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OBJECTIVES: A reappraisal of the validity of the conclusions of systematic reviews (SRs) related to nirmatrelvir/ritonavir for the treatment of COVID-19. METHODS: An overview of SRs (umbrella review). The methodological quality of the SRs was assessed using the AMSTAR 2 checklist; quality of the evidence from the trials included in each SR was appraised following the GRADE approach. RESULTS: Sixteen SRs with meta-analysis published between 2020 and 2023 were included in this overview. The SRs reported data from 108 overlapping reports, based on 43 individual primary studies [3 randomized clinical trials (RCTs), 40 non-RCTs]. In outpatient settings the use of nirmatrelvir/ritonavir reduced overall mortality, hospital admission and progression of disease compared with controls (from moderate to low certainty of evidence); nirmatrelvir/ritonavir reduced mortality, hospital admission and progression of disease in both immunized and non-immunized patients. No differences in the occurrence of any adverse events between groups were observed in the large majority of SRs; serious adverse events, including adverse events requiring discontinuation of treatment, were reported with lower prevalence in nirmatrelvir recipients compared with controls (from low to moderate certainty of evidence). CONCLUSIONS: There is low to moderate certainty of evidence from SRs that nirmatrelvir/ritonavir reduces mortality, clinical progression and hospitalization rate in COVID-19 patients compared with controls, without increasing the occurrence of overall and serious adverse events. Based on the overall methodological assessment, on average we can have high confidence in the quality of results generated by the SRs.
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COVID-19 , Humanos , Tratamento Farmacológico da COVID-19 , Ritonavir/uso terapêutico , Revisões Sistemáticas como AssuntoRESUMO
Artificial intelligence (AI) uses sophisticated algorithms to "learn" from large volumes of data. This could be used to optimise recruitment of blood donors through predictive modelling of future blood supply, based on previous donation and transfusion demand. We sought to assess utilisation of predictive modelling and AI blood establishments (BE) and conducted predictive modelling to illustrate its use. A BE survey of data modelling and AI was disseminated to the International Society of Blood transfusion members. Additional anonymzed data were obtained from Italy, Singapore and the United States (US) to build predictive models for each region, using January 2018 through August 2019 data to determine likelihood of donation within a prescribed number of months. Donations were from March 2020 to June 2021. Ninety ISBT members responded to the survey. Predictive modelling was used by 33 (36.7%) respondents and 12 (13.3%) reported AI use. Forty-four (48.9%) indicated their institutions do not utilise predictive modelling nor AI to predict transfusion demand or optimise donor recruitment. In the predictive modelling case study involving three sites, the most important variable for predicting donor return was number of previous donations for Italy and the US, and donation frequency for Singapore. Donation rates declined in each region during COVID-19. Throughout the observation period the predictive model was able to consistently identify those individuals who were most likely to return to donate blood. The majority of BE do not use predictive modelling and AI. The effectiveness of predictive model in determining likelihood of donor return was validated; implementation of this method could prove useful for BE operations.
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Doação de Sangue , Doadores de Sangue , COVID-19 , Pandemias , Feminino , Humanos , Masculino , Inteligência Artificial , COVID-19/epidemiologia , COVID-19/prevenção & controle , Seleção do Doador , Itália/epidemiologia , SARS-CoV-2 , Singapura/epidemiologia , Inquéritos e Questionários , Estados Unidos , Doação de Sangue/estatística & dados numéricosRESUMO
BackgroundIn high-income countries, hepatitis E virus (HEV) infection is mainly a zoonosis. However, it is also transfusion-transmissible and some countries, but not Italy, have introduced HEV screening for blood donations.AimWe assessed HEV infection prevalence and risk factors in a nationwide sample of Italian blood donors.MethodsWe selected 107 blood establishments (BE) distributed in the 20 Italian regions by a stratified two-stage design and invited them to participate in the study. Donors were tested for anti-HEV IgG and IgM and HEV RNA. Sociodemographic data and risk factors were collected through a questionnaire.ResultsOverall, 60 BE from 60 provinces in 19 Italian regions joined the study. We assessed HEV markers in 7,172 blood donors, of whom 6,235 completed the questionnaire. Overall crude and adjusted anti-HEV IgG prevalences were 8.3% and 5.5%, respectively. Overall anti-HEV IgM prevalence was 0.5%, while no blood donor was HEV RNA-positive. Anti-HEV IgG prevalence varied widely among regions (range: 1.3%-27.20%) and hyperendemic prevalences (> 40%) were detected in some provinces in two regions. Older age (AORâ¯=â¯1.81; 95% CI: 1.36-2.41), foreign nationality (AORâ¯=â¯2.77; 95% CI: 1.06-7.24), eating raw pork liver sausages (AORâ¯=â¯2.23; 95% CI: 1.55-3.20) and raw homemade sausages (AORâ¯=â¯3.63; 95% CI: 2.50-5.24) were independent infection predictors.ConclusionItalian blood donors showed a low to moderate HEV seroprevalence. High levels in some regions and/or provinces were mainly attributable to eating habits. Prevention should include avoiding consumption of raw or undercooked meat and safe production of commercial pork products.
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Vírus da Hepatite E , Hepatite E , Doadores de Sangue , Anticorpos Anti-Hepatite , Hepatite E/epidemiologia , Humanos , Imunoglobulina G , Imunoglobulina M , Prevalência , Fatores de Risco , Estudos Soroepidemiológicos , Inquéritos e QuestionáriosRESUMO
As in 2018, when a large West Nile virus (WNV) epidemic occurred, the 2022 vector season in Italy was marked by an early onset of WNV circulation in mosquitoes and birds. Human infections were limited until early July, when we observed a rapid increase in the number of cases. We describe the epidemiology of human infections and animal and vector surveillance for WNV and compare the more consolidated data of June and July 2022 with the same period in 2018.
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Culicidae , Febre do Nilo Ocidental , Vírus do Nilo Ocidental , Animais , Aves , Humanos , Itália/epidemiologia , Mosquitos Vetores , Febre do Nilo Ocidental/epidemiologia , Febre do Nilo Ocidental/veterináriaRESUMO
OBJECTIVES: To estimate the number of actually Severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) infected blood donors applying a statistical forecasting model. BACKGROUND: Following the outbreak of the SARS-CoV-2 epidemic, a drop in blood donation has been observed. It is crucial to determine the actual number of potential SARS-CoV-2-positive donors to define the measures and ensure adequate blood supply. METHODS: The cumulative incidence of SARS-CoV-2 positivity, calculated on the general population, was applied to the donor population by estimating the number of positive subjects. The calculation model was validated by the linear interpolation method. The number of blood units actually discarded based on post-donation information was also taken into account. RESULTS: Three months after the outbreak, 5322 donors were estimated to be positive for SARS-CoV-2 and were therefore potentially excluded from donation. A total of units of blood components were discarded following post donation information. The estimated number of donors deceased (180) and the number of clinically recovered individuals in the same period was also considered. CONCLUSION: This forecasting model can be used to obtain information on blood donors' involvement during future SARS-CoV-2 outbreaks, especially in case of changes concerning epidemiology, incidence by age bracket and geographical distribution and also for new outbreaks of emerging viruses.
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Doadores de Sangue/estatística & dados numéricos , COVID-19/diagnóstico , COVID-19/epidemiologia , SARS-CoV-2 , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Bancos de Sangue/provisão & distribuição , Segurança do Sangue/estatística & dados numéricos , Seleção do Doador/estatística & dados numéricos , Feminino , Previsões , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Pandemias , Adulto JovemRESUMO
There is little information available on the possible toxic effects that antiretroviral (ARV) drugs used for the treatment of human immunodeficiency virus (HIV)-infected subjects, may have on the central nervous system (CNS) resident cells. Moreover, it remains unclear whether the efficacy of the ARV drugs may also be due to their ability to exert extravirological effects on factors responsible for the development of HIV brain injury, e.g., matrix metalloproteinases (MMPs). This study investigates the toxicity of three different ARV drugs and on their ability to modulate levels and expression of gelatinases A (MMP-2) and B (MMP-9) in astrocytes. Primary cultures of rat astrocytes were activated by exposure to lipopolysaccaride (LPS) and simultaneously treated with darunavir, maraviroc, or raltegravir, used alone or in combination. Among the tested drugs, maraviroc was the less toxic for astrocytes. At toxic concentration (TC50 ), the studied drugs induced the production of reactive oxygen species (ROS), suggesting that the oxidative stress may represent a mechanism of ARV toxicity. As assessed by gelatin zymography and RT-PCR, the single antiretroviral drugs reduced levels and expression of both MMP-2 and MMP-9 through the inhibition of the signaling transduction pathway of extracellular signal-regulated kinase1/2, which is involved in the regulation of MMP-9 gene. A synergistic inhibition of MMP-2 and MMP-9 was observed with combinations of the studied ARV drugs. The present results indicate that maraviroc, darunavir, and raltegravir, through their ability to inhibit MMP-2 and MMP-9 at doses non-toxic for astrocytes, might have a great potential for the management of HIV-associated neurological complications.
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Antirretrovirais/toxicidade , Astrócitos/efeitos dos fármacos , Astrócitos/metabolismo , Metaloproteinase 2 da Matriz/metabolismo , Metaloproteinase 9 da Matriz/metabolismo , Animais , Sobrevivência Celular , Darunavir/toxicidade , Feminino , Masculino , Maraviroc/toxicidade , Cultura Primária de Células , Raltegravir Potássico/toxicidade , Ratos Wistar , Espécies Reativas de OxigênioRESUMO
An imbalance between matrix metalloproteinases (MMPs) and tissue inhibitors of metalloproteinases (TIMPs) may contribute to liver fibrosis in patients with hepatitis C (HCV) infection. We measured the circulating levels of different MMPs and TIMPs in HCV monoinfected and HIV/HCV coinfected patients and evaluated the potential for anti-HCV therapy to modulate MMP and TIMP levels in HCV subjects. We analyzed 83 plasma samples from 16 HCV monoinfected patients undergoing dual or triple anti-HCV therapy, 15 HIV/HCV coinfected patients with undetectable HIV load, and 10 healthy donors (HD). Levels of MMP-1, MMP-2, MMP-3, MMP-8, MMP-9, MMP-10, TIMP-1, and TIMP-2 were measured by a SearchLight Multiplex Immunoassay Kit. MMP-2 and MMP-9 were the highest expressed MMPs among all the analyzed samples and their levels significantly increased in HCV monoinfected and HIV/HCV coinfected subjects compared to HD. TIMP-1 levels were significantly higher in HCV and HIV/HCV subjects compared to HD and were correlated with liver stiffness. These findings raise the possibility of using circulating TIMP-1 as a non-invasive marker of liver fibrosis in HCV infection. A longitudinal study demonstrated that MMP-9 levels significantly decreased (40% reduction from baseline) in patients receiving dual as well as triple direct-acting antivirals (DAA) anti-HCV therapy, which had no effect on MMP-2, TIMP-1, and TIMP-2. As the dysregulation of MMP-2 and MMP-9 may reflect inflammatory processes in the liver, the decrease of MMP-9 following HCV protease inhibitor treatment suggests a positive effect on the reduction of liver inflammation.
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Infecções por HIV/complicações , Hepatite C/tratamento farmacológico , Cirrose Hepática/patologia , Metaloproteinases da Matriz/sangue , Inibidores de Proteases/uso terapêutico , Inibidores Teciduais de Metaloproteinases/sangue , Adulto , Idoso , Antivirais/uso terapêutico , Feminino , Hepatite C/complicações , Humanos , Imunoensaio , Cirrose Hepática/complicações , Estudos Longitudinais , Masculino , Metaloproteinases da Matriz/metabolismo , Pessoa de Meia-Idade , Inibidores Teciduais de Metaloproteinases/metabolismoAssuntos
COVID-19 , Coronavirus , Segurança do Sangue , Transfusão de Sangue , Surtos de Doenças , Humanos , Itália/epidemiologia , SARS-CoV-2RESUMO
BACKGROUND: Platelet-rich plasma (PRP) as a non-surgical therapy for facial rejuvenation is increasingly adopted. This article aims to review the literature and critically appraise the available evidence regarding the efficacy and safety of PRP for facial rejuvenation. MATERIAL AND METHODS: An overview of systematic reviews (SRs) of PRP use for facial rejuvenation. The methodological quality of the SRs was assessed using the AMSTAR-2 checklist; quality of the evidence from the trials included in each SR was appraised following the GRADE approach. RESULTS: Thirteen SRs published between 2015 and 2023, reporting data from 114 overlapping reports, based on 28 individual primary studies (18 uncontrolled reports), were included in this umbrella review. Eight primary studies evaluated PRP in combination with other treatments (laser therapy, fat grafting, hyaluronic acid, basic fibroblast growth factor), and 20 PRP monotherapy. Most of the included primary studies were uncontrolled, and meta-analysis for outcomes related to facial rejuvenation was conducted in only 1 of the 13 SRs, showing that patients treated with PRP as an adjunct treatment have increased satisfaction over controls without PRP (mean difference, 0.63; 95% confidence intervals (CIs) 0.25/1; p=0-001; low certainty of evidence due to risk of bias (ROB) and inconsistency). No other quantitative data were available from the SRs, although 4 SRs concluded in a descriptive way reveal that PRP combined with laser therapy increased subject satisfaction and skin elasticity, and decreased the erythema index (very low certainty of evidence due to imprecision, unsystematic clinical observations, and ROB). The occurrence of adverse events was a predefined outcome in only 2 SRs (15%). Almost all the SRs demonstrated poor compliance with the AMSTAR 2 items, and the confidence in the results of SRs was graded as low or critically low in 12 of the 13 SRs. DISCUSSION: The available evidence is insufficient to suggest firm conclusions about the use of PRP, alone or in combination with other treatments, in promoting facial rejuvenation.
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Plasma Rico em Plaquetas , Rejuvenescimento , Humanos , Técnicas Cosméticas/efeitos adversos , Face , Envelhecimento da Pele , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: There is some evidence showing rebound of COVID-19 infections in patients treated with nirmatrelvir-ritonavir between 2 and 8 days following cessation of the antiviral treatment. COVID-19 rebound is not unique to patients treated with nirmatrelvir-ritonavir, but is also observed in molnupiravir recipients, in patients who did not receive any antiviral treatment and in patients who received convalescent plasma (CP). MATERIALS AND METHODS: This was a systematic review with meta-analysis of clinical trials evaluating rates of virologic and clinical rebound in COVID-19 patients receiving antiviral agents, CP or no treatment. Both randomized clinical trials and controlled cohort studies were considered. The methodological quality of trials was assessed using ROB-2 and ROBIN-1 checklists, and the GRADE approach. RESULTS: Data were available from 16 trials. The occurrence of virologic rebound was more commonly observed among nirmatrelvir recipients than among untreated patients (relative risk [RR]=2.12; 95% confidence interval [CI]: 1.38-3.28; p=0.0007). No differences were observed in the occurrence of virologic rebound between nirmatrelvir-ritonavir and molnupiravir recipients (RR=1.01; 95% CI: 0.71-1.43). Similar rates of virologic rebounds were observed in molnupiravir recipients and untreated patients (RR=1.14; 95% CI: 0.81-1.6). One study in the pre-omicron period compared rates of virologic rebound between patients receiving standard of care with or without CP: no differences were observed between groups (RR=1.04; 95% CI: 0.55-1.99). Rates of clinical rebound were reported in seven trials, five evaluating nirmatrelvir-ritonavir and untreated patients, and two evaluating nirmatrelvir-ritonavir and molnupiravir recipients. No statistically significant differences between groups were observed. For all these comparisons, the certainty of the available evidence was graded as low or moderate. DISCUSSION: Virologic rebound of COVID-19 infections appears to be mild and self-limited, and was observed more commonly in nirmatrelvir-ritonavir recipients than in untreated patients, but was also observed in patients treated with molnupiravir or CP.
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BACKGROUND: A reappraisal of the conclusions of systematic reviews (SRs) and meta-analyses validity related to Platelet-rich plasma (PRP), alone or in combination with other treatments, compared to regimens PRP-free for the treatment of acne scars. MATERIALS AND METHODS: An overview of SRs. The methodological quality of the reviews was assessed using AMSTAR-2 checklist; quality of the evidence of primary studies was appraised following the GRADE approach. RESULTS: Fifteen SRs were included in this overview. Data were from 124 overlapping reports, based on 34 individual primary studies (10 parallel arm randomized trials, 21 split-face studies, and 3 uncontrolled studies). Most of the studies evaluated combination of PRP with microneedling or with laser therapy compared to microneedling or laser therapy without PRP. Clinical improvement (reported as degree of improvement or improvement score) and patient's satisfaction rate were significantly higher in PRP recipients compared to controls. Crusting time and duration of erythema were significantly shorter in PRP recipients compared to controls. Most of the reviews considered in this overview can be considered of low methodological quality due to the fact that several critical methodological requirements of AMSTAR-2 checklist were unmet or partially met; only 6 of the 15 reviews incorporated study quality in their conclusions, and no GRADE assessment was performed for the reported outcomes in any of the SRs. With the GRADE approach, the quality of the evidence for the outcomes analysed ranged from very low to low due to risk of bias in the primary studies, inconsistency between the studies, and imprecision. DISCUSSION: The low or very low certainty of evidence does not support clear clinical decision about the PRP use in combination with microneedling or laser therapy for the treatment of acne scars. Further well-designed studies are required to improve the evidence base for PRP combination therapy for acne scars.
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BACKGROUND: In this systematic review and meta-analysis, we evaluated ultrasound (US)-guided injections of platelet-rich plasma (PRP) as conservative treatment of tendinopathies. MATERIALS AND METHODS: We searched MEDLINE, EMBASE, SCOPUS, OVID, and the Cochrane Library to identify randomized controlled trials (RCT) on the use of US-guided PRP for tendinopathies. RESULTS: We found 33 RCT (2,025 subjects) that met our inclusion criteria: 8 in lateral epicondylitis, 5 in plantar fasciitis, 5 in Achilles tendinopathy, 7 in rotator cuff tendinopathy, 3 in patellar tendinopathy and 5 in carpal tunnel syndrome. PRP, given as a single injection (20 trials) or multiple injections (13 trials), was compared to US-guided injection of steroids, saline, autologous whole blood, local anesthetic, dry needling, prolotherapy, bone marrow mesenchymal stem cells, or with non-injective interventions. The outcomes more commonly reported included pain and functional measures, subgrouped as in the short-term (<3 months from the intervention), medium-term (3 to 6 months) or long-term (≥12 months). No clear between-group differences in these outcomes were observed in patients with lateral epicondylitis, plantar fasciitis, or Achilles, rotator cuff or patellar tendinopathy. In patients with carpal tunnel syndrome, visual analog scale scores for pain at 3 and 6 months and Boston Carpal Tunnel Questionnaire severity scores at 1, 3 and 6 months were significantly lower in PRP recipients than in controls. The certainty of evidence of all these comparisons was graded as low or very low due to risk of bias, imprecision and/or inconsistency. Pain at the injection site was more common among PRP recipients than among controls receiving other US-guided injections. DISCUSSION: In patients with tendinopathies, a trend towards pain reduction and functional improvement from baseline was observed after US-guided PRP injection, but in the majority of the comparisons, the effect size was comparable to that observed in control groups.
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Síndrome do Túnel Carpal , Fasciíte Plantar , Plasma Rico em Plaquetas , Tendinopatia , Cotovelo de Tenista , Humanos , Cotovelo de Tenista/diagnóstico por imagem , Cotovelo de Tenista/terapia , Tendinopatia/diagnóstico por imagem , Tendinopatia/terapia , Ultrassonografia de Intervenção , Dor , Resultado do TratamentoRESUMO
BACKGROUND: In recent years, co-infection from HIV and Treponema pallidum has become more common. Early detection of the co-infection allows us to implement therapeutic strategies to control the evolution of the disease and to contain its transmission in the general population. The donor population is the target of choice for the detection of early-stage infections. This study aims to evaluate the trend of HIV/T. pallidum positivity in the Italian blood donor population, defining the type of donor most involved. MATERIALS AND METHODS: A retrospective analysis of consecutive blood donors' records, covering the period between January 2009 and December 2021, was conducted using the database of the National Blood Information System. The data extracted were the results of of confirmed positivity notifications for T. pallidum and sociodemographic variables of blood donors. The effect of age, female gender, donor category, year, and Italian origin on the probability of HIV/T. pallidum co-infection were estimated using a logistic regression model. RESULTS: In the period of observation, we found 79 subjects with HIV/T. pallidum dual co-infection, 3 with HIV/HCV/T. pallidum triple co-infections, and 2 with HIV/HBV/T. pallidum triple co-infections. Seventy-one out of 84 co-infections (89%) were among first-time tested donors, reporting sexual behaviors at risk. The results of the logistic regression show that age, female gender and regular donor status were not associated with HIV/T. pallidum co-infection. DISCUSSION: The transfusion network can provide a valid contribution to containing the spread of HIV and T. pallidum infections, raising the awareness of donors, and promptly referring the donor with confirmed positivity to the reference specialist.
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Coinfecção , Infecções por HIV , Sífilis , Humanos , Feminino , Treponema pallidum , Doadores de Sangue , Sífilis/epidemiologia , Coinfecção/epidemiologia , Estudos Retrospectivos , Estudos Soroepidemiológicos , Prevalência , Infecções por HIV/epidemiologiaRESUMO
BACKGROUND: The number of articles evaluating the efficacy of platelet-rich plasma (PRP) in androgenetic alopecia (AGA) and alopecia areata (AA) has increased exponentially during the last years. This systematic review and meta-analysis is aimed at evaluating the benefit of PRP in the treatment of alopecia. MATERIAL AND METHODS: We searched MEDLINE (through PUBMED), Embase, and CENTRAL for relevant data. Treatment effect was described by mean difference (MD) and risk difference with 95% confidence intervals (CI). The GRADE system was used to assess the certainty of the body of evidence. RESULTS: We found 27 controlled trials (1,117 subjects) that met our inclusion criteria: 18 trials (713 subjects) in patients with AGA, and 9 (404 subjects) in patients with AA. Eleven studies had a split head design. There was heterogeneity in types of PRP (e.g., activated and non-activated) and administration schedules. PRP was compared to saline injections (18 studies), local steroid injections (4 studies) and other comparators (5 studies). Most commonly reported outcomes were hair density and hair regrowth. It was not possible to pool all outcome data because of heterogeneity in reporting, and because reporting was often limited to a single study. Compared to saline injections, PRP injections increased hair density over a medium-term follow-up (MD, 25.6 hairs/cm2; 95 % CI: 2.62-48.57), but the evidence was rated as low quality due to inconsistency and risk of bias. In individuals with AA, it is unclear whether PRP injection compared with triamcinolone injection increase the rate of subjects with hair regrowth (very-low quality of evidence due to inconsistency, imprecision, and risk of bias). There were no serious adverse events related to PRP injection or control treatments. CONCLUSIONS: There is limited evidence showing benefit of PRP for treatment of alopecia, and most of this evidence is of low quality.
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Alopecia em Áreas , Plasma Rico em Plaquetas , Humanos , Alopecia em Áreas/terapia , Protocolos Clínicos , Resultado do TratamentoRESUMO
This review is focused on the use of hyperimmune globulin therapy to treat some infectious diseases of viral or bacterial origin. Despite the introduction of antibiotics and vaccines, plasma immunoglobulin therapy from whole blood donation can still play a key role. These treatments provide passive transfer of high-titer antibodies that either reduces the risk or the severity of the infection and offer immediate but short-term protection against specific diseases. Antibody preparations derived from immunized human donors are commonly used for the prophylaxis and treatment of rabies, hepatitis A and B viruses, varicella-zoster virus, and pneumonia caused by respiratory syncytial virus, Clostridium tetani, Clostridium botulinum. The use of hyperimmune globulin therapy is a promising challenge, especially for the treatment of emerging viral infections for which there are no specific therapies or licensed vaccines.
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Doenças Transmissíveis , Globulinas , Vacinas , Humanos , Imunoglobulinas/uso terapêutico , Imunização Passiva , Doenças Transmissíveis/terapia , Anticorpos AntiviraisRESUMO
Purpose: A reappraisal of the validity of the conclusions of systematic reviews (SRs) and meta-analyses related to corticosteroids use for the treatment of COVID-19. Material and Methods: An overview of SRs (umbrella review). The methodological quality of the SRs was assessed using tha AMSTAR-2 checklist; quality of the evidence was appraised following the GRADE approach. Results: 35 SRs were included in this overview. Data were from 307 overlapping reports, based on 121 individual primary studies (25 randomized clinical trials (RCTs), 96 non-RCTs. In critically ill patients the use of steroids significantly reduced mortality compared to standard of care in 80% of the SRs, more often with moderate/high level of certainty; however, in patients not requiring oxygen supplementation the use of steroids increased the overall mortality in 2/3 of the comparisons. Clinical progression of diseases (need for mechanical ventilation, or for intensive care admission) was more commonly observed among controls compared to steroids recipients (in 9 out of 14 comparisons; certainty of evidence from very-low to moderate). The occurrence of adverse events was similar among steroids recipients and controls. Other outcomes (i.e., viral clearance, length of hospital stay) or issue related to optimal dose and type of steroids were addressed in a minority of SRs, with a high level of uncertainty, so that no definitive conclusions can be drawn. Conclusions: There is moderate certainty of evidence that corticosteroids reduce mortality and progression of disease in critically ill COVID-19 patients compared to standard of care, without increasing the occurrence of adverse events.
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In this systematic review, we evaluate the efficacy and safety of blood components treated with pathogen reduction technologies (PRTs). We searched the Medline, Embase, Scopus, Ovid, and Cochrane Library to identify RCTs evaluating PRTs. Risk of bias assessment and the Mantel-Haenszel method for data synthesis were used. We included in this review 19 RCTs evaluating 4332 patients (mostly oncohematological patients) receiving blood components treated with three different PRTs. Compared with standard platelets (St-PLTs), the treatment with pathogen-reduced platelets (PR-PLTs) does not increase the occurrence of bleeding events, although a slight increase in the occurrence of severe bleeding events was observed in the overall comparison. No between-groups difference in the occurrence of serious adverse events was observed. PR-PLT recipients had a lower 1 and 24 h CI and CCI. The number of patients with platelet refractoriness and alloimmunization was significantly higher in PR-PLT recipients compared with St-PLT recipients. PR-PLT recipients had a higher number of platelet and RBC transfusions compared with St-PLT recipients, with a shorter transfusion time interval. The quality of evidence for these outcomes was from moderate to high. Blood components treated with PRTs are not implicated in serious adverse events, and PR-PLTs do not have a major effect on the increase in bleeding events. However, treatment with PRTs may require a greater number of transfusions in shorter time intervals and may be implicated in an increase in platelet refractoriness and alloimmunization.
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Background: Eligibility criteria for blood donation require hemoglobin levels of ≥12.5 g/dL for women and ≥13.5 g/dL for men, and a platelet count of ≥180 × 109/L. Screening methods before donation should ensure high accuracy, precision, and ease in operation. We assessed the performance, precision, and repeatability of the Horiba Micros ES 60 (Horiba) compared to the Beckman Coulter DXH 800. Methods: Performance was compared by testing samples for each of the 11 devices across 6 sites in the Transfusion Service of Friuli Venezia Giulia Region, Italy. We measured precision by calculating the coefficient of variation (CV), concordance with ρ-Pearson's correlation coefficient, and accuracy with F-tests. The intra-assay agreement was examined in the 11 devices, and repeatability was performed by using CV and the Kruskal−Wallis test. Results: The precision of Horiba was acceptable. Overall, ρ-Pearson's coefficients indicated a strong correlation and positive relationship between all variables. The Bland−Altman plots showed that most of the differences lay within the limits of agreement. All CV were below the reference threshold for all the parameters. Finally, the Kruskal−Wallis test reported non-significant statistical differences for all parameters, except platelet count (p < 0.000). Conclusions: Horiba is adequate for routine pre-donation screening. The intra-assay agreement further demonstrates the accuracy of the device.