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Supplementation with Iron in Pulmonary Arterial Hypertension: Two Randomized Crossover Trials
Howard Lsge, He J, Watson GMJ, Huang L, Wharton J, Luo Q, Kiely DG, Condliffe R, Pepke-Zaba J, Morrell NW, et al
Annals of the American Thoracic Society. 2021
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Abstract
RATIONALE Iron deficiency, in the absence of anaemia, is common in patients with idiopathic and heritable pulmonary arterial hypertension (PAH) and is associated with a worse clinical outcome. Oral iron absorption may be impeded by elevated circulating hepcidin levels. The safety and benefit of parenteral iron replacement in this patient population is unclear. OBJECTIVES To evaluate the safety and efficacy of parenteral iron replacement in pulmonary arterial hypertension. METHODS In two randomised, double blind, placebo-controlled 12 week crossover studies, 39 patients in Europe received a single infusion of ferric carboxymaltose (Ferinject®) 1000 mg (or 15 mg/kg if weight < 66.7Kg) or saline as placebo and 17 patients in China received iron dextran (Cosmofer®) 20 mg iron/kg body weight or saline placebo. All patients had idiopathic or heritable PAH and iron deficiency at entry as defined by: a serum ferritin < 37 µg/l or iron < 10.3 µmol/l or transferrin saturations < 16.4%. RESULTS Both iron treatments were well tolerated and improved iron status. Analysed separately and combined, there was no effect on any measure of exercise capacity (using cardiopulmonary exercise testing or 6 minute walk test) or cardio-pulmonary haemodynamics, as assessed by right heart catheterisation, cardiac magnetic resonance or plasma NT-proBNP, at 12 weeks. CONCLUSION Iron repletion by administration of a slow release iron preparation as a single infusion to PAH patients with iron deficiency without overt anaemia was well tolerated but provided no significant clinical benefit at 12 weeks. Clinical trial registered with ClinicalTrials.gov (NCT01447628).
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Effectiveness of intravenous immunoglobulin for children with severe COVID-19: A rapid review
Zhang J, Yang Y, Yang N, Ma Y, Zhou Q, Li W, Wang X, Huang L, Luo X, Fukuoka T, et al
Annals of Translational Medicine. 2020
Abstract
Background: Intravenous immunoglobulin (IVIG) is usually used as supportive therapy, but the treatment of COVID-19 by IVIG is controversial This rapid review aims to explore the clinical effectiveness and safety of IVIG in the treatment of children with severe COVID-19 Methods: We systematically searched the literature on the use of IVIG in patients with COVID-19, severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS), including both adults and children We assessed the risk of bias and quality of evidence and reported the main findings descriptively Results: A total of 1,519 articles were identified by initial literature search, and finally six studies met our inclusion criteria, included one randomized controlled trial (RCT), four case series and one case report involving 198 patients One case series showed the survival of COVID-19 patients with acute respiratory distress syndrome (ARDS) was not improved by IVIG One case report showed high-dose IVIG could improve the outcome of COVID-19 adults Three observational studies showed inconsistent results of the effect of IVIG on SARS patients One RCT showed that IVIG did not reduce mortality or the incidence of nosocomial infection in adults with severe SARS The quality of evidence was between low and very low Conclusions: The existing evidence is insufficient to support the efficacy or safety of IVIG in the treatment of COVID-19
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Antiviral agents, glucocorticoids, antibiotics, and intravenous immunoglobulin usage in 1142 patients with coronavirus disease 2019: a systematic review and meta-analysis
Pei L, Zhang S, Huang L, Geng X, Ma L, Jiang W, Li W, Chen D
Pol Arch Intern Med. 2020
Abstract
INTRODUCTION Treatment effects of antiviral agents, glucocorticoids, antibiotics, and intravenous immunoglobulin are controversial in patients with Coronavirus disease 2019 (COVID-19). OBJECTIVES To evaluate the impact of drug therapy on the risk of death in patients with COVID-19. PATIENTS AND METHODS The PubMed, EMBASE, Web of Science, Cochrane Library, and major preprint platforms were searched to retrieve articles till 7 April 2020. The effects of specific drug interventions on mortality were assessed in COVID-19 patients. Odds ratios (ORs) and Risk Ratios (RRs) with corresponding 95% confidence intervals (CIs) were pooled using random-effects models. RESULTS Of 3421 references, six studies were included. Pooled results from retrospective studies revealed that antiviral agents may contribute to survival benefit (OR, 0.42, 95% CI, 0.17-0.99, p=0.048, I2=82.8%), while the RCT found no effects of antiviral agent on mortality (RR 0.77, 95% CI, 0.45-1.30, p=0.33). Glucocorticoids usage leads to an increased risk of death (OR 2.43, 95% CI, 1.44-4.10, p=0.001, I2=61.9%). Antibiotics intervention did not significantly affect mortality (OR 1.13, 95% CI, 0.67-1.89, p=0.64, I2=0%). Likewise, intravenous immunoglobulin had non-significant effects on mortality (OR 2.66, 95% CI, 0.72-9.89, p=0.14, I2=93.1%). CONCLUSIONS With the varied heterogeneities across interventions, the current evidence indicated a probable survival benefit of antiviral agent usage and a harmful effect of glucocorticoids in patients with COVID-19. None of antibiotics or intravenous immunoglobulin usage was associated with survival benefit in patients with COVID-19.
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Intra-articular platelet-rich plasma injection for knee osteoarthritis: a summary of meta-analyses
Chen P, Huang L, Ma Y, Zhang D, Zhang X, Zhou J, Ruan A, Wang Q
Journal of orthopaedic surgery and research. 2019;14(1):385
Abstract
OBJECTIVE The purpose of this study was (1) to perform a summary of meta-analyses comparing platelet-rich plasma (PRP) injection with hyaluronic acid (HA) and placebo injection for KOA patients, (2) to determine which meta-analysis provides the best available evidence to making proposals for the use of PRP in the treatment of KOA patients, and (3) to highlight gaps in the literature that require future investigation. MATERIAL AND METHODS PubMed, EMBASE, and Cochrane databases search were performed for meta-analyses which compared PRP injection with HA or placebo. Clinical outcomes and adverse events were extracted from these meta-analyses. Meta-analysis quality was assessed using the Quality of Reporting of Meta-analyses (QUOROM) systems and the Oxman-Guyatt quality appraisal tool. The Jadad decision algorithm was also used to determine which meta-analysis provided the best available evidence. RESULTS Four meta-analyses were included in our study, and all of these articles were Level I evidence. The QUOROM score of each included meta-analysis range from 14 to 17 points (mean score 15, maximum score 18), and the Oxman-Guyatt score range from 4 to 6 points (mean score 5, maximum score 7). Three meta-analyses indicated PRP showed more benefit in pain relief and functional improvement than the control group, and the other one suggested no difference between these groups. All included meta-analyses found no statistical difference in adverse events between these groups. In addition, a meta-analysis conducted by Shen et al. got the highest methodological quality score and suggested that PRP provided better pain relief and function improvement in the treatment of KOA. CONCLUSIONS For short-term follow-up (≤1 year), intra-articular PRP injection is more effective in terms of pain relief and function improvement in the treatment of KOA patients than HA and placebo, and there is no difference in the risk of an adverse event between PRP and HA or placebo. LEVEL OF EVIDENCE Level I evidence, a summary of meta-analyses TRIAL REGISTRATION PROSPERO ID CRD42018116168.
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Effects of intravenous iron on fibroblast growth factor 23 (FGF23) in haemodialysis patients: a randomized controlled trial
Roberts MA, Huang L, Lee D, MacGinley R, Troster SM, Kent AB, Bansal SS, Macdougall IC, McMahon LP
Bmc Nephrology. 2016;17((1)):177.
Abstract
BACKGROUND Intravenous iron affects serum levels of intact fibroblast growth factor-23 (iFGF23) and its cleavage product c-terminal FGF23 (cFGF23) in iron-deficient people with normal renal function. We hypothesized that intravenous iron modulates iFGF23 and cFGF23 in haemodialysis patients differently according to the type of iron used. METHODS Prevalent, stable haemodialysis patients requiring protocol-based intravenous iron therapy were randomized to a single 200 mg dose of either ferric carboxymaltose (FCM) or iron sucrose (IS). The primary outcome was change in iFGF23 and cFGF23 from pre-infusion to Day 2 post-infusion. Serum hepcidin, ferritin and phosphate were also measured. Pair-wise comparisons utilised the Wilcoxon rank sum test; linear mixed models with an interaction term for treatment and time evaluated between-group effects. RESULTS Forty-two participants completed the study. In those randomized to FCM (n = 22), median (interquartile range) values pre-infusion and Day 2, respectively, were 843 pg/mL (313-1922) and 576 pg/mL (356-1296, p = 0.05) for iFGF23, 704RU/mL (475-1204) and 813RU/mL (267-1156, p = 0.04) for cFGF23, and 1.53 mmol/L (1.14-1.71) and 1.37 (1.05-1.67, p = 0.03) for phosphate. These parameters did not change following IS. Both serum ferritin (p < 0.001) and hepcidin (p < 0.001) increased in both groups, and the increase in hepcidin was greater in the FCM group (p = 0.03 for between-group difference). CONCLUSIONS Contrary to iron-deficient people with normal renal function, haemodialysis patients given protocol-driven intravenous FCM demonstrated a fall in iFGF23 and a rise in cFGF23, changes not evident with IS. This suggests a differential effect of intravenous iron treatment according to both formulation and renal function. TRIAL REGISTRATION Australian and New Zealand Clinical Trials Register ACTRN12614000548639 . Registered 22 May 2014 (retrospectively registered).