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A single-center experience of non-bioartificial DFAPP support systems among Chinese patients with hyperlipidemic moderate/severe acute pancreatitis
Cheng, X., Zhan, Y., Wang, Z., Wang, F., Zeng, X., Mao, Y., Liu, Y.
Scientific reports. 2024;14(1):1128
Abstract
To assess the clinical efficacy of Double Filtration Plasmapheresis (DFAPP), a novel blood purification method, in treating hyperlipidemic moderate/severe pancreatitis (HL-M/SAP). A total of 68 HL-M/SAP patients were enrolled in this study. The observation group, comprising 34 patients, received DFAPP treatment, while the control group underwent CVVH + PA treatment. We compared the efficacy changes between the two groups post-treatment. Patients treated with DFAPP showed significant improvements in clinical outcomes. After 72 h of DFAPP treatment, HL-M/SAP patients exhibited notably lower multiple organ failure scores and a reduced mortality rate compared to those in the CVVH + PA group. Triglyceride levels in HL-M/SAP patients treated with DFAPP for 48 h averaged 3.75 ± 1.95, significantly lower than the 9.57 ± 3.84 levels in the CVVH + PA group (P < 0.05). Moreover, CRP levels decreased markedly, IL-17 levels diminished, IL-10 levels increased, and the decline in IL-35 levels was significantly less pronounced compared to the CVVH + PA group. The recurrence rate of pancreatitis was also significantly lower after 6 months. The early implementation of DFAPP in HL-M/SAP patients effectively reduces triglyceride levels, suppresses pro-inflammatory factors, enhances anti-inflammatory factors, and mitigates cytokine storm-induced sepsis damage. Consequently, this leads to a decrease in the incidence of multiple organ failure, improved patient survival rates, and a reduce the recurrence rate of lipogenic pancreatitis.Trial registration: Chinese Clinical Trial Registry, ChiCTR2300076066.
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Predicting response to iron supplementation in patients with active inflammatory bowel disease (PRIme): a randomised trial protocol
Loveikyte, R., Duijvestein, M., Mujagic, Z., Goetgebuer, R. L., Dijkstra, G., van der Meulen-de Jong, A. E.
BMJ open. 2024;14(1):e077511
Abstract
INTRODUCTION Iron deficiency anaemia (IDA) is the most common systemic manifestation of inflammatory bowel disease (IBD) that has detrimental effects on quality of life (QoL) and disease outcomes. Iron deficiency (ID), with or without anaemia, poses a diagnostic and therapeutic challenge in patients with IBD due to the multifactorial nature of ID(A) and its frequent recurrence. Elevated hepcidin-a systemic iron regulator that modulates systemic iron availability and intestinal iron absorption-has been associated with oral iron malabsorption in IBD. Therefore, hepcidin could assist in therapeutic decision-making. In this study, we investigate whether hepcidin can predict response to oral and intravenous iron supplementation in patients with active IBD undergoing anti-inflammatory treatment. METHODS AND ANALYSIS PRIme is an exploratory, multicentre, open-label and randomised trial. All adult patients with active IBD and ID(A) will be assessed for eligibility. The participants (n=90) will be recruited at five academic hospitals within the Netherlands and randomised into three groups (1:1:1): oral ferrous fumarate, oral ferric maltol or intravenous iron. Clinical and biochemical data will be collected at the baseline and after 6, 14 and 24 weeks. Blood samples will be collected to measure hepcidin and other biomarkers related to iron status. In addition, patient-reported outcomes regarding QoL and disease burden will be evaluated. The primary outcome is the utility of hepcidin as a predictive biomarker for response to iron therapy, which will be assessed using receiver operating curve analysis. ETHICS AND DISSEMINATION The study has been approved by the Institutional Review Board at the Leiden University Medical Center (IRB No. P21.109) and other study sites. All participants will provide written informed consent to enrol in the study. The findings will be published in a peer-reviewed journal and disseminated at scientific conferences; the dataset will be available on reasonable request. TRIAL REGISTRATION Prospectively registered in the https://clinicaltrials.gov/ and the Eudra registries. First submitted on 10 May 2022 to the ClinicalTrials.gov (ID: NCT05456932) and on 3 March 2022 to the European Union Drug Regulating Authorities Clinical Trials Database (ID: 2022-000894-16).
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Intravenous ferric carboxymaltose versus oral ferrous sulfate replacement in elderly patients after acute non-variceal gastrointestinal bleeding (FIERCE): protocol of a multicentre, open-label, randomised controlled trial
Teutsch, B., Váncsa, S., Farkas, N., Szakács, Z., Vörhendi, N., Boros, E., Szabó, I., Hágendorn, R., Alizadeh, H., Hegyi, P., et al
BMJ open. 2023;13(3):e063554
Abstract
INTRODUCTION Acute gastrointestinal bleeding (GIB) is a life-threatening emergency with a critical economic burden. As a result of bleeding, anaemia often requires intravenous or oral iron supplementation. Elderly patients are even more prone to untoward outcomes after hospital discharge if iron supplementation is inefficient. There is a gap in current guidelines on which supplementation route clinicians should choose. We aim to investigate the effect of one dose of intravenous iron therapy versus 3-month oral iron administration on anaemia in an elderly population. METHODS AND ANALYSIS The FIERCE study is an open-label, randomised controlled, two-armed trial. At least 48 hours after the acute non-variceal GIB treatment, patients will be recruited in participating centres. A random sequence generator will allocate the participants to group A (intravenous ferric carboxymaltose, 1000 mg) or group B (oral ferrous sulfate (FS), ca. 200 mg every day) with an allocation ratio of 1:1 on the day of the planned discharge from the hospital. Randomisation will be stratified for participating centres and the need for transfusion within the same hospitalisation before recruitment to the trial. Quality of life assessment, functional measurement and laboratory tests will be performed at baseline, 1 and 3 months±7 days after enrolment to the trial. The primary endpoint is a composite endpoint, including all-cause mortality, anaemia-associated unplanned emergency visit and anaemia-associated unplanned hospital admission within 3 months of enrolment in the trial. ETHICS AND DISSEMINATION The study has been approved by the relevant organisation, the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (46395-5/2021/EÜIG). We will disseminate our results to the medical community and will publish our results in peer-reviewed journals. TRIAL REGISTRATION The trial has been registered at ClinicalTrials.gov (NCT05060731).
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Informative cluster size in cluster-randomised trials: A case study from the TRIGGER trial
Kahan, B. C., Li, F., Blette, B., Jairath, V., Copas, A., Harhay, M.
Clinical trials (London, England). 2023;:17407745231186094
Abstract
BACKGROUND Recent work has shown that cluster-randomised trials can estimate two distinct estimands: the participant-average and cluster-average treatment effects. These can differ when participant outcomes or the treatment effect depends on the cluster size (termed informative cluster size). In this case, estimators that target one estimand (such as the analysis of unweighted cluster-level summaries, which targets the cluster-average effect) may be biased for the other. Furthermore, commonly used estimators such as mixed-effects models or generalised estimating equations with an exchangeable correlation structure can be biased for both estimands. However, there has been little empirical research into whether informative cluster size is likely to occur in practice. METHOD We re-analysed a cluster-randomised trial comparing two different thresholds for red blood cell transfusion in patients with acute upper gastrointestinal bleeding to explore whether estimates for the participant- and cluster-average effects differed, to provide empirical evidence for whether informative cluster size may be present. For each outcome, we first estimated a participant-average effect using independence estimating equations, which are unbiased under informative cluster size. We then compared this to two further methods: (1) a cluster-average effect estimated using either weighted independence estimating equations or unweighted cluster-level summaries, and (2) estimates from a mixed-effects model or generalised estimating equations with an exchangeable correlation structure. We then performed a small simulation study to evaluate whether observed differences between cluster- and participant-average estimates were likely to occur even if no informative cluster size was present. RESULTS For most outcomes, treatment effect estimates from different methods were similar. However, differences of >10% occurred between participant- and cluster-average estimates for 5 of 17 outcomes (29%). We also observed several notable differences between estimates from mixed-effects models or generalised estimating equations with an exchangeable correlation structure and those based on independence estimating equations. For example, for the EQ-5D VAS score, the independence estimating equation estimate of the participant-average difference was 4.15 (95% confidence interval: -3.37 to 11.66), compared with 2.84 (95% confidence interval: -7.37 to 13.04) for the cluster-average independence estimating equation estimate, and 3.23 (95% confidence interval: -6.70 to 13.16) from a mixed-effects model. Similarly, for thromboembolic/ischaemic events, the independence estimating equation estimate for the participant-average odds ratio was 0.43 (95% confidence interval: 0.07 to 2.48), compared with 0.33 (95% confidence interval: 0.06 to 1.77) from the cluster-average estimator. CONCLUSION In this re-analysis, we found that estimates from the various approaches could differ, which may be due to the presence of informative cluster size. Careful consideration of the estimand and the plausibility of assumptions underpinning each estimator can help ensure an appropriate analysis methods are used. Independence estimating equations and the analysis of cluster-level summaries (with appropriate weighting for each to correspond to either the participant-average or cluster-average treatment effect) are a desirable choice when informative cluster size is deemed possible, due to their unbiasedness in this setting.
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Somatostatin plus Gastroscopic Administration of Omeprazole for the Treatment of Acute Upper Gastrointestinal Bleeding: An Exploration of a Promising Alternative
Feng L, Fu J
Evidence-based complementary and alternative medicine : eCAM. 2022;2022:6329592
Abstract
OBJECTIVE To analyze the efficacy and safety of somatostatin combined with gastroscopic administration of omeprazole in the treatment of acute upper gastrointestinal bleeding. METHODS Eligible 112 patients with acute upper gastrointestinal bleeding treated in our hospital from May 2019 to July 2020 were randomized at a ratio of 1 : 1 either to the control group (somatostatin) or observation group (somatostatin combined with omeprazole gastroscope administration). The treatment efficacy, the average hemostasis time, rebleeding rate, average length of hospital stay, and the incidence of adverse reactions were compared. RESULTS The study group demonstrated significantly higher total effective rate than the control group (96.45% vs. 80.36%, <0.05). The study group demonstrated superior performances compared to the control group with respect to the average hemostasis time ((14.17 ± 2.53 h) vs. (28.84 ± 4.07 h)), rebleeding rate (3.57% vs. 14.28%), and average length of hospital stay ((5.86 ± 1.26 d) vs. (9.74 ± 1.07 d)) (all p < 0.05). The chi-square test revealed a remarkably lower total incidence of adverse reactions in the study group vs. control group which was (4 (7.14%) vs. 12 (21.43%)) (p < 0.05). CONCLUSION The combination of somatostatin and gastroscopic administration of omeprazole might be a promising alternative for the treatment of acute upper gastrointestinal bleeding. It improves the clinical treatment effect and controls the symptoms of patients, with a good safety profile.
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Effects of Autologous Platelet-Rich Plasma on Healing of Peptic Ulcers: A Randomized Controlled Trial
Xu T, Tian Y, Wang Y, Yi Z, Li C, Wang S, Fan Y, Yao C, Peng G, Lu H
Gastroenterology research and practice. 2022;2022:7944849
Abstract
PURPOSE Peptic ulcer is a multifactorial and complex disease and affects a wide range of people worldwide. We provided a novel therapeutic approach for peptic ulcer and observed its effect. METHODS Peptic ulcer patients were enrolled from 2016 to 2017 in Chongqing and randomly assigned to two groups: a control group that used only rabeprazole and a platelet-rich plasma (PRP) group that received a combination therapy of autologous PRP (aPRP) and rabeprazole. The therapeutic effect was assessed via the ulcer size and symptom score. RESULTS A total of 27 patients were included (12 patients in the control group and 15 patients in the PRP group) in this study. Our results showed that all participants have healed in 30 days, and there was no significant difference in healing time between the PRP group and the control group in different independent variables. However, regression analysis revealed that the healing time was 6.99 days shorter in the PRP group than that in the control group, and patients with higher symptom scores in the initial examination need more time to heal during treatment. Endoscopic results showed that the repaired ulcer in the PRP group was more similar to the normal gastric mucosa tissue than that the control group. CONCLUSION This study showed an encouraging preliminary result that aPRP has a positive result in patients with peptic ulcer and seems to be a better choice for refractory peptic ulcer treatment. Although further follow-up studies are needed to determine the duration of efficacy of aPRP, the approach will be helpful in improving the clinical treatment of peptic ulcer.
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An extended 36-week oral esomeprazole improved long-term recurrent peptic ulcer bleeding in patients at high risk of rebleeding
Chiang HC, Yang EH, Hu HM, Chen WY, Chang WL, Wu CT, Wu DC, Sheu BS, Cheng HC
BMC gastroenterology. 2022;22(1):439
Abstract
BACKGROUND Patients with Rockall scores ≥6 have an increased risk of long-term peptic ulcer rebleeding. This study was aimed toward investigating whether an extended course of oral esomeprazole up to 1 year decreased ulcer rebleeding in such patients. METHODS We prospectively enrolled 120 patients with peptic ulcer bleeding and Rockall scores ≥6. After an initial 16-week oral proton pump inhibitor (PPI) treatment, patients were randomized to receive a 36-week course of oral twice-daily esomeprazole 20 mg (Group D, n = 60) or once-daily (Group S, n = 60). Thereafter, they were divided into the PPI-on-demand (n = 32) and PPI-discontinued (n = 77) subgroups. Our previous cohort with Rockall scores ≥6 served as the controls (Group C, n = 135); they received only an initial 8- to 16-week oral PPI. The primary and secondary outcomes were peptic ulcer rebleeding during the first year and the second year-and-thereafter, respectively. RESULTS For the primary outcome, groups D and S comprised a higher proportion of rebleeding-free than Group C (P = 0.008 and 0.03, log-rank test). The competing-risks regression analysis confirmed that extended PPI use and American Society of Anesthesiologists classification were independent factors contributing to the primary outcome. For the secondary outcome, PPI-on-demand had a borderline higher proportion of rebleeding-free than Group C (P = 0.07, log-rank test); however, only the Rockall score was the independent factor. CONCLUSIONS An extended 36-week course of oral esomeprazole 20 mg, twice- or once-daily for patients with Rockall scores ≥6 reduced ulcer rebleeding during the first year, but the effect needed to be further validated when PPIs were shifted to on-demand or discontinued thereafter (NCT02456012, 28/05/2015).
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Clinical efficacy of norepinephrine combined with cimetidine in treatment of neonatal upper gastrointestinal hemorrhage and its adverse reactions
Dong X, Li H, Zhu T
Pakistan journal of medical sciences. 2022;38(8):2215-2219
Abstract
OBJECTIVES To investigate the clinical efficacy of norepinephrine combined with cimetidine in the treatment of neonatal upper gastrointestinal hemorrhage and its adverse reactions. METHODS A total of 68 cases of neonatal upper gastrointestinal hemorrhage in Huangshi Maternal and Child Health Care Hospital from please mention dates October 2018 to February 2020 were selected and randomly divided into treatment group and control group by coin tossing, with 34 infants in each group. The control group received conventional therapy, and the treatment group was additionally treated with norepinephrine combined with cimetidine. The efficacy and safety were compared between the two groups. RESULTS The time when the bleeding stops, the time of fecal occult blood turning negative and hospital stay of the treatment group were shorter than those of the control group (P < 0.05). Superoxide dismutase (SOD) level increased while malondialdehyde (MDA) level decreased in both groups after treatment compared with those before treatment (P < 0.05). After treatment, the SOD level was higher while the MDA level was lower in the treatment group than those in the control group (P < 0.05). The effective rate of the treatment group was higher than that of the control group (P < 0.05). However, no significance was found in adverse reactions between the two groups (P > 0.05). CONCLUSION Norepinephrine combined with cimetidine in the treatment of neonatal upper gastrointestinal hemorrhage can shorten the recovery time of symptoms, improve efficacy and reduce stress reaction. It is safe, effective and worthy of use in clinical practice.
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Ferric carboxymaltose versus ferrous fumarate in anemic children with inflammatory bowel disease: the POPEYE randomized controlled clinical trial
Bevers N, Van de Vijver E, Aliu A, Ardabili AR, Rosias P, Stapelbroek J, Maartens IAB, van de Feen C, Escher JC, Oudshoorn A, et al
The Journal of pediatrics. 2022
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Editor's Choice
Abstract
OBJECTIVE To determine whether intravenous (IV) or oral iron suppletion is superior in improving physical fitness in anemic children with inflammatory bowel disease (IBD). STUDY DESIGN We conducted a clinical trial at 11 centers. Children aged 8 to 18 with IBD and anemia (defined as hemoglobin (Hb) z-score < -2) were randomly assigned to a single IV dose of ferric carboxymaltose or 12 weeks of oral ferrous fumarate. Primary endpoint was the change in 6-minute walking distance (6MWD) from baseline, expressed as z-score. Secondary outcome was a change in Hb z-score from baseline. RESULTS We randomized 64 patients (33 IV iron; 31 oral iron) and followed them for 6 months. One month after the start of iron therapy, the 6MWD z-score of patients in the IV group had increased by 0.71 compared with -0.11 in the oral group (P=0.01). At 3- and 6-months follow-up, no significant differences in 6MWD z-scores were observed. Hb z-scores gradually increased in both groups and the rate of increase was not different between groups at 1, 3 and 6 months after initiation of iron therapy (overall P=0.97). CONCLUSION In this trial involving anemic children with IBD, a single dose of IV ferric carboxymaltose was superior to oral ferrous fumarate with respect to quick improvement of physical fitness. At 3 and 6 months after initiation of therapy, no differences were discovered between oral or IV therapy. The increase of Hb over time was comparable in both treatment groups. TRIAL REGISTRATION NTR4487 [Netherlands Trial Registry].
PICO Summary
Population
Children with anaemia and inflammatory bowel disease, enrolled in the POPEYE trial, in 9 Dutch and 2 Belgian hospitals (n= 64).
Intervention
Single intravenous dose of ferric carboxymaltose (IV group), (n= 33).
Comparison
12 weeks of oral ferrous fumarate (oral group), (n= 31).
Outcome
The primary endpoint was the change in 6-minute walking distance (6MWD) from baseline, expressed as z-score. The secondary outcome was a change in Hb z-score from baseline. One month after the start of iron therapy, the 6MWD z-score of patients in the IV group had increased by 0.71 compared with -0.11 in the oral group. At 3- and 6- months follow-up, no significant differences in 6MWD z-scores were observed. Hb z-scores gradually increased in both groups and the rate of increase was not different between groups at 1, 3 and 6 months after initiation of iron therapy.
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Hypophosphataemia following ferric derisomaltose and ferric carboxymaltose in patients with iron deficiency anaemia due to inflammatory bowel disease (PHOSPHARE-IBD): a randomised clinical trial
Zoller H, Wolf M, Blumenstein I, Primas C, Lindgren S, Thomsen LL, Reinisch W, Iqbal T
Gut. 2022
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Editor's Choice
Abstract
OBJECTIVE Intravenous iron-a common treatment for anaemia and iron deficiency due to inflammatory bowel disease (IBD)-can cause hypophosphataemia. This trial compared the incidence of hypophosphataemia after treatment with ferric carboxymaltose (FCM) or ferric derisomaltose (FDI). DESIGN This randomised, double-blind, clinical trial was conducted at 20 outpatient hospital clinics in Europe (Austria, Denmark, Germany, Sweden, UK). Adults with IBD and iron deficiency anaemia (IDA) were randomised 1:1 to receive FCM or FDI at baseline and at Day 35 using identical haemoglobin- and weight-based dosing regimens. The primary outcome was the incidence of hypophosphataemia (serum phosphate <2.0 mg/dL) at any time from baseline to Day 35 in the safety analysis set (all patients who received ≥1 dose of study drug). Markers of mineral and bone homeostasis, and patient-reported fatigue scores, were measured. RESULTS A total of 156 patients were screened; 97 (49 FDI, 48 FCM) were included and treated. Incident hypophosphataemia occurred in 8.3% (4/48) FDI-treated patients and in 51.0% (25/49) FCM-treated patients (adjusted risk difference: -42.8% (95% CI -57.1% to -24.6%) p<0.0001). Both iron formulations corrected IDA. Patient-reported fatigue scores improved in both groups, but more slowly and to a lesser extent with FCM than FDI; slower improvement in fatigue was associated with greater decrease in phosphate concentration. CONCLUSION Despite comparably effective treatment of IDA, FCM caused a significantly higher rate of hypophosphataemia than FDI. Further studies are needed to address the longer-term clinical consequences of hypophosphataemia and to investigate mechanisms underpinning the differential effects of FCM and FDI on patient-reported fatigue.
PICO Summary
Population
Adults with inflammatory bowel disease and iron deficiency anaemia enrolled in the PHOSPHARE-IBD trial in five European countries (n= 97).
Intervention
Ferric carboxymaltose (FCM), (n= 48).
Comparison
Ferric derisomaltose (FDI), (n= 49).
Outcome
Incident hypophosphataemia occurred in 8.3% FDI-treated patients and in 51% FCM-treated patients (adjusted risk difference: -42.8% (95% CI -57.1% to -24.6%)). Both iron formulations corrected iron deficiency anaemia. Patient-reported fatigue scores improved in both groups, but more slowly and to a lesser extent with FCM than FDI; slower improvement in fatigue was associated with greater decrease in phosphate concentration.