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癌症患者轻中度非化疗药物诱导性缺铁性贫血的治疗:甘氨酸亚铁双螯合物与硫酸亚铁的比较。

Treatment of mild non-chemotherapy-induced iron deficiency anemia in cancer patients: comparison between oral ferrous bisglycinate chelate and ferrous sulfate.

机构信息

Department of Oncology, University of Pisa, Pisa, Italy.

出版信息

Biomed Pharmacother. 2012 Sep;66(6):414-8. doi: 10.1016/j.biopha.2012.06.003. Epub 2012 Jun 29.

Abstract

In cancer patients mild-moderate non-chemotherapy-induced iron deficiency anemia (IDA) is usually treated with oral iron salts, mostly ferrous sulfate. In this study, we compare efficacy and toxicity of oral ferrous bisglycinate chelate and ferrous sulfate in cancer patients with mild IDA. Twenty-four patients operated on for solid tumors (10 breast, 12 colorectal, 2 gastric), aged 61±10 years (range 45-75), with non-chemotherapy-induced hemoglobin (Hb) values between 10 and 12 g/dL and ferritin lower than 30 ng/mL were randomized to receive oral ferrous bisglycinate chelate, 28 mg per day for 20 days, and then 14 mg per day for 40 days (12 patients) (A group) or oral ferrous sulphate, 105 mg per day for 60 days (12 patients) (B group). Values of hemoglobin and ferritin obtained at diagnosis, 1 and 2 months from the beginning of treatment were compared. Adverse events (AEs) related to the two treatments were recorded. In the 12 patients treated with ferrous bisglycinate chelate, basal hemoglobin and ferritin values (mean±SD) were 11.6±0.8 g/dL and 16.1±8.0 ng/mL. After 2 months of treatment, they were 13.0±1.4 g/dL and 33.8±22.0 ng/mL, respectively (P=0.0003 and P=0.020). In the group treated with ferrous sulphate, hemoglobin and ferritin mean values were 11.3±0.6 g/dL and 19.0±6.4 ng/mL basally, and 12.7±0.70 g/dL and 40.8±28.1 ng/mL (P<0.0001 and P=0.017) after 2 months of treatment. AEs occurred in six cases. In all these six cases, two (17%) treated with ferrous bisglycinate chelate and four (33%) with ferrous sulphate, toxicity was grade 1. In conclusion, these data suggest that ferrous bisglycinate chelate has similar efficacy and likely lower GI toxicity than ferrous sulphate given at the conventional dose of 105 mg per day for the same time.

摘要

在癌症患者中,轻度至中度非化疗引起的缺铁性贫血(IDA)通常采用口服铁盐治疗,主要是硫酸亚铁。在这项研究中,我们比较了口服双甘氨酸亚铁螯合物和硫酸亚铁在轻度 IDA 癌症患者中的疗效和毒性。24 例接受实体瘤手术的患者(10 例乳腺癌,12 例结直肠癌,2 例胃癌),年龄 61±10 岁(45-75 岁),非化疗诱导的血红蛋白(Hb)值在 10-12g/dL 之间,铁蛋白值低于 30ng/mL,随机分为口服双甘氨酸亚铁螯合物组,每天 28mg,共 20 天,然后每天 14mg,共 40 天(12 例)(A 组)或口服硫酸亚铁组,每天 105mg,共 60 天(12 例)(B 组)。比较治疗开始时、1 个月和 2 个月时血红蛋白和铁蛋白的值。记录与两种治疗相关的不良反应(AE)。在 12 例接受双甘氨酸亚铁螯合物治疗的患者中,基础血红蛋白和铁蛋白值(平均值±标准差)分别为 11.6±0.8g/dL 和 16.1±8.0ng/mL。治疗 2 个月后,分别为 13.0±1.4g/dL 和 33.8±22.0ng/mL(P=0.0003 和 P=0.020)。在硫酸亚铁组中,治疗前血红蛋白和铁蛋白平均值分别为 11.3±0.6g/dL 和 19.0±6.4ng/mL,治疗 2 个月后分别为 12.7±0.70g/dL 和 40.8±28.1ng/mL(P<0.0001 和 P=0.017)。6 例发生 AE。在所有这 6 例中,2 例(17%)接受双甘氨酸亚铁螯合物治疗,4 例(33%)接受硫酸亚铁治疗,毒性为 1 级。总之,这些数据表明,双甘氨酸亚铁螯合物具有相似的疗效,且胃肠道毒性可能低于每天 105mg 硫酸亚铁的常规剂量,治疗时间相同。

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