新药乳酸亚铁片治疗缺铁性贫血的临床研究

Clinical study of the effectiveness and side effects of ferrous lactate tablets on patients with iron deficiency anemia.

目的 研究新药乳酸亚铁片治疗缺铁性贫血 (IDA)的疗效和不良反应。方法 用随机对照试验方法将太极制药有限公司生产的新药乳酸亚铁治疗IDA的疗效及不良反应与上市药琥珀酸亚铁进行比较 ,前者每天口服 2片tid ,后者 1片tid ,疗程 6周。结果 乳酸亚铁治疗IDA 6周显效率达 86 7% ,而对照药琥珀酸亚铁显效率 93 3 % ,两药疗效无统计学差异 (P >0 .0 5 ) ;在服用的开始 1～ 2周内 ,两药均有轻至中度可耐受的腹痛、腹泻及恶心 ,两药不良反应发生率均为 13 3 % ( 2 / 15 )。结论 乳酸亚铁片治疗IDA疗效好 ,不良反应轻 ,值得在临床上推广应用。

Objective To study the effectiveness and side effects of ferrous lactate tablets on the patients with iron deficiency anemia(IDA).Methods The effectiveness and side effects of ferrous lactate tablets,a new producetd by Tai ji Pharmacy Company Limited,were compared ranuomly with those of marketed ferrous succinate tablets on patients with IDA one tablet of medicine was taken orally three times a day for 6 weeks.Results The remarkable effectiveness of ferrous lactate was 86.7%,while the effectiveness of ferrous succinate was 93.3%,with no statistical difference(P>0.05).During the first two weeks of taking these drugs, 2 case in each group(2/15,13.3%)had endurably mild to mediate abdominal pain,and diarrhea or nausea.Conclusion Ferrous lactate tablets are a highly effective drug as compared with marketed ferrous succinate tablets and have only endurably mild side effects on patients with IDA.