医药学论文：果糖对鼻腔手术后患者血糖和胰岛功能影响的双盲随机对照研究

【摘要】 目的 评价果糖对鼻腔手术后患者血糖和胰岛功能的影响。方法 采用前瞻、随机、双盲和对照的研究方法，选择满足方案入选标准并获得知情同意的鼻腔手术后患者共60例进入本研究。术后1～2天开始空腹静脉注射5%果糖注射液或5%葡萄糖注射液500ml，连续3天。观察用药前和用药中血糖和胰岛素、胰岛素CP的变化，比较两组之间的差别。同时观察用药中血尿酸和乳酸。结果 按计划完成本研究60例，无淘汰病例；两组在输液前后血糖3天的平均变化值分别为（2.39±2.34）和（0.32±1.53）mmol/L；两组比较差异有非常显著性（P< 0.01）。研究组输注5%的果糖注射液中，血胰岛素和胰岛素C肽的变化值分别为（7.9±21.5）μu/ml和（312±264）pmol/L；对照组相应的结果是（14.6±19.8）μu/ml和（524±212）pmol/L，对照组输注葡萄糖胰岛素和C肽升高的幅度显著大于研究组，差异有显著性（P< 0.05）；输注果糖注射液中两组的血乳酸和尿酸结果相似。结论 适量静脉输注果糖对手术后患者血糖和胰岛功能的影响较小。
【关键词】 果糖；外科手术；血糖；胰岛；随机对照试验

【Abstract】 Objective To evaluate the effects of fructose on serum glucose and pancreas islet function in post nasal cavity operation patients.Methods It is a prospective，doubleblind，randomized and controlled clinical study.60 consented post nasal cavity operation patients who met with defined criteria were control into the study.The subjects in study group were administered with 500ml 5% fructose injections intravenously in a series of three days since postoperation 1st or 2nd day；it was administered with 5% glucose in control group.The changes of serum glucose，INS and INS CP，lactic acid and uric acid，before and after injection were measured；adverse events were observed.Results We had achieved 60 cases according to the study protocol.The effects of intravenous injection of 5% fructose 500ml of on serum glucose were relatively mild.After the injection，the changes of serum glucose were (0.32±1.53)mmol/L；however the serum glucose increased remarkably in control group，in which the changes of serum glucose were (2.39±2.34)mmol/L.The difference between 2 groups was significant (P< 0.01).In study groups，the changes of insulin and insulin peptide C were mild；while in control group，the parameters described above increased remarkably.The differences between 2 groups were significant (P< 0.05).No effect on serum lactic acid and uric acid was observed in all groups.No adverse event was reported.Conclusion Adequate intravenous injection of fructose has relatively mild effects on serum glucose and pancreas is let function.
【Key words】 fructose；operation；glucose；pancreas islets function；RCT
果糖（fructose）是葡萄糖的同分异构体，可在无胰岛素参与的情况下，直接转化为糖原，对血糖的影响小，更易机体的吸收利用，临床上主要用于供给机体能量和补充体液。笔者于2005年4月～2005年11月期间，在接受鼻腔手术后患者中，进行了5%果糖双盲、随机、对照的临床研究，观察其对机体血糖和胰岛功能的影响。现报告如下。
1 对象与方法
1.1 研究对象 因鼻窦炎、肥厚性鼻炎和鼻中隔偏曲等病因接受鼻腔手术后；年龄18～70岁；无糖尿病史，且空腹血糖在130mg/dl内；肝肾功能大致正常；研究前4h内未使用其他糖类能量补充剂；并在研究开始前签署书面知情同意书的60例住院患者进入本研究。有遗传性果糖不耐受病史；痛风、高尿酸血症（血尿酸＞7.7mg/dl）；体重过重或过轻（超过标准体重的±20%）；糖尿病患者或空腹血糖＞130mg/dl；甲状腺功能亢进；肝、肾功能严重异常（转氨酶＞60u，胆红素＞1.5mg/dl；尿素氮＞30mg/dl，肌酐＞1.8mg/dl）的患者不能进入本研究。研究开始前，方案经卫生部北京医院伦理委员会批准通过。研究结束时分出研究组（study group）30例和对照组（control group）30例。2组患者在研究前的一般资料见表1，可见2组在年龄、性别、体重、身高以及所患疾病类型等方面差异无显著性，具有可比性。