Combinada/métodos , Trombectomía/efectos adversos , Trombectomía/métodos , Resultado del Tratamiento , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Incidencia , AdultoRESUMEN
BACKGROUND: Targeting pituitary adenylate cyclase-activating polypeptide (PACAP) is a new avenue for treating migraine. The efficacy and safety of intravenous Lu AG09222, a humanized monoclonal antibody directed against the PACAP ligand, for migraine prevention are unclear. METHODS: In a phase 2, double-blind, randomized, placebo-controlled trial, we enrolled adult participants (18 to 65 years of age) with migraine for whom two to four previous preventive treatments had failed to provide a benefit. The trial included a 4-week treatment period and an 8-week follow-up period. Participants were randomly assigned in a 2:1:2 ratio to receive a single-dose baseline infusion of 750 mg of Lu AG09222, 100 mg of Lu AG09222, or placebo. The primary end point was the mean change from baseline in the number of migraine days per month, during weeks 1 through 4, in the Lu AG09222 750-mg group as compared with the placebo group. RESULTS: Of 237 participants enrolled, 97 received 750 mg of Lu AG09222, 46 received 100 mg of Lu AG09222, and 94 received placebo. The mean number of baseline migraine days per month was 16.7 in the overall population, and the mean change from baseline over weeks 1 through 4 was -6.2 days in the Lu AG09222 750-mg group, as compared with -4.2 days in the placebo group (difference, -2.0 days; 95% confidence interval, -3.8 to -0.3; P = 0.02). Adverse events with a higher incidence in the Lu AG09222 750-mg group than in the placebo group during the 12-week observation period included coronavirus disease 2019 (7% vs. 3%), nasopharyngitis (7% vs. 4%), and fatigue (5% vs. 1%). CONCLUSIONS: In a phase 2 trial, a single intravenous infusion of 750 mg of Lu AG09222 showed superiority over placebo in reducing migraine frequency over the subsequent 4 weeks. (Funded by H. Lundbeck; HOPE ClinicalTrials.gov number, NCT05133323.).
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Anticuerpos Monoclonales Humanizados , Trastornos Migrañosos , Polipéptido Hipofisario Activador de la Adenilato-Ciclasa , Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Anticuerpos Monoclonales Humanizados/administración & dosificación , Anticuerpos Monoclonales Humanizados/efectos adversos , Método Doble Ciego , Infusiones Intravenosas , Trastornos Migrañosos/diagnóstico , Trastornos Migrañosos/tratamiento farmacológico , Trastornos Migrañosos/metabolismo , Polipéptido Hipofisario Activador de la Adenilato-Ciclasa/antagonistas & inhibidores , Polipéptido Hipofisario Activador de la Adenilato-Ciclasa/metabolismo , Brote de los SíntomasAsunto(s)
Anticuerpos Monoclonales Humanizados , Trastornos Migrañosos , Polipéptido Hipofisario Activador de la Adenilato-Ciclasa , Humanos , Anticuerpos Monoclonales Humanizados/uso terapéutico , Trastornos Migrañosos/diagnóstico , Trastornos Migrañosos/tratamiento farmacológico , Trastornos Migrañosos/metabolismo , Ensayos Clínicos Controlados Aleatorios como Asunto , Ensayos Clínicos Fase II como Asunto , Estudios Multicéntricos como Asunto , Infusiones Intravenosas , Polipéptido Hipofisario Activador de la Adenilato-Ciclasa/antagonistas & inhibidores , Polipéptido Hipofisario Activador de la Adenilato-Ciclasa/metabolismo , Brote de los SíntomasRESUMEN
BACKGROUND: Oxaliplatin, a major drug in metastatic colorectal cancer (mCRC), is responsible for cumulative, dose-limiting peripheral neuropathy (PN). Whether the hepatic arterial infusion (HAI) route can limit oxaliplatin-induced PN in comparison with the intravenous (IV) route has not been specifically explored so far. METHODS: We compared the frequency and severity of PN in oxaliplatin-naive patients with mCRC included in trials that evaluated treatment with oxaliplatin administered either by HAI (ACCORD 04, CHOICE, OSCAR, and PACHA-01 trials) or by IV route (FFCD 2000-05 trial). We retrieved anonymized, prospectively collected data from trial databases for the ACCORD 04, CHOICE, and FFCD 2000-05 trials and through a review of Gustave Roussy patients' electronic medical records for PACHA-01 and OSCAR trials. The primary endpoint was the incidence of clinically significant PN (grades 2 to 4) according to the cumulative dose of oxaliplatin received. Secondary endpoints were time to onset of neuropathy as a function of the cumulative dose of oxaliplatin, discontinuation of oxaliplatin for neurotoxicity, and safety. RESULTS: A total of 363 patients were included (IV, 300; HAI, 63). In total, 180 patients in the IV group (60%) and 30 patients in the HAI group (48%) developed clinically significant PN, with no significant difference between the two groups (p = 0.23). No difference was shown in the time to onset of PN either (p = 0.23). CONCLUSION: The administration of oxaliplatin HAI rather than IV in the treatment of mCRC does not reduce the incidence, precocity, and severity of PN.
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Antineoplásicos , Neoplasias Colorrectales , Arteria Hepática , Infusiones Intraarteriales , Compuestos Organoplatinos , Oxaliplatino , Enfermedades del Sistema Nervioso Periférico , Humanos , Oxaliplatino/administración & dosificación , Oxaliplatino/efectos adversos , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/patología , Masculino , Femenino , Infusiones Intraarteriales/métodos , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Persona de Mediana Edad , Infusiones Intravenosas , Anciano , Antineoplásicos/efectos adversos , Antineoplásicos/administración & dosificación , Compuestos Organoplatinos/administración & dosificación , Compuestos Organoplatinos/efectos adversos , Adulto , Estudios Prospectivos , Índice de Severidad de la Enfermedad , Metástasis de la Neoplasia , Relación Dosis-Respuesta a DrogaRESUMEN
Background: Available therapeutic options are currently limited by their modest efficacy. As a result, novel pharmacotherapeutic treatments with different mechanisms have recently attracted empirical attention. Magnesium, a divalent cation, is postulated to provide analgesic and anti-nociceptive effect through its action at the N-methyl-D-aspartate (NMDA) receptor. Objective: Considering the evidence surrounding magnesium's potential as a therapeutic modality for chronic pain, we conducted a narrative review on the evidence of magnesium's therapeutic effects in chronic pain. Methods: A review of the PubMed, and Google scholar databases was undertaken in May 2022 to identify completed studies that investigated the effectiveness of magnesium in the treatment of chronic pain from database inception to May 2022. Results: A total of 33 studies were included in the narrative review, out of which 26 were randomized controlled trials. Findings on available studies suggest that intravenous infusion of magnesium is an emerging and promising option that may alleviate pain in some clinical populations. Our narrative synthesis showed that evidence for intravenous magnesium is currently equivocal for a variety of chronic pain syndrome. Findings indicate that evidence for efficacy is poor or equivocal for: CRPS, neuropathic pain, chronic low back pain, and migraine prophylaxis. However, there is good evidence supporting the efficacy of intravenous magnesium for treating renal colic pain and pelvic pain related to endometriosis. Conclusion: Magnesium may be a promising pharmacologic solution for chronic pain. Future investigation is warranted on elucidating the neurobiological mechanisms of magnesium in attenuating pain signaling pathways.
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Dolor Crónico , Magnesio , Humanos , Dolor Crónico/tratamiento farmacológico , Magnesio/administración & dosificación , Analgésicos/administración & dosificación , Analgésicos/farmacología , Ensayos Clínicos Controlados Aleatorios como Asunto , Infusiones Intravenosas , Administración Intravenosa , Receptores de N-Metil-D-Aspartato/antagonistas & inhibidoresRESUMEN
BACKGROUND: During laparoscopic hysterectomy (LH), the elevation of intra-abdominal and intra-thoracic pressures due to pneumoperitoneum (PP) results in an increase in intracranial pressure (ICP). The Trendelenburg position (TP) is an accentuating factor. This trial aimed to assess the effect of intravenous (IV) lidocaine infusion on optic nerve sheath diameter (ONSD), a widely accepted surrogate measure for ICP, during PP and TP. METHODS: A randomized, placebo-controlled study was conducted on 66 patients scheduled for LH, equally divided into a lidocaine group and a saline group. ONSD, the primary outcome, was recorded before induction (T1), before PP initiation in the supine position (T2), five minutes (T3), 30 minutes (T4), and 60 minutes (T5) after PP and TP, and five minutes after termination of PP in the supine position (T6). Secondary outcomes included numerical rating scale (NRS) scores at arrival to the post-anesthesia care unit (PACU), 6, 12, and 24 hours after surgery, and postoperative adverse effects. RESULTS: ONSD at T4 and T5 was significantly lower in the lidocaine group than in the saline group (T4: 4.94±0.43 mm vs. 5.27±0.37 mm; P =0.003, T5: 5.08±0.46 vs. 5.41±0.38 mm; P =0.004). The lidocaine group had significantly lower NRS values than the saline group only at PACU arrival (median [Q1-Q3]: 5 [4-6] vs. 6 [5-6.25]; P =0.016). Fewer patients in the lidocaine group experienced postoperative headache (P =0.029). CONCLUSIONS: IV lidocaine during LH can attenuate the ONSD distension, decrease pain scores at PACU arrival, and reduce the incidence of postoperative headache.
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Anestésicos Locales , Histerectomía , Laparoscopía , Lidocaína , Nervio Óptico , Humanos , Femenino , Lidocaína/administración & dosificación , Persona de Mediana Edad , Nervio Óptico/efectos de los fármacos , Anestésicos Locales/administración & dosificación , Adulto , Infusiones Intravenosas , Inclinación de Cabeza , Método Doble Ciego , Presión Intracraneal/efectos de los fármacosRESUMEN
SOURCE CITATION: Abdul-Aziz MH, Hammond NE, Brett SJ, et al. Prolonged vs intermittent infusions of ß-lactam antibiotics in adults with sepsis or septic shock: a systematic review and meta-analysis. JAMA. 12 June 2024. [Epub ahead of print.] 38864162.
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Antibacterianos , Sepsis , Choque Séptico , beta-Lactamas , Humanos , Antibacterianos/administración & dosificación , Antibacterianos/uso terapéutico , Choque Séptico/tratamiento farmacológico , Choque Séptico/mortalidad , beta-Lactamas/administración & dosificación , beta-Lactamas/uso terapéutico , Sepsis/tratamiento farmacológico , Sepsis/mortalidad , Infusiones Intravenosas , Esquema de Medicación , Antibióticos BetalactámicosRESUMEN
SOURCE CITATION: Dulhunty JM, Brett SJ, De Waele JJ, et al; BLING III Study Investigators. Continuous vs intermittent ß-lactam antibiotic infusions in critically ill patients with sepsis: the BLING III randomized clinical trial. JAMA. 12 June 2024. [Epub ahead of print.] 38864155.
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Antibacterianos , Sepsis , beta-Lactamas , Humanos , Sepsis/tratamiento farmacológico , Sepsis/mortalidad , Antibacterianos/administración & dosificación , Antibacterianos/uso terapéutico , beta-Lactamas/administración & dosificación , beta-Lactamas/uso terapéutico , Infusiones Intravenosas , Enfermedad Crítica/mortalidad , Esquema de Medicación , Persona de Mediana Edad , Masculino , Antibióticos BetalactámicosRESUMEN
OBJECTIVE: The study compared the impact of unfractionated heparin (UFH) administered via two routes (infusion and subcutaneous injection) on heparin-binding protein (HBP) and plasminogen activator inhibitor-1 (PAI-1) levels in critically ill sepsis patients. PATIENTS AND METHODS: Forty critically ill sepsis patients were randomly assigned to receive either a low-dose intravenous infusion of UFH (500 units/hour) or subcutaneous UFH (5,000 units/8 hours) for seven days. HBP and PAI-1 were measured at baseline and on days one, two, and seven. RESULTS: Intravenous administration of UFH showed a significant reduction in percentage change of HBP compared to subcutaneous administration on days one [(-35% vs. -13%, p = 0.03*) (*indicates a significant result *p < 0.05, relative to the subcutaneous group)] and seven (-62% vs. -39%, p = 0.02*). Also, the percentage change of PAI-1 was significantly reduced in the infusion group compared to the subcutaneous group on days one (-28% vs. -3%, p = 0.008*), two (-42% vs. -3%, p = 0.001*), and seven (-62% vs. 27%, p = 0.001*), respectively. Furthermore, a significant improvement in the 14-day survival was observed in the infusion group compared to the subcutaneous group (p = 0.008*). CONCLUSIONS: Intravenous infusion was the route of choice for UFH administration in critically ill septic patients, with a promising effect on HBP, PAI-1, and survival.
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Enfermedad Crítica , Heparina , Inhibidor 1 de Activador Plasminogénico , Sepsis , Humanos , Heparina/administración & dosificación , Infusiones Intravenosas , Sepsis/tratamiento farmacológico , Inyecciones Subcutáneas , Masculino , Femenino , Persona de Mediana Edad , Inhibidor 1 de Activador Plasminogénico/administración & dosificación , Inhibidor 1 de Activador Plasminogénico/metabolismo , Proteínas Sanguíneas/metabolismo , Anciano , Péptidos Catiónicos Antimicrobianos/administración & dosificación , Anticoagulantes/administración & dosificaciónRESUMEN
The aim of this study was to evaluate the efficacy of fast-track cardiac anesthesia using target-controlled infusion of sufentanil and propofol in valve replacement surgery. The clinical data of 88 patients with rheumatic heart disease undergoing valve replacement surgery were retrospectively analyzed and grouped based on different treatment methods. Among them, 44 cases received fast-track cardiac anesthesia using target-controlled infusion of fentanyl and propofol from November 2019 to July 2021 were set as the control group, and 44 cases received fast-track cardiac anesthesia using target-controlled infusion of sufentanil and propofol from August 2021 to February 2022 were set as the study group. The study group showed shorter postoperative awakening time, extubation time, and hospital stay duration, and lower dosage of dopamine and nitroglycerin consumption compared to the control group (Pâ <â .05). At T5 and T6, both groups exhibited higher ACTH, cortisol (Cor), and C3a than at T0, and the study group showed significantly lower ACTH, Cor, and C3a at T5 and T6 than the control group (Pâ <â .05). At T7, the control group showed higher ACTH, Cor, and C3a than at T0, and ACTH, Cor, and C3a were significantly lower in the study group than in the control group at T7 (Pâ <â .05). Fast-track cardiac anesthesia using target-controlled infusion of sufentanil and propofol in valve replacement surgery has demonstrated favorable application effects, which stabilizes hemodynamics, alleviates myocardial damage, suppresses endocrine stress responses, and does not increase adverse reactions, thereby exhibiting good safety.
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Anestésicos Intravenosos , Implantación de Prótesis de Válvulas Cardíacas , Propofol , Sufentanilo , Humanos , Sufentanilo/administración & dosificación , Propofol/administración & dosificación , Masculino , Femenino , Estudios Retrospectivos , Anestésicos Intravenosos/administración & dosificación , Persona de Mediana Edad , Implantación de Prótesis de Válvulas Cardíacas/métodos , Adulto , Cardiopatía Reumática/cirugía , Anestesia en Procedimientos Quirúrgicos Cardíacos/métodos , Tiempo de Internación/estadística & datos numéricos , Infusiones Intravenosas , Periodo de Recuperación de la AnestesiaAsunto(s)
Inmunoglobulinas Intravenosas , Síndrome Mucocutáneo Linfonodular , Síndrome Mucocutáneo Linfonodular/tratamiento farmacológico , Humanos , Inmunoglobulinas Intravenosas/administración & dosificación , Inmunoglobulinas Intravenosas/uso terapéutico , Infusiones Intravenosas , Factores Inmunológicos/uso terapéutico , Factores Inmunológicos/administración & dosificaciónRESUMEN
OBJECTIVES: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the relative effectiveness and vascular access device (VAD)-related complications of VADs in people requiring prolonged systemic anti-cancer treatment.
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Antineoplásicos , Neoplasias , Dispositivos de Acceso Vascular , Humanos , Neoplasias/tratamiento farmacológico , Dispositivos de Acceso Vascular/efectos adversos , Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Infusiones Intravenosas/instrumentaciónAsunto(s)
Antifúngicos , Nitrilos , Piridinas , Triazoles , Humanos , Triazoles/farmacocinética , Triazoles/administración & dosificación , Antifúngicos/farmacocinética , Antifúngicos/administración & dosificación , Piridinas/farmacocinética , Piridinas/administración & dosificación , Nitrilos/farmacocinética , Nitrilos/administración & dosificación , Infusiones Intravenosas , Enfermedades Pulmonares Fúngicas/tratamiento farmacológico , Voluntarios SanosRESUMEN
Background Intravenous prostate-specific membrane antigen (PSMA)-targeted radioligand therapy improves survival in men with metastatic castration-resistant prostate cancer. Yet, the impact of selective prostatic arterial administration on primary tumor uptake is unclear. Purpose To compare gallium 68 (68Ga)-PSMA-11 uptake using dynamic PET/CT in prostatic tumoral volumes of interest (VOIs) during intravenous and selective prostatic arterial infusions for individuals with untreated, high-risk prostate cancer. Materials and Methods In this prospective, intraindividual comparative study conducted at an academic medical center, five men aged 58, 61, 64, 66, and 68 years with treatment-naive prostate cancer were enrolled between January 2022 and February 2023 and underwent two dynamic 68Ga-PSMA-11 PET/CT examinations 1 week apart. During the first examination, the radiotracer was administered intravenously. During the second administration, the radiotracer was delivered into either the right or left prostatic artery through an angiographically placed microcatheter. The primary outcome was maximum standardized uptake value (SUVmax) in prostatic tumoral VOIs. The secondary outcomes included mean SUV (SUVmean) in prostatic tumoral VOIs and area under the SUVmean curves (AUC). Longitudinal mixed-effects models were used to compare dynamic SUVmax and SUVmean time-activity curves (TACs), and paired t tests were used for the remaining data. Results The mean SUVmax within tumoral VOIs was 14 (range, 3-43) for venous sessions and 938 (range, 460-1436) for arterial sessions (P = .008). The SUVmean within VOIs was greater during arterial sessions (P < .001) overall and 46-fold and 19-fold greater at peak uptake and final time points, respectively. The mean AUC was greater on arterial TACs than on venous TACs at 14600 SUV × min (range, 8353-20025 SUV × min) and 240 SUV × min (range, 69-622 SUV × min), respectively (P = .002). Conclusion Selective prostatic arterial infusion resulted in greater 68Ga-PSMA-11 tumoral SUV than intravenous infusion. Further study of local-regional, intra-arterial delivery of a PSMA-targeted theranostic agent is warranted in high-risk prostate cancer. ClinicalTrials.gov identifier: NCT04976257 © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Civelek in this issue.
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Radioisótopos de Galio , Tomografía Computarizada por Tomografía de Emisión de Positrones , Neoplasias de la Próstata , Humanos , Masculino , Tomografía Computarizada por Tomografía de Emisión de Positrones/métodos , Anciano , Estudios Prospectivos , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/metabolismo , Persona de Mediana Edad , Radioisótopos de Galio/farmacocinética , Próstata/diagnóstico por imagen , Próstata/irrigación sanguínea , Isótopos de Galio , Radiofármacos/farmacocinética , Infusiones Intravenosas , Adenocarcinoma/diagnóstico por imagen , Adenocarcinoma/metabolismoRESUMEN
There is insufficient evidence to guide dose and frequency optimization with repeated-dose ketamine for depression. This study assessed the value of symptomatic non-improvement after the first few ketamine infusions as a predictor of overall non-response in depression for early decision-making to discontinue treatment. A total of 135 individuals with major depressive disorder or bipolar disorder experiencing a current major depressive episode were administered six repeated doses of intravenous ketamine. Depressive symptoms were assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline, 4 h after the first infusion, and 24 h after each infusion. Improvement, partial response, and response were defined as a reduction rate of ≥ 20%, 30%, and 50% in MADRS scores, respectively. This study examined the relationship between improvement (as opposed to non-improvement after each infusion or consecutive non-improvements after the first few infusions) and partial response and response after the sixth infusion. This analysis was summarized using sensitivity, specificity, and other diagnostic test parameters. The sensitivities of improvement at 24 h post-infusion 4 and improvement at 24 h post-infusion 3, vs. three consecutive non-improvements, as predictors for overall partial response and response exceeded 90%. No significant reduction in depressive symptoms was seen in non-improvers following the remaining infusions after the above-identified point. Our study suggests that non-improvement after four infusions, or more conservatively three consecutive non-improvements after three infusions, could serve as a signal of overall non-response to repeated-dose intravenous ketamine for depression and that subsequent treatments would not be warranted.
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Trastorno Bipolar , Trastorno Depresivo Mayor , Ketamina , Humanos , Ketamina/administración & dosificación , Trastorno Bipolar/tratamiento farmacológico , Femenino , Masculino , Adulto , Trastorno Depresivo Mayor/tratamiento farmacológico , Persona de Mediana Edad , Infusiones Intravenosas , Escalas de Valoración Psiquiátrica , Resultado del Tratamiento , Antidepresivos/administración & dosificación , Antidepresivos/uso terapéuticoRESUMEN
N-chlorotaurine (NCT) is a broad-spectrum antimicrobial agent with outstanding tolerability, effective for topical and inhalation use. This paper presents the results of studies of single and repeated intravenous infusions of NCT to laboratory animals. The studies were conducted on female Wistar Han rats. The effect of NCT infusions on the general condition, behavioral reactions, main biochemical and hematological parameters, hemocoagulation system, cardiovascular system, and on the condition of the internal organs was studied. It was found that NCT infusions do not reveal deviations in the studied parameters that could indicate a toxic effect. The estimated LD50 is more than 80 mg/kg. In a subchronic experiment, a statistically significant decrease in cholesterol (by up to 11%), glucose (by up to 15%) and excess bases (up to four times) in the blood, and an increase in heart rate (by up to 31%) and frequency of defecations (by up to 35%), as well as pronounced antiplatelet effect, were found. In animals with simulated endotoxicosis, a decrease in the cytolysis and oxidative stress markers was observed. Such effects are caused by both chlorine-active compounds and taurine.The results obtained indicate broad prospects for the use of NCT solutions as an infusion detoxifying agent.