AJKD 49(5), 569-580 (May 2007)
Efficacy and Safety of a Very-Low-Protein Diet When Postponing Dialysis in the Elderly: A Prospective Randomized Multicenter Controlled Study
Giuliano Brunori, MD1, Battista F. Viola, MD1, Giovanni Parrinello, PhD2, Vincenzo De Biase, MD3, Giovanna Como, MD4, Vincenzo Franco, MD5, Giacomo Garibotto, MD6, Roberto Zubani, MD, PhD17, Giovanni C. Cancarini, MD17
Background
A supplemented very-low-protein diet (sVLPD) seems to be safe when postponing dialysis therapy.
Study Design
Prospective multicenter randomized controlled study designed to assess the noninferiority of diet versus dialysis in 1-year mortality assessed by using intention-to-treat and per-protocol analysis.
Setting & Participants
Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min (0.08 to 0.12 mL/s).
Intervention
Randomization to an sVLPD (diet group) or dialysis. The sVLPD is a vegan diet (35 kcal; proteins, 0.3 g/kg body weight daily) supplemented with keto-analogues, amino acids, and vitamins. Patients following an sVLPD started dialysis therapy in the case of malnutrition, intractable fluid overload, hyperkalemia, or appearance of uremic symptoms.
Outcomes & Measurements
Mortality, hospitalization, and metabolic markers.
Results
56 patients were randomly assigned to each group, median follow-up was 26.5 months (interquartile range, 40), and patients in the diet group spent a median of 10.7 months (interquartile range, 11) following an sVLPD. Forty patients in the diet group started dialysis treatment because of either fluid overload or hyperkalemia. There were 31 deaths (55%) in the dialysis group and 28 deaths (50%) in the diet group. One-year observed survival rates at intention to treat were 83.7% (95% confidence interval [CI], 74.5 to 94.0) in the dialysis group versus 87.3% (95% CI, 78.9 to 96.5) in the diet group (log-rank test for noninferiority, P < 0.001; for superiority, P = 0.6): the difference in survival was −3.6% (95% CI, −17 to +10; P = 0.002). The hazard ratio for hospitalization was 1.50 for the dialysis group (95% CI, 1.11 to 2.01; P < 0.01).
Limitations
The unblinded nature of the study, exclusion of patients with diabetes, and incomplete enrollment.
Conclusion
An sVLPD was effective and safe when postponing dialysis treatment in elderly patients without diabetes.
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AJKD 49(5), 569-580 (May 2007)
Efficacy and Safety of a Very-Low-Protein Diet When Postponing Dialysis in the Elderly: A Prospective Randomized Multicenter Controlled Study
老年人延迟透析时接受极低蛋白饮食的有效性和安全性，一个随机多盲对照研究
Giuliano Brunori, MD1, Battista F. Viola, MD1, Giovanni Parrinello, PhD2, Vincenzo De Biase, MD3, Giovanna Como, MD4, Vincenzo Franco, MD5, Giacomo Garibotto, MD6, Roberto Zubani, MD, PhD17, Giovanni C. Cancarini, MD17
Background
A supplemented very-low-protein diet (sVLPD) seems to be safe when postponing dialysis therapy.当延迟透析治疗时，极低蛋白饮食看起是安全的。
Study Design研究设计
Prospective multicenter randomized controlled study designed to assess the noninferiority of diet versus dialysis in 1-year mortality assessed by using intention-to-treat and per-protocol analysis. 采用预期的随机多盲试验对照设计 ，通过意向性治疗分析和完成治疗分析方法 对相同饮食的条件下的一年死亡率进行分析。
Setting & Participants环境和参与者
Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min (0.08 to 0.12 mL/s).意大利的尿毒症患者，不包括70岁以上的糖尿病患者和肾小球虑过率5-7 mL/min (0.08 to 0.12 mL/s)的患者.
Intervention干涉
Randomization to an sVLPD (diet group) or dialysis. The sVLPD is a vegan diet (35 kcal; proteins, 0.3 g/kg body weight daily) supplemented with keto-analogues, amino acids, and vitamins. Patients following an sVLPD started dialysis therapy in the case of malnutrition, intractable fluid overload, hyperkalemia, or appearance of uremic symptoms.随即给与极低蛋白饮食或者透析。极低蛋白饮食是素食(35卡路里; 蛋白, 0.3 g/kg 千克体重/天)，给与酮类物质、氨基酸和维生素。极低蛋白饮食患者在营养失调、难治性液体负荷过大、高血钾或者出现尿毒症症状时透析。
Outcomes & Measurements结果和测量方法
Mortality, hospitalization, and metabolic markers.
死亡率，住院和代谢标记
Results结果
56 patients were randomly assigned to each group, median follow-up was 26.5 months (interquartile range, 40), and patients in the diet group spent a median of 10.7 months (interquartile range, 11) following an sVLPD. Forty patients in the diet group started dialysis treatment because of either fluid overload or hyperkalemia. There were 31 deaths (55%) in the dialysis group and 28 deaths (50%) in the diet group. One-year observed survival rates at intention to treat were 83.7% (95% confidence interval [CI], 74.5 to 94.0) in the dialysis group versus 87.3% (95% CI, 78.9 to 96.5) in the diet group (log-rank test for noninferiority, P < 0.001; for superiority, P = 0.6): the difference in survival was −3.6% (95% CI, −17 to +10; P = 0.002). The hazard ratio for hospitalization was 1.50 for the dialysis group (95% CI, 1.11 to 2.01; P < 0.01).患者被随即分为两组，每组56个人，对造组平均受试26.5 个月(interquartile range, 40), 极低蛋白饮食平均受试10.7个月 (interquartile range, 11).40个极低蛋白饮食患者由于液体超负荷和高血钾而透析，正常组透析31(55%)个死亡，极低蛋白饮食组28人死亡。透析组经治疗一年生存率83.7% (95% confidence interval [CI], 74.5 to 94.0) ，极低蛋白饮食组是87.3% (95% CI, 78.9 to 96.5) (log-rank test for noninferiority, P < 0.001; for superiority, P = 0.6)。区别是−3.6% (95% CI, −17 to +10; P = 0.002)。对于透析组，住院患者的危险率是1.5(95% CI, 1.11 to 2.01; P < 0.01)
Limitations局限性
The unblinded nature of the study, exclusion of patients with diabetes, and incomplete enrollment.这个尚无经验的研究，排除了糖尿病患者和不完善的记录。
Conclusion结论
An sVLPD was effective and safe when postponing dialysis treatment in elderly patients without diabetes.非糖尿病延迟透析患者接受极低蛋白饮食是有效性和安全的。
老年人延迟透析时接受极低蛋白饮食的有效性和安全性，一个随机多盲对照研究
背景：当延迟透析治疗时，极低蛋白饮食看起是安全的。
研究设计：采用预期的随机多盲试验对照设计 ，通过意向性治疗分析和完成治疗分析方法，对不同饮食的条件下的一年死亡率进行分析。
环境和参与者：意大利的尿毒症患者，不包括70岁以上的糖尿病患者和肾小球虑过率5-7 mL/min (0.08 to 0.12 mL/s)的患者.
干涉：随机给与极低蛋白饮食或者透析。极低蛋白饮食是素食(35卡路里; 蛋白, 0.3 g/kg 千克体重/天)，给与酮类物质、氨基酸和维生素。极低蛋白饮食患者在营养失调、难治性液体负荷过大、高血钾或者出现尿毒症症状时透析。结果和测量方法：死亡率，住院和代谢标记
结果：患者被随即分为两组，每组56个人，对造组平均受试26.5 个月(interquartile range, 40), 极低蛋白饮食平均受试10.7个月 (interquartile range, 11).40个极低蛋白饮食患者由于液体超负荷和高血钾而透析，正常组透析31(55%)个死亡，极低蛋白饮食组28人死亡。透析组经治疗一年生存率83.7% (95% confidence interval [CI], 74.5 to 94.0) ，极低蛋白饮食组是87.3% (95% CI, 78.9 to 96.5) (log-rank test for noninferiority, P < 0.001; for superiority, P = 0.6)。区别是−3.6% (95% CI, −17 to +10; P = 0.002)。对于透析组，住院患者的危险率是1.5(95% CI, 1.11 to 2.01; P < 0.01)
局限性：这个尚无经验的研究，排除了糖尿病患者和不完善的记录。
结论：非糖尿病延迟透析患者接受极低蛋白饮食是有效性和安全的。
A Prospective Randomized Multicenter Controlled Study
一项前瞻性随机多中心对照研究
A supplemented very-low-protein diet
有补充的极低蛋白饮食。
noninferiority
非劣性
即不比…差
Setting & Participants
设计和参与者
Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min
70岁以上肾小球滤过率为5~7 mL/min的意大利非糖尿病性尿毒症患者。
log-rank test for noninferiority
非劣性对数秩检验
interquartile range
四分位距范围
95% confidence interval
95% 可信区间
The unblinded nature of the study, exclusion of patients with diabetes, and incomplete enrollment
该研究的非盲性、排除了糖尿病、纳入不完全。
