机构地区:[1]中国医学科学院中国协和医科大学协和医院外科,北京100730
出 处:《中国医学科学院学报》2001年第5期515-518,共4页Acta Academiae Medicinae Sinicae
基 金:国家自然科学基金(39970723);卫生部"肠粘膜屏障"(97010204)重点项目基金资助~~
摘 要:目的观察精氨酸、w-3脂肪酸等强化的肠内营养对术后患者免疫、肠通透性及预后等的影响。方法前瞻、随机、对照、双盲和多中心的临床研究。120例行食道和胃肠道手术的患者,均知情同意参加本临床研究,以等氮等热卡的基本型肠内营养剂作为对照。结果患者资料输入电脑后开盲,完成计划的对照组为58例,研究组为60例。两组患者均无肝、肾功能损害及其他不良反应。替代有效性指标Surrogateefficacyendpoint∶1.用药前后两组精氨酸的差值研究组为(33.7±58.5)μmol/L,对照组为(-2.5±30.7)μmol/L两组间差异有显著性(P=0.004);2.两组在用药前后,乳果糖/甘露醇比值的差值研究组为0.017±0.012,对照组为:0.072±0.020,两组间差异有显著性(P=0.047);3.体液免疫:用药前后IgM差值在研究组与对照组分别为(0.60±0.40)g/L,(0.20±0.40)g/L,两组间差异显著P=0.006;用药前后CD3差值在研究组与对照组分别为2.00±6.940.63±6.46,组间差异有显著性P=0.010;CD4为(3.4±5.3)%,(0.3±5.7)%,组间差异显著P=0.0324.感染相关并发症,对照组2例,研究组无,组间差异不显著(P=0.46);术后住院日:研究组与对照组分别为(13.1±2.5)d,(14.5±3.0)d,差异显著(P=0.008);住院费用研究组与对照组分别为(15122±6279)元;Objective To evaluate the role of arginine,RNA and omega3fatty acid enrich ed enteral nutr-ition.Methods The study was designed as a prospective,randomi zed,double blind,multi-central tri-al.It was an isocaloric and isonitrogenic intake in both groups.The protocol was approved by the Et -hic Committee and,w ritten informed consents were obtained.Results There were120patients enrolle d in this protocol.After data were input to computer,open the code.118out of120patients comple te d the study and,2of them were dropped out.One is because the nasal jejunum tubes dropped and not willing to be replaced.Second patient had fistula of anastomosis on4th days after operation.Th-ere were fin ally60patients in the study group and58in the control group.There were no l iver or re nal functions damage and,obvious adverse in both groups.Plasma ami no acid profile:There was sign-ific an t difference(delta)of plasma arginine levels pre-and after study [(33.7±58.5)μmol/L vs(-2.4± 30.7)μmol/L](P=0.004).Intestinal Permeability(lactulose/man nitol ratio):The differences(delta)of lac tul ose/mannitol ratio pre-and aft er the study were0.017±0.012in study group and,0.027±0.01 6in con trol group.(P=0.047).Immunological markers:Humoral immunity :The differences of IgM levels pre-and after the study were(0.6±0.4)g /L in study group and,(0.2±0.4)g /L in control group(P=0.006) .Cellular immunity:The differences(delta)of CD3levels pre-and after the stu dy were(3.8±5.2)%in study group and (0.3±6.5)%in control gro up (P=0.01).In CD4,(3.4±5.3)%in study group and,(-0.3 ±5.7)%in control group (P=0.032).Clinical Outcomes:There was no infec t-ion-related in study group and,2abdominal infection patients in contro l group.No significant differe-nce was found between groups(P=0.46).T he hospital stays were(13±2.5)days in study group and,(14.5±3. 0)days in control group (P=0.004).The cost for full hospitalization w as(15122±6279)Yuan in study group and,(17403±7091)Yuan in control group.There was2281Yuan lo-wer in study
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