[Translation] A randomized, double-blind, triple-dummy, positive drug parallel-controlled, multicenter clinical study to evaluate the efficacy and safety of compound ferrous sulfate sustained-release tablets in the treatment of iron deficiency anemia
1)评价复方硫酸亚铁缓释片治疗缺铁性贫血在升高血红蛋白的有效性方面,与硫酸亚铁片联合叶酸比较,非劣效检验成立; 2)治疗缺铁性贫血的安全性方面,与硫酸亚铁片联合叶酸比较,降低胃肠道不良反应发生率。 3)治疗缺铁性贫血的有效率和血清铁蛋白(SF)升高水平,以及其他不良反应发生率。
[Translation] 1) To evaluate the effectiveness of compound ferrous sulfate sustained-release tablets in increasing hemoglobin in the treatment of iron deficiency anemia, and the non-inferiority test was established when compared with ferrous sulfate tablets combined with folic acid; 2) In terms of the safety of treating iron deficiency anemia, compared with ferrous sulfate tablets combined with folic acid, the incidence of gastrointestinal adverse reactions was reduced. 3) The effective rate of treating iron deficiency anemia and the level of serum ferritin (SF), as well as the incidence of other adverse reactions.