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1.
Ultrasound-guided injection of platelet-rich plasma for tendinopathies: a systematic review and meta-analysis
Masiello F, Pati I, Veropalumbo E, Pupella S, Cruciani M, De Angelis V
Blood transfusion = Trasfusione del sangue. 2022
Abstract
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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2.
Efficacy and Safety of Pathogen-Reduced Platelets Compared with Standard Apheresis Platelets: A Systematic Review of RCTs
Pati I, Masiello F, Pupella S, Cruciani M, De Angelis V
Pathogens (Basel, Switzerland). 2022;11(6)
Abstract
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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3.
Platelet-rich plasma for the treatment of alopecia: a systematic review and meta-analysis
Cruciani M, Masiello F, Pati I, Marano G, Pupella S, De Angelis V
Blood transfusion = Trasfusione del sangue. 2021
Abstract
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/cm(2); 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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4.
The use of whole blood in traumatic bleeding: a systematic review
Cruciani M, Franchini M, Mengoli C, Marano G, Pati I, Masiello F, Veropalumbo E, Pupella S, Vaglio S, Agostini V, et al
Internal and emergency medicine. 2020
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Editor's Choice
Abstract
Hemostatic resuscitation is currently considered a standard of care for the management of life-threatening hemorrhage, but in some critical settings the access to high quantities of blood components is problematic. Whole blood (WB) transfusion has been proposed as an alternative modality for hemostatic resuscitation of traumatic major bleeding. To assess the efficacy and safety of WB in trauma-associated massive bleeding, we performed a systematic review of the literature. We selected studies comparing WB transfusions to transfusion of blood components (COMP) in massive trauma bleeding; both randomized clinical trial (RCT) and observational studies were considered. The outcomes were mortality (30-day/in-hospital and 24-h mortality) and adverse events/transfusion reactions. The effect sizes were crude odds ratio (OR), adjusted OR and hazard ratio (HR). The methodological quality of studies was assessed using the Cochrane Risk of Bias tool for RCTs, and the ROBIN-1 tool for observational studies. The overall quality of the available evidence was assessed with the GRADE system. One RCT (2 reports) and 6 cohort studies were included (3642 adult patients; 675 receiving WB, 2967 receiving COMP). Three studies were conducted in military setting, and 4 in civilian setting. In the overall analysis, 30-day/in-hospital and 24-h mortality did not differ significantly between groups (very low quality of the evidence due to high risk of bias, imprecision and inconsistency). After adjustment for baseline covariates in three cohort studies, the OR for mortality was significantly lower in WB recipients compared to COMP (OR 0.22; 95% CIs 0.10/0.45) (moderate grade of evidence). Adverse events and transfusion reactions were overlooked and not consistently reported. The available evidence does not allow to draw definite conclusions on the short-term and long-term efficacy and safety of WB transfusion compared to COMP transfusion. Further well designed research is needed.
PICO Summary
Population
Patients with massive trauma bleeding (7 studies, n= 3642).
Intervention
Whole blood (WB) transfusion (n= 675).
Comparison
Blood components (COMP), (n= 2967).
Outcome
In the overall analysis, 30-day/in-hospital and 24-h mortality did not differ significantly between groups. After adjustment for baseline covariates in three cohort studies, the odds ratio for mortality was significantly lower in WB recipients compared to COMP. Adverse events and transfusion reactions were overlooked and not consistently reported.
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5.
Red blood cell alloimmunisation in transfusion-dependent thalassaemia: a systematic review
Franchini M, Forni GL, Marano G, Cruciani M, Mengoli C, Pinto V, De Franceschi L, Venturelli D, Casale M, Amerini M, et al
Blood transfusion = Trasfusione del sangue. 2019;17(1):4-15
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Editor's Choice
Abstract
BACKGROUND Chronic red blood cell transfusion is the first-line treatment for severe forms of thalassaemia. This therapy is, however, hampered by a number of adverse effects, including red blood cell alloimmunisation. The aim of this systematic review was to collect the current literature data on erythrocyte alloimmunisation. MATERIALS AND METHODS We performed a systematic search of the literature which identified 41 cohort studies involving 9,256 patients. RESULTS The prevalence of erythrocyte alloimmunisation was 11.4% (95% CI: 9.3-13.9%) with a higher rate of alloimmunisation against antigens of the Rh (52.4%) and Kell (25.6%) systems. Overall, alloantibodies against antigens belonging to the Rh and Kell systems accounted for 78% of the cases. A higher prevalence of red blood cell alloimmunisation was found in patients with thalassaemia intermedia compared to that among patients with thalassaemia major (15.5 vs 12.8%). DISCUSSION Matching transfusion-dependent thalassaemia patients and red blood cell units for Rh and Kell antigens should be able to reduce the risk of red blood cell alloimmunisation by about 80%.
PICO Summary
Population
Patients with transfusion-dependent thalassaemia (41 studies, n= 9,256).
Intervention
Systematic review on the prevalence of red blood cell alloimmunisation.
Comparison
Outcome
The prevalence of erythrocyte alloimmunisation was 11.4% with a higher rate of alloimmunisation against antigens of the Rh (52.4%) and Kell (25.6%) systems. Overall, alloantibodies against antigens belonging to the Rh and Kell systems accounted for 78% of the cases. A higher prevalence of red blood cell alloimmunisation was found in patients with thalassaemia intermedia compared to that among patients with thalassaemia major (15.5 vs. 12.8%).
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6.
The use of platelet-rich plasma in oral surgery: a systematic review and meta-analysis
Franchini M, Cruciani M, Mengoli C, Masiello F, Marano G, D'Aloja E, Dell'Aringa C, Pati I, Veropalumbo E, Pupella S, et al
Blood transfusion = Trasfusione del sangue. 2019;17(5):357-367
Abstract
BACKGROUND The aim of this systematic review and meta-analysis was to evaluate the benefit of platelet rich plasma (PRP) in oral surgery. MATERIALS AND METHODS We performed a systematic search of the literature. The GRADE system was used to assess the certainty of the body of evidence. RESULTS We found 21 randomised controlled trials that met our inclusion criteria: 12 studies included patients with periodontal defects, five studies focused on healing of extraction sockets, three studies on sinus lift augmentation, and one study on periapical osseous defects. However, for the quantitative synthesis (meta-analysis), we evaluated "periodontal defects" studies only, since for other clinical contexts the number of studies were too low and the procedural heterogeneity was too high to allow pooling of data. PRP-containing regimens were compared to non-PRP-containing regimens. Primary outcomes for the evaluation of periodontal defects were probing depths, clinical attachment level, gingival recession, and radiographic bone defect. It is not usually clear whether or not the use of PRP compared to controls affects "probing depth" at long-term follow up; the between group differences were small and unlikely to be of clinical importance (i.e., very low quality of evidence). For the other outcomes analysed ("clinical attachment levels", "gingival recession", "bony defect"), we observed a very slight marginal clinical benefit of PRP compared to controls. The available evidence for these comparisons was rated as low quality as most of the studies selected showed inconsistency, imprecision, and risk of bias. DISCUSSION Evidence from a comparison between the use in oral surgery of PRP-containing regimens compared to other regimens not-containing PRP was of low quality. The results of the meta-analysis, limited to studies in patients with periodontal defects, document that PRP was slightly more effective compared to controls not-containing PRP.
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7.
Platelet-rich plasma for sports-related muscle, tendon and ligament injuries: an umbrella review
Cruciani M, Franchini M, Mengoli C, Marano G, Pati I, Masiello F, Profili S, Veropalumbo E, Pupella S, Vaglio S, et al
Blood transfusion = Trasfusione del sangue. 2019;17(6):465-478
Abstract
BACKGROUND Platelet-rich plasma (PRP) has been used in different non-transfusion indications due to its role in tissue regeneration and healing. The aim of this overview of systematic reviews (umbrella review) is to provide a summary of the existing research syntheses related to PRP use for sports-related muscle, tendon and ligament injuries. MATERIALS AND METHODS Literature searches were performed in MEDLINE, Embase, and Cochrane Library to identify systematic reviews focusing on PRP use for sports-related muscle, tendon and ligament injuries. The methodological quality of included studies was assessed using the checklist for systematic reviews and research syntheses developed by the Joanna Briggs Institute and the GRADE assessment. RESULTS Twenty-two studies met the inclusion criteria. Five studies evaluated PRP use for acute muscle injury, and 17 evaluated PRP use for tendon and ligament injury. Studies were heterogeneous in terms of the dose and number of PRP injections, and the control groups. Three of the 5 reviews evaluating acute muscle injury concluded that PRP had no effect on the outcomes considered. One review shows superior efficacy of rehabilitation exercise compared to PRP. One review shows that PRP may result in an earlier return to sport for acute grade I-II injury. Eight out of the 17 reviews evaluating PRP for tendon and ligament injuries show a statistically significant (p<0.05) difference in pain and/or function outcome measures favouring PRP compared to controls, although most of the observed differences were small. Adverse events data and quality of life outcomes were rarely analysed or reported in the included studies and were considered clinically insignificant. DISCUSSION In most of the included reviews, the available evidence was judged to be of low/very low quality due to risk of bias, inconsistency and imprecision, thus making the level of certainty of these findings low and not adequate to support the general use of PRP in this setting.
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Safety and efficacy of tranexamic acid for prevention of obstetric haemorrhage: an updated systematic review and meta-analysis
Franchini M, Mengoli C, Cruciani M, Bergamini V, Presti F, Marano G, Pupella S, Vaglio S, Masiello F, Veropalumbo E, et al
Blood Transfusion = Trasfusione Del Sangue. 2018;:1-10.
Abstract
BACKGROUND A number of clinical systematic review and meta-analysis have been published on the use of tranexamic in the obstetric setting. The aim of this meta-analysis was to evaluate the safety and effectiveness of tranexamic acid in reducing blood loss when given prior to caesarean delivery. MATERIALS AND METHODS We searched the Cochrane Wounds Specialized Register, Cochrane Central, MEDLINE (through PUBMED), Embase, and SCOPUS electronic databases. We also searched clinical trials registries for ongoing and unpublished studies, and checked reference lists to identify additional studies. We used no restrictions with respect to language and date of publication. Two review authors independently performed study selection, "Risk of bias" assessment, and data extraction. Initial disagreements were resolved by discussion, or by including a third review author when necessary. RESULTS We found 18 randomised controlled trials (RCTs) that met our inclusion criteria. Overall, 1,764 women receiving intravenous tranexamic acid for prevention of bleeding following caesarean sections and 1,793 controls receiving placebo were enrolled in the 18 RCTs evaluated. The use of tranexamic acid compared to controls (placebo or no intervention) reduces post-partum haemorrhage >400 mL (risk ratio [RR] 0.40, 95% confidence interval [CI] 0.24-0.65; 5 trials with a total of 786 participants), severe post-partum haemorrhage >1,000 mL (RR 0.32, 95% CI: 0.12-0.84; 5 trials with a total of 1,850 participants), and need for red blood cell transfusion (RR 0.30, 95% CI: 0.18-0.49; 10 trials with a total of 1,873 participants). No particular safety concerns on the use of this antifibrinolytic agent emerged from the analysis of the 18 RCTs included. DISCUSSION Overall, the results of this meta-analysis support the evidence of a beneficial effect of tranexamic acid in reducing blood loss and need for blood transfusion in pregnant women undergoing caesarean section.
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9.
The use of viscoelastic haemostatic assays in non-cardiac surgical settings: a systematic review and meta-analysis
Franchini M, Mengoli C, Cruciani M, Marietta M, Marano G, Vaglio S, Pupella S, Veropalumbo E, Masiello F, Liumbruno G M
Blood Transfusion = Trasfusione Del Sangue. 2018;:1-9.
Abstract
BACKGROUND Thrombelastography (TEG) and rotational thromboelastometry (ROTEM) are viscoelastic haemostatic assays (VHA) which exploit the elastic properties of clotting blood. The aim of this systematic review and meta-analysis was to evaluate the usefulness of these tests in bleeding patients outside the cardiac surgical setting. MATERIALS AND METHODS We searched the Cochrane Library, MEDLINE, EMBASE and SCOPUS. We also searched clinical trial registries for ongoing and unpublished studies, and checked reference lists to identify additional studies. RESULTS We found 4 randomised controlled trials (RCTs) that met our inclusion criteria with a total of 229 participants. The sample size was small (from 28 to 111 patients) and the follow-up periods very heterogenous (from 4 weeks to 3 years). Pooled data from the 3 trials reporting on mortality (199 participants) do not show any effect of the use of TEG on mortality as compared to standard monitoring (based on the average treatment effect from a fixed-effects model): Risk Ratio (RR) 0.71; 95% Confidence Interval (CI): 0.43 to 1.16. Likewise, the use of VHA does not reduce the need for red blood cells (mean difference -0.64; 95% CI: -1.51 to 0.23), platelet concentrates (mean difference -1.12; 95% CI: -3.25 to 1.02), and fresh frozen plasma (mean difference -0.91; 95% CI: -2.02 to 0.19) transfusion. The evidence on mortality and other outcomes was uncertain (very low-certainty evidence, down-graded due to risk of biases, imprecision, and inconsistency). CONCLUSIONS Overall, the certainty of the evidence provided by the trials was too low for us to be certain of the benefits and harms of viscoelastic haemostatic assay in non-cardiac surgical settings. More, larger, and better-designed RCTs should be carried out in this area.
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10.
Efficacy of platelet-rich plasma as conservative treatment in orthopaedics: a systematic review and meta-analysis
Franchini M, Cruciani M, Mengoli C, Marano G, Pupella S, Veropalumbo E, Masiello F, Pati I, Vaglio S, Liumbruno GM
Blood Transfusion = Trasfusione Del Sangue. 2018;:1-12.
Abstract
BACKGROUND The aim of this systematic review and meta-analysis was to evaluate the benefit of platelet-rich plasma (PRP) in non-surgical orthopaedic procedures. MATERIAL AND METHODS We searched the Cochrane Wounds Specialized Register, CENTRAL, MEDLINE (through PUBMED), Embase, and SCOPUS. We also searched clinical trials registries for ongoing and unpublished studies and checked reference lists to identify additional studies. RESULTS We found 36 randomised controlled trials (2,073 patients) that met our inclusion criteria. The included studies mostly had small numbers of participants (from 20 to 225). Twenty-eight studies included patients with lateral epicondylitis or plantar fasciitis. PRP was compared to local steroids injection (19 studies), saline injection (6 studies), autologous whole blood (4 studies), local anaesthetic injection (3 studies), dry needling injection (3 studies), and to other comparators (4 studies). Primary outcomes were pain and function scores, and adverse events. On average, it is unclear whether or not use of PRP compared to controls reduces pain scores and functional score at short- (up to 3 months) and medium- (4-6 months) term follow-up. The available evidence for all the comparisons was rated as very low quality due to inconsistency, imprecision, and risk of bias in most of the selected studies. There were no serious adverse events related to PRP injection or control treatments. CONCLUSIONS The results of this meta-analysis, which documents the very marginal effectiveness of PRP compared to controls, does not support the use of PRP as conservative treatment in orthopaedics.