Platelet rich plasma for facial rejuvenation: an overview of systematic reviews.

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.

A survey on the implementation of Patient Blood Management programs in Italy.

BACKGROUND: Since 2012, in line with the World Health Organization (WHO) resolution WHA63.12 of 05/21/2010, the Italian National Blood Center has been promoting patient blood management (PBM). In order to verify the level of PBM implementation nationwide, we submitted a survey to all healthcare providers. MATERIAL AND METHODS: In line with what was proposed in the international scientific literature in the field, a series of indicators were used derived from the four main blocks related to PBM strategies: the management of patient anemia; the optimization of hemostasis; blood conservation strategies; patient-centred decision-making. We also added two blocks containing important information on general PBM management and other PBM-related aspects. RESULTS: The survey showed good implementation of anemia screening programs in accordance with the timelines established by national and international guidelines, and the single unit policy is used in line with national guideline recommendations. However, the survey also revealed limited auditing of PBM programs and reduced monitoring and reporting of clinical outcomes and indicators. DISCUSSION: The first national survey on the level of PBM implementation in Italy shows widespread adoption of diagnostic-therapeutic care pathways aimed at the diagnosis and treatment of anemia in the perioperative setting.

The Italian registry of therapeutic apheresis in SISTRA: Year of activity 2022.

Therapeutic apheresis refers to a group of extracorporeal blood processing procedures used in the treatment of a variety of systemic diseases. These complex procedures are burdened by adverse reactions related to both procedures and underlying medical conditions. Given the importance of centralizing the collection and the analysis of information on therapeutic apheresis, the Italian National Blood Center (NBC), at the request of the Italian Scientific Society of Hemapheresis and Cell Manipulation (SIdEM), implemented the Italian Registry of Therapeutic Apheresis (IRTA) including it in the Information System of Transfusion Services (SISTRA), coordinated by the NBC. In 2022, a total of 34,702 therapeutic apheresis procedures was carried out in 8,781 patients, including paediatric patients, with an average of 3.9 procedures per patient. The 2022 IRTA data indicate that the patient with hematological and/or neurological disorders mainly turns to the apheresis centers. These results confirm the IRTA data from years 2020 and 2021. In the hematological field, the apheresis centers supply hematopoietic stem cells collection for autologous transplantation as well as mononuclear cell collection for extracorporeal photopheresis. With regard to the neurological field, myasthenia, chronic inflammatory demyelinating polyneuropathy and Guillain-Barré syndrome along with other neurological pathologies related to immune disorders are the most treated. In conclusion, this manuscript presents 2022 activity data of IRTA providing institutions and scientific societies with a wide range of information including type and number of therapeutic procedures, adverse events and patients' outcome.

Nirmatrelvir/ritonavir for COVID-19: an overview of systematic reviews.

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.

Platelet rich plasma use for treatment of acne scars: an overview of systematic reviews.

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.

Hyperimmune Globulins for the Management of Infectious Diseases.

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.

Plasma collection and supply in Europe: Proceedings of an International Plasma and Fractionation Association and European Blood Alliance symposium.

At the symposium organized by the International Plasma and Fractionation Association and European Blood Alliance, experts presented their views and experiences showing that the public sector and its blood establishments may strengthen the collection and increase the supply of plasma using the right strategies in plasma donor recruitment, retention and protection, scaling-up collection by increasing the number of donors within improved/new infrastructure, supportive funding, policies and legislation as well as harmonization of clinical guidelines and the collaboration of all stakeholders. Such approaches should contribute to increased plasma collection in Europe to meet patients' needs for plasma-derived medicinal products, notably immunoglobulins and avoid shortages. Overall, presentations and discussions confirmed that European non-profit transfusion institutions are committed to increasing the collection of plasma for fractionation from unpaid donors through dedicated programmes as well as novel strategies and research.

Ethics in transfusion medicine: Are the intricate layers of ethics all universal? A global view.

Ethical principles have been considered, and in several respects regulated, along the entire blood procurement chain from donor motivation to transfusion to the patient. Consent of donors and voluntary non-remunerated donation are fields which have been addressed by codes of ethics and legislation. Caring for donor health is an area of further development of ethical standards. In part, blood products have also become a market, where commercial principles may synergize, but also creating issues in equality and maintaining human dignity that challenge societal solutions. At the bedside, the main global challenge remains to procure enough blood products for each patient in medical need. Allocation of rare blood, ethical evaluation of transfusion triggers, attitudes towards refusing blood transfusion and provision of blood products to remote settings are areas which should receive consideration.

The Italian registry of therapeutic apheresis: year of activity 2021.

In 2019, the Italian National Blood Center (NBC), at the request of the Italian Scientific Society of Haemapheresis and Cell Manipulation (SIdEM), included the Italian Registry of Therapeutic Apheresis (IRTA) in the Information System of Transfusion Services (SISTRA), whose activity is coordinated by the NBC. The IRTA provides institutions and scientific societies with a wide range of information including therapeutic procedures and outcomes of treated patients. The Italian National Health Service offers therapeutic apheresis for patients with various conditions, but it is mainly the patient with haematological and/or neurological disorders who turns to the apheresis centres as evidenced by the activity data of 2021. In the haematological field, the apheresis centres mainly supply haematopoietic stem cells for autologous or allogeneic transplantation as well as mononuclear cell collection for extracorporeal photopheresis (ECP), a therapeutic approach of II line in post-transplant Graft versus Host Disease. The activity of 2021 in the neurological field confirms the data of 2019, the pre-pandemic year, and indicates that myasthenia, chronic inflammatory demyelinating polyneuropathy and Guillain-Barré syndrome along with other neurological pathologies related to immune disorders are the diseases in which apheresis procedures are most used. In conclusion, the IRTA is a valuable tool for monitoring the activity of apheresis centres carried out at a national level and above all for providing an overall picture of how the use of this therapeutic tool evolves and changes over time.

Education in transfusion medicine, Part III - The importance of haemovigilance education.

According to the literature, there are significant differences in the availability of education and training in transfusion medicine worldwide, with significant heterogeneity in the existing curricula. Recognising the need for education with the aim of achieving globally standardised competencies in transfusion medicine, a group of experts collaborating in the European and Mediterranean Initiative in Transfusion medicine (EMITm) proposed a process of incremental training and education. Subsequent to two previous papers published by this group on general education in transfusion medicine, this paper specifically refers to the field of education in haemovigilance. This topic is of particular importance when one considers the role of haemovigilance in improving the safety of transfusion practice, and the fact that this role can only be realised through the cooperation of all participants in the transfusion chain. In addition to promoting the importance of education in haemovigilance, this paper provides an overview of the available literature on this topic and proposes an education programme on haemovigilance for medical students and residents.

A survey on preoperative autologous blood donation policy in bone marrow stem cell donors in Italy.

BACKGROUND: The high safety of homologous blood components, together with the introduction of the Patient Blood Management strategy, has led to the progressive abandonment of preoperative autologous blood donation (PAD) in surgery. Furthermore, recent scientific publications provide evidence about the non-usefulness of PAD in the collection of hematopoietic stem cells (HSC) from bone marrow (BM), also in consideration of harvest procedure safety. Nevertheless, no conclusive studies have been published yet. MATERIALS AND METHODS: Blood Establishments (BE) and Bone Marrow Collection Centers (BMCC) participated in a specific qualitative survey proposed by Italian National Blood and Transplant centers with the support of the relevant Italian Scientific Societies. The survey aimed at evaluating the policy adopted for PAD in related and unrelated adult HSC donors in Italy during the period 2018-2020. RESULTS: Forty-one BE corresponding to 37 BMCC filled in the questionnaire. Of 830 BM donors, 661 (80%) underwent 1063 PAD (mean 1.6 PAD/donor). The remaining 169 donors (20%) underwent BM harvest without PAD. No serious adverse events were reported for either donor group. In the case of ineligibility of donors for the PAD program, due to low hemoglobin values, 7/10 centers shifted donors to peripheral blood stem cell collection and three centers chose a different donor. Remarkably, only 51% of the PAD units requested were eventually transfused during the BM harvest process. Finally, the iron support policy among centers was heterogeneous. DISCUSSION: The results of this survey show that PAD is heterogeneously applied in Italian BMCC, as in other countries. However, all BMCC except two are willing to adopt a Patient Blood Management strategy as an alternative approach to adult related and unrelated BM donor harvests.

Thirty years of hemovigilance - Achievements and future perspectives.

Since its emergence in the early 1990s, hemovigilance has gradually evolved from a blood safety concept focused on surveillance of adverse reactions and events in patients, to a well-defined system that monitors the entire transfusion chain and improves its safety. The importance of hemovigilance has been recognized globally in a relatively short time, but the level of its implementation varies significantly between countries. The cooperation of international organizations has significantly contributed to the promotion, implementation, and education in this field. Thanks to initiatives taken, the safety of transfusion practice has been improved in many segments, primarily related to the risks of adverse events in recipients of blood components. In parallel with changing transfusion practice, the hemovigilance process has also matured. In addition to the reduction of existing risks and the early detection of emerging risks, hemovigilance has also embraced the principles of patient blood management. Research in hemovigilance is more increasingly focused on specific categories of patients, specific blood components and methods of their preparation, rare reactions, and transfusion efficacy and efficiency. A proactive approach and use of big data can play an important role in achieving these goals. Additional and sustained efforts should be made to prevent underreporting of events and to improve data comparability through clear definitions and grading systems. This review provides a historical overview of hemovigilance and its achievements, current challenges, and future plans.

Ultrasound-guided injection of platelet-rich plasma for tendinopathies: a systematic review and meta-analysis.

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.

Epidemiology of Treponema pallidum and HIV co-infections in the Italian blood donor population: 2009-2021.

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.

Platelet-rich plasma for the treatment of alopecia: a systematic review and meta-analysis.

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.

Corticosteroids use for COVID-19: an overview of systematic reviews.

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.

A centralized contact-tracing protocol for the COVID-19 pandemic.

Digital contact tracing (DCT) is one of the weapons to be used against the COVID-19 pandemic, especially in a post-lockdown phase, to prevent or block foci of infection. As DCT systems can handle highly private information about people, great care must be taken to prevent misuse of the system and actions detrimental to people's privacy, up to mass surveillance. This paper presents a new centralized DCT protocol, called ZE2-P3T (Zero Ephemeral Exchanging Privacy-Preserving Proximity Protocol), which relies on smartphone localization but does not give any information about the user's location and identity to the server. Importantly, the fact that no exchange of ephemeral identities among users is required is the basis of the strong security of the protocol, which is proven to be more secure than the state-of-the-art protocol DP-3T/GAEN.

Horiba Micros ES 60 Blood Cell Analyzer in Blood Donor Eligibility: A Validation Study.

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.

Chagas Disease and Transfusion Risk in Italy: The Results of a National Survey.

BACKGROUND: Universal serological screening in endemic areas is essential for preventing Chagas disease transmission by transfusions, while in non-endemic areas, screening is provided only to donors exposed to the infection risk. In this respect, in order to ensure high and uniform standards of quality and safety of blood components, the Italian National Blood Centre conducted a survey to detect information on management of donors at risk of Chagas disease and on the current transfusion risk. METHODS: The National Blood Centre conducted a survey on preventive measures for Chagas disease in the years 2020-2021. RESULTS: Survey results are broadly representative of the national situation; out of 24,269 tested donors, only 15 donors were confirmed positive (0.4 out of 100,000 donors). This rate is lower than the number of positive donors (72/100,000) for transfusion transmissible infections (HIV, HBV, HCV, and T. pallidum) in the same period. Furthermore, the number of T. cruzi positive blood donors is lower than the T. cruzi positive subjects in the general population. CONCLUSIONS: In Italy, T. cruzi infection transfusion risk may be considered still very low, and this is confirmed by the absence of documented transfusion transmission.