-
1.
Safety and tolerability of intravenous immunoglobulin in patients with active dermatomyositis: results from the randomised, placebo-controlled ProDERM study
Aggarwal, R., Schessl, J., Charles-Schoeman, C., Bata-Csörgő, Z., Dimachkie, M. M., Griger, Z., Moiseev, S., Oddis, C. V., Schiopu, E., Vencovský, J., et al
Arthritis research & therapy. 2024;26(1):27
Abstract
BACKGROUND Dermatomyositis is an idiopathic inflammatory myopathy characterised by rashes and progressive muscle weakness. The recent ProDERM (Progress in DERMatomyositis) study is the first large randomised, placebo-controlled trial to establish the efficacy and safety of intravenous immunoglobulin (IVIg) in adult patients with dermatomyositis. Objectives of this analysis were to closely examine the safety and tolerability of IVIg in patients from the ProDERM study. METHODS ProDERM was a double-blind, randomised, placebo-controlled, multicentre, phase 3 study. In the first period (weeks 0-16), adults with active dermatomyositis received 2.0 g/kg IVIg (Octagam 10%; Octapharma AG) or placebo every 4 weeks. In the open-label extension period (weeks 16-40), all patients received IVIg for 6 additional cycles; dose reduction (1.0 g/kg) was permitted if patients were stable. Treatment-emergent adverse events (TEAEs) were documented. RESULTS The 95 patients enrolled were randomised to receive IVIg (N = 47) or placebo (N = 48) in the first period, with 5 switching from placebo to IVIg. Overall, 664 IVIg infusion cycles were administered. During the first period, 113 TEAEs were possibly/probably related to treatment in 30/52 patients (57.7%) receiving IVIg and 38 in 11 patients (22.9%) on placebo. Eight patients discontinued therapy due to IVIg-related TEAEs. Eight thromboembolic events (TEEs) occurred in six patients on IVIg; six in five patients were deemed possibly/probably related to IVIg. Patients with TEEs exhibited more baseline TEE risk factors than those without TEEs (2.4-15.2-fold higher). Lowering infusion rate reduced the rate of TEEs, and none occurred at the lower IVIg dose. No haemolytic transfusion reactions or deaths occurred. CONCLUSIONS Results from this study demonstrate that IVIg has a favourable safety profile for treatment of adult dermatomyositis patients and provides evidence that will help to inform treatment choice for these patients. Dermatomyositis patients receiving high-dose IVIg should be monitored for TEEs, and a low rate of infusion should be used to minimise TEE risk, particularly in those with pre-existing risk factors. TRIAL REGISTRATION ProDERM study (NCT02728752).
-
2.
Efficacy of Platelet-Rich Plasma <em>versus</em> 5% Topical Monixidil for the Treatment of Androgenetic Alopecia
Afzal, G., Ahmed, N., Zahoor, F., Malik, T., Farooq, O.
Journal of the College of Physicians and Surgeons--Pakistan : JCPSP. 2024;34(1):11-15
Abstract
OBJECTIVE To compare the efficacy of platelet-rich plasma (PRP) versus 5% topical minoxidil for the treatment of androgenetic alopecia (AGA). STUDY DESIGN Randomised-controlled trial. Place and Duration of the Study: Department of Dermatology, PNS Shifa Hospital, Karachi, Pakistan, from 1st November 2021 to 31st July 2022. METHODOLOGY Seventy AGA patients aged between 18-60 years of either gender were randomly divided into two groups. Group A was given 5% topical minoxidil and Group B was given PRP. Both groups were followed up over a period of 6 months, and the final analysis was done with the help of global photography, hair pull test, and patient satisfaction score. RESULTS At the end of 6th month, 27 patients (77%) in Group A had a negative hair pull test as compared to only 14 (40%) in Group B (p = 0.001). In Group A, 32 patients (91.4%) reported improvement in hair scalp from baseline. Whereas, in Group B, 26 patients (74.3%) reported improvement from baseline (p = 1.00). PRP was effective in 26 patients (74.5%) and 5% topical minoxidil in 15 patients (43.7%) (p = 0.007). CONCLUSION PRP therapy can be a useful alternative to topical minoxidil in the treatment of AGA. KEY WORDS Androgenetic alopecia, Global photography, Platelet-rich plasma, 5% Topical minoxidil, Treatment.
-
3.
Reported outcomes in patients with iron deficiency or iron deficiency anemia undergoing major surgery: a systematic review of outcomes
Stangl, S., Popp, M., Reis, S., Sitter, M., Saal-Bauernschubert, L., Schießer, S., Kranke, P., Choorapoikayil, S., Weibel, S., Meybohm, P.
Systematic reviews. 2024;13(1):5
-
-
-
Free full text
-
Editor's Choice
Abstract
BACKGROUND Iron deficiency (ID) is the leading cause of anemia worldwide. The prevalence of preoperative ID ranges from 23 to 33%. Preoperative anemia is associated with worse outcomes, making it important to diagnose and treat ID before elective surgery. Several studies indicated the effectiveness of intravenous iron supplementation in iron deficiency with or without anemia (ID(A)). However, it remains challenging to establish reliable evidence due to heterogeneity in utilized study outcomes. The development of a core outcome set (COS) can help to reduce this heterogeneity by proposing a minimal set of meaningful and standardized outcomes. The aim of our systematic review was to identify and assess outcomes reported in randomized controlled trials (RCTs) and observational studies investigating iron supplementation in iron-deficient patients with or without anemia. METHODS We searched MEDLINE, CENTRAL, and ClinicalTrials.gov systematically from 2000 to April 1, 2022. RCTs and observational studies investigating iron supplementation in patients with a preoperative diagnosis of ID(A), were included. Study characteristics and reported outcomes were extracted. Outcomes were categorized according to an established outcome taxonomy. Quality of outcome reporting was assessed with a pre-specified tool. Reported clinically relevant differences for sample size calculation were extracted. RESULTS Out of 2898 records, 346 underwent full-text screening and 13 studies (five RCTs, eight observational studies) with sufficient diagnostic inclusion criteria for iron deficiency with or without anemia (ID(A)) were eligible. It is noteworthy to mention that 49 studies were excluded due to no confirmed diagnosis of ID(A). Overall, 111 outcomes were structured into five core areas including nine domains. Most studies (92%) reported outcomes within the 'blood and lymphatic system' domain, followed by "adverse event" (77%) and "need for further resources" (77%). All of the latter reported on the need for blood transfusion. Reported outcomes were heterogeneous in measures and timing. Merely, two (33%) of six prospective studies were registered prospectively of which one (17%) showed no signs of selective outcome reporting. CONCLUSION This systematic review comprehensively depicts the heterogeneity of reported outcomes in studies investigating iron supplementation in ID(A) patients regarding exact definitions and timing. Our analysis provides a systematic base for consenting to a minimal COS. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42020214247.
PICO Summary
Population
Patients with iron deficiency or iron deficiency anaemia undergoing major surgery (13 studies: 5 randomised controlled trials and 8 observational studies).
Intervention
Systematic review to identify and appraise outcomes reported for preoperative or perioperative treatment of iron deficiency, with or without anemia.
Comparison
Outcome
Overall, 111 outcomes were structured into five core areas including nine domains. Most studies (92%) reported outcomes within the 'blood and lymphatic system' domain, followed by ‘adverse event’ (77%) and ‘need for further resources’ (77%). All of the latter reported on the need for blood transfusion. Reported outcomes were heterogeneous in measures and timing. Merely, two (33%) of six prospective studies were registered prospectively of which one (17%) showed no signs of selective outcome reporting.
-
4.
Esophageal Stent in Acute Refractory Variceal Bleeding: A Systematic Review and a Meta-Analysis
Songtanin, B., Kahathuduwa, C., Nugent, K.
Journal of clinical medicine. 2024;13(2)
Abstract
Background: Acute esophageal variceal bleeding accounts for up to 70% of upper-gastrointestinal bleeding in cirrhotic patients. About 10-20% of patients with acute variceal bleeding have refractory bleeding that is not controlled by medical or endoscopic therapy, and this condition can be life-threatening. Balloon tamponade is a long-standing therapy which is only effective temporarily and has several complications, while transjugular intrahepatic portosystemic shunt (TIPS) and liver transplantation may not be readily available at some centers. The use of self-expandable metal stents (SEMSs) in refractory esophageal variceal bleeding has been studied for effectiveness and adverse events and has been recommended for use as a bridge to a more definitive treatment. Aim: To investigate the effectiveness and safety of SEMSs in managing refractory variceal bleeding. Methods: A systematic search of the MEDLINE, EMBASE, and Cochrane library databases was performed from inception to October 2022 using the following terms: "esophageal stent", "self-expandable metal stents", "endoscopic hemostasis", "refractory esophageal varices", and "esophageal variceal bleeding". Studies were included in the meta-analysis if they met the following criteria: (1) patients' age older than 18 and (2) a study (or case series) that has at least 10 patients in the study. Exclusion criteria included (1) non-English publications, (2) in case of overlapping cohorts, data from the most recent and/or most appropriate comprehensive report were collected. DerSimonian-Laird random-effects meta-analysis was performed using the meta package in R statistical software(version 4.2.2). Results: Twelve studies involving 225 patients with 228 stents were included in the analyses. The mean age and/or median age ranged from 49.4 to 69 years, with a male-to-female ratio of 4.4 to 1. The median follow-up period was 42 days. The mean SEMS dwell time was 9.4 days. The most common cause of acute refractory variceal bleeding in chronic liver disease patients included alcohol use followed by viral hepatitis. The pooled rate of immediate bleeding control was 91% (95% CI 82-95%, I(2) = 0). The pooled rate of rebleeding was 17% (95% CI 8-32%, I(2) = 69). The pooled rate of stent ulceration was 7% (95% CI 3-13%, I(2) = 0), and the pooled rate of stent migration was 18% (95% CI 9-32%, I(2) = 38). The pooled rate of all-cause mortality was 38% (95% CI 30-47%, I(2) = 34). Conclusions: SEMSs should be primarily considered as salvage therapy when endoscopic band ligation and sclerotherapy fail and can be used as a bridge to emergent TIPS or definitive therapy, such as liver transplantation.
-
5.
[Translated article] Efficacy of platelet-rich plasma in rotator cuff repair: systematic review and meta-analysis
Sánchez-Losilla, C., Ferré-Aniorte, A., Álvarez-Díaz, P., Barastegui-Fernández, D., Cugat, R., Alentorn-Geli, E.
Revista espanola de cirugia ortopedica y traumatologia. 2024
Abstract
OBJECTIVE To analyze the efficacy and safety after the application of platelet-rich-plasma (PRP) as an adjuvant in arthroscopic rotator cuff repairs. MATERIAL AND METHODS A bibliographic search of the literature of prospective studies with level of evidence one or two was carried out from January 2004 to December 2021, including studies that compare the functional and re-tear results after arthroscopic cuff repair rotator with or without PRP. RESULTS A total of 281 articles were identified, of which 14 met the inclusion criteria. The overall re-rupture rate was 24%. In the PRP group, a decrease in the re-rupture rate and better functional results were demonstrated, although these differences were not significant. CONCLUSIONS Adjuvant treatment with PRP has shown promising results, although there is not yet enough evidence to provide a clear advantage for routine use in clinical practice.
-
6.
Platelet-Rich Plasma Versus Platelet-Poor Plasma for Treating Facial Photoaging: a Double-Blind Randomized Controlled Splitting Face Study
Tsai, Y. W., Cheng, C. Y., Hu, S., Chang, S. L., Lin, T. M., Huang, Y. L.
Aesthetic plastic surgery. 2024
Abstract
BACKGROUND As the demand for non-invasive esthetic procedures to maintain a youthful appearance increases, there has been growing interest in the use of autologous platelet-rich plasma (PRP) and platelet-poor plasma (PPP) for the treatment of facial aging. However, there are few studies directly comparing the efficacy of PRP and PPP for facial rejuvenation. OBJECTIVES This study aimed to compare the efficacy of PRP and PPP for facial rejuvenation. METHODS This single-center, double-blind, randomized controlled trial was conducted from January 1, 2022, to July 31, 2022, and included ten participants who completed the follow-up. The participants were randomly assigned to receive 2.5-mL injections of PRP and PPP on different sides of the face in three sessions with 1-month intervals. The outcome was primarily determined by blinded photographic assessments and secondly by scores of the VISIA® system during the follow-up. RESULTS Both PRP and PPP treatments resulted in significant improvement in the Global Aesthetic Improvement Scales and Modified Fitzpatrick Wrinkle Scale for periocular Powered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation wrinkles, with no significant difference between the two groups. However, no improvement was observed in the Wrinkle Severity Rating Scales for nasolabial folds in either the PRP- or PPP-treated groups. Furthermore, no severe adverse events were reported. CONCLUSIONS Both PRP and PPP are effective in treating facial photoaging. PRP exhibited slightly superior efficacy in enhancing overall skin condition, while PPP was slightly more effective in improving shallow wrinkles. This study provides valuable evidence for the use of PRP and PPP in facial rejuvenation procedures. LEVEL OF EVIDENCE I This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
-
7.
Clinical Applications of Tranexamic Acid (TXA) in Plastic and Reconstructive Surgery
Brown, S., Brown, T., Rohrich, R. J.
Plastic and reconstructive surgery. 2024
Abstract
PURPOSE Tranexamic Acid (TXA) has gained increasing recognition as a valuable pharmacologic agent within plastic surgery. This study reviews the scientific evidence regarding the use of TXA in the full range of plastic and reconstructive surgery to provide clinical recommendations regarding for safe and effective use in various plastic surgical procedures. METHODS A systematic review and meta-analysis were conducted following the PRISMA guidelines. An established appraisal process was used to rate the quality of articles (Grading of Recommendations Assessment, Development, and Evaluation methodology). RESULTS Forty-five studies describing the use of TXA in plastic surgery were included. There is moderate-certainty evidence to support the use of intravenous administration of TXA in craniofacial surgery procedures to reduce blood-loss and transfusion requirements. There is high-certainty evidence to support the use of TXA in cosmetic surgery and intravenous administration in rhinoplasty procedures to reduce blood-loss. Further high-level studies are needed to determine TXA's effects on hematoma rates in facelift surgery and breast-related procedures. There is moderate-certainty evidence to support the use of TXA in burn care. Further studies are required to provide quantitative conclusions on the effects of TXA administration in microsurgery. CONCLUSIONS This is the largest study to date on the use of TXA in plastic surgery and the first to provide clinical recommendations. The literature highlights TXA's promising role in the fields of craniofacial surgery, cosmetic surgery and burn care. Standardized, objective measurements are required to provide quantitative conclusions regarding TXAs effects on ecchymoses and edema in cosmetic surgery procedures.
-
8.
Core decompression combined with platelet-rich plasma-augmented bone grafting for femur head necrosis: a systematic review and meta-analysis
Zhu, B., Feng, S., Li, X., Li, B., Li, J.
International journal of surgery (London, England). 2024
Abstract
BACKGROUND The clinical potential of biologic augmentation in core decompression and bone grafting for femoral head necrosis is widely acknowledged, with platelet-rich plasma (PRP) being a frequently employed biologic adjunct. However, its clinical application is not standardized, and high-level evidence is lacking. This study aimed to evaluate the efficacy and safety of core decompression and bone grafting combined with PRP for femur head necrosis. METHODS Several databases were systematically retrieved for randomized controlled trials comparing core decompression and bone grafting combined with or without PRP. A systematic review and meta-analysis were conducted following the PRISMA 2020 and AMSTAR 2 guidelines. The study is registered with PROSPERO under the code CRD42022361007, and it is also listed in the Research Registry under the identification number reviewregistry1537. RESULTS 11 studies with 642 participants (742 hips) were included. The pooled estimates revealed that when core decompression and bone grafting were combined with PRP, the Harris hip score (MD:7.98; 95% CI: 5.77 - 10.20; P<0.001), VAS(SMD:-0.68; 95% CI: -0.96 - -0.40; P<0.001) and the pain component of HHS (SMD: 8.4; 95% CI: 4.12 - 12.68; P<0.001), and reduction of radiographic progression (RR: 0.40; 95% CI: 0.27 -0.59; P<0.001) were superior to core decompression and bone grafting alone. Fewer patients with treatment failure (RR: 0.27; 95% CI: 0.14 - 0.52; P<0.001) and higher good-to-excellent results (RR: 1.48; 95% CI: 1.17 - 1.86; P<0.001) were observed in treatment groups than control groups. Meanwhile, the pooled analysis substantiated the superior safety profile of PRP (RR: 0.29; 95% CI: 0.11 - 0.77; P=0.01). CONCLUSIONS The combination of core decompression and bone grafting with PRP is superior to the approach without PRP, demonstrating enhanced effectiveness in terms of function, pain relief, and radiographic progression. Additionally, it results in lower rates of treatment failure and adverse events. However, further high-quality RCTs are needed to evaluate their effectiveness due to methodological and implementation limitations observed in the existing evidence.
-
9.
Cardiac assessment and inflammatory markers in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV2 (PIMS-TS) treated with methylprednisolone versus intravenous immunoglobulins: 6-month follow-up outcomes of the randomised controlled Swissped RECOVERY trial
Andre, M. C., Sanchez, C., Bressieux-Degueldre, S., Perez, M. H., Wütz, D., Blanchard-Rohner, G., Grazioli, S., Schöbi, N., Trück, J., Welzel, T., et al
EClinicalMedicine. 2024;67:102358
Abstract
BACKGROUND Previous findings from the Swissped RECOVERY trial showed that patients with Pediatric Inflammatory Multisystem Syndrome-Temporally Associated with SARS-CoV-2 (PIMS-TS) who were randomly assigned to intravenous immunoglobulins or methylprednisolone have a comparable length of hospital stay. Here, we report the 6-month follow-up outcomes of cardiac pathologies and normalisation of clinical or laboratory signs of inflammation from this study population. METHODS This pre-planned follow-up of patients with PIMS-TS included the Swissped RECOVERY Trial reports on the 6-month outcomes of the cohort after randomisation, with a focus on cardiac, haematological, and biochemical findings. The trial was an investigator-initiated randomised multicentre open-label two-arm trial in children and adolescents hospitalised with PIMS-TS at ten hospitals in Switzerland. Cardiological assessments and laboratory analyses were prospectively collected in the intention-to-treat analysis on pre-defined intervals after hospital discharge. Differences between randomised arms were investigated using Chi-square test for categorical and Wilcoxon test for continuous variables. The trial is registered with the Swiss National Clinical Trials Portal (SNCTP000004720) and ClinicalTrials.gov (NCT04826588). FINDINGS Between May 21, 2021 and April 15, 2022, 75 patients with a median age of 9.1 years (IQR 6.2-12.2) were included in the intention-to-treat population (37 in the methylprednisolone group and 38 in the intravenous immunoglobulin group). During follow-up, the incidence of abnormal left ventricular systolic function, coronary artery aneurysms (CAA), and other signs of inflammation were comparable in both groups. However, we detected cardiac abnormalities with low incidence and a mild degree grade of pathology. CAAs were observed in 2/38 children (5.3%) in the IVIG group and 1/37 children (2.7%) in the methylprednisolone group at 6-month follow-up (difference proportion 0.75; 95% confidence interval (CI) -0.05 to 1.0; p = 0.39). INTERPRETATION Methylprednisolone alone may be an acceptable first-line treatment as left ventricular systolic dysfunction and clinical/laboratory evidence for inflammation quickly resolved in all children. However, our findings need further confirmation through larger studies as our sample size is likely to be of insufficient power to address rare clinically relevant adverse outcomes. FUNDING NOMIS, Vontobel, and Gaydoul Foundation.
-
10.
Autologous platelet-rich plasma (APRP) in diabetes foot disease: a meta-analysis
Ruiz-Muñoz, M., Martinez-Barrios, F. J., Fernandez-Torres, R., Lopezosa-Reca, E., Marchena-Rodriguez, A.
Journal of diabetes and its complications. 2024;38(2):108690
Abstract
INTRODUCTION This study will explore the effectiveness of autologous platelet-rich plasma in the treatment of diabetic foot disease compared to conventional treatments, based on the ulcer healing rate. METHODS The electronic databases of PubMed, EMBASE, and WOS internet were searched. Evaluated outcome rate of complete ulcer healing. Statistical analysis was performed with RevMan 5.0 software and SPSS 25.0. RESULTS Eleven RCTs with 828 patients were included in this study. The meta-analysis showed a higher complete ulcer healing rate (OR = 3.69, 95 % CI 2.62 to 5.20, P < 0.01, I(2) = 0 %) in growth factors based in autologous platelech-rich plasma (aPRP) group compared with control. Mixed evidence was seen for publication bias, but analyses by using the trim-and-fill method did not appreciably alter results. CONCLUSION Autologous platelet-rich plasma can improve the complete healing rate of the ulcer compared to current conventional treatments in diabetic foot ulcer patients.