Article(id=1241522853653304202, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241522846384583426, articleNumber=null, orderNo=null, doi=10.20043/j.cnki.MPM.202306139, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1686240000000, receivedDateStr=2023-06-09, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1773931714690, onlineDateStr=2026-03-19, pubDate=1707494400000, pubDateStr=2024-02-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773931714690, onlineIssueDateStr=2026-03-19, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773931714690, creator=13701087609, updateTime=1773931714690, updator=13701087609, issue=Issue{id=1241522846384583426, tenantId=1146029695717560320, journalId=1227665162245664772, year='2024', volume='51', issue='3', pageStart='385', pageEnd='576', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773931712956, creator=13701087609, updateTime=1773931842201, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1241523388544504301, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241522846384583426, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1241523388544504302, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241522846384583426, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=564, endPage=571, ext={EN=ArticleExt(id=1241522855507186617, articleId=1241522853653304202, tenantId=1146029695717560320, journalId=1227665162245664772, language=EN, title=Study on the effect of new low-protein enteral nutritional preparation on patients with chronic kidney disease, columnId=1228016569138213037, journalTitle=Modern Preventive Medicine, columnName=Clinical Medicine and Prevention, runingTitle=null, highlight=null, articleAbstract=
Objective

To explore the effect of a new type of low-protein enteral nutrition on the nutritional status of patients with chronic kidney disease in stage 3-4 under the guidance of individualized diet.

Methods

Sixty follow-up outpatients in West China Hospital of Sichuan University were randomly divided into the experimental group and the control group. The two groups were followed up on intervention day 0, day 45, and day 90. According to the principle of intentional analysis, the generalized estimation equation was used to analyze the between-group differences, time change trend, and interaction effect, and the principle of data analysis in accordance with the scheme was used to further verify the stability of results.

Results

There was no significant difference in nutritional adequacy, clinical effectiveness, and anthropometric indexes between the test group and the control group (P > 0.05). During the intervention period, when the energy intake was stable, the intake of protein (χ2=17.680, P<0.001) and sodium salt (χ2=21.427, P<0.001) decreased significantly, while the total protein (χ2=18.075, P<0.001), calcium (χ2=9.438, P=0.009), phosphorus (χ2=13.866, P=0.001), and uric acid (χ2=9.005, P=0.011) fluctuated within the normal range. The results of data analysis in accordance with the scheme were basically consistent with those of intentionality analysis. Only the time change trend of upper arm muscle circumference (χ2=6.435, P=0.040) and the comparison of energy ratio between groups(χ2=4.478, P=0.034) were significantly different.

Conclusion

The new low-protein enteral nutrition preparation is not inferior to the total nutritional formula food for special medical use in improving the nutritional status of patients and delaying the progression of the disease. The use of enteral nutrition under dietary guidance is beneficial to the clinical nutrition management of

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目的

探索个体化饮食指导下,新型低蛋白肠内营养制剂对慢性肾脏病3~4期患者营养状况的影响。

方法

选取四川大学华西医院随访门诊患者60例,随机分为试验组与对照组,两组在个体化饮食指导的基础上使用新型低蛋白肠内营养制剂或特殊医学用途全营养型配方食品,在干预第0、45和90 d各随访一次。根据意向性分析原则,采用广义估计方程分析不同营养制剂干预患者的组间差异、时间变化趋势及其交互作用,并采用符合方案数据分析原则进一步验证试验结果的稳定性。

结果

试验组与对照组在营养充足性、临床有效性及人体测量指标上均不存在组间差异(P>0.05)。干预期间,两组患者在能量摄入稳定情况下蛋白质(χ2=17.680, P<0.001)、钠盐(χ2=21.427, P<0.001)摄入量显著降低,而总蛋白(χ2=18.075, P<0.001)、钙(χ2=9.438, P=0.009)、磷(χ2=13.866, P=0.001)、尿酸(χ2=9.005, P=0.011)在正常范围内波动。符合方案数据分析结果与意向性分析结果基本一致,仅有上臂肌围的时间变化趋势(χ2=6.435, P=0.040)及能量比率的组间比较(χ2=4.478, P=0.034)存在显著性差异。

结论

该新型低蛋白肠内营养制剂在改善患者营养状况,延缓疾病进展方面不劣于特殊医学用途全营养型配方食品。饮食指导下使用肠内营养制剂有利于慢性肾脏疾病患者的临床营养管理。

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胡雯,E-mail: patients with chronic kidney disease
, copyrightStatement=本刊刊出的所有文章不代表中华预防医学会和本刊编委会的观点,除非特别声明。, copyrightOwner=中华预防医学会和四川大学华西公共卫生学院, extLink=null, articleAbsUrl=null, sourceXml=GsFYqSYI4PseBcxd6+0usQ==, magXml=to3N1+IuyGHGnmDVyUjHGw==, pdfUrl=null, pdf=CtY/wnynxdRaNvC6QwFANg==, pdfFileSize=886906, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=Mppu9PAe1+S/xhE4RM1hJQ==, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=VWpMTTLnVa4O+0YKrg07TA==, mapNumber=null, authorCompany=null, fund=null, authors=

郭鉴葵(1997—),男,硕士在读,研究方向:营养与健康

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郭鉴葵(1997—),男,硕士在读,研究方向:营养与健康

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Acta Nutrimenta Sinica,2021, 43(4): 358-361, 369., articleTitle=Current status of nutrition departments in tertiary hospitals from 24 provinces of China, refAbstract=null)], funds=[Fund(id=1241680467049631924, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, awardId=spaq-2017-015, language=CN, fundingSource=2017年食品安全国家标准制定、修订项目(spaq-2017-015), fundOrder=null, country=null), Fund(id=1241680467162878138, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, awardId=2019B020213002, language=CN, fundingSource=广东省重点领域研发计划(2019B020213002), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1241680455876006687, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, xref=1., ext=[AuthorCompanyExt(id=1241680455884395298, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, companyId=1241680455876006687, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Nutrition and Food Hygiene, West China School of Public Health, Sichuan University/West China Fourth Hospital, Chengdu, Sichuan 610041, China), AuthorCompanyExt(id=1241680455901172517, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, companyId=1241680455876006687, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.四川大学华西公共卫生学院/华西第四医院营养与食品卫生学系,四川 成都 610041)]), AuthorCompany(id=1241680456006030124, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, xref=2., ext=[AuthorCompanyExt(id=1241680456018613037, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, companyId=1241680456006030124, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.四川大学华西医院临床营养科,四川 成都 610041)]), AuthorCompany(id=1241680456136053560, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, xref=3., ext=[AuthorCompanyExt(id=1241680456152830777, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, companyId=1241680456136053560, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.四川大学华西医院肾内科)])], figs=[ArticleFig(id=1241680463740325999, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, language=EN, label=Figure 1, caption=Flowchart of patient inclusion and exclusion, figureFileSmall=GTlAlrdyAQ5W9fM5M0swXw==, figureFileBig=nWJbnUG3+Vw970Y3WdkptA==, tableContent=null), ArticleFig(id=1241680463845183601, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, language=CN, label=图1, caption=患者纳排流程图, figureFileSmall=GTlAlrdyAQ5W9fM5M0swXw==, figureFileBig=nWJbnUG3+Vw970Y3WdkptA==, tableContent=null), ArticleFig(id=1241680464008761463, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, language=EN, label=Table 1, caption=

Nutritional composition of new low-protein nutritional preparation and food for special medical purposes of total nutrition type formula

, figureFileSmall=null, figureFileBig=null, tableContent=
营养成分新型低蛋白肠内营养制剂(100 g)特殊医学用途全营养型配方食品(100 g)
能量(kJ)1 8121 913
蛋白质(g)10.018.5
脂肪(g)15.017.5
碳水化合物(g)61.253.2
Na(mg)330460
K(mg)500685
P(mg)220220
Ca(mg)310430
), ArticleFig(id=1241680464109424760, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, language=CN, label=表1, caption=

新型低蛋白肠内营养制剂与特殊医学用途全营养型配方食品营养成分

, figureFileSmall=null, figureFileBig=null, tableContent=
营养成分新型低蛋白肠内营养制剂(100 g)特殊医学用途全营养型配方食品(100 g)
能量(kJ)1 8121 913
蛋白质(g)10.018.5
脂肪(g)15.017.5
碳水化合物(g)61.253.2
Na(mg)330460
K(mg)500685
P(mg)220220
Ca(mg)310430
), ArticleFig(id=1241680464214282369, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, language=EN, label=Table 2, caption=

Basic information of patients in both groups[(),n(%)]

, figureFileSmall=null, figureFileBig=null, tableContent=
项目试验组对照组t/χ2P
年龄(岁)46.11±9.6646.83±9.48-0.2730.786
性别0.1540.695
12(42.86)9(37.50)
16(57.14)15(62.50)
疾病分期
3期23(82.14)19(79.17)*1.000
4期5(17.86)5(20.33)
), ArticleFig(id=1241680464306557059, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, language=CN, label=表2, caption=

两组患者基本情况[(),n(%)]

, figureFileSmall=null, figureFileBig=null, tableContent=
项目试验组对照组t/χ2P
年龄(岁)46.11±9.6646.83±9.48-0.2730.786
性别0.1540.695
12(42.86)9(37.50)
16(57.14)15(62.50)
疾病分期
3期23(82.14)19(79.17)*1.000
4期5(17.86)5(20.33)
), ArticleFig(id=1241680464461746315, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, language=EN, label=Table 3, caption=

Nutrition status of patients in both groups (

, figureFileSmall=null, figureFileBig=null, tableContent=
指标试验组对照组Wald χ2组间P组间Wald χ2时间P时间Wald χ2交互P交互
0 d45 d90 d0 d45 d90 d
Hb(g/L)133.07±17.38134.10±18.79134.70±19.70128.40±22.09128.23±20.20127.93±19.831.4070.2360.3100.8560.8230.663
TP(g/L)73.64±3.6071.91±3.7773.15±4.2372.24±3.4770.67±4.7271.03±5.052.8710.09018.075<0.0011.6170.445
ALB(g/L)45.83±2.8545.17±3.4245.91±3.1945.80±2.6345.15±3.0345.14±3.520.1520.6965.2880.0711.5000.472
PAB(mg/L)319.50±44.88320.27±53.81331.00±51.58335.20±64.81336.63±64.05341.07±67.660.9910.3195.8610.0530.8060.668
), ArticleFig(id=1241680464629518479, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, language=CN, label=表3, caption=

两组患者营养状况(

, figureFileSmall=null, figureFileBig=null, tableContent=
指标试验组对照组Wald χ2组间P组间Wald χ2时间P时间Wald χ2交互P交互
0 d45 d90 d0 d45 d90 d
Hb(g/L)133.07±17.38134.10±18.79134.70±19.70128.40±22.09128.23±20.20127.93±19.831.4070.2360.3100.8560.8230.663
TP(g/L)73.64±3.6071.91±3.7773.15±4.2372.24±3.4770.67±4.7271.03±5.052.8710.09018.075<0.0011.6170.445
ALB(g/L)45.83±2.8545.17±3.4245.91±3.1945.80±2.6345.15±3.0345.14±3.520.1520.6965.2880.0711.5000.472
PAB(mg/L)319.50±44.88320.27±53.81331.00±51.58335.20±64.81336.63±64.05341.07±67.660.9910.3195.8610.0530.8060.668
), ArticleFig(id=1241680464763736212, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, language=EN, label=Table 4, caption=

Clinical information of patients in both groups (

, figureFileSmall=null, figureFileBig=null, tableContent=
指标试验组对照组Wald χ2组间P组间Wald χ2时间P时间Wald χ2交互P交互
0 d45 d90 d0 d45 d90 d
GLU(mmol/L)5.06±0.384.91±0.394.93±0.385.12±0.595.08±0.524.98±0.550.8050.3705.1880.0752.6620.264
TG(mmol/L)1.47±0.761.58±0.831.60±0.651.24±0.631.28±0.431.28±0.443.6900.0552.5030.2860.5700.752
TC(mmol/L)4.60±1.114.44±0.864.57±0.704.45±0.894.36±0.974.31±0.970.5770.4473.0290.2201.4860.476
CREA(μmol/L)155.17±45.77158.70±51.24168.40±54.12183.37±93.75190.10±108.49197.60±114.992.0080.15724.530<0.0010.6450.724
Urea(mmol/L)8.84±3.678.60±3.339.02±3.439.69±4.719.89±4.6310.07±4.651.1030.2942.6900.2610.7610.683
UA(μmol/L)355.67±82.03357.53±79.91382.63±82.45334.27±63.15328.27±70.49362.50±73.472.7370.0989.0050.0110.1730.917
eGFR(ml/min·1.73m2)42.99±13.9742.38±14.5839.52±14.2138.46±15.2738.44±16.1736.95±15.750.9620.32724.407<0.0013.1640.206
Na(mmol/L)140.36±1.86140.39±2.29140.69±2.08140.78±1.84141.19±1.70140.96±2.051.3280.2491.3860.5001.6270.443
K(mmol/L)4.45±0.394.50±0.334.57±0.454.47±0.454.60±0.524.47±0.430.0010.9772.9380.2303.1080.211
Ca(mmol/L)2.36±0.092.37±0.102.39±0.122.34±0.082.36±0.082.38±0.110.1290.7199.4380.0090.2400.887
P(mmol/L)1.11±0.191.20±0.291.23±0.281.12±0.191.17±0.211.17±0.220.2780.59813.8660.0012.6430.267
), ArticleFig(id=1241680464885371037, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, language=CN, label=表4, caption=

两组患者临床状况(

, figureFileSmall=null, figureFileBig=null, tableContent=
指标试验组对照组Wald χ2组间P组间Wald χ2时间P时间Wald χ2交互P交互
0 d45 d90 d0 d45 d90 d
GLU(mmol/L)5.06±0.384.91±0.394.93±0.385.12±0.595.08±0.524.98±0.550.8050.3705.1880.0752.6620.264
TG(mmol/L)1.47±0.761.58±0.831.60±0.651.24±0.631.28±0.431.28±0.443.6900.0552.5030.2860.5700.752
TC(mmol/L)4.60±1.114.44±0.864.57±0.704.45±0.894.36±0.974.31±0.970.5770.4473.0290.2201.4860.476
CREA(μmol/L)155.17±45.77158.70±51.24168.40±54.12183.37±93.75190.10±108.49197.60±114.992.0080.15724.530<0.0010.6450.724
Urea(mmol/L)8.84±3.678.60±3.339.02±3.439.69±4.719.89±4.6310.07±4.651.1030.2942.6900.2610.7610.683
UA(μmol/L)355.67±82.03357.53±79.91382.63±82.45334.27±63.15328.27±70.49362.50±73.472.7370.0989.0050.0110.1730.917
eGFR(ml/min·1.73m2)42.99±13.9742.38±14.5839.52±14.2138.46±15.2738.44±16.1736.95±15.750.9620.32724.407<0.0013.1640.206
Na(mmol/L)140.36±1.86140.39±2.29140.69±2.08140.78±1.84141.19±1.70140.96±2.051.3280.2491.3860.5001.6270.443
K(mmol/L)4.45±0.394.50±0.334.57±0.454.47±0.454.60±0.524.47±0.430.0010.9772.9380.2303.1080.211
Ca(mmol/L)2.36±0.092.37±0.102.39±0.122.34±0.082.36±0.082.38±0.110.1290.7199.4380.0090.2400.887
P(mmol/L)1.11±0.191.20±0.291.23±0.281.12±0.191.17±0.211.17±0.220.2780.59813.8660.0012.6430.267
), ArticleFig(id=1241680465002811551, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, language=EN, label=Table 5, caption=

Anthropometric results of patients in both groups (

, figureFileSmall=null, figureFileBig=null, tableContent=
指标试验组对照组Wald χ2组间P组间Wald χ2时间P时间Wald χ2交互P交互
0 d45 d90 d0 d45 d90 d
体重(kg)60.03±13.9559.65±14.1959.62±13.9356.52±10.0956.71±10.0556.49±10.161.0650.3021.2530.5344.6650.097
BMI(kg/m2)22.40±3.6122.26±3.6222.24±3.5321.21±2.4321.30±2.3221.21±2.301.9260.1651.1410.5654.3470.114
TSF(mm)11.44±3.2411.33±3.0611.42±3.0610.01±3.4510.21±3.7910.11±3.332.3650.1240.2990.8612.1940.334
AC(cm)28.62±3.1928.45±3.1328.43±3.0627.63±2.5427.63±2.4227.56±2.391.5850.2082.4540.2932.0030.367
AMC(cm)25.02±2.6924.89±2.7424.84±2.6824.48±2.5124.42±2.4224.39±2.380.5650.4523.8930.1430.3880.824
握力(kg)32.94±12.4233.42±12.1333.99±12.1931.90±9.9531.84±9.6432.36±10.090.2600.6102.4610.2920.5230.770
), ArticleFig(id=1241680465090891939, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, language=CN, label=表5, caption=

两组患者人体测量结果(

, figureFileSmall=null, figureFileBig=null, tableContent=
指标试验组对照组Wald χ2组间P组间Wald χ2时间P时间Wald χ2交互P交互
0 d45 d90 d0 d45 d90 d
体重(kg)60.03±13.9559.65±14.1959.62±13.9356.52±10.0956.71±10.0556.49±10.161.0650.3021.2530.5344.6650.097
BMI(kg/m2)22.40±3.6122.26±3.6222.24±3.5321.21±2.4321.30±2.3221.21±2.301.9260.1651.1410.5654.3470.114
TSF(mm)11.44±3.2411.33±3.0611.42±3.0610.01±3.4510.21±3.7910.11±3.332.3650.1240.2990.8612.1940.334
AC(cm)28.62±3.1928.45±3.1328.43±3.0627.63±2.5427.63±2.4227.56±2.391.5850.2082.4540.2932.0030.367
AMC(cm)25.02±2.6924.89±2.7424.84±2.6824.48±2.5124.42±2.4224.39±2.380.5650.4523.8930.1430.3880.824
握力(kg)32.94±12.4233.42±12.1333.99±12.1931.90±9.9531.84±9.6432.36±10.090.2600.6102.4610.2920.5230.770
), ArticleFig(id=1241680465279635625, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, language=EN, label=Table 6, caption=

Energy, protein, and sodium intake of patients in both groups (

, figureFileSmall=null, figureFileBig=null, tableContent=
指标试验组对照组Wald χ2组间P组间Wald χ2时间P时间Wald χ2交互P交互
0 d45 d90 d0 d45 d90 d
能量摄入
(kcal)
1 467.23±354.411 582.65±243.231 532.71±254.541 556.83±356.351 579.70±366.441 548.85±315.460.2530.6155.0640.0801.3800.501
DEI[kcal/(kg·d)]25.58±6.1027.51±3.4126.64±3.6427.40±6.3527.61±5.3827.15±5.200.5770.4474.5300.1041.6470.439
ER(%)0.81±0.210.86±0.120.83±0.100.89±0.240.89±0.180.87±0.171.7920.1813.9850.1361.7690.413
蛋白摄入量(g)48.46±16.9440.40±9.6740.20±11.0247.12±11.5042.47±10.5841.64±8.730.0900.76417.680<0.0010.9830.612
DPI[g/(kg·d)]0.85±0.300.71±0.160.69±0.150.83±0.230.74±0.160.73±0.140.1840.66819.057<0.0010.7310.694
PR(%)1.37±0.461.14±0.261.13±0.221.27±0.401.13±0.291.10±0.240.5500.45818.978<0.0010.7750.679
蛋白质供能比(%)0.13±0.030.10±0.020.10±0.020.12±0.030.11±0.030.11±0.030.0520.82043.121<0.0015.9090.052
钠盐摄入量(g)7.90±2.307.30±1.396.93±1.347.80±1.867.40±1.676.82±1.000.0110.91621.427<0.0010.9080.635
), ArticleFig(id=1241680466789585066, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522853653304202, language=CN, label=表6, caption=

两组患者能量、蛋白质及钠盐摄入情况(

, figureFileSmall=null, figureFileBig=null, tableContent=
指标试验组对照组Wald χ2组间P组间Wald χ2时间P时间Wald χ2交互P交互
0 d45 d90 d0 d45 d90 d
能量摄入
(kcal)
1 467.23±354.411 582.65±243.231 532.71±254.541 556.83±356.351 579.70±366.441 548.85±315.460.2530.6155.0640.0801.3800.501
DEI[kcal/(kg·d)]25.58±6.1027.51±3.4126.64±3.6427.40±6.3527.61±5.3827.15±5.200.5770.4474.5300.1041.6470.439
ER(%)0.81±0.210.86±0.120.83±0.100.89±0.240.89±0.180.87±0.171.7920.1813.9850.1361.7690.413
蛋白摄入量(g)48.46±16.9440.40±9.6740.20±11.0247.12±11.5042.47±10.5841.64±8.730.0900.76417.680<0.0010.9830.612
DPI[g/(kg·d)]0.85±0.300.71±0.160.69±0.150.83±0.230.74±0.160.73±0.140.1840.66819.057<0.0010.7310.694
PR(%)1.37±0.461.14±0.261.13±0.221.27±0.401.13±0.291.10±0.240.5500.45818.978<0.0010.7750.679
蛋白质供能比(%)0.13±0.030.10±0.020.10±0.020.12±0.030.11±0.030.11±0.030.0520.82043.121<0.0015.9090.052
钠盐摄入量(g)7.90±2.307.30±1.396.93±1.347.80±1.867.40±1.676.82±1.000.0110.91621.427<0.0010.9080.635
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新型低蛋白肠内营养制剂对慢性肾脏疾病患者效果研究
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郭鉴葵 1 , 周子琪 2 , 柳园 2 , 陈懿 3 , 黄月阳 3 , 胡雯 1, 2
现代预防医学 | 临床与预防 2024,51(3): 564-571
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现代预防医学 | 临床与预防 2024, 51(3): 564-571
新型低蛋白肠内营养制剂对慢性肾脏疾病患者效果研究
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郭鉴葵1, 周子琪2, 柳园2, 陈懿3, 黄月阳3, 胡雯1, 2
作者信息
  • 1.四川大学华西公共卫生学院/华西第四医院营养与食品卫生学系,四川 成都 610041
  • 2.四川大学华西医院临床营养科,四川 成都 610041
  • 3.四川大学华西医院肾内科
  • 郭鉴葵(1997—),男,硕士在读,研究方向:营养与健康

通讯作者:

胡雯,E-mail: patients with chronic kidney disease
Study on the effect of new low-protein enteral nutritional preparation on patients with chronic kidney disease
Jian-kui GUO1, Zi-qi ZHOU2, Yuan LIU2, Yi CHEN3, Yue-yang HUANG3, Wen HU1, 2
Affiliations
  • Department of Nutrition and Food Hygiene, West China School of Public Health, Sichuan University/West China Fourth Hospital, Chengdu, Sichuan 610041, China
出版时间: 2024-02-10 doi: 10.20043/j.cnki.MPM.202306139
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目的

探索个体化饮食指导下,新型低蛋白肠内营养制剂对慢性肾脏病3~4期患者营养状况的影响。

方法

选取四川大学华西医院随访门诊患者60例,随机分为试验组与对照组,两组在个体化饮食指导的基础上使用新型低蛋白肠内营养制剂或特殊医学用途全营养型配方食品,在干预第0、45和90 d各随访一次。根据意向性分析原则,采用广义估计方程分析不同营养制剂干预患者的组间差异、时间变化趋势及其交互作用,并采用符合方案数据分析原则进一步验证试验结果的稳定性。

结果

试验组与对照组在营养充足性、临床有效性及人体测量指标上均不存在组间差异(P>0.05)。干预期间,两组患者在能量摄入稳定情况下蛋白质(χ2=17.680, P<0.001)、钠盐(χ2=21.427, P<0.001)摄入量显著降低,而总蛋白(χ2=18.075, P<0.001)、钙(χ2=9.438, P=0.009)、磷(χ2=13.866, P=0.001)、尿酸(χ2=9.005, P=0.011)在正常范围内波动。符合方案数据分析结果与意向性分析结果基本一致,仅有上臂肌围的时间变化趋势(χ2=6.435, P=0.040)及能量比率的组间比较(χ2=4.478, P=0.034)存在显著性差异。

结论

该新型低蛋白肠内营养制剂在改善患者营养状况,延缓疾病进展方面不劣于特殊医学用途全营养型配方食品。饮食指导下使用肠内营养制剂有利于慢性肾脏疾病患者的临床营养管理。

慢性肾脏病  /  饮食指导  /  低蛋白饮食  /  肠内营养制剂  /  特殊医学用途配方食品
Objective

To explore the effect of a new type of low-protein enteral nutrition on the nutritional status of patients with chronic kidney disease in stage 3-4 under the guidance of individualized diet.

Methods

Sixty follow-up outpatients in West China Hospital of Sichuan University were randomly divided into the experimental group and the control group. The two groups were followed up on intervention day 0, day 45, and day 90. According to the principle of intentional analysis, the generalized estimation equation was used to analyze the between-group differences, time change trend, and interaction effect, and the principle of data analysis in accordance with the scheme was used to further verify the stability of results.

Results

There was no significant difference in nutritional adequacy, clinical effectiveness, and anthropometric indexes between the test group and the control group (P > 0.05). During the intervention period, when the energy intake was stable, the intake of protein (χ2=17.680, P<0.001) and sodium salt (χ2=21.427, P<0.001) decreased significantly, while the total protein (χ2=18.075, P<0.001), calcium (χ2=9.438, P=0.009), phosphorus (χ2=13.866, P=0.001), and uric acid (χ2=9.005, P=0.011) fluctuated within the normal range. The results of data analysis in accordance with the scheme were basically consistent with those of intentionality analysis. Only the time change trend of upper arm muscle circumference (χ2=6.435, P=0.040) and the comparison of energy ratio between groups(χ2=4.478, P=0.034) were significantly different.

Conclusion

The new low-protein enteral nutrition preparation is not inferior to the total nutritional formula food for special medical use in improving the nutritional status of patients and delaying the progression of the disease. The use of enteral nutrition under dietary guidance is beneficial to the clinical nutrition management of

Renal insufficiency  /  Chronic  /  Nutritional status  /  Dietary guidance  /  Low-protein diet  /  Compliance  /  Enteral nutrition preparation  /  Formula food for special medical purposes
郭鉴葵, 周子琪, 柳园, 陈懿, 黄月阳, 胡雯. 新型低蛋白肠内营养制剂对慢性肾脏疾病患者效果研究. 现代预防医学, 2024 , 51 (3) : 564 -571 . DOI: 10.20043/j.cnki.MPM.202306139
Jian-kui GUO, Zi-qi ZHOU, Yuan LIU, Yi CHEN, Yue-yang HUANG, Wen HU. Study on the effect of new low-protein enteral nutritional preparation on patients with chronic kidney disease[J]. Modern Preventive Medicine, 2024 , 51 (3) : 564 -571 . DOI: 10.20043/j.cnki.MPM.202306139
慢性肾脏疾病(chronic kidney disease, CKD)是指病程超过三个月,由各种原因引起的慢性肾脏结构和功能障碍[1]。研究显示,CKD全球患病率约13.4%,中国约10.8%,且患病率呈逐年上升趋势,已成为重大公共卫生问题[2-3]。营养状况是CKD患者预后的关键因素之一,随着病情发展,患者肾功能逐步下降,其营养不良发生率也不断上升,而营养不良会加速CKD患者肾功能下降,增加心脑血管并发症及住院风险,影响患者生活质量,形成恶性循环[4-6]。营养干预是CKD患者的基本治疗,科学合理的营养支持是改善CKD患者营养状况的关键,有助于改善患者的生活质量,降低死亡率[7-8]。尽管已证明低蛋白饮食可保护肾脏功能,延缓疾病进展,但低蛋白饮食的依从性较差,CKD患者中普遍存在蛋白质能量消耗(protein energy wasting, PEW)营养不良,患病率约为11%~54%,且随着CKD进展而增加[9-13]。现行临床实践指南推荐经口摄入无法满足膳食需求的患者通过口服营养补充剂改善饮食情况,采用肠内营养制剂帮助患者在提高能量摄入的同时降低蛋白质摄入,对维持或改善患者营养状况,延缓疾病进展具有重要作用[14-15]
为了规范肠内营养制剂的管理,国家相关部门提出了特殊医学用途配方食品(food for special medical purposes, FSMP),即为了满足进食受限、消化吸收障碍、代谢紊乱或特定疾病状态人群对营养素或膳食的特殊需要,专门加工配制而成的配方食品,是患者营养治疗的必要工具[16-17]。但FSMP在我国大众知晓度并不高,市场普及率低,截至2023年2月,通过食品药品总局注册的特殊医学用途配方食品及组件有101种,无1种是CKD特定全营养配方食品,且临床常见的肾病营养食品不足20种,CKD患者的选择极少,不利于患者的营养管理[18-19]。开发新型低蛋白营养制剂,提高患者营养治疗效果,延缓CKD病程发展,减少疾病带来的寿命损失及经济负担是当前迫切需要关注的问题[20-21]。因此,本研究针对CKD 3~4期患者,采用项目前期研发的新型低蛋白肠内营养制剂干预,观察在个体化饮食指导下使用肠内营养制剂对于维持或改善CKD 3~4期患者营养状况的有效性,以促进肾病专用型FSMP的发展。
研究对象为四川省某三甲医院CKD随访管理门诊的随访患者。纳入年龄18~70岁,经口进食且胃肠道功能良好且明确诊断CKD 3~4期的患者。排除标准为:(1)肾病综合征、合并糖尿病、接受透析治疗、肾脏移植患者;(2)管饲、胃肠造瘘或接受肠外营养;(3)妊娠期或哺乳期妇女;(4)其他研究者认为患者不适合参加本研究的情况。本研究经四川大学华西医院伦理委员会审核批准(2021年审(1194)号),临床注册号ChiCTR2300070604,所有患者均签署知情同意书。
本研究为单中心随机对照研究。研究目的为探究在个体化饮食指导下新型低蛋白肠内营养制剂与全营养型FSMP对CKD 3~4期患者营养状况及疾病进展的影响。分别在干预第0、45及90 d进行随访,评估患者饮食、营养状况变化及疾病进展。
采用随机数字表法将患者分为试验组及对照组。试验组在个体化饮食指导基础上采用新型低蛋白肠内营养制剂进行干预,对照组在个体化饮食指导基础上采用全营养型FSMP干预。每次随访,营养师针对患者情况,制定个体化食谱,食谱能量摄入范围为30~35 kcal/(kg·d),蛋白摄入范围为0.6~0.8 g/(kg·d),其中两组患者均通过营养制剂摄入400 kcal能量[14-15]。试验组每日摄入95 g新型低蛋白肠内营养制剂(提供约10 g蛋白质),对照组每日摄入90 g全营养型FSMP(提供约15 g蛋白质),见表1。本研究所用的新型低蛋白肠内营养制剂是根据CKD患者低蛋白、低钠饮食要求,由广东省农业科学院蚕业与农产品加工研究所等合作团队研发生产。
随访当天采集患者空腹静脉血样检测相关指标。检验指标包括营养充足性指标,血红蛋白(hemoglobin, Hb, g/L)、总蛋白(total protein, TP,g/L)、白蛋白(serum albumin, ALB, g/L)、前白蛋白(prealbumin, PAB, mg/L);临床有效性指标,葡萄糖(glucose, GLU, mmol/L)、甘油三酯(triglyceride, TG,mmol/L)、总胆固醇(total cholesterol, TC, mmol/L)、尿素(urea, mmol/L)、肌酐(creatine, CREA, μmol/L)、估算肾小球滤过率(estimated glomerular filtration rate, eGFR,mL/min·1.73m2)、尿酸(uric acid, UA, μmol/L)、钠(sodium, Na, mmol/L)、钾(potassium, K, mmol/L)、钙(calcium, Ca, mmol/L)、磷(phosphorus, P, mmol/L)。
采用便携式握力计测量受试者右手握力(grip strength, kg),测量时要求患者双手自然下垂,每次随访测量两次,记录最大值。采用软卷尺测量患者上臂围(arm circumference, AC, cm),双手自然下垂,取右上臂中点进行测量。利用皮褶厚度计测量患者三头肌皮褶厚度(triceps skinfold thickness,TSF, mm),受试者双手自然下垂,充分暴露右上臂,取右上臂背侧肩峰于尺骨鹰嘴连线中点上方2 cm处测量。通过上臂围和三头肌皮褶厚度,计算上臂肌围(arm muscle circumference, AMC, cm),AMC=AC-0.314×TSF。利用体重计及身高仪测量受试者体重及身高,并计算体质指数(body mass index, BMI, kg/m2),BMI=体重/身高的二次方。
采用24 h回顾法进行膳食调查,记录研究对象的食物摄入情况。患者每日能量及蛋白质摄入情况采用每日能量摄入[daily energy intake,DEI, kcal/(kg·d)]及每日蛋白摄入[daily protein intake, DPI, g/(kg·d)]表示。能量及蛋白质摄入的充足性采用能量比率(energy ratio, ER)及蛋白质比率(protein ratio, PR)反映,ER或PR为实际摄入量除以推荐摄入量,比值≥1.00,提示受试者能量或蛋白质摄入充足/过量,若比值<1.00,提示受试者能量摄入或蛋白质摄入不足。计算患者每次随访的蛋白质供能比,记录钠盐摄入量。
根据意向性分析(intention-to-treat analysis, ITT)行统计分析。定量资料采用()表示,分类资料报告为例数(构成比)。定量资料采用独立student t检验分析组间差异,计数资料采用χ2检验或Fisher确切概率法分析组间差异。采用广义估计方程(generalized estimated equation, GEE)分析患者不同营养制剂干预的组间差距、时间变化趋势及其交互作用。GEE分析中,计量资料采用线性模型,分类资料采用二元logistic模型,工作相关性矩阵均为不确定型相关。同时,为进一步验证试验结果的稳定性,采用符合方案数据分析(per-protocol population,PP)原则进行重复分析。统计分析均采用IBM SPSS Statistics for Windows,版本26.0 (IBM Corp,Armonk, N.Y., USA),所有统计软件均为双侧检验。检验水准α=0.05。
研究纳入60名患者,失访8名,最终共52人完成全程研究,失访率13.33%,见图1。52名患者平均年龄(46.44±9.486)岁,男性21人,占40.38%,CKD 3期患者42人,占80.77%。两组患者在年龄、性别及疾病分期上没有显著性差异,见表2
研究过程中,两组患者均未出现严重不良反应,试验组未有患者报告腹痛、腹胀、恶心、呕吐、腹泻、便秘,对照组有两例患者报告腹痛,一例为干预后期阑尾炎急性感染,一例经调整肠内营养制剂使用方法后好转。可以认为两种肠内营养制剂安全性及耐受性均较好。
Hb、TP、ALB、PAB在两组间均不存在统计学差异(P>0.05)。但两组的TP(χ2=18.075, P<0.001)随时间存在下降趋势。见表3
两组GLU、TG、TC、CREA、Urea、UA、eGFR、Na、K、Ca、P均不存在统计学差异(P>0.05),但两组CREA(χ2=24.530, P<0.001)、UA(χ2=9.005, P=0.011)、Ca(χ2=9.438, P=0.009)、P(χ2=13.866, P=0.001)均随时间存在上升趋势,eGFR(χ2=24.407, P<0.001)随时间存在下降趋势。见表4
两组患者在体重、BMI、TSF、AC、AMC及握力上均不存在组间差异,也未表现出随时间变化的趋势(P>0.05)。见表5
试验组与对照组在能量、蛋白质、盐摄入方面没有组间统计学差异(P>0.05),但随干预进行,两组患者的蛋白质(χ2=17.680, P<0.001)、盐(χ2=21.427, P<0.001)摄入量均显著降低。见表6
PP分析结果提示,随着干预进行,TP(χ2=15.066, P=0.00)、eGFR(χ2=21.416, P<0.001)、AMC(χ2=6.435, P=0.040)降低,蛋白质(χ2=17.699, P<0.001)及钠盐(χ2=21.235, P<0.001)摄入减少,CREA(χ2=18.803, P<0.001)、UA(χ2=9.212, P=0.010)、Ca(χ2=12.022, P=0.002)、P(χ2=12.793, P=0.002)增加,而试验组ER低于对照组(χ2=4.478, P=0.034),其余指标不存在显著性差异(P>0.05)。见表14。PP原则分析结果与ITT原则分析结果基本一致,仅有AMC随时间变化趋势(χ2=6.435, P=0.040)及ER的组间比较(χ2=4.478, P=0.034)存在显著性差异,试验结果稳定,结论具有可靠性。
营养状况是影响CKD患者病情发展的重要因素,及时评估和改善患者的营养状况对延缓疾病进展、提高生存质量、降低死亡率具有重要意义[7]。本研究比较了两种肠内营养制剂在CKD 3~4期患者中的应用效果,发现新型低蛋白肠内营养制剂在安全性和耐受性、改善营养状况、维持临床状态方面均不劣于全营养型FSMP。同时,本研究提示了饮食指导在CKD患者临床管理中的重要作用。
FSMP受国家市场监督管理局监管,其商业价值和营养价值都建立在对于人体没有损害的情况下[22-24]。临床实践中,CKD患者可能由于激素、免疫抑制剂等药物出现食欲减退、恶心、呕吐、腹泻等副作用,导致蛋白质、能量摄入不足,进而引起营养不良,影响患者治疗效果[25-26]。故应用胃肠道耐受性好的肠内营养制剂可以有效帮助患者保证营养摄入,减缓不适,改善患者临床预后。本研究中,干预组未出现不良反应,对照组虽然报告了两例腹痛,但一例为干预后期出现的急性阑尾炎,一例经调整服用频次后腹痛好转,考虑可能是个体化差异对于高营养食物不耐受。
慢性肾功能衰竭会导致尿素、肌酐等代谢物质蓄积,并发水电解质紊乱、酸碱失衡、内分泌激素水平紊乱等,从而引起厌食、微炎症等状态,机体分解代谢增强,造成患者蛋白质能量摄入不足,导致营养不良[1,27]。本研究新型低蛋白肠内营养制剂与全营养型FSMP两组间的营养充足性指标及临床有效性指标在各个时间点上均不存在统计学差异,提示两种肠内营养制剂在改善CKD 3~4期患者营养状况,维持患者肾功能方面不存在显著差异,而人体测量各指标在组间及时间维度上均不存在统计学差异,可能是随访时间较短,短期内指标变化幅度较小,且本研究纳入患者均为门诊随访患者,营养状况较好,加上个体化的饮食指导、营养师的高频次随访,使患者在饮食方案执行过程中依从性及正确性均较高,最终能够维持良好的营养状况[28-29]
随着干预的进行,部分指标在时间维度上发生显著性变化。在营养指标方面,PAB反应短期营养状况,尽管没有统计学差异,但两组患者PAB均有随干预时间上升的趋势,说明两组营养制剂干预可能都能够改善患者营养状况。在临床进展方面,虽然TP、Ca、P随时间有所变化,但都是在正常参考值范围内波动。CREA随时间升高,UA在正常范围内有所波动,eGFR随时间降低,但在两组间不存在显著性差异,时间与干预也不存在交互作用,提示两种肠内营养制剂在维持患者肾功能上无显著性差异。FSMP与肠内营养制剂均属于食品,不是药品,其作用是通过补充营养素摄入,提高营养状况,减少营养不良发生,进而帮助患者延缓疾病进展,减少因营养不良而导致不良临床结局[17]
既往研究证实,个体化饮食指导可以有效帮助CKD患者改正不良饮食习惯,降低营养不良风险[28-31]。在本研究中,尽管试验组与对照组在饮食情况上不存在组间差异,随着干预的进行,患者蛋白质及钠盐摄入量均显著降低。干预过程中,患者在保证能量摄入的情况下,DPI及蛋白质供能比降低,DPI从高于指南推荐落入指南推荐范围,钠盐尽管依旧高于推荐摄入量,但较干预前明显降低,这些饮食改变都有利于在维持患者营养状况的基础上减轻肾脏负担,延缓疾病进展[31-32]
但在实践过程中,患者的个体化营养管理还存在重重障碍。首先,临床医师在诊疗过程中往往忽略患者的营养管理,或对营养管理重视不足,只有当患者住院或已经存在营养不良及营养不良高风险时才会请营养科会诊,未能早期开展营养管理;其次,营养专业人才不足,临床营养师占比较低;再次,患者营养管理意识薄弱,对CKD饮食存在一些误解;最后,由于我国以米面为主的饮食习惯,长期食用藕粉、粉丝等淀粉类食物容易导致患者产生抵触心理,而低蛋白大米口味较为单一,相较普通大米口感较粗糙,长期食用依从性差,不利于患者坚持低蛋白饮食[33-35]。相较低蛋白大米,肠内营养制剂有口味丰富、携带简便、使用方便、营养全面、个体性强的优点,可作为代餐参与到CKD患者的个体化营养管理中,特别是在经口摄入不足,处于营养不良高风险或已经患有营养不良的患者中有较高的应用价值。
本研究仍有不足之处。首先,作为一个上市前探索研究,本研究的样本量较小,未能观察到营养制剂对患者的长期影响。其次,受新冠疫情影响,第三轮随访失访患者较多,可能存在偏倚。最后,受疫情等现实条件所限,患者招募困难,缺乏空白对照组,不能全面分析肠内营养制剂与饮食指导对患者的独立影响。未来应在住院患者或者有营养不良风险的CKD患者中进行大样本、多中心的前瞻性随访研究,进一步探索低蛋白肠内营养制剂对患者的营养改善作用,填补FSMP在肾病应用上的空白。
  • 2017年食品安全国家标准制定、修订项目(spaq-2017-015)
  • 广东省重点领域研发计划(2019B020213002)
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doi: 10.20043/j.cnki.MPM.202306139
  • 接收时间:2023-06-09
  • 首发时间:2026-03-19
  • 出版时间:2024-02-10
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  • 收稿日期:2023-06-09
基金
2017年食品安全国家标准制定、修订项目(spaq-2017-015)
广东省重点领域研发计划(2019B020213002)
作者信息
    1.四川大学华西公共卫生学院/华西第四医院营养与食品卫生学系,四川 成都 610041
    2.四川大学华西医院临床营养科,四川 成都 610041
    3.四川大学华西医院肾内科

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胡雯,E-mail: patients with chronic kidney disease
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
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Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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