Safety and efficacy of thalidomide in patients with transfusiondependentβ-thalassemia:a randomized clinical trial

Thalidomide inducesγ-globin expression in erythroid progenitor cells,but its efficacy on patients with transfusion-dependentβ-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 nonβ0/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.

Induced Abortion and the Risk of Tubal Infertility

Objective To explore the association between induced abortion and tubal infertility in Chengdu, China.Methods A 1 ： 2 case-control study was designed. Infertile women with bilateral tubal occlusion in the case group compared with two control groups： infertile control group with bilateral tubal patency and pregnant control group with currently pregnancy. Data were collected using questionnaires through face-to-face interviews, covering the subjects＇ demographic details and histories of gynecology and obstetrics. Adjusted odds ratio was calculated as a measure of the association using stepwise multiple logistic regression analysis.Results Induced abortion was not found to be associated with tubal infertility in the analysis including either the infertile controls or the pregnant controls, but other risk factors were found, such as history of acute pelvic inflammatory disease （PID）, lower abdominal surgeries, dysmenorrhea and pregnancy.Conclusion It is contended that facing an increasing trend of infertile cases with tubal occlusion in China, it is emphasized that special attention should paid to the long term impact of reproductive tract infection, especially, asymptomatic ones, rather than induced abortion.