Effects of increased peritoneal clearances on mortality rates in peritoneal dialysis: ADEMEX, a prospective, randomized, controlled trial
Effects of increased peritoneal clearances on mortality rates in peritoneal dialysis: ADEMEX, a prospective, randomized, controlled trial
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DOI：
10.1681/asn.v1351307
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发表时间：
2002-05-01
影响因子：
13.6
通讯作者：
Mujais, S
中科院分区：
文献类型：
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作者：
Paniagua, R;Amato, D;Mujais, S
腹膜透析（PD）的小溶质清除率目标是基于腹膜和肾脏清除率相等的默认假设，因此是相加的。虽然几项研究已经确定患者生存率与肾脏清除率直接相关，但尚未有随机、对照、干预性试验检查腹膜小溶质清除率增加对患者生存率的影响。一个未来的。随机的控制。进行了一项临床试验，以研究腹膜小溶质清除率增加对接受PD治疗的终末期肾病患者临床结局的影响。共有965名受试者被随机分配到干预组或对照组（比例为1：1）。对照组中的受试者继续接受其先前存在的PD处方，包括每日4次交换2 L标准PD溶液。干预组采用改良处方治疗。达到腹膜肌酐清除率（pCrCl]）为60 L/周/1.73 m2。主要终点为死亡，最短随访期为2年。研究组在人口统计学特征、肾脏疾病原因、共存疾病患病率、残余肾功能、干预前腹膜清除率、红细胞压积值和营养状态的多个指标方面相似。在对照组中，腹膜肌酐清除率（pCrCl）和腹膜尿素清除率（Kt/V）值在研究期间保持恒定。在干预组中，pCrCl和腹膜Kt[V]值可预测地增加，并且在整个研究期间与对照组的值保持分离（P < 0.01）。在意向治疗分析中，对照组和干预组的患者生存率相似，相对死亡风险（干预组/对照组）为1.00 [95%置信区间（CI），0.80 - 1.24]。总体而言，对照组的1年生存率为85.5%（CI，82.2 - 88.7%），2年生存率为68.3%（CI，64.2 - 72.9%）。同样，干预组的1年生存率为83.9%（CI，80.6 - 87.2%），2年生存率为69.3%（CI，65.1 - 73.6%）。实际治疗分析显示了相似的结果（总体相对风险= 0.93; CI，0.71 - 1.22; P = 0.6121）。两组的死亡率保持相似，即使在调整了已知与接受PD患者生存相关的因素（例如，年龄、糖尿病、血清白蛋白水平、总氮外观的标准化蛋白当量和无尿）。本研究提供的证据表明，在研究范围内，腹膜小溶质清除率的增加对患者生存率有中性影响，即使根据已知影响生存率的各种因素（年龄、糖尿病、血清白蛋白水平、总氮外观的标准化蛋白当量和无尿）对各组进行分层。在本研究达到的范围内，腹膜小溶质清除率增加未获得明显的生存优势。
Small-solute clearance targets for peritoneal dialysis (PD) have been based on the tacit assumption that peritoneal and renal clearances are equivalent and therefore additive. Although several studies have established that patient survival is directly correlated with renal clearances, there have been no randomized, controlled, interventional trials examining the effects of increases in peritoneal small-solute clearances on patient survival. A prospective. randomized. controlled. clinical trial was performed to study the effects of increased peritonea] small-solute clearances on clinical outcomes among patients with end-stage renal disease who were being treated with PD. A total of 965 subjects were randomly assigned to the intervention or control group (in a 1: 1 ratio). Subjects in the control group continued to receive their preexisting PD prescriptions, which consisted of four daily exchanges with 2 L of standard PD solution. The subjects in the intervention group were treated with a modified prescription. to achieve a peritoneal creatinine clearance (pCrCl]) of 60 L/wk per 1.73 m(2). The primary endpoint was death, The minimal follow-up period was 2 yr. The study groups were similar with respect to demographic characteristics, causes of renal disease, prevalence of coexisting conditions, residual renal function, peritoneal clearances before intervention, hematocrit values, and multiple indicators of nutritional status. In the control group, peritoneal creatinine clearance (pCrCl) and peritoneal urea clearance (Kt/V) values remained constant for the duration of the study. In the intervention group, pCrCl and peritoneal Kt[V values predictably increased and remained separated from the values for the control group for the entire duration of the study (P < 0.01). Patient survival was similar for the control and intervention groups in an intent-to-treat analysis, with a relative risk of death (intervention/control) of 1.00 [95% confidence interval (CI), 0.80 to 1.24]. Overall, the control group exhibited a 1-yr survival of 85.5% (Cl, 82.2 to 88.7%) and a 2-yr survival of 68.3% (Cl, 64.2 to 72.9%). Similarly, the intervention group exhibited a 1-yr survival of 83.9% (CI, 80.6 to 87.2%) and a 2-yr survival of 69.3% (Cl, 65.1 to 73.6%). An as-treated analysis revealed similar results (overall relative risk = 0.93; CI, 0.71 to 1.22; P = 0.6121). Mortality rates for the two groups remained similar even after adjustment for factors known to be associated with survival for patients undergoing PD (e.g., age, diabetes mellitus, serum albumin levels, normalized protein equivalent of total nitrogen appearance, and anuria). This study provides evidence that increases in peritoneal small-solute clearances within the range studied have a neutral effect on patient survival, even when the groups are stratified according to a variety of factors (age, diabetes mellitus, serum albumin levels, normalized protein equivalent of total nitrogen appearance, and anuria) known to affect survival. No clear survival advantage was obtained with increases in peritoneal small-solute clearances within the range achieved in this study.