Abstract

Thalidomide induces γ-globin expression in erythroid progenitor cells, but its efficacy on patients with transfusion-dependent β-thalassemia (TDT) remains unclear. In this phase 2, multi-center, randomized, double-blind clinical trial, we aimed to determine the safety and efficacy of thalidomide in TDT patients. A hundred patients of 14 years or older were randomly assigned to receive placebo or thalidomide for 12 weeks, followed by an extension phase of at least 36 weeks. The primary endpoint was the change of hemoglobin (Hb) level in the patients. The secondary endpoints included the red blood cell (RBC) units transfused and adverse effects. In the placebo-controlled period, Hb concentrations in patients treated with thalidomide achieved a median elevation of 14.0 (range, 2.5 to 37.5) g/L, whereas Hb in patients treated with placebo did not significantly change. Within the 12 weeks, the mean RBC transfusion volume for patients treated with thalidomide and placebo was 5.4 ± 5.0 U and 10.3 ± 6.4 U, respectively (P < 0.001). Adverse events of drowsiness, dizziness, fatigue, pyrexia, sore throat, and rash were more common with thalidomide than placebo. In the extension phase, treatment with thalidomide for 24 weeks resulted in a sustainable increase in Hb concentrations which reached 104.9 ± 19.0 g/L, without blood transfusion. Significant increase in Hb concentration and reduction in RBC transfusions were associated with non β0/β0 and HBS1L-MYB (rs9399137 C/T, C/C; rs4895441 A/G, G/G) genotypes. These results demonstrated that thalidomide is effective in patients with TDT.

Abstract

BACKGROUND Platelet-rich plasma (PRP), as a promising alternative to traditional corticosteroid (CS), is now increasingly used in the treatment of elbow epicondylitis (EE) and plantar fasciitis (PF). To date, however, the synthesis of information on the clinical efficacy of PRP versus CS is limited with divergent conclusions. PURPOSE To compare the clinical efficacy of PRP and CS injections in reducing pain and improving function in EE and PF. STUDY DESIGN Systematic review and meta-analysis. METHODS Online databases were searched from inception to October 2018 for prospective studies evaluating PRP versus CS injections for EE or PF. Independent reviewers undertook searches, screening, and risk-of-bias appraisals. The primary outcomes of interest were pain and function in both the short term (1-3 months) and the long term (≥6 months). RESULTS Twenty trials with 1268 participants were included. For EE, PRP provides a statistically and clinically meaningful long-term improvement in pain, with a very large effect size of -1.3 (95% CI, -1.9 to -0.7) when compared with CS, but the evidence level was low. For EE, there was moderate evidence that CS provides a statistically meaningful improvement in pain in the short term, with a medium effect size of 0.56 (95% CI, 0.08-1.03) as compared with PRP; this improvement might not be clinically significant. For PF, there was low evidence that PRP provides a statistically and clinically meaningful long-term improvement in function (American Orthopedic Foot & Ankle Society score), with a very large effect size of 1.94 (95% CI, 0.61-3.28). There were no significant differences between the groups in improvement in function in EE and pain and short-term function in PF, but the quality of the evidence was low. CONCLUSION The use of PRP yields statistically and clinically better improvement in long-term pain than does CS in the treatment of EE. The use of PRP yields statistically and clinically better long-term functional improvement than that of CS in the treatment of PF.

Abstract

BACKGROUND Total joint arthroplasty is associated with significant blood loss and often requires blood transfusion. However, allogeneic blood transfusion (ABT) may lead to severe problems, such as immunoreaction and infection. Postoperative autotransfusion, an alternative to ABT, is controversial. We conducted a meta-analysis to evaluate the ability of postoperative autotransfusion to reduce the need for ABT following total knee arthroplasty (TKA) and total hip arthroplasty (THA). METHODS Systematic literature searches for randomized controlled trials were performed using PubMed, Embase, and the Cochrane Library until February 2016. Relative risks (RRs) and weighted mean differences with 95% confidence intervals (CIs) were calculated using fixed-effect or random-effect models; we also evaluated publication bias and heterogeneity. RESULTS Seventeen trials with a total of 2314 patients were included in the meta-analysis. The pooled RRs of ABT rate between autotransfusion and the regular drainage/no drainage groups for TKA and THA were 0.446 (95% CI = 0.287, 0.693; p < 0.001) and 0.757 (95% CI = 0.599, 0.958; p = 0.020), respectively. In the subgroup analysis performed in TKA patients according to control interventions, the pooled RRs were 0.377 (95% CI = 0.224, 0.634; p < 0.001) (compared with regular drainage) and 0.804 (95% CI = 0.453, 1.426, p = 0.456) (compared with no drainage). In the subgroup analysis performed for THA, the pooled RRs were 0.536 (95% CI = 0.379, 0.757, p < 0.001) (compared with regular drainage) and 1.020 (95% CI = 0.740, 1.405, p = 0.904) (compared with no drainage). CONCLUSIONS Compared to regular drainage, autotransfusion reduces the need for ABT following TKA and THA. This reduction is not present when comparing autotransfusion to no drainage. However, the reliability of the meta-analytic results concerning TKA was limited by significant heterogeneity in methods among the included studies.