Asthma is a chronic inflammatory airway disease with a characteristic of airway hyperresponsiveness. One of the most pivotal mechanisms involved in asthma is Thl/Th2 imbalance. Emerging immune targets gradually enter clinical practice, for example, anti-IgE antibody, and more on research and development.Thymosin is an immune modulator or stimulator. It has been empirically used in patients with asthma for a long period of time in China. Although its mechanisms remain unclear, it is supposed to have effects on Th1/Th2 balance via Thl cytokine stimulation. Biologically synthesized thymosin α1 (Zadaxin) may produce better outcome on asthma than thymosin products from animals because of its higher purification, lower side-effects and higher potential effects. However, the effectiveness of thymosin in asthma has not been proven yet. In this study, a randomized double-blinded placebo-controlled trial was conducted to clarify the effectiveness and safety of thymosin α1 (Zadaxin) in chronic adult asthma.29 patients were recruited, 15 in thymosin group, 14 in placebo group. Thymosin α1 or placebo was administered subcutaneously for six weeks (1.6 mg, qod, 2 weeks, then twice a week, 4 weeks). The primary endpoints included Asthma Quality of Life Questionnaire (AQLQ) scores, forced expiratory volume in 1 second (FEV1) and IFN-γ and IL-4 production from culture of peripheral blood mononuclear cells (PBMC). Other endpoints included asthma symptom scores, peak expiratory flow, blood eosinophils, T cell subtypes, serum eosinophil cation protein, immunoglobin E and specific immunoglobin E, and the safety. |