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BACKGROUND: Platinum-based doublet chemotherapy is commonly used in the treatment of non-small cell lung cancer (NSCLC). A growing body of evidence indicates that incorporating antiangiogenic agents into platinum-based chemotherapy may enhance the survival outcomes for NSCLC patients. However, the optimal administration protocol for intravenous recombinant human endostatin (rh-endostatin), an antiangiogenic agent, remains uncertain at present. AIM: This study aims to investigate the efficacy and safety of 5-d continuous intravenous infusion of rh-endostatin in combination with chemotherapy for patients with advanced NSCLC. The predictive biomarkers for this treatment regimen were further probed. METHODS: This prospective, single-arm multicenter study enrolled a total of 48 patients with advanced NSCLC who were histologically or cytologically confirmed but had not received any prior treatment from January 2021 to December 2022. Prior to the chemotherapy, these patients received a continuous intravenous infusion of rh-endostatin (210 mg) over a period of 120 h, using an infusion pump. The chemotherapy regimen included a combination of platinum with either pemetrexed or paclitaxel, given in 21-day cycles. The primary endpoint of the study was median progression-free survival (mPFS), and the secondary endpoints included median overall survival (mOS), objective response rate (ORR), disease control rate (DCR), and assessment of adverse events (AEs). RESULTS: The mPFS was 6.5 months (95% confidence interval (CI): 3.8-9.1 m) while the mOS was 12.3 months (95% CI: 7.6-18.5 m). The ORR and DCR was 52.1% and 75.0%, respectively. Leukopenia (52.1%), anemia (33.3%), and thrombocytopenia (20.8%) were the most common adverse effects and these toxicities were deemed acceptable and manageable. In addition, a correlation was noted between elevated serum carcinoembryonic antigen (CEA) levels and decreased PFS and OS. CONCLUSIONS: The incorporation of a 5-day continuous intravenous infusion of rh-endostatin into platinum-based doublet chemotherapy has demonstrated both safety and efficacy in the treatment of advanced NSCLC. Furthermore, the baseline serum levels of CEA may potentially function as a predictor for the efficacy of rh-endostatin when combined with chemotherapy in NSCLC patients. CLINICALTRIALS: GOV: NCT05574998.
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Protocolos de Quimioterapia Combinada Antineoplásica , Carcinoma de Pulmón de Células no Pequeñas , Endostatinas , Neoplasias Pulmonares , Paclitaxel , Pemetrexed , Proteínas Recombinantes , Humanos , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Endostatinas/administración & dosificación , Endostatinas/efectos adversos , Endostatinas/uso terapéutico , Femenino , Masculino , Neoplasias Pulmonares/tratamiento farmacológico , Persona de Mediana Edad , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Anciano , Infusiones Intravenosas , Proteínas Recombinantes/administración & dosificación , Proteínas Recombinantes/efectos adversos , Proteínas Recombinantes/uso terapéutico , Estudios Prospectivos , Paclitaxel/administración & dosificación , Paclitaxel/efectos adversos , Paclitaxel/uso terapéutico , Pemetrexed/administración & dosificación , Pemetrexed/efectos adversos , Pemetrexed/uso terapéutico , Adulto , Supervivencia sin ProgresiónRESUMEN
BACKGROUND: Evidence for the management of moderate-to-severe postpartum anemia is limited. A randomized trial is needed; recruitment may be challenging. STUDY DESIGN AND METHODS: Randomized pilot trial with feasibility surveys. INCLUSION: hemoglobin 65-79 g/L, ≤7 days of birth, hemodynamically stable. EXCLUSION: ongoing heavy bleeding; already received, or contraindication to intravenous (IV)-iron or red blood cell transfusion (RBC-T). Intervention/control: IV-iron; RBC-T; or IV-iron and RBC-T. PRIMARY OUTCOME: number of recruits; proportion of those approached; proportion considered potentially eligible. SECONDARY OUTCOMES: fatigue, depression, baby-feeding, and hemoglobin at 1, 6 and 12 weeks; ferritin at 6 and 12 weeks. Surveys explored attitudes to trial participation. RESULTS: Over 16 weeks and three sites, 26/34 (76%) women approached consented to trial participation, including eight (31%) Maori women. Of those potentially eligible, 26/167 (15.6%) consented to participate. Key participation enablers were altruism and study relevance. For clinicians and stakeholders the availability of research assistance was the key barrier/enabler. Between-group rates of fatigue and depression were similar. Although underpowered to address secondary outcomes, IV-iron and RBC-T compared with RBC-T were associated with higher hemoglobin concentrations at 6 (mean difference [MD] 11.7 g/L, 95% confidence interval [CI] 2.7-20.7) and 12 (MD 12.8 g/L, 95% CI 1.5-24.2) weeks, and higher ferritin concentrations at 6 weeks (MD 136.8 mcg/L, 95% CI 76.6-196.9). DISCUSSION: Willingness to participate supports feasibility for a future trial assessing the effectiveness of IV-iron and RBC-T for postpartum anemia. Dedicated research assistance will be critical to the success of an appropriately powered trial including women-centered outcomes.
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Anemia , Transfusión de Eritrocitos , Hematínicos , Periodo Posparto , Femenino , Humanos , Anemia/terapia , Fatiga/etiología , Estudios de Factibilidad , Compuestos Férricos , Ferritinas , Hematínicos/uso terapéutico , Hemoglobinas , Hierro/uso terapéutico , Proyectos PilotoRESUMEN
BACKGROUND: The implementation of antibiotic intravenous-to-oral switch (IVOS) therapy in hospitals can slow down the development of drug resistance, reduce the occurrence of adverse reactions, and bring significant economic benefits. The aim of this study is to investigate the understanding of physicians at the Second Affiliated Hospital of Soochow University in Suzhou, China towards the antibiotic IVOS therapy. METHODS: 15 physicians working in 9 different departments of the Second Affiliated Hospital of Soochow University participated in this study. A semi-structured face-to-face interview was conducted to collect interview information about the antibiotic IVOS therapy. NVivo12 software was used to organize the entire interview content, and the interview data was analyzed and summarized using the Colaizzi seven step method. RESULTS: 60% of participants were not familiar with antibiotic IVOS therapy. Barriers of antibiotic IVOS therapy were included by three key issues: (i) Physicians' potential cognition: 'Iv is always better than oral'; (ii) Subjective infusion intention of patients; and (iii) Limitations of drug selection. 60% of participants expressed welcome for pharmacists to help them perform antibiotic IVOS treatment. And electronic recognition technology may be a feasible method for prompting IVOS conversion that recognized by all participants in the interview. Participants also provided some suggestions for pharmacists and IVOS computer reminders. CONCLUSION: Physicians' in China still have insufficient understanding of antibiotic IVOS therapy. The promotion of antibiotic IVOS therapy in China faces many challenges and obstacles. Strategies such as IVOS therapy computer reminders and clinical pharmacists' medication guidance were worth studying to help physicians develop antibiotic IVOS treatment.
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Antibacterianos , Investigación Cualitativa , Humanos , China , Antibacterianos/uso terapéutico , Antibacterianos/administración & dosificación , Masculino , Femenino , Administración Oral , Adulto , Entrevistas como Asunto , Administración Intravenosa , Médicos/psicología , Persona de Mediana Edad , Pautas de la Práctica en Medicina/estadística & datos numéricosRESUMEN
BACKGROUND: We performed an analysis of a large intensive care unit electronic database to provide preliminary estimates of various blood pressure parameters in patients with acute stroke receiving intravenous (IV) antihypertensive medication and determine the relationship with in-hospital outcomes. METHODS: We identified the relationship between pre-treatment and post-treatment systolic blood pressure (SBP) and heart rate (HR)-related variables and in-hospital mortality and acute kidney injury in patients with acute stroke receiving IV clevidipine, nicardipine, or nitroprusside using data provided in the Medical Information Mart for Intensive Care (MIMIC) IV database. RESULTS: A total of 1830 patients were treated with IV clevidipine (n = 64), nicardipine (n = 1623), or nitroprusside (n = 143). The standard deviations [SDs] of pre-treatment SBP (16.3 vs. 13.7, p ≤ 0.001) and post-treatment SBP (15.4 vs. 14.4, p = 0.004) were higher in patients who died compared with those who survived, particularly in patients with intracerebral hemorrhage (ICH). The mean SBP was significantly lower post treatment compared with pre-treatment values for clevidipine (130.7 mm Hg vs. 142.5 mm Hg, p = 0.006), nicardipine (132.8 mm Hg vs. 141.6 mm Hg, p ≤ 0.001), and nitroprusside (126.2 mm Hg vs. 139.6 mm Hg, p ≤ 0.001). There were no differences in mean SDs post treatment compared with pre-treatment values for clevidipine (14.5 vs. 13.5, p = 0.407), nicardipine (14.2 vs. 14.6, p = 0.142), and nitroprusside (14.8 vs. 14.8, p = 0.997). The SDs of pre-treatment and post-treatment SBP were not significantly different in patients with ischemic stroke treated with IV clevidipine, nicardipine, or nitroprusside or for patients with ICH treated with IV clevidipine or nitroprusside. However, patients with ICH treated with IV nicardipine had a significantly higher SD of post-treatment SBP (13.1 vs. 14.2, p = 0.0032). CONCLUSIONS: We found that SBP fluctuations were associated with in-hospital mortality in patients with acute stroke. IV antihypertensive medication reduced SBP but did not reduce SBP fluctuations in this observational study. Our results highlight the need for optimizing therapeutic interventions to reduce SBP fluctuations in patients with acute stroke.
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PURPOSE: To evaluate the effect of intravenous infusion versus intramyometrial injection of oxytocin on hemoglobin levels in neonates with delayed umbilical cord clamping during cesarean section. METHODS: The multi-centre randomized controlled trial was performed at three hospitals from February to June 2023. Women with term singleton gestations scheduled for cesarean delivery were allocated to receive an intravenous infusion of 10 units of oxytocin or a myometrial injection of 10 units of oxytocin during the surgery. The primary outcome was neonatal hemoglobin at 48 to 96 h after birth. Secondary outcomes were side-effects of oxytocin, postpartum haemorrhage, phototherapy for jaundice, feeding at 1 month, maternal and neonatal morbidity and re-admissions. RESULTS: A total of 360 women were randomized (180 women in each group). The mean neonatal hemoglobin did not show a significant difference between the intravenous infusion group (194.3 ± 21.7 g/L) and the intramyometrial groups (195.2 ± 24.3 g/L) (p = 0.715). Secondary neonatal outcomes, involving phototherapy for jaundice, feeding at 1 month and neonatal intensive care unit admission were similar between the two groups. The maternal outcomes did not differ significantly between the two groups, except for a 200 mL higher intraoperative infusion volume observed in the intravenous group compared to the intramyometrial group. CONCLUSION: Among women undergoing elective cesarean delivery of term singleton pregnancies, there was no significant difference in neonatal hemoglobin at 48 to 96 h after birth between infants with delayed cord clamping, whether the oxytocin was administrated by intravenous infusion or intramyometrial injection. TRIAL REGISTRATION: Chinese Clinical trial registry: ChiCTR2300067953 (1 February 2023).
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Cesárea , Hemoglobinas , Oxitócicos , Oxitocina , Clampeo del Cordón Umbilical , Humanos , Femenino , Oxitocina/administración & dosificación , Recién Nacido , Embarazo , Hemoglobinas/análisis , Adulto , Infusiones Intravenosas , Oxitócicos/administración & dosificación , Hemorragia Posparto/prevención & control , Factores de Tiempo , Cordón Umbilical , Inyecciones IntramuscularesRESUMEN
OBJECTIVE: To investigate the compatibility of oxytocin and tranexamic acid injection products when mixed for the purpose of co-administration by intravenous infusion. DESIGN: Compatibility testing. SETTING: Hospitals taking part in a multicentre postpartum haemorrhage treatment (E-MOTIVE) trial in Kenya, Nigeria, Tanzania and South Africa. SAMPLE: Oxytocin and tranexamic acid products. METHODS: The compatibility of two sentinel products of oxytocin injection and tranexamic acid injection in 200-mL infusion bags of both 0.9% w/v saline and Ringer's lactate solution was assessed. We analysed all tranexamic acid-oxytocin combinations, and each evaluation was conducted for up to 3 h. Subsequently, the compatibility of multiple tranexamic acid products with reference oxytocin products when mixed in 0.9% w/v saline over a period of 1 h was investigated. MAIN OUTCOME MEASURES: Concentration of oxytocin over time after mixing with tranexamic acid products. RESULTS: We found significant interaction between certain oxytocin and tranexamic acid products after mixing them in vitro and observing for 1 h. The interaction substantially impacted oxytocin content leading to reduction in concentration (14.8%-29.0%) immediately on mixing (t = 0 min). In some combinations, the concentration continued to decline throughout the stability assessment period. Oxytocin loss was observed in 7 out of 22 (32%) of combinations tested. CONCLUSIONS: In a clinical setting, mixing certain oxytocin and tranexamic acid products before administration may result in an underdosing of oxytocin, compromising care in an emergency life-threatening situation. The mixing of oxytocin and tranexamic acid injection products for co-administration with intravenous infusion fluids should be avoided until the exact nature of the observed interaction and its implications are understood.
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Antifibrinolíticos , Hemorragia Posparto , Ácido Tranexámico , Femenino , Humanos , Oxitocina/uso terapéutico , Hemorragia Posparto/tratamiento farmacológico , Ácido Tranexámico/uso terapéutico , Antifibrinolíticos/uso terapéutico , Infusiones IntravenosasRESUMEN
A woman in her 20s presented to our clinic with a lower gastrointestinal infection. When we administered intravenous antibacterial and vitamin infusions, she developed anaphylaxis. We performed skin tests to investigate the cause, and an intradermal test was positive for a 1% intravenous vitamin complex. We then performed a component-specific test, which was positive for thiamine disulfide phosphate, a vitamin B1 derivative. We therefore diagnosed anaphylaxis due to thiamine disulfide phosphate. No previous reports have described cross-reactivity between vitamin B1 derivatives. In our case, however, the patient tested positive for fluthiamine hydrochloride, suggesting cross-reactivity. Intravenous vitamin complexes are used in daily clinical practice and should be administered with caution because of the possibility of anaphylaxis, although it occurs infrequently.
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Anafilaxia , Humanos , Femenino , Anafilaxia/inducido químicamente , Anafilaxia/tratamiento farmacológico , Inyecciones Intravenosas , Tiamina/uso terapéutico , Tiamina/efectos adversos , Vitaminas/efectos adversos , Tiamina MonofosfatoRESUMEN
Background and Aims: Intravenous nefopam reduces postoperative pain and opioid consumption but can cause infusion-related pain. We aimed to investigate whether lidocaine can effectively reduce this pain. Material and Methods: This prospective, randomized, double-blind, controlled, intrasubject comparison trial included 42 patients (20-60 years) undergoing elective surgery under regional or peripheral anesthesia. In the postanesthesia care unit, two 50 mL syringes containing nefopam (20 mg) diluted in saline (100 mL) were sequentially infused in 15 min into venous catheters in the left and right arms. Patients were randomly assigned to the "left side" or "right side" group based on the arm in which a bolus of 1% lidocaine (2 mL) (study group) was administered before nefopam infusion. Normal saline (2 mL) was administered on the control side. Numerical Rating Scale scores and the incidence of pain (scores > 3) and nausea or vomiting were recorded at 1, 5, 10, and 15 min. Results: The analysis included 42 patients (84 infusions). Compared with the placebo, lidocaine lowered the mean infusion-related pain at 1 (0.07 vs. 2.21, P < 0.001), 5 (2 vs. 4.21, P < 0.001), 10 (2.02 vs. 3.95, P < 0.001), and 15 min (1.62 vs. 3.16, P = 0.003). At 5 min, significantly higher percentages of infusion sites with moderate and higher pain scores (> 3) were observed on the control side (30.95% vs. 14.29%, P = 0.000). Seven patients exhibited nausea or vomiting (16.7%). Conclusion: For the nefopam infusion rate and concentration that we used, a 20 mg lidocaine pretreatment bolus significantly reduces infusion-related pain.
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RRx-001 is a small molecule NLRP3 inflammasome inhibitor with anti-CD47 and antiangiogenic/vascular normalization properties in a Phase 3 clinical trial that has been designated as a drug-device combination by the FDA. In the Phase 1 first-in-man dose escalation clinical trial, where RRx-001 was given by direct intravenous (IV) infusion, the main adverse event was a sterile painful infusion phlebitis (IP). Less pain was experienced when RRx-001 was infused at a slower rate over multiple hours which was impractical on an outpatient basis. In Phase 2, for reasons of convenience and safety, RRx-001 was co-administered with an aliquot of autologous blood from an ex-vivo device called the eLOOP on the premise that RRx-001 binds to hemoglobin on red blood cells (RBCs), making it unavailable to directly interact with venous nociceptors. Phlebitis has the potential to progress to deep venous thrombosis or septic thrombophlebitis or post-thrombotic syndrome in hypercoagulable and immunosuppressed cancer patients. In this 13-week toxicology study of once weekly IV RRx-001 administration to Wistar Han rats followed by a recovery period of 28 days. The main observed toxicity was a significant inflammatory response in the vein wall, consistent with superficial venous thrombosis observed in man. Due to this development, direct IV infusion of RRx-001 is relatively contraindicated in favor of co-administration with autologous blood.
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Inflamasomas , Flebitis , Animales , Azetidinas , Hemoglobinas/metabolismo , Inflamación/inducido químicamente , Proteína con Dominio Pirina 3 de la Familia NLR , Nitrocompuestos , Ratas , Ratas WistarRESUMEN
INTRODUCTION: The objectives of this study were to develop a stability-indicating high performance liquid chromatography (HPLC) assay for benzylpenicillin (BPC) in pharmaceutical fluids, and to investigate the stability of (i) isotonic citrate-buffered BPC solutions at the clinically relevant concentration of 30 mg/mL, and (ii) low concentration citrate-buffered BPC intravenous infusions (5-30 µg/mL). METHODS: The stability of isotonic BPC solutions containing 3.4 or 7.2 mg/mL sodium citrate was compared against contemporary hypertonic solutions. The HPLC assay was shown to be stability-indicating following acidic, alkali, oxidative and elevated temperature stress testing. RESULTS: After 7 d storage at 4 °C and 24 h at 35 °C, the concentrations of isotonic BPC 30 mg/mL solutions containing 3.4 and 7.2 mg/mL sodium citrate were 96% and 95% respectively, compared to day 0. After 3 d at 4 °C and 24 h at room temperature (22 °C), the concentrations of isotonic BPC solutions with 3.4 and 7.2 mg/mL sodium citrate were 99% and 96% respectively, compared to day 0. These data were comparable to the hypertonic solutions and meet pharmacopeial stability requirements. Low concentration BPC infusions showed 0.5% and 2.5% degradation after 24 h storage at 22 °C and 35 °C, respectively. CONCLUSIONS: The isotonic BPC 30 mg/mL formulation is simple to prepare and may offer clinical benefits in settings where hypertonic solutions are problematic. This study provides assurance that high- and low-dose isotonic BPC infusions are stable at room temperature and our findings may be applicable to in vitro studies of BPC.
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Penicilina G , Estabilidad de Medicamentos , Humanos , Soluciones Hipertónicas , Infusiones Intravenosas , Soluciones Isotónicas/química , Citrato de Sodio , TemperaturaRESUMEN
BACKGROUND: Human umbilical cord mesenchymal stem cells (UCMSCs) transplantation is a promising therapy for the treatment of retinitis pigmentosa (RP). However, intravenously infused cells may be blocked in the lung, increasing the risk of vascular obstruction, which needs to be optimized to further improve safety and efficacy. METHODS: We derived small UCMSCs (S-UCMSCs) from filtering UCMSCs with a 10-µm filter, and compared with UCMSCs by flow cytometry, directional differentiation culture and transcriptome sequencing. Then the S-UCMSCs and UCMSCs were intravenously infused in the Royal College Surgeons (RCS) rats to evaluate the safety and the efficacy. RESULTS: The diameter of S-UCMSCs ranged from 5.568 to 17.231 µm, with an average diameter of 8.636 ± 2.256 µm, which was significantly smaller than that of UCMSCs. Flow cytometry, immunofluorescence and transcriptome sequencing demonstrated that the S-UCMSCs and UCMSCs were the same kind of MSCs, and the S-UCMSCs were more proliferative. After the S-UCMSCs and UCMSCs were intravenously infused into the Royal College of Surgeons (RCS) rats at a dose of 1 × 106 cells/rat, the S-UCMSCs blocked in the lungs were significantly fewer and disappeared more quickly than UCMSCs. The b wave of the flash electroretinogram was improved at 7 d, and the retinal outer nuclear layer thickness was thicker at 7 d and 14 d. The expression level of inflammation was inhibited, and the expression level of neurotrophic factors was upregulated in the retina and serum after transplantation. CONCLUSIONS: S-UCMSCs intravenous infusion was safer than UCMSCs and could delay retinal degeneration and protect visual function in RCS rats, which may be a preferable therapeutic approach for RP.
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Trasplante de Células Madre Mesenquimatosas , Células Madre Mesenquimatosas , Degeneración Retiniana , Cirujanos , Animales , Células Cultivadas , Humanos , Infusiones Intravenosas , Ratas , Degeneración Retiniana/terapia , Cordón UmbilicalRESUMEN
BACKGROUND: Thoracoscopic radical pneumonectomy is associated with a high incidence of postoperative chronic pain. Studies on the benefits of lidocaine intravenous infusion during the perioperative period were still controversial in thoracoscopic surgery. METHODS: Sixty-four lung cancer patients scheduled for thoracoscopic radical pneumonectomy were randomly divided into two groups: normal saline group (control group) or lidocaine group. In the lidocaine group, 1.5 mg/kg lidocaine was administered during the anesthesia induction, and 2 mg·kg-1·h-1 lidocaine was continuously intravenous infused until the end of the surgery. After the surgery, a mixture of 2 µg/kg sufentanil and 10 mg/kg lidocaine was continuously intravenous infused by postoperative patient-controlled intravenous analgesia pump (100 ml). In the control group, the same volume of normal saline was administered according to the calculation of lidocaine during anesthesia induction, maintenance and postoperative patient-controlled intravenous analgesia. The primary outcome was the incidence of chronic postoperative pain at 3 months after the surgery. The secondary outcomes include the incidence of chronic postoperative pain at 6 months after the surgery; the effect of lidocaine on postoperative pain within the first 24 and 48 h; total amount of sufentanil administered during entire procedure and the number of PCA triggers within 48 h after surgery. RESULTS: Compared with the control group, the incidence of chronic pain at 3 months after the surgery was significantly lower (13 cases, 46.4% vs. 6 cases, 20.7%, p < 0.05), but no significant difference at 6 months between two group. The cumulative dosage of sufentanil in perioperative period was significantly lower (149.64 ± 18.20 µg vs. 139.47 ± 16.75 µg) (p < 0.05), and the number of PCA triggers (8.21 ± 4.37 vs. 5.83 ± 4.12, p < 0.05) was significantly greater in the control group. The NRS pain scores at 24 h (1.68 ± 0.72 vs. 1.90 ± 0.86) and 48 h (1.21 ± 0.42 vs. 1.20 ± 0.41) after the operation were no significant difference. CONCLUSION: Perioperative infusion lidocaine significantly reduced the number of PCA triggers and the incidence of chronic postoperative pain at 3 months after the thoracoscopic radical pneumonectomy. TRIAL REGISTRATION: http://www.chictr.org.cn : ChiCTR1900024759, frist registration date 26/07/2019.
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Dolor Crónico , Lidocaína , Analgésicos Opioides , Anestésicos Locales , Dolor Crónico/complicaciones , Dolor Crónico/epidemiología , Dolor Crónico/prevención & control , Método Doble Ciego , Humanos , Dolor Postoperatorio/etiología , Dolor Postoperatorio/prevención & control , Neumonectomía/efectos adversos , Estudios Prospectivos , Solución Salina , SufentaniloRESUMEN
OBJECTIVES: To compare the effects of programmed intermittent bolus infusion (PIBI), continuous thoracic paravertebral infusion (CTPI), and continuous intravenous infusion (CII) on postoperative analgesia in patients undergoing video-assisted thoracoscopic surgery (VATS). DESIGN: Prospective, randomized, controlled. SETTING: The operating room, post-anesthesia care unit, and patient ward of a university hospital. PARTICIPANTS: Ninety patients with American Society of Anesthesiologists (ASA) physical status Ι to II, aged 35-70 years, and scheduled for VATS. INTERVENTIONS: Postoperative analgesia was randomized to PIBI, CTPI, and CII. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the numeric rating scale (NRS) score at rest and during coughing at 1, 4, 24, and 48 hours after surgery. The secondary outcomes included the actual and effective numbers of patient-controlled analgesia (PCA), ropivacaine use, Ramsay sedation scale score, quality of recovery-15 (QoR-15) score, values of hemodynamic parameters at different periods, intraoperative consumption of anesthetic drugs, and postoperative adverse events. Postoperatively, the NRS score was reduced in the PIBI group compared with the CTPI and CII groups at rest and during coughing (p < 0.05). The number of PCAs was significantly lower in the PIBI group compared with the CTPI and CII groups (p < 0.05). The QoR-15 score noticeably increased in the PIBI group compared with the CTPI and CII groups (p = 0.001 and p = 0.000, respectively). CONCLUSIONS: PIBI outperformed CTPI and CII in inducing analgesia for postoperative pain in patients undergoing VATS.
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Analgésicos Opioides , Cirugía Torácica Asistida por Video , Analgesia Controlada por el Paciente , Analgésicos Opioides/uso terapéutico , Humanos , Dolor Postoperatorio/diagnóstico , Dolor Postoperatorio/etiología , Dolor Postoperatorio/prevención & control , Estudios Prospectivos , Cirugía Torácica Asistida por Video/efectos adversosRESUMEN
Real-time monitoring of drug delivery in an intravenous infusion system can prevent injury caused by improper drug doses. As the medicine must be administered into the vein at different rates and doses in different people, an ideal intravenous infusion system requires both a low flow rate and large dynamic range monitoring. In this study, a bio-inspired and micromachined volumetric flow sensor is presented for the biomedical application of an intravenous system. This was realized by integrating two sensing units with different sensitivities on one silicon die to achieve a large dynamic range of the volumetric flow rate. The sensor was coated with a parylene layer for waterproofing and biocompatibility purposes. A new packaging scheme incorporating a silicon die into a flow channel was employed to demonstrate the working prototype. The test results indicate that the sensor can detect a volumetric flow rate as low as 2 mL/h, and its dynamic range is from 2 mL/h to 200 mL/h. The sensor performed better than the other two commercial sensors for low-flow detection. The high sensitivity, low cost, and small size of this flow sensor make it promising for intravenous applications.
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Silicio , HumanosRESUMEN
OBJECTIVE: To identify and analyse topical treatments for peripheral venous catheter (PVC)-related phlebitis. DESIGN: The methodological framework used to make this scoping review was developed by Arksey and O'Malley (2005; (International Journal of Social Research Methodology, 8, 2005 and 19)). DATA SOURCES: A literature search was performed in various databases such as PubMed, Scopus, CINAHL, Cochrane, Cuiden, Web of Science, WorldWideScience and Joanna Briggs. Additionally, articles from informal sources were incorporated. REVIEW METHODS: A search and selection were made of experimental, quasi-experimental and pre-experimental studies published between January 2015 and September 2020 that consider the use of topical products for the treatment of hospital in-patients with PVC-related phlebitis. Appraisal of the methodological quality of the study was performed independently by pairs of reviewers on the basis of the Cochrane Collaboration tool. The review was based on the guidelines in the PRISMA-ScR statement. RESULTS: Twenty-two articles were selected (8 randomised controlled trials (RCTs), 12 quasi-RCTs and 2 pre-experimental studies) which considered treatments applied to a total of 2042 adult patients. The topical treatments described were classified into physical measures and phytotherapeutic and pharmacological treatments. The physical measures are easy to apply, but their effectiveness is limited. The main limitation of the phytotherapeutic treatments is their marketing and use in eastern culture. The best performing pharmacological treatment is the application of magnesium sulphate either with or without glycerine. These products can be presented in different pharmaceutical formulas: ointment, solution and oil. CONCLUSIONS AND RELEVANCE TO CLINICAL PRACTICE: The evidence currently available on this issue is limited and often of dubious methodological rigour. Further studies are required on the treatment and follow-up of intravenous therapy-related phlebitis in different national and international contexts.
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Flebitis , Administración Tópica , Adulto , Catéteres , Humanos , Flebitis/etiologíaRESUMEN
AIMS AND OBJECTIVES: To describe the outcomes of midclavicular catheters related to first insertion success rate, catheter dwell time, rate of catheter survival until the end of the treatment, and complication rates, as well as identify risk factors associated with early catheter removal. BACKGROUND: Midclavicular catheters are peripheral venous catheters that are typically 20-25 cm in length. DESIGN: Inception cohort study. METHODS: We included all the midclavicular lines inserted in patients who met any of the following criteria: (a) difficult venous access; (b) administration of intravenous therapy expected to last between 6 and 30 days with non-irritant (pH=5-9) and/or non-vesicant drugs; or (c) contraindications to central venous catheter placement. The incidence of adverse events was calculated using percentages and episodes per 1,000 catheter days. Univariate and multivariate logistic regression analyses were performed to identify significant risk factors for unexpected catheter removal by calculating odds ratios. Catheter survival was assessed using Cox regression analysis. The STROBE guidelines were followed. RESULTS: Overall, 2,275 midclavicular lines were placed in 1,841 participants. The insertion success rate was 99.4% and the mean catheter dwell time was 21.82 days. The rate of adverse events was .7 per 1,000 catheter days, the most common complications being thrombosis (.39) and catheter-associated bacteraemia (.14). No significant association was found between adverse events and the administration of irritant drugs. The incidence of unexpected removal was 6.7 per 1,000 catheter days. The multivariate analysis showed that both age ≤70 years and home therapy were associated with a lower likelihood of catheter failure. CONCLUSIONS: Midclavicular catheters are associated with a high rate of insertion success and low rates of adverse events and unplanned removal. RELEVANCE TO CLINICAL PRACTICE: Midclavicular lines are a safe alternative for intravenous therapy lasting more than 6 days, even with irritant drugs.
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Infecciones Relacionadas con Catéteres , Cateterismo Venoso Central , Cateterismo Periférico , Catéteres Venosos Centrales , Anciano , Infecciones Relacionadas con Catéteres/etiología , Cateterismo Venoso Central/efectos adversos , Cateterismo Periférico/efectos adversos , Catéteres , Catéteres de Permanencia/efectos adversos , Estudios de Cohortes , Remoción de Dispositivos , Humanos , Estudios RetrospectivosRESUMEN
OBJECTIVES: Report on the practices of prescribing continuous infusion of heparin sodium by syringe pump in our hospital and shed qualitative light on the protocols used in other French hospitals. METHODS: We interviewed prescribers about the protocol they were using through the computerized provider order entry system. At the same time, we asked hospital pharmacists, particularly through a social network, whether in their hospital one or more protocols were used and which ones. RESULTS: In all, 81 prescribers responded to our request: 22 indicated prescribing the 25,000IU/50mL protocol, 7 the 20,000IU/48mL protocol, 2 the 25,000IU/48mL protocol and 14 indicated that they had no preference for one of them. Ten responded that they did not prescribe any protocols and 26 left the question unanswered. The responses of 42 pharmacists practicing in other establishments allowed us to identify 16 different protocols. Of these 42 establishments, 10 had at least two protocols. CONCLUSIONS: Several protocols for the administration by continuous infusion of heparin sodium with a syringe pump can coexist within a hospital. This diversity is confusing and puts patients and caregivers at risk of medication errors. Among all these protocols, it is not known whether some are riskier than others and research to clarify this unknown is warranted. Defining a national standard concentration of heparin and bringing to the market ready-to-administer solutions are measures to be promoted in order to reduce the risk of errors.
Asunto(s)
Sistemas de Entrada de Órdenes Médicas , Jeringas , Humanos , Heparina , Errores de Medicación/prevención & control , FarmacéuticosRESUMEN
INTRODUCTION: In patients with haemophilia A undergoing surgery, factor VIII (FVIII) replacement therapy by continuous infusion (CI) may offer an alternative to bolus infusion (BI). AIM: To compare the perioperative haemostatic efficacy and safety of antihaemophilic factor (recombinant) (ADVATE® ; Baxalta US Inc., a Takeda company, Lexington, MA, USA) CI or BI administration. METHODS: In this multicentre, phase III/IV, controlled study (NCT00357656), 60 previously treated adult patients with severe or moderately severe disease undergoing elective unilateral major orthopaedic surgery (knee replacement, n = 48; hip surgery, n = 4; other, n = 8) requiring drain placement were randomized to receive antihaemophilic factor (recombinant) CI (n = 29) or BI (n = 31) through postoperative day 7. Primary outcome measure was cumulative packed red blood cell (PRBC)/blood volume in the drainage fluid within 24 h after surgery, used to establish non-inferiority of CI to BI. RESULTS: CI:BI ratio of cumulative PRBC volume in the 24-h drainage fluid was 0.92 (p-value <.001 for non-inferiority; 95% confidence interval, 0.82-1.05). Total antihaemophilic factor (recombinant) dose per kg body weight received in the combined trans- and postoperative periods was similar with CI and BI to maintain targeted FVIII levels during/after surgery. Treatment-related adverse events (AEs) were reported in five patients treated by CI (eight events) and five treated by BI (six events), including two serious AEs in each arm. CONCLUSION: CI administration of antihaemophilic factor (recombinant) is a viable alternative to BI in patients with haemophilia A undergoing major orthopaedic surgery, providing comparable efficacy and safety.
Asunto(s)
Hemofilia A , Procedimientos Ortopédicos , Adulto , Pruebas de Coagulación Sanguínea , Factor VIII/uso terapéutico , Hemofilia A/tratamiento farmacológico , Hemofilia A/cirugía , Hemostasis , Humanos , Proteínas RecombinantesRESUMEN
BACKGROUND: The concept that upper extremities can be used as an infusion route during cardiopulmonary resuscitation in pregnant women is a reasonable recommendation considering the characteristic circulation of pregnant women; however, this method is not based on scientific evidence. OBJECTIVE OF THE REVIEW: We conducted a scoping review to determine whether the infusion route should be established above the diaphragm during cardiopulmonary resuscitation in a pregnant woman. DISCUSSION: We included randomized controlled trials (RCTs) and non-RCTs on the infusion of fluids in pregnant women after 20 weeks of gestation requiring establishment of an infusion route due to cardiac arrest, massive bleeding, intra-abdominal bleeding, cesarean section, severe infection, or thrombosis. In total, 3150 articles from electronic database were extracted, respectively. After title and abstract review, 265 articles were extracted, and 116 articles were extracted by full-text screening, which were included in the final analysis. The 116 articles included 78 studies on infusion for pregnant women. The location of the intravenous infusion route could be confirmed in only 17 studies, all of which used the upper extremity to secure the venous route. CONCLUSION: Pregnant women undergo significant physiological changes that differ from those of normal adults, because of pressure and drainage of the inferior vena cava and pelvic veins by the enlarged uterus. Therefore, despite a lack of evidence, it seems logical to secure the infusion route above the diaphragm when resuscitating a pregnant woman.
Asunto(s)
Cesárea , Adulto , Femenino , Humanos , Infusiones Intravenosas , EmbarazoRESUMEN
BACKGROUND: The extravasation of potassium chloride will cause serious harm, especially if it is not diagnosed or treated promptly. Objective:to report the clinical course of a patient who was suffering a potassium extravasation and to discuss steps that can be done to decrease the chances of this event from occurring in other patients. METHODS: After discontinuation of infusion device and withdrawal of intravenous catheter, wet packing with magnesium sulfate and local injection of papaverine and lidocaine were applied. RESULTS: After 11 days, the extravasation injury had recovered. CONCLUSIONS: To avoid a repeat of such an adverse event, proper sites for administering, accurate dilution of potassium chloride solutions, close observation, and increased awareness of trained personnel of extravasation dangers are vital. Once extravasation occurs, timely wet application with magnesium sulfate and local injection of papaverine and lidocaine may have been useful in producing a favorable recovery.