乌梅消食颗粒治疗溃疡性结肠炎合并缺铁性贫血的临床效果(1)
[摘要] 目的 观察乌梅消食颗粒联合铁剂对溃疡性结肠炎(UC)合并缺铁性贫血(IDA)的临床疗效。 方法 入组病例来自于廊坊市中医医院2014年3月～2015年2月收治的128例UC合并IDA患者，入组病例进行随机分组，采用随机、双盲、安慰剂对照的实验设计，治疗组64例，采用乌梅消食颗粒和铁剂联合治疗，对照组64例，采用铁剂加安慰剂治疗。共有55例(86%)治疗组患者及53例(83%)对照组患者完成了预计的12周治疗。对比治疗前后两组患者血红蛋白及血清铁蛋白数值的变化进行疗效分析，同时进行安全性及耐受性分析。 结果 在第4、8、12周随访时发现，治疗组患者血红蛋白恢复较对照组快，提升的均值分别为(1.04±0.61)、(1.76±0.89)、(2.25±1.13)g/dL(在所有时间节点，P < 0.01)。血清铁蛋白同样提示治疗组相比对照组存在优势。对于安全性及耐受性进行分析发现，对照组有27名患者出现了明显的消化道副作用，有4名患者出现了UC症状的加重，治疗组仅有3名患者出现了轻微的消化道反应，无原发疾病的进展或恶化。 结论 乌梅消食颗粒能够加快UC患者血红蛋白回升，且具有良好的安全性，并能显著提高UC患者的铁剂耐受性。提示这种联合可能取代或减少UC患者对静脉铁剂的依赖。
[关键词] 缺铁性贫血；溃疡性结肠炎；乌梅消食颗粒
[中图分类号] R574.62 [文献标识码] A [文章编号] 1673-7210(2016)09(a)-0134-04
[Abstract] Objective To observe the effect of Wumeixiaoshi powder in the iron deficiency anemia (IDA) patients with the complication of ulcerative colitis together. Methods 128 UC combined with IDA patients in Langfang Hospital of TCM from March 2014 to February 2015 were selected and randomly divided into two groups. A randomized， double-blind， placebo-controlled trial was used. Treatment group (n=64) were treated with Wumeixiaoshi powder and ferrous lactate together； control group (n=64) were treated with placebo and ferrous lactate； 55 patients (86%) in treatment group and 53 patients (83%) completed the trial. Hemoglobin and serum ferritin values of two groups were analyzed before and after treatment. Safety and tolerability were analyzed then. S and all of them received detections of cytometry， ferroprotein to estimate the effect of their treatment. Results A series of comparisons were conducted after the 4， 8 and 12 weeks respectively. Of 128 patients screened， significant improvement of Hb were obvious in treatment group versus control group， elevating (1.04±0.61) g/dL， (1.76±0.89) g/dL， and (2.25±1.13) g/dL respectively (P < 0.01)， serum ferritin reminded that treatment group had advantages over control group， obvious gastrointestinal side effects occured in 3 patients in control group， while only 3 slight side effect patients in treatment group. No primary disease progression or exacerbation occuerd. Conclusion Wumeixiaoshi powder can offer improvements in Hb of UC patients and showed a favorable safety profile， which suggests to be alternative to intravenous iron in IDA ulcerative colitis.
[Key words] Iron deficiency anemia； Ulcerative colitis； Wumeixiaoshi powder
贫血是溃疡性结肠炎(ulcerative colitis，UC)常见的临床并发症，约70%以上的溃疡性结肠炎患者均合并贫血，其中，由于摄入不足、吸收障碍、慢性炎症、以及肠道出血导致的缺铁是其贫血最主要的原因[1-2]。传统的单独口服二价铁盐治疗对于UC患者而言并不完美，一方面大部分的铁盐在UC患者中存在吸收障碍，未被吸收的铁随后在肠腔内被氧化，这导致了氧自由基的生成，这将会进一步损伤肠黏膜，导致广泛的消化道副反应发生，最终形成腹痛、恶心、腹泻、便秘等一系列临床症状。胃肠道脆弱的耐受能力以及UC潜在的复发风险使得很多患者对口服铁剂的耐受能力大打折扣[3-4]。对于患有UC并导致IDA的患者，在欧洲，对于UC患者同时合并IDA的情况，推荐采用静脉铁剂作为标准的补铁治疗，虽然这种治疗效果明确，但是往往导致治疗费用的大幅上涨，同时因为静脉用药的不方便，往往导致依从性下降以及时有发生的不良反应[5]。乌梅消食颗粒是廊坊市中医医院(以下简称“我院”)制剂室生产的院内中成药制剂，主要成分包括枳实、鸡内金、白术、焦山楂、太子参、蒲公英、乌梅、木瓜、莪术、焦神曲等，具有完备的药品审批手续和临床应用经验，既往曾作为降低铁剂不良反应的辅助用药应用于临床，后经临床检验发现该药物不但可以降低消化道不良反应，且可能对患者铁剂吸收有促进作用，对贫血恢复及血清铁蛋白储备有积极影响[6]，现将我院2014年3月～2015年2月收治的128例患者进行了随机分组，进行安慰剂对照，并对所有患者进行为期12周的治疗，监测血红蛋白、铁蛋白变化情况，报道如下： (周振环 郎立新 刘震 吕春颖 范华 )
[关键词] 缺铁性贫血；溃疡性结肠炎；乌梅消食颗粒
[中图分类号] R574.62 [文献标识码] A [文章编号] 1673-7210(2016)09(a)-0134-04
[Abstract] Objective To observe the effect of Wumeixiaoshi powder in the iron deficiency anemia (IDA) patients with the complication of ulcerative colitis together. Methods 128 UC combined with IDA patients in Langfang Hospital of TCM from March 2014 to February 2015 were selected and randomly divided into two groups. A randomized， double-blind， placebo-controlled trial was used. Treatment group (n=64) were treated with Wumeixiaoshi powder and ferrous lactate together； control group (n=64) were treated with placebo and ferrous lactate； 55 patients (86%) in treatment group and 53 patients (83%) completed the trial. Hemoglobin and serum ferritin values of two groups were analyzed before and after treatment. Safety and tolerability were analyzed then. S and all of them received detections of cytometry， ferroprotein to estimate the effect of their treatment. Results A series of comparisons were conducted after the 4， 8 and 12 weeks respectively. Of 128 patients screened， significant improvement of Hb were obvious in treatment group versus control group， elevating (1.04±0.61) g/dL， (1.76±0.89) g/dL， and (2.25±1.13) g/dL respectively (P < 0.01)， serum ferritin reminded that treatment group had advantages over control group， obvious gastrointestinal side effects occured in 3 patients in control group， while only 3 slight side effect patients in treatment group. No primary disease progression or exacerbation occuerd. Conclusion Wumeixiaoshi powder can offer improvements in Hb of UC patients and showed a favorable safety profile， which suggests to be alternative to intravenous iron in IDA ulcerative colitis.
[Key words] Iron deficiency anemia； Ulcerative colitis； Wumeixiaoshi powder
贫血是溃疡性结肠炎(ulcerative colitis，UC)常见的临床并发症，约70%以上的溃疡性结肠炎患者均合并贫血，其中，由于摄入不足、吸收障碍、慢性炎症、以及肠道出血导致的缺铁是其贫血最主要的原因[1-2]。传统的单独口服二价铁盐治疗对于UC患者而言并不完美，一方面大部分的铁盐在UC患者中存在吸收障碍，未被吸收的铁随后在肠腔内被氧化，这导致了氧自由基的生成，这将会进一步损伤肠黏膜，导致广泛的消化道副反应发生，最终形成腹痛、恶心、腹泻、便秘等一系列临床症状。胃肠道脆弱的耐受能力以及UC潜在的复发风险使得很多患者对口服铁剂的耐受能力大打折扣[3-4]。对于患有UC并导致IDA的患者，在欧洲，对于UC患者同时合并IDA的情况，推荐采用静脉铁剂作为标准的补铁治疗，虽然这种治疗效果明确，但是往往导致治疗费用的大幅上涨，同时因为静脉用药的不方便，往往导致依从性下降以及时有发生的不良反应[5]。乌梅消食颗粒是廊坊市中医医院(以下简称“我院”)制剂室生产的院内中成药制剂，主要成分包括枳实、鸡内金、白术、焦山楂、太子参、蒲公英、乌梅、木瓜、莪术、焦神曲等，具有完备的药品审批手续和临床应用经验，既往曾作为降低铁剂不良反应的辅助用药应用于临床，后经临床检验发现该药物不但可以降低消化道不良反应，且可能对患者铁剂吸收有促进作用，对贫血恢复及血清铁蛋白储备有积极影响[6]，现将我院2014年3月～2015年2月收治的128例患者进行了随机分组，进行安慰剂对照，并对所有患者进行为期12周的治疗，监测血红蛋白、铁蛋白变化情况，报道如下： (周振环 郎立新 刘震 吕春颖 范华 )