摘要
目的 :观察l 苏糖酸亚铁治疗缺铁性贫血的疗效及安全性。方法 :采用随机、双盲、双模拟、阳性药物平行对照临床试验方法。 4 8例合格受试者分别给予事先编盲的药物 ,分 2组 ,试验组 (2 4例 )给予l 苏糖酸亚铁胶囊 4粒 +模拟琥珀酸亚铁片 2片 ,po ,tid ,对照组 (2 4例 )给予琥珀酸亚铁片 2片 +模拟l 苏糖酸亚铁胶囊 4粒 ,po ,tid。试验周期为 8wk。结果 :治疗后 4wk对照组总有效率 86 % ,试验组总有效率 10 0 %。治疗后 8wk ,对照组、试验组总有效率均为 10 0 %。 2组疗效比较无显著差别(P >0 .0 5 )。不良反应的发生率对照组为 4例(19% ) ,试验组为 2例 (9% ) ,差别无显著意义(P >0 .0 5 )。结论 :l 苏糖酸亚铁用于治疗缺铁性贫血起效快、疗效显著 ,不良反应轻微 ,发生率低。
AIM: To evaluate the effect and safety of ferrous l-threonate in treating iron deficiency anemia. METHODS: A random, double blind, double modeling and parallel comparative study with positive control was desiged. Forty-eight eligible patients were randomly divided into trial group(n=24) and positive control group(n=24). Patients in trial group were given ferrous l-threonate plus the modeling ferrous succinate, and patients in control group were given ferrous succinate plus the modeling ferrous l-threonate. The treatment course was 8 wk. The clinical effective evaluation was made at 4,8 wk. RESULTS: After 4 wk treatment,the total effective rate was 86 % in the control group and 100 % in the trial group.After 8 wk treatment , the total effective rate was 100 % in both control group and trial group.There was no significant difference between two groups(P> 0.05). Adverse reactions occurred in only 4(19 %) patients in control group,and only 2(9 %)patients in trial group. There were no significant differences between two groups(P>0.05). CONCLUSION: The effect of ferrous l-threonate in treating iron deficiency anemia is certain,significant and rapid. Its adverse reactions are few and minimal.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2004年第5期296-299,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
贫血
缺铁性
临床试验
Ⅲ期
随机对照试验
双盲法
l-苏糖酸亚铁
琥珀酸亚铁
anemia, iron deficiency
clinical trials,phase Ⅲ
randomized controlled trial
double-blind method
ferrous l-threonate
ferrous succinate