1.营养风险、营养不良发生率和营养支持应用情况的调查—北京和Baltimore教学医院1277例内科患者的前瞻性、多中心、描述性研究 2.营养支持对有营养风险的炎性肠病等消化科患者的结局和成本/效果的影响—275例前瞻性队列研究
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摘要
研究背景和目的
     营养风险是患者由于现存或潜在的营养相关问题导致不良临床结局的风险,在住院患者中普遍存在,此部分患者从营养支持中受益的可能性比较大。中华医学会推荐用营养风险筛查工具(NRS-2002)对住院患者进行营养风险筛查,而对NRS-2002筛查的有营养风险患者,给与营养支持能否改善临床结局,减少住院费用尚缺乏前瞻性研究报道。
     成本/效果分析是转化医学T1,T2,T3阶段中与T3有密切关系的部分,在营养支持领域内,虽然国内有少数报告,但是方法学和结果有明显缺陷。
     本研究目的为(1)了解内科患者营养风险、临床营养支持应用情况(2)分析营养支持、临床结局及住院费用间的关系,进行成本/效果分析。
     方法
     本研究为前瞻性、描述性及队列研究设计,采取定点连续抽样的方法,选择北京协和医院消化内科、呼吸内科和神经内科5个病房和美国约翰霍普金斯医院2个内科病房的患者为研究对象,共有符合不同入选条件的1277名患者进入描述性研究队列,有符合不同入选条件的541例患者进入营养支持与临床结局队列研究,有275例患者进入成本效果分析队列研究。
     符合不同入选条件的患者用NRS-2002进行入院营养风险筛查,观察记录住院期间营养支持应用情况、并发症发生及处理情况、住院时间和出院转归等信息,并计算住院期间营养支持和并发症相关的直接医疗费用,采用多因素方法分析营养支持对有营养风险患者临床结局和费用的影响,并对不同营养支持的方式进行成本效果分析。
     结果
     1.描述性研究:北京、Baltimore教学医院不同科室营养风险、营养支持应用情况
     共1277例患者纳入分析,其中消化内科、呼吸内科和脑卒中患者营养风险的发生率分别为49.24%,29.36%和47.62%,约翰霍普金斯医院综合内科患者营养风险发生率为55.47%,炎性肠病、胰腺疾病、消化道出血和消化道梗阻患者营养风险发生率最高。对有营养风险的患者,消化内科、呼吸内科和脑卒中分别有45.99%、15.84%、28.57%应用了营养支持,约翰霍普金斯医院综合内科有36.62%应用了营养支持。对无营养风险的患者,消化内科有15.57%接受了营养支持,其他三个科室只有极少数患者应用了营养支持。
     2.队列研究
     (1)营养支持对有营养风险患者的感染性并发症的发生率的影响
     有541例有营养风险患者纳入分析,其中36.8%接受了营养支持,63.2%没有接受营养支持。
     控制其他相关影响因素后,营养支持降低了感染性并发症的发生率(OR=0.32,95%CI=0.18~0.6)和总并发症的发生率(OR=0.53,95%CI=0.32~0.85)。
     入院7日内开始营养支持的有营养风险患者感染性并发症发生率低于入院7日后开始营养支持的患者(χ2=4.41,P=0.036)。
     肠内营养患者非感染性并发症(P=0.008)和总并发症发生率(P=0.002)低于肠外营养患者,感染性并发症(P=0.13)有降低的趋势。
     但是,由于总病例数不够多,目前还没有在“用营养支持”和“不用营养支持”的两个队列中,按营养风险的评分(大于等于3分、大于等于4分、大于等于5分)来分亚群,在两个队列的基线接近的亚群进行对比。此部分工作有待进行。
     (2)营养支持对有营养风险消化内科患者成本效果探索分析
     有275例患者纳入分析,其中42.5%接受营养支持,57.5%没有接受营养支持。
     接受肠外营养支持患者的总住院费用、平均日住院费用和常规基础用药费用均高于没有接受营养支持的患者和接受肠内营养支持的患者(P均<0.0001)。
     根据多元线性回归分析结果,接受肠外营养支持、出现并发症、发生非预期手术和住院时间延长均是增加总住院费用的因素,而接受肠内营养支持对总住院费用无影响。
     以<无感染性并发症病例>为效果指标(在全文中有说明)时,所有患者的成本效果分析结果显示肠内营养是比较经济有效的营养支持方式,其经过协方差分析调整后的成本效果比为1257元,肠外营养、肠外与肠内联合应用以及无营养支持组患者的成本效果比分别为6105、5680和1664元。
     在以<无感染性并发症病例>为效果指标进行对比时,在“用营养支持”和“不用营养支持”的两个队列中,应按营养风险的评分(大于等于3分大、大于等于4分、大于等于5分)来分亚群,在基线相近的亚组中进行对比。由于总病例数不够多,此部分工作有待进一步进行。
     结论
     1.内科患者尤其是消化内科和脑卒中患者的营养风险发生率较高
     2.对有营养风险的患者,营养支持可降低感染性并发症和总并发症的发生率。肠内营养支持可能是比较经济的营养支持方式,有较好的成本效果比。但是,由于总入组的病例数不够多,还需要在更大范围、更多病例的研究中得到支持。
     3.按目前的认知,对住院患者进行常规NRS-2002营养风险筛查,加强对有营养风险患者的临床营养支持管理均有助于营养支持的合理应用、减少并发症、让患者受益。
Background & Aims
     The patients at nutritional risk have a higher probability to benefit from nutritional support by the reports from ESPEN Experts Group in 2003 (Europe). But there is still a lack of data about the prevalence of nutritional risk and malnutrition from China and the prospective study to evaluate the association of nutritional risk, nutritional support and clinical outcomes in internal medicine patients. There are seldom reports about the cost-effectiveness of nutrition support from China up to now. However these studies had methodological flaws. In fact, the economical studies are still lack even from the worldwide. The present study aims to (1) investigate the prevalence of nutritional risk and malnutrition in internal medicine patients in Beijing and Baltimore, and (2) to examine the clinical outcomes of nutrition support in the gastroenterology patients at nutritional risk identified by NRS-2002 and to compare the "cost/effectiveness" of parenteral nutrition, enteral nutrition, parenteral combined enteral nutrition support with non-nutrition support.
     Methods
     (1)The descriptive study:A total of 1277 patients who were consecutively admitted to the gastroenterology unit, pulmonary medicine unit and neurology unit of Peking Union Medical College Hospital (PUMCH) and the internal medicine unit of Johns Hopkins Hospital (JHH) were enrolled in this prospective cohort study. Nutritional risk was determined by NRS-2002 on admission. The information with respect to nutritional support and complications during hospitalization was monitored and recorded. Estimate of association between nutritional risk, nutritional support and complications was carried out.
     (2)A prospective cohort study was designed. The patients who were consecutively admitted to the gastroenterology wards and with certain predetermined diagnoses were screened for nutritional risk. Those who were identified as at nutritional risk were the candidates of this study. The information with respect to nutrition support, complication occurrence and treatment, length of hospital stay was monitored and recorded of these patients in the whole course of hospitalization. The direct costs of nutrition support, the costs of diagnosing and treating complications were calculated in detail. The impact of nutrition support on the infectious complications was evaluated by multivariate statistical analysis. The "rate of infectious complication-free patients" was used as the index of effectiveness. The cost-effectiveness ratios of four different cohorts were calculated.
     Results
     (1) Descripitive research--the prevalence of nutritional risk and the clinical practice of nutritional support.
     1277 patients were included The prevalence of nutritional risk in patients with digestive disease, respiratory disease and stoke was 49.24%,29.36% and 41.62% respectively. The prevalence of nutritional risk in internal medicine patients of Johns Hopkins Hospital was 55.47%. The patients with inflammatory bowel disease, pancreatic disease and gastrointestinal hemorrhage or obstruction had the highest prevalence of nutritional risk.45.99% of the digestive medicine patients,15.84% of the respiratory medicine patients,28.57% of the patients with stroke, and 36.62% of the internal medicine patients in Johns Hopkins Hospital who were at nutritional risk received nutritional support.15.57% of the digestive medicine patients who were not at nutritional risk were also applied nutritional support.
     (2) Cohort study
     Total 623 patients who were consistent with the four predetermined diagnoses groups were screened for nutritional risk by NRS-2002. Of these patients,289 (46.4%) who were identified as at nutritional risk were enrolled in this cohort study and were tracked in the course of hospitalization. Finally,275 cases were involved in the analysis.
     8 patients in the cohort with nutrition support encountered infectious complications while 31 patients in the patients without nutrition support had infectious complications. The patients with nutrition support had lower incidence of infectious complications than the patients without nutrition support (6.8% vs.19.6%, x2=9.0, P=0.003).
     The adjusted (by ANCOVA) costs of PN cohort, EN cohort, PN combined EN cohort and the cohort without nutrition support were USD 869,187,805,207 (CNY 5635,1212,5220 and 1339), and the rates of "infectious complication-free patients" were 92.3%,96.4%,91.9% and 80.4% respectively. Cost-effectiveness ratios adjusted by ANCOVA were USD 942,194,876, 257 (CNY 6105,1257,5680, and 1664) respectively. Enteral nutrition support had the lowest cost-effectiveness ratio in this study.
     Conclusion
     (1) A large number of internal medicine patients were at nutritional risk or malnourished. Only a proportion of them received nutritional support.
     (2) Nutritional support had a protective effect from infectious complication. Nutrition support for gastroenterology patients at nutritional risk improved clinical outcomes. Enteral nutrition was the most cost-effective way of nutrition support for the gastroenterology patients at nutritional risk in this cohort study. Further multi-center cohort studies will be needed.
引文
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