静脉铁剂治疗慢性心力衰竭合并铁缺乏患者的疗效观察

发布时间：2018-09-13 11:37

【摘要】：目的本研究通过静脉使用铁剂在慢性心力衰竭(chronic heart failure,CHF)合并铁缺乏(iron deficiency,ID)患者治疗中疗效的观察,进一步明确静脉使用铁剂能否改善CHF合并ID患者的生活质量、心功能、运动耐量、减少再入院率及死亡率。研究方法选取2013年4月-2014年2月于第二炮兵总医院心内科门诊CHF并伴有ID的患者为研究对象。共纳入101例,经随机数表法给予分组,其中静脉铁剂治疗组(A组)51例,男性28例,女性23例;对照组(B组)50例,男性26例,女性24例。两组患者个体化给予利尿药、血管紧张素转换酶抑制剂、β受体阻滞剂等药物治疗。A组在常规药物治疗的基础上给予静脉注射蔗糖铁注射液10ml,每周1次,每月监测血清铁蛋白水平,若铁蛋白200ug/L和(或)血红蛋白160g/L则给予换为安慰剂继续治疗,一个月后复查若血清铁蛋白低于上述目标值则继续给予使用,治疗时间为6个月。B组给予常规治疗,每月监测血清铁蛋白及血红蛋白水平,治疗随访时间为6个月。A组患者在使用蔗糖铁时,先给予小剂量测试,若出现不良反应则禁止进一步参与本研究,试验期间若B组或A组患者出现血红蛋白下降速度较快或低于90g/L,则停止研究。对A、B两组患者于研究开始直至研究结束,每个月给予监测血红蛋白水平、血清铁蛋白水平、心功能、活动耐力及生活质量。采用OLYMPUS AU2700全自动生化分析仪,通过免疫比浊法对血清铁蛋白进行测定;血红蛋白由五分类分析仪XE-5000进行测定;NTpro-BNP由法国生物梅里埃公司生产的mini VIDAS免疫分析仪采用酶联荧光分析技术进行检测;心功能的测定:由NYHA心功能分级标准对其进行测定;应用6分钟步行试验对患者运动耐量进行测定;使用明尼苏达心力衰竭生活质量调查表(Li HFe)对患者生活质量进行测定。采用SPASS 20.0软件统计包进行统计分析。计量资料以均数±标准差(?x±s)表示,组间比较采用t检验;计数资料以例数与百分比(%)表示,采用χ2检验。P0.05差异有统计学意义,P0.01表示有显著差异。结果1.对入组患者进行药物测试时,A组及B组患者均未出现不良反应。对患者进行随访治疗期间:两组患者均未出现不良反应及相关并发症;A组失访2人,而B组无一例患者出现失访,将A组与B组失访人数进行统计学分析,无统计学意义(P0.05);A组因心功能恶化而入院患者为2人,而B组为9人,经A组与B组再入院患者相比,两组存在显著的统计学差异(P0.01)。死亡人数在A、B两组间的比较,无统计学意义(P0.05)。2.对A、B两组患者随访6个月期间的血红蛋白进行比较,第1、2、3个月期间A组患者与B组患者比较血红蛋白差异存在统计学意义(P0.05);第4、5、6月两组患者相比较,血红蛋白差异有显著的统计学意义(P0.01);随着时间的推移,A组患者血红蛋白呈上升趋势,B组患者血红蛋白呈下降趋势。3.对A、B两组患者随访6个月期间的血清铁蛋白浓度进行比较,第1-6个月期间A组患者与B组血清铁蛋白浓度相比较存在显著统计学差异(P0.01);A组患者平均血清铁蛋白水平呈上升趋势,而B组患者平均血清铁蛋白水平呈下降趋势。4.对两组患者随访期间的6分钟步行距离进行比较,在第1个月的随访期间6分钟步行的距离在统计学上无明显差异(P0.05);在第2个月的随访期间A、B两组患者的6分钟步行距离相比较,存在统计学差异(P0.05);在第3、4、5、6月的随访期间A组患者6分钟步行距离与B组患者相比较存在显著的统计学差异(P0.01);两组患者在随访期间的6分钟步行距离均呈上升趋势。5.两组患者随访期间的心功能进行比较:在第1个月两组心功能无明显统计学差异;第2、3月两组患者心功能分级存在统计学差异(P0.05);第4-6个月,A、B两组患者心功能存在显著的统计学差异(P0.01)。6.对两组患者随访期间将两组患者Li HFe得分进行比较:在第1个月两组Li HFe得分无明显统计学差异;第2月两组患者Li HFe得分存在统计学差异(P0.05);第3-6个月,A、B两组患者Li HFe得分存在显著的统计学差异(P0.01);两组患者Li HFe得分较前均有所下降。7.对两组患者随访治疗6个月前后的各观察指标比较,A组在治疗后血红蛋白浓度与治疗前比较存在统计学差异(P0.05),而A组治疗后血清铁蛋白浓度、心功能分级、6分钟步行距离较治疗前均存在显著的统计学差异(P0.01);B组治疗后的血红蛋白浓度、血清铁蛋白浓度、心功能分级、6分钟步行距离较治疗前均存在显著的统计学差异(P0.01)。结论1.对CHF合并ID的患者给予静脉补充铁剂可明显改善其运动耐量、生活质量、心功能,降低再入院率。2.静脉补铁可增加CHF合并ID患者的血清铁蛋白及血红蛋白浓度3.静脉使用铁剂治疗CHF合并ID患者安全性较高。
[Abstract]:Objective To observe the effect of intravenous iron in the treatment of chronic heart failure (CHF) patients with iron deficiency (ID), and to further clarify whether intravenous iron can improve the quality of life, cardiac function, exercise tolerance, and reduce readmission rate and mortality in CHF patients with ID. A total of 101 patients with CHF accompanied by ID were enrolled in this study. They were divided into two groups randomly: intravenous iron group (group A) 51 cases, 28 males and 23 females; control group (group B) 50 cases, 26 males and 24 females. Patients in group A were given intravenous injection of 10 ml of sucrose iron once a week to monitor the level of serum ferritin once a month. Patients in group A were given placebo instead of 200 ug/L of ferritin and/or 160 g/L of hemoglobin. Patients in group B received routine treatment for 6 months. Serum ferritin and hemoglobin levels were monitored monthly for 6 months. Patients in group A were given small doses of iron sucrose first, and were forbidden to participate in the study if adverse reactions occurred. Patients in group A and group B were monitored for hemoglobin levels, serum ferritin levels, cardiac function, activity endurance and quality of life every month from the beginning of the study to the end of the study. OLYMPUS AU2700 automatic biochemical analyzer was used for immunization. Serum ferritin was determined by turbidimetry; hemoglobin was determined by five-class analyzer XE-5000; NTpro-BNP Mini VIDAS immunoassay produced by French BioMeriere Company was detected by ELISA; cardiac function was measured by NYHA cardiac function classification standard; and 6-minute walking test was used. The exercise tolerance of the patients was measured and the quality of life of the patients was measured with the Minnesota Heart Failure Quality of Life Questionnaire (Li HFe). The statistical analysis was carried out with SPASS 20.0 software statistical package. The measurement data were expressed as mean (?) standard deviation (?) x (?) s), and the comparison between groups was performed with t test. The counting data were expressed as cases and percentage (%). Results 1. There were no adverse reactions in group A and group B. During the follow-up period, there were no adverse reactions and related complications in both groups; there were 2 patients in group A and no patients in group B who were missing the visit. The number of missing visits in group A and group B was statistically significant (P The hemoglobin of group A was significantly different from that of group B during the first, second and third months (P 0.05); the hemoglobin of group A was significantly different from that of group B in the fourth, fifth and sixth months (P 0.01); with the passage of time, the hemoglobin of group A was on the rise, and the blood of group B was on the rise. The serum ferritin levels of group A and group B were compared during the follow-up period of 6 months. The serum ferritin levels of group A and group B were significantly different from those of group B during the first 6 months (P 0.01); the average serum ferritin level of group A was on the rise, while the average serum ferritin level of group B was on the rise. The 6-minute walking distance between the two groups during the follow-up period was not statistically significant (P 0.05) during the first month of follow-up period; during the second month of follow-up period, the 6-minute walking distance between the two groups was statistically significant (P 0.05); during the follow-up period of 3, 4, 5 and 6 months, there was a significant difference between the two groups (P 0.05). The 6-minute walking distance in group A was significantly different from that in group B (P There were significant differences in heart function between groups A and B (P 0.01) at 4-6 months (P 0.05). There was significant difference in the scores of Li HFe between group A and group B at 6 months (P 0.01); the scores of Li HFe in both groups were lower than before. 7. Compared with the observation indexes before and after 6 months of follow-up treatment, there was significant difference in the concentration of hemoglobin after treatment between group A and before treatment (P 0.05). There were significant differences in hemoglobin concentration, serum ferritin concentration, cardiac function grading and 6-minute walking distance between the two groups (P 0.01). Conclusion 1. Intravenous iron supplementation is effective in the treatment of CHF with ID. Intravenous iron supplementation can increase the concentration of serum ferritin and hemoglobin in CHF patients with ID. Intravenous iron therapy is safe for CHF patients with ID.
【学位授予单位】：苏州大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R541.6;R591.1

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