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Orthopaedics & Traumatology, Surgery &... Apr 2024Recent studies have shown a growing concern regarding the cost-effectiveness and the lack of supporting data for the biologic agents that are being increasingly used in... (Review)
Review
INTRODUCTION
Recent studies have shown a growing concern regarding the cost-effectiveness and the lack of supporting data for the biologic agents that are being increasingly used in the orthopedic field. Our aim was to conduct a systematic scoping review of recent publications (last five years) on the use of orthobiologics to treat fracture non-union and summarize the latest available data.
PATIENTS AND METHODS
The inclusion criteria for this review were articles published in English, from 2016 to 2022, and focusing on the use of orthobiologics for the surgical treatment of non-union. Searches were conducted in March 2023 using Pubmed/MEDLINE and Embase. Studies on spinal fusion or gene therapy were excluded. Reviews, case reports with five cases or less, conference proceedings, preliminary reports, pediatric or non-human studies were excluded as well.
RESULTS
The search found 1807 articles, 15 were eligible after PRISMA checklist and exclusions. The evidence was heterogenous and there was only one level II RCT. Recent data suggests that bone morphogenic protein (BMP-2) products could be effective for septic and aseptic tibial non-unions. However, the evidence was not conclusive regarding BMP-7, plasma rich platelets (PRP), stem cells or demineralized bone matrix (DBM).
DISCUSSION
Every non-union case is different in terms of bone defect, biology, mechanical stability, surgical technique and host factors, which contributes to the conflicting reports on the efficacy of orthobiologics in the literature. We might never see a level 1, high powered and robust study defining the efficacy, safety profile and cost-effectiveness of such products.
LEVEL OF EVIDENCE
IV.
PubMed: 38663743
DOI: 10.1016/j.otsr.2024.103896 -
Frontiers in Neurology 2024The purpose of this study was to evaluate the risk of secondary immune thrombocytopenia in multiple sclerosis patients treated with alemtuzumab through a meta-analysis.
OBJECT
The purpose of this study was to evaluate the risk of secondary immune thrombocytopenia in multiple sclerosis patients treated with alemtuzumab through a meta-analysis.
METHODS
We searched databases including PubMed, Web of Science, OVID and EMBASE for studies reporting changes in platelet levels in MS patients treated with alemtuzumab from their inception until May 2023 and performed a meta-analysis. Information and data were screened and extracted by two researchers. The inclusion and exclusion criteria were established according to the PICOS principle. The obtained data were analyzed using the R software meta package and the quality assessment was conducted using Newcastle-Ottawa Scale (NOS). The causes of heterogeneity were analyzed using subgroup analysis and sensitivity analysis. Publication bias was evaluated using funnel plots and Egger test.
RESULTS
A total of 15 studies were included, encompassing 1,729 multiple sclerosis patients. Meta-analysis of overall secondary ITP in the included studies yielded a pooled rate of 0.0243. The overall incidence of secondary autoimmune events was 0.2589. In addition, subgroup analysis was applied using study regions and study types. The results showed that the incidence rate of secondary ITP in Europe was about 0.0207, while the incidence of autoimmune events (AEs) was 0.2158. The incidence rate of secondary ITP and AEs in North America was significantly higher than in Europe, being 0.0352 and 0.2622. And the analysis showed that the incidence rates of secondary ITP and AEs in prospective studies were 0.0391 and 0.1771. Retrospective studies had an incidence rate of secondary ITP at 2.16, and an incidence rate of AEs at 0.2743.
CONCLUSION
This study found that there was a certain incidence of Immune thrombocytopenia in multiple sclerosis patients after treatment with alemtuzumab. Alemtuzumab may have some interference with platelet levels, and the mechanism may be associated with Treg cells. But due to the absence of a control group in the included literature, we cannot determine the specific impact of Alemtuzumab on platelet levels in patients with MS. Therefore, clinical physicians should perform a comprehensive assessment of the patient's benefit-to-risk ratio before initiating alemtuzumab.
SYSTEMATIC REVIEW REGISTRATION
Inplasy website, DOI number is 10.37766/inplasy2024.3.0007.
PubMed: 38660089
DOI: 10.3389/fneur.2024.1375615 -
Journal of Neurology Apr 2024Mechanical Thrombectomy (MT) has improved outcomes in acute ischemic stroke (AIS) due to Large Vessel Obstruction (LVO). However, there is limited data on the safety and...
BACKGROUND
Mechanical Thrombectomy (MT) has improved outcomes in acute ischemic stroke (AIS) due to Large Vessel Obstruction (LVO). However, there is limited data on the safety and outcomes of MT in AIS patients with thrombocytopenia. This study aims to assess the efficacy and safety of MT in this population.
METHODS
Following the PRISMA guidelines, a comprehensive systematic review was conducted using PubMed, Embase, Web of Science, and Scopus. Studies meeting inclusion criteria underwent rigorous risk of bias assessment using the ROBINS-I tool. We compared outcomes between patients with and without thrombocytopenia undergoing MT. Using the R software version 4.3.1, meta-analyses were conducted employing random-effect models.
RESULTS
This meta-analysis encompassed data from 5 studies. Thrombocytopenic AIS patients who underwent MT (n = 974) exhibited lower rates of functional independence (OR 0.83, 95% CI 0.71-0.98; p = 0.030) compared to patients with normal platelet counts (n = 2036). In addition, the thrombocytopenic group experienced higher mortality as compared to the group with normal platelet counts (OR 1.76, 95% CI 1.26-2.45; p < 0.001). Rates of sICH were found to be similar between groups (OR 1.20, 95% CI 0.74-1.93; p = 0.456), as were rates of successful recanalization (OR 0.94, 95% CI 0.47-1.87; p = 0.863). Lastly, no significant differences were observed in procedure times between thrombocytopenic and non-thrombocytopenic groups.
CONCLUSION
As compared to patients without thrombocytopenia, thrombocytopenic AIS patients undergoing MT displayed lower functional independence and higher mortality rates, with no significant differences in sICH or successful recanalization.
PubMed: 38658432
DOI: 10.1007/s00415-024-12363-8 -
Annals of Hematology Apr 2024Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by a low platelet count with increased risk of bleeding, and viral infection may trigger ITP.... (Review)
Review
Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by a low platelet count with increased risk of bleeding, and viral infection may trigger ITP. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-induced ITP has been increasingly reported. We systemically reviewed the previously reported cases of SARS-CoV-2 infection-induced ITP and identified a total of 105 patients from 68 studies. The median age was 61 years, and 14 patients (12%) were < 18 years old (pediatric cases). In adult cases, a total of 53% patients were classified as moderate to severe SARS-CoV-2 infection. The median platelet count at diagnosis and nadir were 6,000/µL and 4,000/µL, respectively. When comparing platelet levels between non-severe SARS-CoV-2 infection and moderate to severe SARS-CoV-2 infection, the median values of platelet levels at diagnosis were not significantly different between the groups (4,000/µL in non-severe SARS-CoV-2 infection and 9,000/µL in moderate to severe SARS-CoV-2 infection, p-value = 0.22). Median nadir platelet levels were also not significantly different between groups (4,000/µL in non-severe SARS-CoV-2 infection and 8,000/µL in moderate to severe SARS-CoV-2 infection, p-value = 0.27). More than half of the cases (53 patients) were treated with combination therapy including steroid, intravenous immunoglobulin, and eltrombopag. Major bleeding and intracranial hemorrhage occurred in ten (11%) and six (6.6%) cases, respectively. The overall mortality rate was 7%. In pediatric cases, none of the patients experienced major bleeding and lethal outcomes.
PubMed: 38652242
DOI: 10.1007/s00277-024-05765-1 -
Annals of Hematology Jun 2024Janus kinase 2 (JAK2) V617F mutation is present in most patients with polycythemia vera (PV). One persistently puzzling aspect unresolved is the association between... (Meta-Analysis)
Meta-Analysis
Janus kinase 2 (JAK2) V617F mutation is present in most patients with polycythemia vera (PV). One persistently puzzling aspect unresolved is the association between JAK2V617F allele burden (also known as variant allele frequency) and the relevant clinical characteristics. Numerous studies have reported associations between allele burden and both hematologic and clinical features. While there are strong indications linking high allele burden in PV patients with symptoms and clinical characteristics, not all associations are definitive, and disparate and contradictory findings have been reported. Hence, this study aimed to synthesize existing data from the literature to better understand the association between JAK2V617F allele burden and relevant clinical correlates. Out of the 1,851 studies identified, 39 studies provided evidence related to the association between JAK2V617F allele burden and clinical correlates, and 21 studies were included in meta-analyses. Meta-analyses of correlation demonstrated that leucocyte and erythrocyte counts were significantly and positively correlated with JAK2V617F allele burden, whereas platelet count was not. Meta-analyses of standardized mean difference demonstrated that leucocyte and hematocrit were significantly higher in patients with higher JAK2V617F allele burden, whereas platelet count was significantly lower. Meta-analyses of odds ratio demonstrated that patients who had higher JAK2V617F allele burden had a significantly greater odds ratio for developing pruritus, splenomegaly, thrombosis, myelofibrosis, and acute myeloid leukemia. Our study integrates data from approximately 5,462 patients, contributing insights into the association between JAK2V617F allele burden and various hematological parameters, symptomatic manifestations, and complications. However, varied methods of data presentation and statistical analyses prevented the execution of high-quality meta-analyses.
Topics: Polycythemia Vera; Janus Kinase 2; Humans; Alleles; Gene Frequency; Amino Acid Substitution; Mutation, Missense
PubMed: 38652240
DOI: 10.1007/s00277-024-05754-4 -
International Journal of Surgery... Apr 2024
PubMed: 38652150
DOI: 10.1097/JS9.0000000000001492 -
American Journal of Health-system... Apr 2024In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been...
DISCLAIMER
In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.
PURPOSE
To investigate the safety and efficacy of direct oral anticoagulants (DOACs) in the treatment of the acute phase of heparin-induced thrombocytopenia (HIT).
SUMMARY
A systematic review of the literature was conducted on PubMed, MEDLINE, Embase, and Web of Science Core Collection through July 2023. Search terms included "heparin-induced thrombocytopenia AND direct-oral-anticoagulants" in addition to a list of oral anticoagulants. Adult patients who used direct oral anticoagulants as the initial treatment for the acute phase of HIT were included. A total of 1,188 articles were initially identified, with 770 articles reviewed following removal of duplicates. Following the application of inclusion and exclusion criteria, 12 articles were ultimately included. Rivaroxaban was the most-utilized DOAC (28 patients), followed by apixaban (7 patients) and dabigatran (1 patient). All patients with thrombocytopenia demonstrated successful platelet recovery, with two patients presenting with normal platelet counts. One patient developed a deep venous thrombosis with no other new or recurrent thromboses. There were no reported clinically significant adverse events in any patient. Obstacles and deterrents to the use of the standards of care in the acute phase of HIT exist. Argatroban and bivalirudin require intravenous infusion and require close aPTT monitoring and dose adjustment. Fondaparinux requires injection and is contraindicated with body weight <50kg. DOACs would offer the novel ability for an oral treatment in the treatment of the acute phase HIT and allow for minimal monitoring and consistent dosing strategies. Therefore, DOACs are an intriguing choice for the treatment of the acute phase of HIT.
CONCLUSION
Data from 12 publications and across 36 patients suggests that the use of DOACs in the acute phase of HIT may be a safe and efficacious treatment option with favorable ease of monitoring and management.
PubMed: 38651828
DOI: 10.1093/ajhp/zxae109 -
Journal of Cranio-maxillo-facial... Jun 2024The systematic review aims to answer the PICOS question: "Are the autologous platelet concentrates (APCs) an effective strategy in prevention and/or treatment of... (Meta-Analysis)
Meta-Analysis Review
The systematic review aims to answer the PICOS question: "Are the autologous platelet concentrates (APCs) an effective strategy in prevention and/or treatment of patients at risk of/affected by medication-related osteonecrosis of the jaws (MRONJ)?". A literature search was conducted via PubMed, MEDLINE, EMBASE, and CINAHL (January 2006 - September 2023). 30 articles were included, evaluating preventive (n = 8*) and treatment strategies (n = 23*). The risk of bias and quality of studies were assessed utilising ROB-2, ROBIN-1 and GRADE criteria. Meta-analysis was undertaken for eligible studies. The application of APCs demonstrated a statistically significant effectiveness in prevention of MRONJ in 86.13% (p < 0.001) but failed to achieve the same level of certainty in treatment of established MRONJ in 83.4% (p = 0.08). High levels of bias were identified; thus, the results should be interpreted with caution. More high quality prospective randomised controlled trials are needed to further evaluate the effectiveness of APCs in management of MRONJ.
Topics: Humans; Bisphosphonate-Associated Osteonecrosis of the Jaw; Platelet-Rich Plasma; Blood Platelets; Platelet Transfusion; Treatment Outcome
PubMed: 38644092
DOI: 10.1016/j.jcms.2024.01.007 -
Journal of the American Heart... May 2024Risk of recurrence after minor ischemic stroke is usually reported with transient ischemic attack. No previous meta-analysis has focused on minor ischemic stroke alone.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Risk of recurrence after minor ischemic stroke is usually reported with transient ischemic attack. No previous meta-analysis has focused on minor ischemic stroke alone. The objective was to evaluate the pooled proportion of 90-day stroke recurrence for minor ischemic stroke, defined as a National Institutes of Health Stroke Scale severity score of ≤5.
METHODS AND RESULTS
Published papers found on PubMed from 2000 to January 12, 2021, reference lists of relevant articles, and experts in the field were involved in identifying relevant studies. Randomized controlled trials and observational studies describing minor stroke cohort with reported 90-day stroke recurrence were selected by 2 independent reviewers. Altogether 14 of 432 (3.2%) studies met inclusion criteria. Multilevel random-effects meta-analysis was performed. A total of 6 randomized controlled trials and 8 observational studies totaling 45 462 patients were included. The pooled 90-day stroke recurrence was 8.6% (95% CI, 6.5-10.7), reducing by 0.60% (95% CI, 0.09-1.1; =0.02) with each subsequent year of publication. Recurrence was lowest in dual antiplatelet trial arms (6.3%, 95% CI, 4.5-8.0) when compared with non-dual antiplatelet trial arms (7.2%, 95% CI, 4.7-9.6) and observational studies 10.6% (95% CI, 7.0-14.2). Age, hypertension, diabetes, ischemic heart disease, or known atrial fibrillation had no significant association with outcome. Defining minor stroke with a lower National Institutes of Health Stroke Scale threshold made no difference - score ≤3: 8.6% (95% CI, 6.0-11.1), score ≤4: 8.4% (95% CI, 6.1-10.6), as did excluding studies with n<500%-7.3% (95% CI, 5.5-9.0).
CONCLUSIONS
The risk of recurrence after minor ischemic stroke is declining over time but remains important.
Topics: Humans; Recurrence; Observational Studies as Topic; Time Factors; Ischemic Stroke; Risk Factors; Randomized Controlled Trials as Topic; Risk Assessment; Stroke; Platelet Aggregation Inhibitors; Severity of Illness Index
PubMed: 38641856
DOI: 10.1161/JAHA.123.032471 -
Journal of ISAKOS : Joint Disorders &... Apr 2024Partial-thickness rotator cuff tears (PTRCTs) commonly affect overhead athletes, leading to a decline in sports performance. Platelet-rich plasma (PRP) is being explored... (Review)
Review
IMPORTANCE
Partial-thickness rotator cuff tears (PTRCTs) commonly affect overhead athletes, leading to a decline in sports performance. Platelet-rich plasma (PRP) is being explored as an alternative treatment modality for individuals with PTRCTs to reduce discomfort and enhance functional recovery. We conducted a systematic review study of randomized controlled clinical trials to determine the effectiveness of PRP in treating PTRCTs.
AIM
To determine the effectiveness of PRP in treating PTRCTs.
EVIDENCE REVIEW
We conducted a comprehensive literature search for randomized controlled trials (RCTs) that compared the effectiveness of PRP with eccentric exercise and placebo injections as treatments for PTRCTs. We searched databases such as the Cochrane Library, Web of Science, PubMed, and EMBASE. The visual analog scale (VAS) score, American Shoulder and Elbow Surgeon (ASES) score, and Constant-Murley Score (CMS) was utilized as an outcome measure. Statistical analysis was performed using RevMan 5.3 software.
FINDINGS
Our meta-analysis included 12 studies involving 762 patients. At six weeks post-treatment, the PRP group had significantly higher VAS scores compared to the control group, indicating improvement (standard mean difference (SMD): -2.04 [95% confidence interval (CI): -4.00 to -0.08], I = 97%, P-value = 0.04). Patients who received PRP showed statistically significant improvements in VAS scores at 3 months and 6 months follow-up (SMD, -1.78 [95% CI: -3.03 to -0.52], I = 96%, P-value = 0.005) (SMD: -2.26 [95% CI: -3.77 to -0.76], I = 97%, P-value = 0.003). A statistically significant difference was also observed in VAS scores at the long-term 1-year follow-up (SMD: -2.27 [95% CI: -4.07 to -0.47]; I = 98%; P-value = 0.031). There were statistically significant differences in ASES scores and CMS scores in the short-term (SMD: 1.21 [95% CI: 0.19 to 2.24], I = 96%, P-value = 0.02) (SMD, 2.01 [95% CI: 0.14 to 3.88], I = 97%, P-value = 0.04). However, in the long-term ASES and CMS scores did not show any statistical significance (SMD: 2.06 [95% CI: -0.54 to 4.65], I = 99%, P-value = 0.12) (SMD: 4.36 [95% CI: -5.48 to 14.21], I = 99%, P-value = 0.39).
CONCLUSIONS AND RELEVANCE
Our findings suggest that PRP treatment is effective in reducing pain for individuals with PTRCTs, providing benefits in the short and long term. However, its impact on functional recovery appears somewhat constrained and doesn't endure over time. Additionally, significant heterogeneity exists among studies, encompassing variations in PRP composition and control group treatments. Consequently, we conclude that compelling evidence for symptom improvement in PTRCT patients following PRP treatment remains elusive.
LEVEL OF EVIDENCE
Level I.
PubMed: 38641254
DOI: 10.1016/j.jisako.2024.04.010