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1.
Roxadustat reduces left ventricular mass index compared to rHuEPO in haemodialysis patients in a randomized controlled trial
Tan, W., Wang, X., Sun, Y., Wang, X., He, J., Zhong, L., Jiang, X., Sun, Y., Tian, E., Li, Z., et al
Journal of internal medicine. 2024
Abstract
BACKGROUND Left ventricular hypertrophy (LVH) is highly prevalent in haemodialysis (HD) patients and is associated with an increased risk of death. Roxadustat and recombinant human erythropoietin (rHuEPO, abbreviated as EPO) are the main treatment strategies for renal anaemia in HD patients, but it has not been clear whether there is a difference in their effect on LVH. METHODS In this multi-centre, prospective, randomized trial of 12-month duration, study participants were randomized in a 1:1 ratio to the roxadustat group or the EPO group. The doses of both treatment regimens were adjusted so that the patients had a haemoglobin level of 10.0-12.0 g per dL. The primary study endpoint was the change from baseline to 12 months in the left ventricular mass index (LVMI, g/m(2) ) measured by echocardiography. RESULTS In total, 114 patients were enrolled. The mean age was 50 years, and the median dialysis duration was 33 months. Sixty-one patients were men, and 24 were diabetic. LVMI decreased from 116.18 ± 27.84 to 110.70 ± 25.74 g/m(2) in the roxadustat group. However, it increased from 109.35 ± 23.41 to 114.99 ± 28.46 g/m(2) in the EPO group, with a significant difference in the change in LVMI between the two groups [-5.48 (-11.60 to 0.65) vs. 5.65 (0.74 to 10.55), p < 0.05]. Changes in left ventricular mass, end-diastolic volume and 6-min walk test seemed superior in the roxadustat group. There were no significant differences in other cardiac geometry, biochemical parameters and major adverse cardiovascular events between the two groups. CONCLUSIONS Compared to EPO, roxadustat is more helpful in the regression of LVH in HD patients.
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2.
Comparison of efficacy of ultrasound-guided platelet rich plasma injection versus dry needling in lateral epicondylitis-a randomised controlled trial
Sharma, G. K., Patil, A., Kaur, P., Rajesh, S., Drakonaki, E., Botchu, R.
Journal of ultrasound. 2024
Abstract
PURPOSE To assess whether Ultrasound guided dry needling is adequate for both common extensor tendon tears and tendinosis or whether ultrasound guided platelet rich plasma (PRP) has a superior outcome when compared to dry needling when there are tears of the common extensor tendon. MATERIALS AND METHODS This is a single-centre, single-blinded, randomised controlled trial conducted between November 2018 and April 2020. 40 patients diagnosed with lateral epicondylitis based on clinical and sonographic features and having comparable baseline characteristics were randomly assigned to the two study groups (dry needling and PRP). Inclusion criteria were patients aged 20 years or more who were symptomatic for at least 3 months with sonographic evidence of lateral epicondylitis. Exclusion criteria were complete tear of common extensor tendon confirmed on ultrasound and presence of other associated diseases like osteoarthritis of shoulder and elbow. RESULTS There was significant improvement in the visual analogue scale pain score in PRP group compared to the dry needling group at 9 months. However, this difference was not evident at 3 and 6 months follow-up. Mean improvement in common extensor tendon thickness in PRP group (5.1 mm at 3 months and 4.3 mm at 6 months) was slightly better than dry needling (4.4 mm at 3 months and 4.0 mm at 6 months). There was no difference in tear (if present) healing between both groups at 3 months. However at 6 months follow up, PRP demonstrated significant (mean-2.5) healing in tear compared to dry needling (mean-3.1). CONCLUSION Two injections of Ultrasound guided PRP are more beneficial non operative treatment compared to ultrasound guided dry needling, in lateral epicondylitis.
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Effects of Adding Extracorporeal Shockwave Therapy (ESWT) to Platelet-Rich Plasma (PRP) among Patients with Rotator Cuff Partial Tear: A Prospective Randomized Comparative Study
Kuo, S. J., Su, Y. H., Hsu, S. C., Huang, P. H., Hsia, C. C., Liao, C. Y., Chen, S. H., Wu, R. W., Hsu, C. C., Lai, Y. C., et al
Journal of personalized medicine. 2024;14(1)
Abstract
A rotator cuff tear is a prevalent ailment affecting the shoulder joint. The clinical efficacy of combined therapy remains uncertain for partial rotator cuff tears. In this study, we integrated extracorporeal shockwave therapy (ESWT) with platelet-rich plasma (PRP) injection, juxtaposed with PRP in isolation. Both cohorts exhibited significant improvements in visual analogue scale (VAS), Constant-Murley score (CMS), degrees of forward flexion, abduction, internal rotation, and external rotation, and the sum of range of motion (SROM) over the six-month assessment period. The application of ESWT in conjunction with PRP exhibited notable additional enhancements in both forward flexion (p = 0.033) and abduction (p = 0.015) after one month. Furthermore, a substantial augmentation in the range of shoulder motion (SROM) (p < 0.001) was observed after six months. We employed isobaric tag for relative and absolute quantitation (iTRAQ) to analyze the differential plasma protein expression in serum samples procured from the two groups after one month. The concentrations of S100A8 (p = 0.042) and S100A9 (p = 0.034), known to modulate local inflammation, were both lower in the ESWT + PRP cohort. These findings not only underscore the advantages of combined therapy but also illuminate the associated molecular changes.
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4.
Roxadustat and Oral Iron Absorption in Chinese Patients with Anemia of Chronic Kidney Disease: A Randomized, Open-Label, Phase 4 Study (ALTAI)
Wu, H., Cheng, H., Wang, C., Yao, L., Qin, S., Zuo, L., Hu, Z., Zhang, C., Wu, Y., Hofherr, A., et al
Advances in therapy. 2024
Abstract
INTRODUCTION Anemia of chronic kidney disease (CKD) has a high incidence and is associated with many disease conditions. Iron dysmetabolism is an important contributor to anemia in CKD patients. METHODS ALTAI, a randomized, active-controlled, phase 4 trial, investigated the efficacy of roxadustat versus recombinant human erythropoietin (rHuEPO) on gastrointestinal iron absorption in patients with anemia of CKD (stage 4/5). The primary endpoint was change from baseline to day 15 in gastrointestinal iron absorption (serum iron area under the concentration-time curve; AUC(0-3h)) following single-dose oral iron. RESULTS Twenty-five patients with a mean age of 55.1 years were randomized 1:1 to roxadustat (n = 13) or rHuEPO (n = 12). Baseline iron profiles were similar between treatment groups. Change from baseline to day 15 in serum iron AUC(0-3h) was not statistically significantly different between the roxadustat and rHuEPO groups. Mean (SD) change from baseline in serum iron AUC(0-3h) was 11.3 (28.2) g × 3 h/dl in the roxadustat group and - 0.3 (9.7) g × 3 h/dl in the rHuEPO group. Roxadustat treatment was associated with decreased hepcidin and also increased transferrin, soluble transferrin receptor, and total iron-binding capacity (TIBC), with nominal significance. The proportion of patients experiencing one or more adverse events was 38.5% when treated with roxadustat and 16.7% with rHuEPO. CONCLUSIONS The study showed no significant difference between roxadustat and rHuEPO in iron absorption but was underpowered because of recruitment challenges. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT04655027.
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Predicting response to iron supplementation in patients with active inflammatory bowel disease (PRIme): a randomised trial protocol
Loveikyte, R., Duijvestein, M., Mujagic, Z., Goetgebuer, R. L., Dijkstra, G., van der Meulen-de Jong, A. E.
BMJ open. 2024;14(1):e077511
Abstract
INTRODUCTION Iron deficiency anaemia (IDA) is the most common systemic manifestation of inflammatory bowel disease (IBD) that has detrimental effects on quality of life (QoL) and disease outcomes. Iron deficiency (ID), with or without anaemia, poses a diagnostic and therapeutic challenge in patients with IBD due to the multifactorial nature of ID(A) and its frequent recurrence. Elevated hepcidin-a systemic iron regulator that modulates systemic iron availability and intestinal iron absorption-has been associated with oral iron malabsorption in IBD. Therefore, hepcidin could assist in therapeutic decision-making. In this study, we investigate whether hepcidin can predict response to oral and intravenous iron supplementation in patients with active IBD undergoing anti-inflammatory treatment. METHODS AND ANALYSIS PRIme is an exploratory, multicentre, open-label and randomised trial. All adult patients with active IBD and ID(A) will be assessed for eligibility. The participants (n=90) will be recruited at five academic hospitals within the Netherlands and randomised into three groups (1:1:1): oral ferrous fumarate, oral ferric maltol or intravenous iron. Clinical and biochemical data will be collected at the baseline and after 6, 14 and 24 weeks. Blood samples will be collected to measure hepcidin and other biomarkers related to iron status. In addition, patient-reported outcomes regarding QoL and disease burden will be evaluated. The primary outcome is the utility of hepcidin as a predictive biomarker for response to iron therapy, which will be assessed using receiver operating curve analysis. ETHICS AND DISSEMINATION The study has been approved by the Institutional Review Board at the Leiden University Medical Center (IRB No. P21.109) and other study sites. All participants will provide written informed consent to enrol in the study. The findings will be published in a peer-reviewed journal and disseminated at scientific conferences; the dataset will be available on reasonable request. TRIAL REGISTRATION Prospectively registered in the https://clinicaltrials.gov/ and the Eudra registries. First submitted on 10 May 2022 to the ClinicalTrials.gov (ID: NCT05456932) and on 3 March 2022 to the European Union Drug Regulating Authorities Clinical Trials Database (ID: 2022-000894-16).
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Clinical Outcome of Multiple Platelet-Rich Plasma Injection and Correlation with PDGF-BB in the Treatment of Knee Osteoarthritis
Partan, R. U., Putra, K. M., Hafizzanovian, H., Darma, S., Reagan, M., Muthia, P., Radiandina, A. S., Rahmawati, E.
Journal of personalized medicine. 2024;14(2)
Abstract
(1) Background: Current treatments for knee osteoarthritis (KOA), such as intra-articular corticosteroids or hyaluronic acid (HA) injections, are controversial due to their ineffectiveness in preventing disease progression. Platelet-rich plasma (PRP) has become a promising and possible treatment for KOA. It is thought to enhance articular cartilage regeneration and reduce OA-related impairment. PRP contains growth factors such as PDGF-BB, which stimulates growth and inhibits joint damage. Based on numerous studies, after a certain amount of time, it was found that multiple PRP treatments reduced pain more than a single injection. This study evaluates the efficacy of multiple PRP (m-PRP) injections compared to multiple HA (m-HA) injections for KOA treatment, focusing on their correlation with PDGF-BB levels. (2) Methods: In this single-center, open-label, randomized, comparative clinical trial, 30 KOA patients received m-PRP and m-HA injections. VAS and WOMAC were used to evaluate clinical outcomes and PDGF-BB concentrations. (3) Results: The study analysis revealed a statistically significant reduction in pain indices. In both the m-PRP and m-HA groups after 12 weeks, m-PRP showed superior results. PDGF-BB concentrations also increased, with a strong negative correlation and statistical significance using Spearman's rho. (4) Conclusions: Multiple PRP injections are safe and associated with elevated PDGF-BB, reduced VAS and WOMAC scores, providing the potential for articular cartilage regeneration and inhibiting knee osteoarthritis progression.
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Efficacy and cost-effectiveness of darbepoetin alfa once every 4 weeks versus continuous erythropoietin receptor activator once every 4 weeks for anemia correction in patients with chronic kidney disease not on dialysis
Park, G. N., Lee, K. H., Moon, J. E., Choi, S. J., Park, M. Y., Kim, J. K., Yu, B. C.
Kidney research and clinical practice. 2024
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Editor's Choice
Abstract
BACKGROUND For anemia management in patients with chronic kidney disease not on dialysis, darbepoetin alfa (DA), which has a shorter half-life but is more inexpensive than continuous erythropoietin receptor activator (CERA), is preferred in Korea. This study evaluated the efficacy, safety, and cost-effectiveness of once-in-4-weeks DA compared with once-in-4-weeks CERA in patients with chronic kidney disease not on dialysis. METHODS In this randomized, prospective, non-inferiority study, 40 erythropoiesis-stimulating agent-naïve patients with chronic kidney disease not on dialysis were randomized 1:1 to the DA group and CERA group. They received the study drug once in 4 weeks during 10- or 12-week correction period and 24-week efficacy evaluation period. The primary outcomes were the mean difference in the changes in hemoglobin levels between baseline and efficacy evaluation period and hemoglobin response rates during the correction period. The secondary outcomes included differences in adverse events and costs. RESULTS DA was non-inferior to CERA for anemia correction; the mean difference in the change in hemoglobin levels between the groups was -0.070 g/dL (95% confidence interval, -0.730 to 0.590 g/dL). Hemoglobin response rates were 100% with DA and 94.1% with CERA. Adverse events were comparable. The mean cost of DA was approximately one-third that of CERA (34,100 ± 7,600 Korean won/4 weeks vs. 115,500 ± 23,600 Korean won/4 weeks; p < 0.001). CONCLUSION Once-in-4-weeks DA safely corrects anemia in erythropoiesis-stimulating agent-naïve patients with chronic kidney disease not on dialysis and is more cost-effective than once-in-4-weeks CERA.
PICO Summary
Population
Patients with chronic kidney disease not on dialysis (n= 40).
Intervention
Darbepoetin alfa (DA), (n= 20).
Comparison
Continuous erythropoietin receptor activator (CERA), (n= 20).
Outcome
The patients received the study drug once in 4 weeks during 10- or 12-week correction period and 24-week efficacy evaluation period. The primary outcomes were the mean difference in the changes in haemoglobin levels between baseline and efficacy evaluation period and haemoglobin response rates during the correction period. DA was non-inferior to CERA for anaemia correction; the mean difference in the change in haemoglobin levels between the groups was -0.070 g/dL (95% confidence interval [-0.730, 0.590 g/dL]). Haemoglobin response rates were 100% with DA and 94.1% with CERA. Adverse events were comparable. The mean cost of DA was approximately one-third that of CERA (34,100 ± 7,600 Korean won/4 weeks vs. 115,500 ± 23,600 Korean won/4 weeks).
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A triple combination of latanoprost, fractional CO(2) laser, and platelet-rich plasma in localized vitiligo: A clinical and histopathologic study
Omar, S. S., Elmulla, K. F., Aly, R. G., Elkaffas, A., Ismail, A.
Photodermatology, photoimmunology & photomedicine. 2024;40(1):e12944
Abstract
BACKGROUND Several treatment modalities are available for the treatment of vitiligo due to the lack of a uniformly effective therapy. Topical latanoprost 0.005% is an effective topical treatment. Fractional CO(2) laser alone or combined with platelet-rich plasma (PRP) has been proposed as effective adjunctive therapies. OBJECTIVES We aimed to compare the efficacy of topical latanoprost 0.005% (Ioprost®, Orchidia, Egypt) combined with either add-on fractional CO(2) laser or fractional CO(2) -PRP versus topical latanoprost monotherapy in the treatment of localized stable vitiligo. PATIENTS/METHODS The study included 60 patients randomly assigned into three equal groups. Group A patients received topical latanoprost drops only. Group B patients received topical latanoprost drops and fractional CO(2) laser sessions at 2-week interval for 3 months. Group C patients received topical latanoprost drops and fractional CO(2) laser sessions combined with PRP at a 2-week interval for 3 months. The mean improvement score by the physician was calculated 4 months after the start of the study. Punch skin biopsies were obtained before treatment and 4 months from the beginning of the study and stained with H&E and HMB-45 antibody for evaluation of pigmentation. RESULTS Significant clinical improvement of vitiligo lesions with significant increase of re-pigmentation were reported in the three treated groups. Latanoprost in combination with fractional CO(2) and PRP was associated with more significant therapeutic outcomes than either combined latanoprost and fractional CO(2) or latanoprost alone. CONCLUSION Fractional CO(2) laser-PRP enhances the therapeutic efficacy of latanoprost 0.005% in the treatment of localized stable vitiligo.
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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 .
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10.
Sex-specific disparities in COVID-19 outcomes
Rafique, Z., Durkalski-Mauldin, V., Peacock, W. F., Yadav, K., Reynolds, J. C., Callaway, C. W.
Journal of the American College of Emergency Physicians open. 2024;5(1):e13110
Abstract
OBJECTIVES Sex-specific disparities in morbidity and mortality of COVID-19 illness are not well understood. Neutralizing antibodies (Ab) may protect against severe COVID-19 illness. We investigated the association of sex with disease progression and SARS-CoV-2 Ab response. METHODS In this exploratory analysis of the phase 3, multicenter, randomized, placebo-controlled Convalescent Plasma in Outpatients (C3PO) trial, we examined whether sex was associated with progression to severe illness, defined as a composite of all-cause hospitalization, emergency/urgent care visit, or death within 15 days from study enrollment. Patients had a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test, symptom onset within 7 days, stable condition for emergency department discharge, and were either ≥50 years old or had at least one high-risk feature for disease progression. Patients received blinded convalescent plasma or placebo in a 1:1 fashion and were evaluated on days 15 and 30 after infusion. Blood samples were collected on day 0 (pre-/post-infusion), 15, and 30 to measure Ab levels with the Broad Institute using the Plaque Reduction Neutralization Test assay. RESULTS Of 511 patients enrolled (median age 54 [Iinterquartile range 41-62] years, 46% male, 66% white, 20% black, 3.5% Asian), disease progression occurred in 36.7% of males and 25.9% of females (unadjusted risk difference 10.8%, 95% confidence interval [CI], 2.8-18.8%). Sex-disparities did not persist when adjusted for treatment group, age, viremic status, symptom onset, and tobacco use (adjusted risk difference 5.6%, 95% confidence interval [CI], -2.2% to 13.4%), but were present in the subgroup presenting 3 or more days after symptom onset (adjusted risk difference 12.6%, 95% CI, 3.4% to 21.9%). Mean baseline Ab levels (log scale) available for 367 patients were similar between sexes (difference 0.19 log units, 95% CI, -0.08 to 0.46). The log-scale mean increase from baseline to day 15 after adjusting for treatment assignment and baseline levels was larger in males than females (3.26 vs. 2.67). A similar difference was noted when the groups were subdivided by outcome. CONCLUSIONS Progression of COVID-19 was similar in males and females when adjusted for age, tobacco use, and viremia status in this study. However, in the cohort presenting 3 or more days after symptom onset, COVID-19 outcomes were worse in males than females. Neutralizing Ab levels increased more in males but did not correlate with sex differences in outcomes.