鱼油脂肪乳剂对胃肠道恶性肿瘤患者术后免疫功能的影响
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摘要
目的:研究鱼油脂肪乳剂对胃肠道恶性肿瘤切除术后免疫功能的影响。
方法:将胃肠道恶性肿瘤切除术后患者40例随机分为对照组和研究组,对照组给予低热量肠外营养治疗,而研究组加用ω-3鱼油脂肪乳。每个患者从术前1-3天观察至术后8天符合入选标准、不存在排除标准的患者,知情同意后得到序号,配液的固定人员根据序号将其分入研究组或对照组,并根据体重配制研究组用药或对照组用药,术后第一天至第七天输入药物,分别于术前、术后第一天和术后第八天测定有关指标。比较两组的安全性指标,免疫功能指标(包括细胞免疫及体液免疫)。
结果:1、一般指标:a、生命体征:两组患者体温、脉搏、呼吸、血压等生命体征无显著性差异。b、术后并发症:在研究过程中,无严重不良事件,所有患者无头痛、呕吐、多汗、面部潮红的不适主诉,仅在研究组发生1例、对照组2例发生手术切口感染,经及时和积极的消炎、换药处理后痊愈,两组比较无差异性。2、安全性指标:在对肝肾功能、血脂和血糖的观察中,术前入组时基本正常,各指标两组基本一致,且极少或无影响。3、免疫指标:a、细胞免疫指标:CD3:两组经历一个先小幅下降,后又升高过程。术前术后及研究对照两组无显著性差异;CD4:变化趋势同上,术后第8天,术后第8天与术前的差值,术后第8天与第1天的差值,均有显著性差异(P＜0.05);CD8:研究组先上升后下降,对照组先下降后上升,术后第8天,术后第8天与第1天的差值,均有显著性差异(P＜0.05);CD4/CD8:研究组先上升后下降,对照组持续下降,术后第8天,术后第8天与术前的差值,术后第8天与第1天的差值,均有显著性差异(P＜0.05)。b、体液免疫指标:IgA:研究组略有下降,对照组持续下降,术后第8天,术后第8天与术前的差值,术后第8天与第1天的差值,均有显著性差异(P＜0.05);IgG:研究组略有下降,对照组持续下降,术后第8天与第1天的差值,有显著性差异(P＜0.05);IgM:研究组持续上升,对照组持续下降,术后第8天,术后第8天与术前的差值,术后第8天与第1天的差值,均有显著性差异(P＜0.05)。
结论:通过前瞻、随机、双盲、平行对照的鱼油脂肪乳临床试验,证明鱼油脂肪乳可以提高胃肠道恶性肿瘤术后免疫功能,并且具有良好的安全性。
Objective:To investigate the immunological effect ofω-3 fish oil fat emulison injection on patients after surgical operation of gastrointestinal malignancy.
Method:It was a randomizd double-blind parallel controlled clinical study design.40 patients after surgical operation of gastrointestinal malignancy were randomly devided into control group and study group.The patients in control group were treated with hypocaloric nutrition,and those in study group receivedω-3 fish oil fat emulison injection additionally.The safety index and immunological effect index were compared.
Result:There were no obvious differences in vital sign between control group and study group.There were no obvious adverse reactions between control group and study group,so it was safe to useω-3 fish oil fat emulison injection.
CD3:It decreased a little at first,then increased;there were no obvious differences between control group and study group.
CD4:It decreased a little at first,then increased;there were obvious differences between control group and study group in postoperative day 8,the margin of postoperative day 8 and ante operation day 1,and the margin of postoperative day 8 and postoperative day 1.
CD8:It increased first and then decreased in study group,while it decreased first and then increased in control group,there were obvious differences between control group and study group in postoperative day 8,and the margin of postoperative day 8 and postoperative day 1.
CD4/CD8 ratio:It increased first and then decreased in study group,while it decreased persistently in control group;there were obvious differences between control group and study group in postoperative day 8,the margin of postoperative day 8 and ante operation day 1,and the margin of postoperative day 8 and postoperative day 1.
IgA:It decreased a little in study group,while it decreased persistently in control group;there were obvious differences between control group and study group in postoperative day 8,the margin of postoperative day 8 and ante operation day 1,and the margin of postoperative day 8 and postoperative day 1.
IgG:It decreased a little in study group,while it decreased persistently in control group;there were obvious differences between control group and study group in the margin of postoperative day 8 and postoperative day 1.
IgM:It increased persistently in study group,while it decreased persistently in control group;there were obvious differences between control group and study group in postoperative day 8,the margin of postoperative day 8 and ante operation day 1,and the margin of postoperative day 8 and postoperative day 1.
Conelution:ω-3 fish oil fat emulison injection could be benefit for the immunological function of patients after surgical operation of gastro-intestinal mallgnancy,and could be used safely.
方法:将胃肠道恶性肿瘤切除术后患者40例随机分为对照组和研究组,对照组给予低热量肠外营养治疗,而研究组加用ω-3鱼油脂肪乳。每个患者从术前1-3天观察至术后8天符合入选标准、不存在排除标准的患者,知情同意后得到序号,配液的固定人员根据序号将其分入研究组或对照组,并根据体重配制研究组用药或对照组用药,术后第一天至第七天输入药物,分别于术前、术后第一天和术后第八天测定有关指标。比较两组的安全性指标,免疫功能指标(包括细胞免疫及体液免疫)。
结果:1、一般指标:a、生命体征:两组患者体温、脉搏、呼吸、血压等生命体征无显著性差异。b、术后并发症:在研究过程中,无严重不良事件,所有患者无头痛、呕吐、多汗、面部潮红的不适主诉,仅在研究组发生1例、对照组2例发生手术切口感染,经及时和积极的消炎、换药处理后痊愈,两组比较无差异性。2、安全性指标:在对肝肾功能、血脂和血糖的观察中,术前入组时基本正常,各指标两组基本一致,且极少或无影响。3、免疫指标:a、细胞免疫指标:CD3:两组经历一个先小幅下降,后又升高过程。术前术后及研究对照两组无显著性差异;CD4:变化趋势同上,术后第8天,术后第8天与术前的差值,术后第8天与第1天的差值,均有显著性差异(P＜0.05);CD8:研究组先上升后下降,对照组先下降后上升,术后第8天,术后第8天与第1天的差值,均有显著性差异(P＜0.05);CD4/CD8:研究组先上升后下降,对照组持续下降,术后第8天,术后第8天与术前的差值,术后第8天与第1天的差值,均有显著性差异(P＜0.05)。b、体液免疫指标:IgA:研究组略有下降,对照组持续下降,术后第8天,术后第8天与术前的差值,术后第8天与第1天的差值,均有显著性差异(P＜0.05);IgG:研究组略有下降,对照组持续下降,术后第8天与第1天的差值,有显著性差异(P＜0.05);IgM:研究组持续上升,对照组持续下降,术后第8天,术后第8天与术前的差值,术后第8天与第1天的差值,均有显著性差异(P＜0.05)。
结论:通过前瞻、随机、双盲、平行对照的鱼油脂肪乳临床试验,证明鱼油脂肪乳可以提高胃肠道恶性肿瘤术后免疫功能,并且具有良好的安全性。
Objective:To investigate the immunological effect ofω-3 fish oil fat emulison injection on patients after surgical operation of gastrointestinal malignancy.
Method:It was a randomizd double-blind parallel controlled clinical study design.40 patients after surgical operation of gastrointestinal malignancy were randomly devided into control group and study group.The patients in control group were treated with hypocaloric nutrition,and those in study group receivedω-3 fish oil fat emulison injection additionally.The safety index and immunological effect index were compared.
Result:There were no obvious differences in vital sign between control group and study group.There were no obvious adverse reactions between control group and study group,so it was safe to useω-3 fish oil fat emulison injection.
CD3:It decreased a little at first,then increased;there were no obvious differences between control group and study group.
CD4:It decreased a little at first,then increased;there were obvious differences between control group and study group in postoperative day 8,the margin of postoperative day 8 and ante operation day 1,and the margin of postoperative day 8 and postoperative day 1.
CD8:It increased first and then decreased in study group,while it decreased first and then increased in control group,there were obvious differences between control group and study group in postoperative day 8,and the margin of postoperative day 8 and postoperative day 1.
CD4/CD8 ratio:It increased first and then decreased in study group,while it decreased persistently in control group;there were obvious differences between control group and study group in postoperative day 8,the margin of postoperative day 8 and ante operation day 1,and the margin of postoperative day 8 and postoperative day 1.
IgA:It decreased a little in study group,while it decreased persistently in control group;there were obvious differences between control group and study group in postoperative day 8,the margin of postoperative day 8 and ante operation day 1,and the margin of postoperative day 8 and postoperative day 1.
IgG:It decreased a little in study group,while it decreased persistently in control group;there were obvious differences between control group and study group in the margin of postoperative day 8 and postoperative day 1.
IgM:It increased persistently in study group,while it decreased persistently in control group;there were obvious differences between control group and study group in postoperative day 8,the margin of postoperative day 8 and ante operation day 1,and the margin of postoperative day 8 and postoperative day 1.
Conelution:ω-3 fish oil fat emulison injection could be benefit for the immunological function of patients after surgical operation of gastro-intestinal mallgnancy,and could be used safely.
引文
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