首页>
外文期刊>clinical drug investigation
>Multicentre Double-Blind Clinical Trial of Iron Protein Succinylate in Comparison With Iron Sulfate in the Treatment of Iron Deficiency Anaemia
【24h】
Multicentre Double-Blind Clinical Trial of Iron Protein Succinylate in Comparison With Iron Sulfate in the Treatment of Iron Deficiency Anaemia
展开▼
机译：Multicentre Double-Blind Clinical Trial of Iron Protein Succinylate in Comparison With Iron Sulfate in the Treatment of Iron Deficiency Anaemia
This prospective, double-blind, controlled, multicentre trial was carried out to evaluate the efficacy and tolerability of iron protein succinylate (ITF 282) in comparison with iron sulfate in the treatment of iron deficiency anaemia. 174 patients (98percnt; females) with iron deficiency anaemia were randomised to receive either two iron protein succinylate tablets per day (60mg iron each; n equals; 86) or one ferrous sulfate controlled-release tablet per day (105mg iron; n equals; 88); both treatments were scheduled to last 60 days. The course of all laboratory efficacy variables (Hb, Hct, RBC, etc.) during the treatment period showed good therapeutic activity of both ITF 282 and iron sulfate. After 2 months of treatment, the haematochemistry data indicated a satisfactory recovery of iron metabolism in both groups of patients: plasma iron increased from 38 to 75 mu;gsol;dl with ITF 282 and from 38 to 66 mu;gsol;dl with iron sulfate; the transferrin saturation rate increased from 9 to 21percnt; with ITF 282 and from 9 to 19percnt; with iron sulfate. The circulating haemoglobin increased from 9.98 to 12.08 gsol;dl with ITF 282 and from 9.92 to 12.21 gsol;dl with iron sulfate. The differences between the treatments were not statistically significant. A marked clinical improvement in anaemic symptoms (paleness, asthenia, tiredness) was observed with both treatments. The general tolerability was favourable with both treatments; however, ITF 282 appeared to be better tolerated than iron sulfate when gastrointestinal symptoms were taken into account. This trial showed that ITF 282 is an interesting, novel approach to iron treatment.
展开▼
