知识与财富的链接
目的 观察肠内营养混悬液(TPF-FOS) JEVITY在急性卒中患者中运用的安全性及有效性.方法 本研究由中国医学科学院北京协和医院、首都医科大学宣武医院、上海交通大学附属第一人民医院分院、第二军医大学上海长海医院、四川大学华西医院和苏州大学附属第二医院合作进行.研究自2009年4月至2010年4月历时一年.前瞻性、多中心、上市后观察,伴吞咽障碍的急性卒中患者接受10 d的鼻饲肠内营养混悬液(TPF-FOS)营养支持.主要评估比较患者血清白蛋白、前白蛋白水平、血糖异常率等.记录研究过程中发生不良事件百分比评价安全性指标.统计学分析采用配对t检验.结果 103例接受肠内营养支持的患者血清前白蛋白显著增加(213 mg/L±56 mg/L比219 mg/L±66 mg/L),白蛋白水平虽较基线值显著降低(38 g/L±5 g/L比36 g/L±5 g/L)但在管饲期间维持稳定状态.血糖异常率(40.78％比38.76％)、体质量指数(23.1 kg/m2±3.0 kg/m2比22.8 kg/m2±2.9 kg/m2)与C反应蛋白水平(13 mg比14mg)无显著变化.制剂相关不良事件仅18例次,多为胃肠道反应.结论 肠内营养混悬液(TPF-FOS) JEVITY可以显著增加血清前白蛋白水平,改善患者营养状态,总体安全性良好.可以作为卒中患者肠内营养支持来源.
Objective To evaluate the safety and efficacy of enteral nutritional suspension (TPF-FOS) JEVITY in acute stroke patients.Methods A multicenter,prospective,post-marketing observational study was conducted.A total of 103 acute stroke patients with dysphagia received a 10-day regimen of enteral nutritional suspension (TPF-FOS) JEVITY via nasal gastric tube feeding.The parameters of serum prealbumin,serum albumin and percentage of abnormal blood glucose were evaluated and compared.The incidence of adverse events was recorded.The data were analyzed by paired t-test.Results At the end of the study in comparison with the baselines,the serum prealbumin increased significantly (213 mg/L ±56 mg/L vs 219 mg/L + 66 mg/L) and serum albumin decreased markedly (38 g/L + 5 g/L vs 36 g/L ±5 g/L) but stayed stable during tube feeding.No significant changes were found in percentage of abnormal blood glucose (40.78％ vs 38.76％ ),body mass index (23.1 kg/m2 ± 3.0 kg/m2 vs 22.8 kg/m2 ±2.9 kg/m2 ) and C-reactive protein ( 13 mg vs 14 mg).Only 18 adverse events were related with the study product.And most of them were gastrointestinal reactions.Conclusion Enteral nutritional suspension (TPF-FOS) JEVITY may increase the level of serum prealbumin in acute stroke patients and improve the patient nutritional status.With a low incidence of adverse events,it is a preferred option for enteral nutrition formulas in stroke.
