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1.
Eur J Pharm Biopharm ; : 114391, 2024 Jul 02.
Article in English | MEDLINE | ID: mdl-38964521

ABSTRACT

BACKGROUND: Sick neonates with haemodynamic instability often require complex medication regimens, which may result in the connection of a catecholamine infusion distally. This increases the dead volume of the infusion system, extending the time to medication delivery. This study evaluated the effects of body weight, and infusion connection point on the delivery rate of two medications infused through a multi-infusion system at infusion rates suitable for extremely and very low birth weight (ELBW and VLBW) neonates. METHODS: An infusion system consisting of six infusions was used to investigate time to delivery, drug concentration at time to delivery and quantity of adrenaline and dopamine administered by intravenous infusions at infusion rates suitable for premature neonates. RESULTS: In an ELBW neonate model, the measured adrenaline and dopamine concentration at 12 T was higher than expected (66.7 (7.5)% (mean (SD)) and 68.0 (4.4)%, respectively, P < 0.001). At the calculated time to delivery, neither drug reached target concentration. In a VLBW neonate model, the measured adrenaline and dopamine concentration at 12 T was higher than expected (92.2 (7.1)% and 97.1 (3.1)%, respectively, P < 0.001). Adrenaline reached target concentration at 27 (11) min and dopamine at 56 (12) min, times significantly shorter than calculated. The measured quantity of adrenaline and dopamine delivered was lower (P < 0.001) than calculated in all tested combinations except adrenaline at proximal connection (97.2 (3.4)%, P = 0.097) in the VLBW neonate model CONCLUSIONS: Using the most proximal available infusion connection considerably improves drug delivery times and drug doses delivered, which is critical during the administration of short-acting cardiovascular medications.

3.
Nurs Stand ; 2024 Jun 20.
Article in English | MEDLINE | ID: mdl-38898723

ABSTRACT

RATIONALE AND KEY POINTS: This article explains how to prepare and administer an intravenous (IV) infusion using a gravity administration (giving) set or a volumetric pump in a safe, effective manner. Nurses undertaking this procedure must ensure they have the knowledge and skills to do so and work within the limits of their competence. This article serves as a revision of best practice in administering IV infusions of fluids and medicines. • IV infusions are delivered directly into the bloodstream, so care must be taken to protect the patient from harm by following the appropriate policies and protocols and monitoring the patient carefully for adverse reactions. • There is a risk of administering large volumes of IV fluid to the patient when using a gravity administration set, so a burette or volumetric pump should be used in patients who may not tolerate this. • Volumetric pumps vary, so it is essential that the nurse is familiar with the device, uses the specific administration set required and follows the manufacturer's instructions. REFLECTIVE ACTIVITY: 'How to' articles can help to update your practice and ensure it remains evidence-based. Apply this article to your practice. Reflect on and write a short account of: • How this article might improve your practice when preparing and administering an IV infusion. • How you could use this information to educate nursing students or your colleagues on the appropriate methods for preparing and administering an IV infusion.

4.
Rheumatol Ther ; 2024 Jun 09.
Article in English | MEDLINE | ID: mdl-38853228

ABSTRACT

INTRODUCTION: Interleukin-17A (IL-17A) plays a crucial role in the pathogenesis of ankylosing spondylitis (AS), although not all patients respond to traditional IL-17A antibody treatments. QX002N injection, as a new monoclonal antibody targeting IL-17A, has shown potential in treating AS, offering a new treatment option for patients who do not respond well to existing therapies. METHODS: A randomized, open, parallel, single-center, phase I study was conducted to assess the pharmacokinetics, safety, and immunogenicity of single doses of QX002N injection administered intravenously (IV) or subcutaneously (SC) to healthy Chinese volunteers. Blood samples were collected at specified time intervals, and then serum concentrations of QX002N were analyzed by enzyme-linked immunosorbent assay. RESULTS: Pharmacokinetic analysis of the drug concentration-time data showed that the mean maximum observed serum QX002N concentration (Cmax) was 110 and 33.9 µg/ml, respectively. The average area under the drug concentration-time curves from 0 to the time of the last quantifiable concentration (AUClast) were 52,656 and 36,269 µg·h/ml, respectively and the average area under the drug concentration-time curves from 0 to infinity (AUCinf) were 54,867 and 38,194 µg·h/ml, respectively. The absolute bioavailability of QX002N after SC injection was 69.6%. CONCLUSIONS: Immunogenicity was assessed and all the subjects in this study were Anti-drug antibody (ADA)-negative, which means no subjects appeared to develop immunogenicity to QX002N. All the results testify to the safety of QX002N injection, which is satisfactory after IV or SC dosing in healthy subjects. TRIAL REGISTRATION: www.chinadrugtirals.org.cn , CTR20220430.

5.
Arch Gynecol Obstet ; 2024 May 16.
Article in English | MEDLINE | ID: mdl-38753205

ABSTRACT

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).

6.
BMC Health Serv Res ; 24(1): 686, 2024 May 30.
Article in English | MEDLINE | ID: mdl-38816777

ABSTRACT

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.


Subject(s)
Anti-Bacterial Agents , Qualitative Research , Humans , China , Anti-Bacterial Agents/therapeutic use , Anti-Bacterial Agents/administration & dosage , Male , Female , Administration, Oral , Adult , Interviews as Topic , Administration, Intravenous , Physicians/psychology , Middle Aged , Practice Patterns, Physicians'/statistics & numerical data
7.
Invest New Drugs ; 42(3): 309-317, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38700579

ABSTRACT

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.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Carcinoma, Non-Small-Cell Lung , Endostatins , Lung Neoplasms , Paclitaxel , Pemetrexed , Recombinant Proteins , Humans , Carcinoma, Non-Small-Cell Lung/drug therapy , Endostatins/administration & dosage , Endostatins/adverse effects , Endostatins/therapeutic use , Female , Male , Lung Neoplasms/drug therapy , Middle Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Aged , Infusions, Intravenous , Recombinant Proteins/administration & dosage , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use , Prospective Studies , Paclitaxel/administration & dosage , Paclitaxel/adverse effects , Paclitaxel/therapeutic use , Pemetrexed/administration & dosage , Pemetrexed/adverse effects , Pemetrexed/therapeutic use , Adult , Progression-Free Survival
8.
Braz J Anesthesiol ; 74(4): 844503, 2024.
Article in English | MEDLINE | ID: mdl-38641324

ABSTRACT

BACKGROUND: The incidence of arterial hypotension during induction of general anesthesia is influenced by the method of propofol administration, but there is a dearth of randomized clinical trials comparing bolus injection and target-controlled infusion in relation to arterial hypotension. This study seeks to compare the incidence of arterial hypotension between these two methods of propofol administration. METHODS: This prospective, randomized, single-center, non-blinded study included 60 patients (aged 35 to 55 years), classified as ASA physical status I or II, who were undergoing non-cardiac surgeries. They were randomly allocated using a computer to two groups based on the method of propofol administration during the induction of general anesthesia: the Target Group, receiving target-controlled infusion at 4 µg.mL-1, and the Bolus Group, receiving a bolus infusion of 2 mg.kg-1. Both groups also received midazolam 2 mg, fentanyl 3 µg.kg-1, and rocuronium 0.6 mg.kg-1. Over the first 10 minutes of anesthesia induction, Mean Arterial Pressure (MAP), Heart Rate (HR), level of Consciousness (qCON), and Suppression Rate (SR) were recorded every 2 minutes. RESULTS: Twenty-seven patients remained in the TCI group, while 28 were in the Bolus group. Repeated measure analysis using mixed-effects models could not reject the null hypothesis for the effect of group-time interactions in MAP (p = 0.85), HR (p = 0.49), SR (p = 0.44), or qCON (p = 0.72). The difference in means for qCON (60.2 for TCI, 50.5 for bolus, p < 0.001), MAP (90.3 for TCI, 86.2 for bolus, p < 0.006), HR (76.2 for TCI, 76.9 for bolus, p = 0.93), and SR (0.01 for TCI, 5.5 for bolus, p < 0.001), irrespective of time (whole period means), revealed some significant differences. CONCLUSION: Patients who received propofol bolus injection exhibited a lower mean arterial pressure, a greater variation in the level of consciousness, and a higher suppression rate compared to those who received it as a target-controlled infusion. However, the interaction effect between groups and time remains inconclusive.


Subject(s)
Anesthesia, General , Anesthetics, Intravenous , Hypotension , Propofol , Humans , Propofol/administration & dosage , Propofol/adverse effects , Adult , Middle Aged , Anesthesia, General/methods , Female , Male , Hypotension/epidemiology , Hypotension/chemically induced , Prospective Studies , Anesthetics, Intravenous/administration & dosage , Anesthetics, Intravenous/adverse effects , Infusions, Intravenous , Incidence , Injections, Intravenous , Arterial Pressure/drug effects
9.
J Clin Med ; 13(5)2024 Feb 27.
Article in English | MEDLINE | ID: mdl-38592179

ABSTRACT

Biological inflammatory bowel disease (IBD) medications, once limited to intravenous (IV) administration, can now be administered both via IV and subcutaneously (SC). This study investigates patient preferences, willingness to switch from IV to SC, and associated factors. A questionnaire covering demographics, disease-related inquiries, quality of life, and IBD medication preferences was distributed via email, the Israeli Crohn's Disease and Ulcerative Colitis Foundation, infusion centers, and clinics. From 454 IBD patients (median age: 42 years; 55.7% female), responses revealed a preference for SC every 8 weeks, which is comparable to daily oral dosing. Both options were significantly favored over IV every 8 weeks and SC every 2 weeks, with no statistically significant differences between the latter two. However, among patients who were experienced with both SC and IV administration, a clear preference for SC administration every 2 weeks over IV every 8 weeks surfaced. Among IV-treated patients, 54.5% resisted switching to SC. Key reasons for this included medical staff presence (57.7%), a fear of needles (46.4%), belief in infusion efficacy (37.1%), and longer intervals between infusions (36.1%). Findings suggest that transitioning from IV to SC treatment is challenging due to patient resistance, which is influenced by specific factors. Identifying and addressing these obstacles is crucial for optimizing IBD management.

10.
Front Pharmacol ; 15: 1310546, 2024.
Article in English | MEDLINE | ID: mdl-38601466

ABSTRACT

Introduction: A better understanding of patient experience of intravenous (IV) or subcutaneous (SC) routes of administration is fundamental to providing optimal administration of medical therapies to oncology patients. The objective of this study was to examine patient experiences of IV and SC treatment with nivolumab and confirm the relevance of item concepts in the Patient Experience and Preference Questionnaire (PEPQ). The PEPQ is a clinical outcomes' assessment instrument developed to obtain patient-centric data and understand the experience with IV and SC treatment administration. Methods: Embedded qualitative interviews were conducted with a subset of participants from three treatment cohorts with metastatic non-small-cell lung cancer (NSCLC), renal cell carcinoma (RCC), unresectable or advanced metastatic melanoma, hepatocellular carcinoma (HCC), or colorectal cancer (CRC) from the CA209-8KX clinical trial. Concept elicitation interviews were conducted within 14 days of the initial treatment cycle and patient experiences with IV and SC treatment administration were assessed. Concepts from interviews were mapped to the PEPQ version 1.0 questions to assess relevance and convergence of concepts. Results: Interviews were conducted with 43 trial participants from clinical sites opting to participate from six countries (Argentina, France, the Netherlands, Poland, Spain, and New Zealand). The mean age of sub-study participants was 66 ± 11.3 years (range 24-80 years), and 67.4% (N = 29) were male. Sub-study participants with experience of SC most frequently reported symptoms or signs of injection-related redness (27.9%), itching (14.0%), and pain (of needle), and described the pain as pricking, stinging, or tingling (11.0% each). The amount of pain and time burden were widely endorsed as important factors for satisfaction and related to the route of medication administration. For 11 sub-study participants with experience with both IV and SC treatments, 10 (90.9%) preferred SC over IV treatment administration. Conclusion: This study summarizes the experience and satisfaction of receiving IV or SC treatment and confirms the relevance of the PEPQ in a subgroup of CA209-8KX clinical trial participants with metastatic NSCLC, RCC, melanoma, HCC, and CRC. Participant treatment experience and satisfaction with the route of medication mapped to the PEPQ question content support the relevance of PEPQ v2.0 in clinical trials as a self-report measure.

11.
Neurocrit Care ; 2024 Apr 22.
Article in English | MEDLINE | ID: mdl-38649651

ABSTRACT

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.

12.
Front Med (Lausanne) ; 11: 1326144, 2024.
Article in English | MEDLINE | ID: mdl-38444409

ABSTRACT

Introduction: Intravenous (IV) therapy is a crucial aspect of care for the critically ill patient. Barriers to IV infusion pumps in low-resource settings include high costs, lack of access to electricity, and insufficient technical support. Inaccuracy of traditional drop-counting practices places patients at risk. By conducting a comparative assessment of IV infusion methods, we analyzed the efficacy of different devices and identified one that most effectively bridges the gap between accuracy, cost, and electricity reliance in low-resource environments. Methods: In this prospective mixed methods study, nurses, residents, and medical students used drop counting, a manual flow regulator, an infusion pump, a DripAssist, and a DripAssist with manual flow regulator to collect normal saline at goal rates of 240, 120, and 60 mL/h. Participants' station setup time was recorded, and the amount of fluid collected in 10 min was recorded (in milliliters). Participants then filled out a post-trial survey to rate each method (on a scale of 1 to 5) in terms of understandability, time consumption, and operability. Cost-effectiveness for use in low-resource settings was also evaluated. Results: The manual flow regulator had the fastest setup time, was the most cost effective, and was rated as the least time consuming to use and the easiest to understand and operate. In contrast, the combination of the DripAssist and manual flow regulator was the most time consuming to use and the hardest to understand and operate. Conclusion: The manual flow regulator alone was the least time consuming and easiest to operate. The DripAssist/Manual flow regulator combination increases accuracy, but this combination was the most difficult to operate. In addition, the manual flow regulator was the most cost-effective. Healthcare providers can adapt these devices to their practice environments and improve the safety of rate-sensitive IV medications without significant strain on electricity, time, or personnel resources.

13.
Risk Manag Healthc Policy ; 17: 525-533, 2024.
Article in English | MEDLINE | ID: mdl-38476200

ABSTRACT

Background: The excessive use of intravenous infusion in China was once a serious problem, but in recent years, attention has been paid to the phenomenon, and the government has implemented several policies to solve the problem, which has been gradually improved. Aim: This study focuses on evaluating the impact of ongoing interventions and improvements in outpatient intravenous infusion therapy. Methods: From January 2016 to December 2022, we conducted a study to gather annual data on intravenous infusion prescriptions. A data questionnaire, encompassing information on departments, clinical diagnosis, and infusion drugs, was developed for this purpose. We analyzed the changing trends of Top 10 clinical departments with higher intravenous infusion usage rates and Top 10 drugs used. We also evaluated the compliance of intravenous infusion prescriptions with management regulations and drug instructions, for further intervention in the future. Results: The analysis of intravenous infusion prescription rates revealed a gradual decrease from 10.89% to 5.63%. This reduction was statistically significant (P < 0.05). High levels of intravenous infusion use were consistently observed in emergency surgery and emergency medicine. Commonly administered drugs via infusion included antibacterial drugs, tumor medications, proton pump inhibitors, and injections of traditional Chinese medicine. Inappropriate prescriptions are often characterized by issues related to drug dosage, usage, indication, and selection. Trend analysis of unreasonable types revealed significant improvements in "Diagnosis incomplete/unwritten", "Solvent selection", "Dosing frequency", and "Treatment without indication" (P < 0.05). Conclusion: The findings of this study indicate a gradual improvement in the situation regarding intravenous infusion. However, there are still prevalent instances of unreasonable practices that need to be addressed.

14.
Healthcare (Basel) ; 12(3)2024 Feb 01.
Article in English | MEDLINE | ID: mdl-38338263

ABSTRACT

BACKGROUND: Phlebitis related to peripheral venous catheters (PVCs) is a common complication in patients who require these devices and can have important consequences for the patients and the healthcare system. The management and control of the PVC-associated complications is related to nursing competency. The present study aims to determine, at the national level in Spain, the consensus on the assessment, treatment, and follow-up of PVC-related phlebitis and the importance of the actions taken. METHOD: A three-round Delphi technique was used with clinical care nurses who are experts in the field of in-hospital intravenous treatment in Spain. For this, an online questionnaire was developed with three open-ended questions on the dimensions of phlebitis assessment, treatment, and follow-up. For the statistical analysis of the results, frequencies and percentages were used to determine consensus, and the measures of central tendency (mean, standard deviation, and the coefficient of variation) were used to rank importance. The coefficient of variation was set as acceptable at ≤30%. RESULTS: The final sample was 27 expert nurses. At the conclusion of round 3, actions were ranked according to their importance, with six items included in the PVC-related phlebitis assessment (symptomatology/observation, redness, the Maddox scale, induration, temperature, and pain), two in treatment (catheter removal, pentosan polysulphate sodium ointment + application of cold), and just one in follow-up (general monitoring + temperature control). CONCLUSIONS: There is a major disparity in relation to the PVC-related phlebitis assessment, treatment, and follow-up actions. More clinical studies are therefore needed to minimise the complications associated with the use of PVCs, given their impact on the quality of care and patient safety and their economic cost.

15.
Braz. j. med. biol. res ; 57: e13284, fev.2024. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1534074

ABSTRACT

This study aimed to analyze the safety and applicability of a 90-min duration of infusion (SDI) of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma (NHL) in a tertiary hospital in China. This exploratory clinical trial was performed at Jiangsu Province Hospital. All patients were treated with the standard infusion regimen for the first infusion. If no grade ≥3 infusion-related reactions (IRRs) occurred, the subsequent infusions were given as SDI. The primary endpoint was the incidence of IRR during the standard infusion (3-4 h) and 90-min SDI regimens. This study enrolled 208 patients and all completed cycle 1. Forty-one patients (19.71%) had IRRs: five (2.40%) with grade 1, twenty-eight (13.46%) with grade 2, and eight (3.85%) with grade 3. The 41 patients had 71 IRRs, mainly fever (40.85%), chest pain/tightness (12.68%), and dyspnea (9.86%). The occurrence of IRRs in the first infusion was significantly lower in patients who received oral acetaminophen prophylaxis than those who did not (10.72% vs 30.21%, P<0.001). For the subsequent cycles with 90-min SDI, only two (0.25%) IRRs occurred among 814 infusions (one grade 1 hand numbness and one grade 2 chill/fever). The 90-min obinutuzumab SDI might be safe and feasible in patients with B-cell NHL in China.

16.
Stud Health Technol Inform ; 310: 1341-1342, 2024 Jan 25.
Article in English | MEDLINE | ID: mdl-38270034

ABSTRACT

Medications administered via intravenous (IV) infusions have high potential for patient harm. Evaluation of the rate of variances between the medication order on the Electronic Medical Record (EMR) and IV infusion details in the smart pump was performed pre and post- implementation of smart pump and EMR interoperability. Introduction of smart pumps with EMR interoperability resulted in a statistically significant reduction in frequency of variances.


Subject(s)
Electronic Health Records , Patient Harm , Humans , Software
17.
Syst Rev ; 13(1): 9, 2024 01 02.
Article in English | MEDLINE | ID: mdl-38169415

ABSTRACT

BACKGROUND: Intravenous iron (IV-iron) is used as an alternative to, or alongside, red blood cell transfusion (RBC-T) to treat more severe postpartum anemia (PPA), although optimal treatment options remain unclear. No previous systematic reviews have examined IV-iron and RBC-T, including patient-reported outcomes and hematological responses. METHODS: A systematic review and meta-analysis of randomized trials comparing IV-iron and RBC-T with each other, oral iron, no treatment, and placebo for the treatment of PPA. Key inclusion criteria were PPA (hemoglobin < 12 g/dL) and IV-iron or RBC-T as interventions. Key exclusion criteria were antenatal IV-iron or RBC-T. Fatigue was the primary outcome. Secondary outcomes included hemoglobin and ferritin concentrations, and adverse events. From 27th August 2020 to 26th September 2022, databases, registries, and hand searches identified studies. A fixed-effect meta-analysis was undertaken using RevMan (5.4) software. The quality of the studies and the evidence was assessed using the Cochrane Risk of Bias table, and Grading of Recommendations, Assessment, Development, and Evaluation. This review is registered with the Prospective Register of Systematic Reviews (CRD42020201115). RESULTS: Twenty studies and 4196 participants were included: 1834 assigned IV-iron, 1771 assigned oral iron, 330 assigned RBC-T, and 261 assigned non-intervention. Six studies reported the primary outcome of fatigue (1251 participants). Only studies of IV-iron vs. oral iron (15 studies) were available for meta-analysis. Of these, three reported on fatigue using different scales; two were available for meta-analysis. There was a significant reduction in fatigue with IV-iron compared to oral iron (standardized mean difference - 0.40, 95% confidence interval (CI) - 0.62, - 0.18, I2 = 0%). The direction of effect also favored IV-iron for hemoglobin (mean difference (MD) 0.54 g/dL, 95% confidence interval (CI) 0.47, 0.61, I2 = 91%), ferritin, (MD 58.07 mcg/L, 95% CI 55.74, 60.41, I2 = 99%), and total adverse events (risk-ratio 0.63, 95% CI 0.52, 0.77, I2 = 84%). The overall quality of the evidence was low-moderate. DISCUSSION: For all outcomes, the evidence for RBC-T, compared to IV-iron, non-intervention, or dose effects of RBC-T is very limited. Further research is needed to determine whether RBC-T or IV-iron for the treatment of PPA is superior for fatigue and hematological outcomes.


Subject(s)
Anemia , Iron , Female , Humans , Pregnancy , Iron/therapeutic use , Anemia/drug therapy , Blood Transfusion , Hemoglobins/metabolism , Ferritins/therapeutic use , Postpartum Period , Fatigue/drug therapy
18.
J Pharm Pharmacol ; 76(1): 34-43, 2024 Jan 06.
Article in English | MEDLINE | ID: mdl-38041860

ABSTRACT

INTRODUCTION: Parenteral drug administration in the neonatal intensive care involves complex pharmacotherapy adjusted for the patient's weight, fluid allowance, and complex multi-infusion systems. OBJECTIVES: We investigated the delivery rate of a model drug through a multi-infusion system consisting of six intravenous infusions. METHODS: Delivery rate of the model drug was determined after infusion initiation and termination. Measurements were collected spectrophotometrically in real time. Time to drug delivery and the amount of drug delivered were measured. KEY FINDINGS: The longest time to drug delivery was observed for a 500 g neonate model with a distal infusion connection point and neutral pump position (337 ± 30 min, P < 0.001). The shortest time was observed for a 1000 g neonate model in the combination of proximal infusion connection point and neutral pump position (18 ± 12 min, P < 0.05). The expected 100% of the drug was delivered only in two combinations: 500 g and 1000 g neonate models, proximal infusion connection point and neutral pump position (100.4 ± 4.7%, P = 0.819 and 100.2 ± 2.7%, P = 0.874, respectively). While the least drug was delivered to a 500 g neonate model in the combination of distal infusion connection point and neutral pump position (27.5 ± 5.8%, P < 0.001). CONCLUSIONS: Delayed drug delivery to premature neonates due to multi-infusion systems may compromise accurate drug administration and lead to dosing errors.


Subject(s)
Drug Delivery Systems , Infusion Pumps , Infant, Newborn , Humans , Infusions, Parenteral , Infusions, Intravenous , Pharmaceutical Preparations , Body Weight
19.
Transfusion ; 64(2): 301-314, 2024 02.
Article in English | MEDLINE | ID: mdl-38149691

ABSTRACT

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.


Subject(s)
Anemia , Erythrocyte Transfusion , Hematinics , Postpartum Period , Female , Humans , Anemia/therapy , Fatigue/etiology , Feasibility Studies , Ferric Compounds , Ferritins , Hematinics/therapeutic use , Hemoglobins , Iron/therapeutic use , Pilot Projects
20.
Article in English | MEDLINE | ID: mdl-38095650

ABSTRACT

Cardiotoxicity caused by anthracyclines chemotherapy is one of the leading causes of mortality and morbidity in cancer survivors. Continuous infusion (CI) instead of bolus (BOL) injection is one of the methods that seem to be effective in reducing doxorubicin (DOX) cardiotoxicity. Due to the variety of results, we decided to compare these two approaches regarding toxicity and efficacy and report the final results for different cancers. We included 21 studies (four preclinical and seventeen clinical trials) up to May 15, 2023. In children with acute lymphoblastic leukemia (ALL) and adults with chronic lymphoblastic leukemia (CLL) and gastric cancer, results were in favor of BOL injection, without increase in cardiotoxicity. On the other hand, CI showed to be better option in patients with small-cell lung cancer (SCLC) and breast cancer. Various results were also observed in adult patients with sarcoma. Overall, it can be concluded that the benefits of CI, especially in adults, outweigh its disadvantages. However, due to the variety of results and heterogeneity of studies, further clinical trials with a larger sample size and a longer duration of follow-up are needed to make a more accurate comparison between CI and BOL injection.

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