Safety and efficacy of thalidomide in patients with transfusion-dependent β-thalassemia: a randomized clinical trial
Chen JM, Zhu WJ, Liu J, Wang GZ, Chen XQ, Tan Y, Xu WW, Qu LW, Li JY, Yang HJ, et al
Signal transduction and targeted therapy. 2021;6(1):405
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.
Effects of the timing of tourniquet release in cemented total knee arthroplasty: a systematic review and meta-analysis of randomized controlled trials
Zhang, Liu A, Hu D, Tan Y, Al-Aidaros M, Pan Z
Journal of Orthopaedic Surgery. 2014;9:125.
BACKGROUND The aim of this study is to evaluate the effects of tourniquet release before wound closure for hemostasis or after wound closure in cemented total knee arthroplasty (TKA). METHODS We conducted a meta-analysis and review work on relevant clinical outcomes to evaluate the effects of the timing of tourniquet release in cemented TKA. Electronic databases were searched for relevant randomized controlled trials (RCTs) that compared outcomes of tourniquet release before wound closure for hemostasis with tourniquet release after wound closure. The methodological quality of each included RCT was assessed in terms of the 12-item scale. The meta-analysis was performed with STATA 12.0 software. RESULTS Eleven RCTs involving 651 patients with 670 TKAs were included in this meta-analysis. Of these, 332 patients (342 knees) were in an early tourniquet release group and 319 patients (328 knees) in the late tourniquet release group. The results showed that there were no significant differences in overt blood loss, hemoglobin drop, and blood transfusions, whereas the tourniquet release after wound closure might increase the risks of overall complications and major complications. CONCLUSIONS Tourniquet release before wound closure for hemostasis might reduce the rate of complications, but it could not limit overall blood loss. The current evidences are not enough to indicate that tourniquet release before wound closure is superior to its release after wound closure in cemented TKA.