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一项随机对照研究评估了在重型地中海贫血患者中,添加氨氯地平与螯合剂联合使用以减少铁负荷的效果。

A randomized, controlled study evaluating effects of amlodipine addition to chelators to reduce iron loading in patients with thalassemia major.

机构信息

Department of Pediatrics, Arak University of Medical Sciences, Arak, Iran.

Department of Biostatistics, Arak University of Medical Sciences, Arak, Iran.

出版信息

Eur J Haematol. 2017 Dec;99(6):577-581. doi: 10.1111/ejh.12977. Epub 2017 Oct 13.

DOI:10.1111/ejh.12977
PMID:28960482
Abstract

AIM

Cardiomyopathy due to iron overload can be fatal in patients with thalassemia major. Calcium channel blockers seem to be effective to reduce iron loading. Our goal was to study effects of amlodipine addition to chelators on iron loading in patients with thalassemia major.

METHODS

This randomized, controlled, and single-center trial was performed on 56 patients with thalassemia major. Patients were randomized 1:1 to combined group (iron chelator plus amlodipine) or control group (iron chelator) for 1 year. Iron content was measured by magnetic resonance imaging; heart T2*, and liver T2*. Serum ferritin was also measured.

RESULTS

After 12 months of treatment, myocardial T2* values had significant improvement in combined group (21.9 ± 8.0 ms to 24.5 ± 7.6 ms; P < .05); Difference between two groups was significant (P = .02). Combined treatment had no effect on hepatic T2* value (9.6 ± 2.8 ms to 9.5 ± 3.6 ms); difference between two groups was not significant (P = .2). In addition, a significant reduction was seen in serum ferritin levels in two groups. Mild gastrointestinal upset was the most common untoward effect.

CONCLUSION

Addition of amlodipine to iron chelators has beneficial effects for reduction of iron loading in patients with thalassemia major. This combination therapy seems safe.

摘要

目的

铁过载导致的心肌病在重型地中海贫血患者中可能是致命的。钙通道阻滞剂似乎可以有效减少铁负荷。我们的目标是研究钙通道阻滞剂氨氯地平联合螯合剂对重型地中海贫血患者铁负荷的影响。

方法

这是一项随机、对照、单中心试验,共纳入 56 例重型地中海贫血患者。患者按 1:1 随机分为联合组(铁螯合剂加氨氯地平)或对照组(铁螯合剂),治疗 1 年。采用磁共振成像测量铁含量;心脏 T2和肝脏 T2。同时检测血清铁蛋白。

结果

治疗 12 个月后,联合组心肌 T2值显著改善(21.9±8.0 ms 至 24.5±7.6 ms;P<.05);两组间差异有统计学意义(P=.02)。联合治疗对肝脏 T2值无影响(9.6±2.8 ms 至 9.5±3.6 ms;P=.2)。两组血清铁蛋白水平均显著降低。最常见的不良反应是轻度胃肠道不适。

结论

铁螯合剂联合氨氯地平对降低重型地中海贫血患者的铁负荷有有益作用。这种联合治疗似乎是安全的。

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