Safety of a 90-min duration of intravenous infusion of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma in a tertiary hospital in China: a prospective, open-label, exploratory clinical trial

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.

Uso clínico de lidocaína intravenosa para manejo de dolor neuropático no oncológico en adultos / Clinical Use of Intravenous Lidocaine for Management of non-Oncologic Neuropathic Pain in Adults

El dolor neuropático es común en la práctica clínica. Se estima que afecta entre el 2 y 3 % de la población a nivel global. Una cantidad considerable de pacientes presentan dolor refractario a tratamientos existentes, volviéndolo un reto diagnóstico y terapéutico. El objetivo de este estudio es describir el uso clínico de lidocaína intravenosa para manejo de dolor neuropático no oncológico en adultos. La búsqueda de información se realizó consultando las bases de datos HINARI, SciELO y PubMed. Se seleccionaron artículos en inglés y español de 2017 a 2021. Se utilizaron artículos originales, ensayos clínicos, revisiones bibliográficas y metaanálisis. Las causas de dolor neuropático en las que ha sido utilizada la lidocaína son la neuralgia posherpética, neuropatía diabética y neuralgia del trigémino. El uso de lidocaína intravenosa demostró que disminuye la intensidad del dolor; sin embargo, al compararlo con otros fármacos de primera línea no hay diferencias a largo plazo. La mayoría de efectos secundarios se presentan en el sistema nervioso, gastrointestinal y cardiovascular. La lidocaína intravenosa como monoterapia para manejo de dolor neuropático no oncológico, si bien fue eficaz a corto plazo con dosis de 3-5 mg/Kg, no tuvo un efecto persistente y duradero

Neuropathic pain is common in clinical practice; it is estimated that 2 to 3 % of the global population is affected; a considerable number of patients present pain refractory to existing treatments, making it a diagnostic and therapeutic challenge. The objective of this study is to describe the clinical use of intravenous lidocaine for the management of non-cancer neuropathic pain in adults. The information search was performed by consulting the HINARI, SciELO and PubMed databases. Articles with an obsolescence of no more than five years, both in English and Spanish, were selected. Original articles, clinical trials, bibliographic reviews and meta-analyses were used. The causes of neuropathic pain in which lidocaine has been used were postherpetic neuralgia, diabetic neuropathy, and trigeminal neuralgia. The use of intravenous lidocaine has been shown to decrease pain intensity; however, when compared with other first line drugs, there are no long-term differences. Most side effects occur in the nervous, gastrointestinal, and cardiovascular systems. Intravenous lidocaine as monotherapy for the management of non-cancer neuropathic pain, although effective in the short term with doses of 3-5 mg/Kg, does not have a persistent and long-lasting effect

Quality of medicinal maltose as a excipient in the production of blood products: a comparative study / 中国输血杂志

【Objective】 To comprehensively compare the quality and filtration efficiency of medicinal maltose between two domestic manufacturers(B, C) and one foreign manufacturer(A), compare their product quality as an excipient for intravenous immunoglobulin(IVIG), so as to determine the feasibility and substitutability of maltose as an excipient for IVIG from different manufacturers. 【Methods】 Quality inspection and comparison of maltose from different manufacturers, small-scale filtration tests, and product quality comparision of IVIG(pH4) were conducted. 【Results】 The comparis on results showed that there was no significant difference in the quality of medicinal maltose between manufacturer B and A, and there was no significant difference in the quality of IVIG (pH4) produced. The quality of manufacturer C did not meet the requirements. 【Conclusion】 There is no significant difference in the quality of medicinal maltose produced by manufacturer B and A, which can be used for the production of IVIG (pH4).

Effects of different doses of statins on clinical outcomes in patients with acute ischemic stroke who received intravenous urokinase thrombolysis / 解放军医学杂志

Objective To investigate the effect of different doses of statins on the clinical efficacy and safety outcome of intravenous thrombolytic therapy of urokinase in patients with acute ischemic stroke(AIS).Methods Based on a large prospective,multicenter study,the Chinese Intravenous Thrombolysis Registry for AIS within 4.5 h of onset(INTRECIS)database,clinical data of 898 patients with urokinase intravenous thrombolysis for AIS were retrospectively analyzed.According to the amount of statin used during hospitalization,the patients were divided into 132 patients in no-statin group,591 patients in conventional statin group and 175 patients in intensive statin group.Clinical outcome measures included 14-day improvement in the National Institutes of Health Stroke Scale(NIHSS)and 90-day excellent prognosis(improved Rankin score≤1 point).Safety measures included recurrent stroke,bleeding events,and 90-day all-cause mortality.Results After adjusting for differences in baseline characteristics(age,coronary heart disease,diabetes,atrial fibrillation,systolic blood pressure,OTT,DNT,previous anti-plate use,blood glucose,and treatment in Class A hospitals),NIHSS scores improved at 14 days after admission and excellent prognosis at 90 days after admission in convention-dose and intensive statin groups were superior to those in no-statin group(P<0.05);Univariate and multivariate analysis of safety outcome indicators showed no statistically significant differences in stroke recurrence and bleeding events among the three groups(P>0.05);The 90-day all-cause mortality was significantly higher in no-statin group(10.6%)than in convention-dose statin group(2.0%)and intensive dose statin group(2.9%)(P<0.01).Conclusions In patients with AIS who were treated with intravenous urokinase thrombolytic therapy,intensive statin use was associated with improved 14-day NIHSS score and near-term prognosis without increasing the risk of stroke recurrence and bleeding events.Statin use is beneficial to reduce mortality.

The efficacy and safety of hydromorphone patients-controlled intravenous analgesia in patients with scar pregnancy after uterine artery embolization / 介入放射学杂志

Objective To evaluate the postoperative analgesia efficacy and clinical safety of hydro-morphone patients-controlled intravenous analgesia(PCIA)in patients with scar pregnancy after auxiliary uterine artery embolization(UAE).Methods A total of 116 patients with scar pregnancy,who received auxiliary UAE at the Fuyang Municipal People's Hospital of China between January 2021 and September 2022,were enrolled in this study.According to the intravenous self-controlled analgesic drugs used after UAE,the patients were randomly and equally divided into observation group(n=58)and control group(n=58).Ten minutes before the procedure,intravenous injection of 2 mg hydromorphone(observation group)or 2 μg/kg sufentanyl(control group)was performed,and the PCIA pump was connected.In the observation group,the mixed solution of 10 mg hydromorphone+100 mg flurbiprofen axetil+100 mL saline was put in the analgesic pump,while in the control group,the mixed solution of 2 μg/kg sufentanyl+flurbiprofen axetil 100 mg+100 mL saline was put in the analgesic pump.The post-UAE 0.5-h,4-h,8-h,12-h,24-h and 48-h visual analogue scale(VAS)scores,the Bruggrmann comfort scale(BCS)scores,the number of pressing analgesic pump times within postoperative 48 hours,the used dosage of analgesic drugs,the adverse reactions,and the incidence of postoperative complications were recorded.Results The difference in the post-UAE 0.5-h VAS scores between the observation group and the control group was not statistically significant(P＞0.05),while the post-UAE 4-h,8-h,12-h,24-h and 48-h VAS scores in the observation group were significantly lower than those in the control group,and the differences were statistically significant(all P＜0.05).The post-UAE 0.5-h,4-h,8-h,12-h,24-h and 48-h BCS scores in the observation group were significantly higher than those in the control group,and the differences were statistically significant(all P＜0.05).The number of pressing analgesic pump times and the used dosage of analgesic drugs within postoperative 48 hours in the observation group were lower than those in the control group,and the differences were statistically significant(all P＜0.05).No statistically significant differences in the complications such as drowsiness,skin itching,hypoxia,or respiratory depression,etc.existed between the two groups,while the difference in the incidence of adverse reactions between the two groups was statistically significant(P＜0.05).Conclusion Hydromorphone and sufentanil PCIA can relieve the pain in scar pregnancy patients after UAE.Hydromorphone is superior to sufentanil in reducing the number of pressing analgesic pump times within postoperative 48 hours,reducing the used dosage of analgesic drugs,and decreasing the incidence of adverse reactions,therefore,hydromorphone PCIA has a certain promotion value.(J Intervent Radiol,2024,33:240-244)

The effect of simple topical and intravenous general anesthesia on the occurrence of pancreatitis after ERCP surgery:a retrospective analysis / 临床外科杂志

Objective To investigate the effects of simple topical anesthesia and intravenous general anesthesia on the occurrence of pancreatitis after ERCP.Methods 400 Patients who underwent ERCP due to pancreaticobiliary duct disease in our hospital from January 2021 to March 2023 were selected and divided into two groups:Simple topical anesthesia group and intravenous general anesthesia group,200 cases in each group.The levels of venous pancreatic amylase and abdominal symptoms and signs were recorded in the two groups before operation and 3 h and 24 h after operation.The observation results were hyperamylaseemia and postoperative pancreatitis at 3 h and 24 h after operation.Results The incidence of postoperative pancreatitis after ERCP was higher in the superficial anesthesia group than in the intravenous general anesthesia group(7.5％and 2.0％,respectively;P＜0.05),there was statistical significance;The level of serum pancreatic amylase(198±216)U/L in intravenous general anesthesia group was significantly lower than that in superficial anesthesia group(379±327)U/L at 3h after surgery(P＜0.05).The level of serum pancreatic amylase(129±98)U/L in intravenous general anesthesia group was lower than that in superficial anesthesia group(187±156)at 24h after surgery(P＜0.05).The incidence of hyperamylasemia was 15.5％(31/200 cases)in the 3h postoperative intravenous general anesthesia group,lower than that in the simple surface anesthesia group(34.5％)(69/200 cases),and 5.5％(11/200 cases)in the 24h postoperative intravenous general anesthesia group,lower than that in the simple surface anesthesia group(19.0％)(38/200 cases)(P＜0.05).Conclusion Compared with simple surface anesthesia,intravenous general anesthesia can reduce the level of serum amylase after ERCP,and can reduce the occurrence of pancreatitis after ERCP.

Strategies for ABO-incompatible liver transplantation / 器官移植

With rapid development of organ transplantation, the issue of global organ shortage has become increasingly prominent. At present, liver transplantation is the most effective treatment for end-stage liver disease. Nevertheless, the shortage of donors has been a key problem restricting the development of liver transplantation. China is a country with a larger number of hepatitis B, and the shortage of donor liver is particularly significant. Many critically ill patients often lose the best opportunity or even die because they cannot obtain a matched donor liver in time. As a strategy to expand the donor pool, ABO-incompatible (ABOi) liver transplantation offers new options for patients who are waiting for matched donors. However, ABOi liver transplantation is highly controversial due to higher risk of complications, such as severe infection, antibody-mediated rejection (AMR), biliary complications, thrombotic microangiopathy, and acute kidney injury, etc. In this article, research progress in preoperative, intraoperative and postoperative strategies of ABOi liver transplantation was reviewed, aiming to provide reference for clinical application and research of ABOi liver transplantation.

Application of FMEA model and 6S management method in reducing dispensing errors in PIVAS of children’s hospitals / 中国药房

OBJECTIVE To reduce dispensing errors in pharmacy intravenous admixture service （PIVAS） of children’s hospitals. METHODS The risk of dispensing procedures in our PIVAS was identified by applying failure mode and effect analysis （FMEA） model. Potential failure modes that might lead to dispensing errors in each link were determined， and failure causes were analyzed. The severity， incidence and detection degree of potential failure modes were quantitatively scored， and their risk priority number （RPN） was calculated to screen failure modes that needed to be improved in priority； the corresponding improvement measures were developed by 6S management method from six aspects， namely， finishing （seiri）， rectifying （seiton）， sweeping （seiso）， sanitation （seiketsu）， literacy （shitsuke） and safety. The effect of intervention before and after rectification was evaluated. RESULTS Based on the RPN， 32 potential failure modes were selected， of which a total of 18 critical failure modes that needed to be improved in priority. After implementing corresponding measures according to 6S management method， the RPN of 18 critical failure modes decreased. The total RPN decreased from 497 to 142 with a decrease rate of 71.43%. The error rates of 15 critical failure modes were significantly lower than before implementation （P＜0.05）. CONCLUSIONS Applying FMEA model and 6S management method to the risk control of all aspects of PIVAS workflow can effectively reduce the risk of PIVAS dispensing errors and ensure the safety of children’s intravenous medication.

Predictive value of triglyceride-glucose index on the outcome in patients with acute ischemic stroke undergoing intravenous alteplase thrombolysis / 中国医科大学学报

Objective To explore the predictive role of the triglyceride-glucose(TyG)index in patients with acute ischemic stroke(AIS)treated with alteplase thrombolysis and create a comprehensive predictive model integrating multiple factors for assessing patient out-comes.Methods The clinical data of 302 patients with AIS undergoing alteplase intravenous thrombolysis at the Neurology Department of Fushun Central Hospital from January 2019 to October 2022 were retrospectively analyzed.The patients were categorized into a good prognosis group(n= 193)and a poor prognosis group(n= 109)based on their mRS scores at 90 days post-thrombolysis.Univariate and multivariate logistic regression analyses were employed to identify risk factors influencing adverse outcomes and to establish a predictive model.The predictive performance of the model was assessed using receiver operating characteristic(ROC)curve analysis.Results The results of the multivariate logistic regression analysis revealed that pre-thrombolysis high NIHSS score and TyG index≥9.37 were inde-pendent risk factors for unfavorable prognosis in AIS patients.A predictive model for AIS patient prognosis was successfully established:Logit(Y)=-17.167 + 1.681×TyG index+0.147×pre-thrombolysis NIHSS score.The optimal cutoff value for the TyG index was 9.37.The ROC areas under the curve for predicting unfavorable prognosis in AIS patients at 90 days post-thrombolysis were 0.713 for TyG index,0.705 for pre-thrombolysis NIHSS score,and 0.787 for the combined variable(Y),with the combined variable(Y)exhibiting the largest ROC curve area.Conclusion TyG index≥9.37 and pre-thrombolysis high NIHSS score are independent risk factors for poor prognosis.The combined variable the combined variable(Y)has higher predictive efficiency than the separate variables.

Analysis on the Influence of Teaching Mode Based on ICARE Concept on the Professional Spirit and Attitude of Intravenous Therapy Specialist Nurses / 中国医院管理

Objective To explore the effect of teaching mode based on ICARE on the professional spirit attitude of intravenous therapy specialist nurses.Methods 100 specialized intravenous therapy nurses who were trained in the Fourth Affiliated Hospital of Harbin Medical University from October 2021 to October 2022 were randomly divided into control group and experimental group.The control group students completed the training with traditional methods,while the experimental group students completed the training with the guidance of ICARE.Before and after the training,the professional spirit and attitude of the two groups of students was evaluated.Results After the implementation of the study,it was verified through independent sample r-test that the public services,autonomy and nurse job satisfaction of professional spirit and attitude scores group students was significantly higher than that of the control group(P＜0.05),and the difference was statistically significant.The Chi-squared test verified that the total incidence of complications of intravenous catheterization in the experimental group was significantly lower than that in the control group,with a statistically significant difference(P＜0.05).Conclusion The teaching mode based on ICARE can significantly improve the professional spirit and attitude of the intravenous treatment specialist nurses and the quality of intravenous infusion treatment.

Study on the application of different-length peripheral intravenous catheters in patients undergoing metabolic and bariatric surgery:a randomized clinical trial / 中华护理杂志

Objective To investigate the appropriate venous access for obese patients undergoing metabolic and bariatric surgery by comparing the clinical outcomes of different lengths of peripheral intravenous catheters.Methods Inpatients who underwent bariatric surgery in a tertiary hospital in Zhejiang from August 2022 to December 2022 were selected as the study population using a fixed-point continuous convenience sampling method.A stratified block randomisation method was used to divide the group into an experimental group 1(mini-midline catheters),an experimental group 2(midline catheters)and a control group(short peripheral intravenous catheters,Short PIVCs).The incidence of catheter-related complications,the rate of extubation due to complications,the duration of catheter retention,the time to first catheter-related complication were compared in the 3 groups.Results A total of 186 patients were included,with 62 patients in each group.The overall incidence of catheter-related complications in experimental group 1,experimental group 2,and control group were 25.81％,8.06％,and 58.06％.The extubation rates due to complications were 19.35％,4.84％,and 41.94％,and the duration of catheter retention was 7.00(6.00,7.00)d,7.00(6.00,7.00)d,6.00(3.00,6.25)d.The differences were statistically different(P＜0.05)when comparing the 3 groups.Among them,the differences in the overall incidence of catheter-related complications and the rate of extubation due to complications were statistically significant when comparing experimental group 1 with the control group,experimental group 2 with the control group,and experimental group 1 with experimental group 2(P＜0.017);the duration of catheter retention in both experimental group 1 and experimental group 2 were higher than it in the control group,and the differences were statistically different(P＜0.017).Conclusion The complication rate of mini-midline catheters and midline catheters is lower than that of short ones,and the indwelling time is consistent with the perioperative period of metabolic and bariatric surgery,which is suitable for use in patients undergoing metabolic and bariatric surgery.

Efficacies of intravenous immunoglobulin for kidney recipients for clearing BK virus and treating BK virus nephropathy / 中华器官移植杂志

Objective:To evaluate the efficacies of intravenous immunoglobulin (IVIG) in the clearance of Bovine Kobu (BK) virus and treatment of BK virus nephropathy (BKVN) in kidney transplantation recipients.Methods:From March 1, 2018 to March 31, 2022, the relevant clinical data were retrospectively reviewed for 13 kidney transplantation recipients with histologically proven BKVN on a full course of IVIG. The changes of serum creatinine and glomerular filtration rate (GFR) were compared before and after Month 1/3/6/12. Univariate Cox regression analysis was performed for examining the overall risk factors of BK virus clearance failure.Results:kidney transplantation (12 cases) and combined pancreatorenal transplantation (1 case) were performed. Among them, 9/13 patients were pathologically classified as stage A (early changes without tubular necrosis) and another 4 cases as stage B (active nephropathy with viral tubular necrosis). After IVIG dosing, all patients with BK virus in blood turned negative. Urinary BK virus DNA load of 7 patients with BK virus declined by 10 3 copies/ml, and 6 patients with BK virus in urine turned negative. Blood BK viral DNA load, urinary BK viral DNA load, GFR and serum creatinine before IVIG were 26 100 (1 000, 254 000) copies /ml and 1 450 (438, 7 480) ×10 6 copies /ml, (35. 36±14. 57) ml/min and (208. 50±66. 89) μmol/L, respectively, after 12 months of use of IVIG were 0、0(0, 0. 58) ×10 6 copies/ml、(46. 05±13. 00) ml/min and(175. 38±50. 64) μmol/L, the differences were statistically significant ( P=0. 012, 0. 027, 0. 046 and 0. 039) . Univariate Cox regression analysis showed that the overall risk factor for viral clearance failure was high initial viral load ( HR=0. 780, 95% CI: 0. 64-0. 98, P=0. 032) , concurrent transplanted kidney rejection ( HR=0. 847, 95% CI: 0. 52-0. 93, P=0. 013) and higher BKVN grade ( HR=0. 426, 95% CI: 0. 22-0. 81 , P=0. 010) were the overall risk factors for urinary BK virus clearance failure. No major adverse events occurred. Conclusions:IVIG may achieve a high efficacy of BK virus clearance. IVIG is effective in the treatment of BKVN. The graft renal function was stable or improved after treatment.

Visual analysis of intravenous thrombolytic drugs for acute ischemic stroke / 中国药房

OBJECTIVE To analyze the research status， hotspots and trends in the research of intravenous thrombolytic drugs in the treatment of acute ischemic stroke. METHODS The original studies related to intravenous thrombolytic drugs for acute ischemic stroke were collected by searching the Web of Science core database； the authors， countries/regions， institutions and keywords of the literature were visualized and analyzed using CiteSpace 6.1.R6 software. RESULTS A total of 1 810 articles were included， and the number of articles published showed an increasing trend year by year， with the United States （556 articles） having the largest number of articles， and China ranking the second （339 articles， with centrality of 0）. The most published author was Ahmed of Sweden （32 articles）， and the most published institution was the University of Calgary in Canada （80 articles）. The current research status and hotspots were mainly the application and therapeutic exploration of new thrombolytic drugs， and the frontier and development trend were the adverse prognosis of neurological deterioration and hemorrhagic transformation accompanied by intravenous thrombolytic drug treatment. CONCLUSIONS The research hotspots and frontier about intravenous thrombolytic drugs for acute ischemic stroke are mainly the third generation of intravenous tissue plasminogen activator， and the exploration of new intravenous thrombolytic drugs and their safety and effectiveness will be the future research hotspots. Chinese scholars and research teams should strengthen cooperation and exchanges with other countries， which can be strengthened by carrying out multi-center clinical trials.

Real-world setting comparison of bridging therapy versus direct mechanical thrombectomy for acute ischemic stroke: A meta-analysis

Abstract Background and purpose Intravenous Thrombolysis (IVT) prior to Mechanical Thrombectomy (MT) for Acute Ischaemic Stroke (AIS) due to Large-Vessel Occlusion (LVO) remains controversial. Therefore, the authors performed a meta-analysis of the available real-world evidence focusing on the efficacy and safety of Bridging Therapy (BT) compared with direct MT in patients with AIS due to LVO. Methods Four databases were searched until 01 February 2023. Retrospective and prospective studies from nationwide or health organization registry databases that compared the clinical outcomes of BT and direct MT were included. Odds Ratios (ORs) and 95 % Confidence Intervals (CIs) for efficacy and safety outcomes were pooled using a random-effects model. Results Of the 12 studies, 86,695 patients were included. In patients with AIS due to LVO, BT group was associated with higher odds of achieving excellent functional outcome (modified Rankin Scale score 0-1) at 90 days (OR = 1.48, 95 % CI 1.25-1.75), favorable discharge disposition (to the home with or without services) (OR = 1.33, 95 % CI 1.29-1.38), and decreased mortality at 90 days (OR = 0.62, 95 % CI 0.56-0.70), as compared with the direct MT group. In addition, the risk of symptomatic intracranial hemorrhage did not increase significantly in the BT group. Conclusion The present meta-analysis indicates that BT was associated with favorable outcomes in patients with AIS due to LVO. These findings support the current practice in a real-world setting and strengthen their validity. For patients eligible for both IVT and MT, BT remains the standard treatment until more data are available.

Development and validity of an algorithm for planning intravenous medication administration in infants / Desarrollo y validación de un algoritmo para la planificación de la administración de medicamentos intravenosos en neonatos / Elaboração e validação de algoritmo para o planejamento da administração de medicamentos intravenosos em neonatos

ABSTRACT Objective: to develop and validate the content of an algorithm for planning intravenous medication administration in infants. Method: this is a methodological study of technology development and validity. A scoping review was carried out, which supported the creation of an algorithm by the researchers and its subsequent validity by 13 expert nurses, which took place between November 2021 and March 2022. Items with a Content Validity Index ≥ 0.8 were considered acceptable. Results: thirty-one references were included in the scoping review, organized into five categories: "recommendation for intravenous access", "polypharmacy-related care", "care prior to intravenous medication administration", "venous catheter handling-related care" and "medication infusion-related care". This division supported the algorithm development, which was validated after three rounds, with an overall Content Validity Index of the instrument of 0.91. Conclusion: algorithm validity indicates reliability and accuracy of its content.

RESUMEN Objetivo: desarrollar y validar el contenido de un algoritmo para la planificación de la administración de medicamentos intravenosos en neonatos. Método: se trata de un estudio metodológico de desarrollo y validación de tecnología. Se realizó una revisión de alcance que apoyó la creación del algoritmo por parte de los investigadores y su posterior validación por 13 enfermeras especialistas, que se llevó a cabo entre noviembre de 2021 y marzo de 2022. Se consideraron aceptables los ítems con un Índice de Validez de Contenido ≥ 0,8. Resultados: se incluyeron 31 referencias en la revisión de alcance, organizadas en cinco categorías: "indicación de acceso intravenoso", "cuidados relacionados con la polifarmacia", "cuidados previos a la administración de medicamentos intravenosos", "cuidados relacionados con la manipulación del catéter venoso" y "cuidados relacionados con la infusión de medicamentos". Esta división apoyó el desarrollo del algoritmo, que fue validado después de tres rondas, con un Índice de Validez de Contenido global del instrumento de 0,91. Conclusión: la validación del algoritmo indica confiabilidad y precisión de su contenido.

RESUMO Objetivo: elaborar e validar o conteúdo de um algoritmo para o planejamento da administração de medicamentos intravenosos em neonatos. Método: estudo metodológico de elaboração e de validação de tecnologia. Foi realizada a revisão de escopo que subsidiou a elaboração do algoritmo pelas pesquisadoras e sua posterior validação por 13 enfermeiros especialistas, a qual ocorreu entre novembro de 2021 e março de 2022. Foram considerados aceitáveis os itens com Índice de Validade de Conteúdo ≥ 0,8. Resultados: foram incluídas 31 referências na revisão de escopo, organizadas em cinco categorias: "indicação de acesso intravenoso", "cuidados relacionados à polifarmácia", "cuidados prévios à administração de medicamentos intravenosos", "cuidados relacionados à manipulação do cateter venoso" e "cuidados relacionados à infusão de medicamentos". Essa divisão subsidiou a elaboração do algoritmo, que foi validado após três rodadas, com Índice de Validade de Conteúdo geral do instrumento de 0,91. Conclusão: a validação do algoritmo indica confiabilidade e precisão do seu conteúdo.

Hemodynamic impact of increasing time between fentanyl and propofol administration during anesthesia induction: a randomised, clinical trial

Abstract Background and objective: Anesthesia induction can produce severe propofol dose-dependent hypotension. Fentanyl coadministration reduces the catecholaminergic response to orotracheal intubation allowing propofol dose reduction. The aim of this study is to determine whether the hemodynamic response is improved by increasing the time between fentanyl and propofol administration and reducing the dose of the latter without increasing the time to achieve optimal hypnosis. Methods: After approval by the Research Ethics Committee, patients undergoing non-cardiac surgery with endotracheal intubation were randomized by a computer-generated table into six time-dose groups (1 or 2 minutes/1, 1.5, or 2mg.kg-1 of propofol). Patients with high bronchoaspiration risk, a difficult airway, hemodynamic instability, or anesthetic allergies were excluded. After giving intravenous fentanyl (2 μg.kg-1 ), each group received different doses of propofol after 1 or 2 minutes. Non-invasive blood pressure (BP) and heart rate (HR) were measured at pre-induction, pre-intubation, and post-intubation. Time to hypnosis (bispectral index < 60) was also recorded. Results: Of the 192 recruited patients, 186 completed the study (1 min group n = 94; 2 min group n = 92). It was observed that HR and BP decreased after propofol administration and increased after intubation in all groups (p<0.0001). In patients over 55 years, the 2 min - 2 mg.kg-1 group showed the greatest systolic BP reduction (36 ± 12%) at pre-intubation, while the 1 min - 1.5 mg.kg-1 group showed the least hemodynamic alteration between pre- and post-intubation (-4 ± 13%). No significant differences were found in younger patients or in the time to reach hypnosis between the six groups. While no cases of severe bradycardia were recorded, 5,4% of the sample required vasopressors. Conclusion: Increasing the time between the administration of fentanyl and propofol by up to two minutes results in greater hypotension in patients over 55 years.

Accuracy of closed-loop and open-loop propofol delivery systems by bispectral index monitoring in breast surgery patients: a prospective randomized trial

Abstract Background: This randomized and controlled prospective study tested the hypothesis that closed-loop Target-Controlled Infusion (TCI) of propofol would be associated with better system performance when compared with open-loop controlled delivery of propofol. Methods: Patients scheduled for elective breast surgery were randomly assigned to two groups: a closed-loop group, in which propofol infusion was performed by a closed-loop TCI system that used the Bispectral Index (BIS) as a feedback parameter to titrate the rate of propofol infusion, and an open-loop group, in which propofol infusion was performed manually and guided by the bispectral index. Results: A total of 156 patients were recruited for this study (closed-loop group n = 79; open-loop group n = 77). The Global Score (GS) of the closed-loop group was lower than that of the open-loop group (34.3 and 42.2) (p = 0.044). The proportions of time with a BIS value between 40 and 60 were almost identical in the closed-loop group and the open-loop group (68.7 ± 10.6% and 66.7 ± 13.3%) (p = 0.318). The individuals in the closed-loop group consumed more propofol compared with those in the open-loop group (7.20 ± 1.65 mg.kg−1.h−1 vs. 6.03 ± 1.31 mg.kg−1.h−1, p < 0.001). No intraoperative recall, somatic events or adverse events occurred. No significant difference in heart rate was observed between the two groups (p = 0.169). Conclusion: The closed-loop protocol was associated with lower BIS variability and lower out-of-range BIS values, at the cost of a greater consumption of propofol when compared to the open loop group. Register number:ChiCTR-INR-17010399.

Michigan appropriateness guide for intravenous catheters in pediatrics — miniMAGIC-Brasil: translation into Brazilian portuguese / Michigan appropriateness guide for intravenous catheters in pediatrics — miniMAGIC-Brasil: tradução para o português do Brasil

ABSTRACT Objective: To perform the translation and adaptation of the Michigan Appropriateness Guide for Intravenous Catheters in Pediatrics (miniMAGIC) into Brazilian Portuguese. Methods: Methodological study performed in five recommended stages: initial translations; synthesis of the translations; back translations; assessment of the back translations; expert committee assessment. The expert committee was composed of three registered nurses and two doctors who had a Master's and/or PhD degree, and an expertise in intravenous therapy and pediatric and neonatal care. To assess the semantic, idiomatic, experiential and conceptual adequacy, a Likert scale was applied, in which 1, "not equivalent"; 2, "inequivalent"; 3, "cannot assess"; 4, "quite equivalent"; 5, "totally equivalent". The terms mostly analyzed as negative in equivalence and with a lower than 20 score were reviewed and submitted to a new assessment, with the Delphi Technique until consensus was obtained. The results were stored in electronic spreadsheets and treated with concordance index, with a minimum acceptable result of 0.80. Results: The content of all recommendations, named as miniMAGIC-Brasil, was validated by the expert committee after two stages of evaluation. All recommendations had an overall agreement index of 0.91. Conclusions: The miniMAGIC-Brazil guide was validated in respect to the adequacy of the translation after two steps.

RESUMO Objetivo: Realizar a tradução e adaptação do miniMAGIC para a língua portuguesa do Brasil. Métodos: Estudo metodológico realizado em cinco etapas: traduções iniciais; síntese das traduções; retrotraduções; avaliação das retrotraduções; avaliação por comitê de especialistas. O comitê foi composto de três enfermeiros e dois médicos que possuíssem pós-graduação stricto sensu e experiência em acesso vascular e pediatria. Para a análise de adequação semântica, idiomática, experiencial e conceitual de cada item do instrumento, foi empregada escala tipo Likert graduada em 1, como "não equivalente"; 2, "pouco equivalente"; 3, "não sei avaliar"; 4, "bastante equivalente"; e 5, "totalmente equivalente". Os termos majoritariamente analisados como negativos quanto à equivalência e com pontuação inferior a 20 foram revisados e submetidos a nova análise segundo a técnica Delphi até que o consenso fosse alcançado. Os resultados obtidos foram armazenados em planilhas eletrônicas e tratados com análise do índice de concordância mínimo de 0,80. Resultados: O conteúdo de todas as recomendações, que receberam nomeação de miniMAGIC-Brasil, alcançou índice de concordância mínimo, segundo julgamento por comitê de especialistas, após duas etapas de avaliação. Todas as recomendações obtiveram índice de concordância ao final de 0,91. Conclusões: O guia miniMAGIC-Brasil obteve índice de concordância dos termos segundo análise da adequação da tradução após duas etapas.

A meta-analysis of ferric carboxymaltose versus other intravenous iron preparations for the management of iron deficiency anemia during pregnancy

Abstract Objective: We conducted a meta-analysis of randomized clinical trials evaluating the clinical effects of ferric carboxymaltose therapy compared to other intravenous iron in improving hemoglobin and serum ferritin in pregnant women. We also assessed the safety of ferric carboxymaltose vs. other intravenous iron. Data source: EMBASE, PubMed, and Web of Science were searched for trials related to ferric carboxymaltose in pregnant women, published between 2005 and 2021. We also reviewed articles from google scholar. The keywords "ferric carboxymaltose," "FCM," "intravenous," "randomized," "pregnancy," "quality of life," and "neonatal outcomes" were used to search the literature. The search was limited to pregnant women. Selection of studies: Studies related to ferric carboxymaltose in pregnancy were scanned. Observational studies, review articles, and case reports were excluded. Randomized studies in pregnant women involving ferric carboxymaltose and other intravenous iron formulations were shortlisted. Of 256 studies, nine randomized control trials were selected. Data collection: Two reviewers independently extracted data from nine selected trials Data synthesis: The final effect size for increase in hemoglobin after treatment was significant for ferric carboxymaltose vs. iron sucrose/iron polymaltose (standard mean difference 0.89g/dl [95% confidence interval 0.27,1.51]). The final effect size for the increase in ferritin after treatment was more for ferric carboxymaltose vs. iron sucrose/iron polymaltose (standard mean difference 22.53µg/L [-7.26, 52.33]). No serious adverse events were reported with ferric carboxymaltose or other intravenous iron. Conclusion: Ferric carboxymaltose demonstrated better efficacy than other intravenous iron in increasing hemoglobin and ferritin levels in treating iron deficiency anemia in pregnant women.

Safety and efficacy of target-controlled infusion versus intermittent bolus administration of propofol for sedation in colonoscopy: a randomized controlled trial

Abstract Background: Our objective was to compare the safety and efficacy of Target-Controlled Infusion (TCI) versus intermittent bolus of propofol for colonoscopy sedation. Methods: We conducted a randomized (1:1), single-blind, parallel-group superiority trial with fifty ASA I or II patients, both sexes, aged 18 to 65 years, Body Mass Index ≤ 30 kg.mr-2, undergoing colonoscopy, allocated to receive propofol by TCI (effect-site, 2 μg.mL-1 plus 0.5 μg.mL-1 until unconsciousness and as necessary for agitation) or intermittent bolus (1 mg.kg-1 plus 0.5 mg.kg-1 every 5 minutes or as above). The primary safety outcome was the need for airway maneuvers and the primary efficacy outcome was the need for interventions to adjust the level of sedation. Secondary outcomes included incidence of agitation, propofol dose, and time to recovery. Results: The median (IQR) number of airway maneuvers and interventions needed to adjust sedation was 0 (0-0) vs. 0 (0-0) (p = 0.239) and 1 (0-1) vs. 3 (1-4) (p < 0.001) in the TCI and control groups, respectively. Agitation was more common in the intermittent bolus group - 2 (0-2) vs. 1 (0-1), p < 0.001. The mean ± SD time to recovery was 4.9 ± 1.4 minutes in the TCI group vs. 2.3 ± 1.6 minutes in the control group (p < 0.001). The total propofol dose was higher in the TCI group (234 ± 46 μg.kg-1.min-1 vs. 195 ± 44 μg.kg-1.min-1 (p = 0.040)). Conclusions: During colonoscopy, TCI is as safe as intermittent bolus of propofol while reducing the incidence of agitation and the need for dose adjustments. However, intermittent bolus administration was associated with lower total propofol dose and earlier recovery.