al-Momen A K, al-Meshari A, al-Nuaim L, Saddique A, Abotalib Z, Khashogji T, Abbas M
Department of Medicine, College of Medicine, Riyadh, Saudi Arabia.
Eur J Obstet Gynecol Reprod Biol. 1996 Nov;69(2):121-4. doi: 10.1016/0301-2115(95)02538-3.
To evaluate the safety and efficacy of intravenous iron sucrose complex (ISC) as compared with oral ferrous sulfate in the treatment of iron deficiency anemia during pregnancy.
prospective, open, controlled study in which pregnant women with iron deficiency anemia were sequentially selected from the antenatal clinic and assigned either to ISC (study group) or to ferrous sulfate (control group).
Each study patient was given the total calculated amount of ICS (Hb deficit (g/l) x body weight (kg) x 0.3) in divided doses (200 mg (elemental iron) in 100 ml normal saline intravenously over 1 h daily) followed by 10 mg/kg to replenish iron stores. Each patient of the control group was given ferrous sulfate 300 mg (60 mg elemental iron) orally three times a day. All patients were monitored for adverse effects, clinical and laboratory response.
There were 52 patients and 59 controls. ISC group achieved a significantly higher Hb level (128.5 +/- 6.6 g/l vs. 111.4 +/- 12.4 g/l in the control group P < or = 0.001) in a shorter period (6.9 +/- 1.8 weeks vs. 14.9 +/- 3.1 weeks in the control group, P < or = 0.001). ISC complex group showed no major side effects while 4 (6%) of the control group could not tolerate ferrous sulfate, 18 (30%) complained of disturbing gastrointestinal symptoms and 18 (30%) had poor compliance.
We conclude that ISC is safe and effective in the treatment of iron deficiency anemia during pregnancy.
评估静脉注射蔗糖铁复合物(ISC)与口服硫酸亚铁治疗孕期缺铁性贫血的安全性和有效性。
前瞻性、开放性对照研究,从产前门诊依次选取缺铁性贫血孕妇,分为ISC组(研究组)和硫酸亚铁组(对照组)。
每位研究患者给予计算出的总ISC剂量(血红蛋白 deficit(g/l)×体重(kg)×0.3),分剂量给药(200mg(元素铁)加入100ml生理盐水中,每日静脉滴注1小时),随后给予10mg/kg以补充铁储备。对照组每位患者口服硫酸亚铁300mg(60mg元素铁),每日3次。所有患者均监测不良反应、临床及实验室反应。
研究组52例,对照组59例。ISC组在较短时间内血红蛋白水平显著更高(128.5±6.6g/l,对照组为111.4±12.4g/l,P≤0.001)(6.9±1.8周,对照组为14.9±3.1周,P≤0.001)。ISC复合物组未出现严重副作用,而对照组有4例(6%)不能耐受硫酸亚铁,18例(30%)主诉胃肠道症状不适,18例(30%)依从性差。
我们得出结论,ISC治疗孕期缺铁性贫血安全有效。