Sanabria M, Muñoz J, Trillos C, Hernández G, Latorre C, Díaz C S, Murad S, Rodríguez K, Rivera A, Amador A, Ardila F, Caicedo A, Camargo D, Díaz A, González J, Leguizamón H, Lopera P, Marín L, Nieto I, Vargas E
Baxter - RTS Colombia, Bogotá, Colombia.
Kidney Int Suppl. 2008 Apr(108):S165-72. doi: 10.1038/sj.ki.5002619.
The goal of the Dialysis Outcomes in Colombia (DOC) study was to compare the survival of patients on hemodialysis (HD) vs peritoneal dialysis (PD) in a network of renal units in Colombia. The DOC study examined a historical cohort of incident patients starting dialysis therapy between 1 January 2001 and 1 December 2003 and followed until 1 December 2005, measuring demographic, socioeconomic, and clinical variables. Only patients older than 18 years were included. As-treated and intention-to-treat statistical analyses were performed using the Kaplan-Meier method and Cox proportional hazard model. There were 1094 eligible patients in total and 923 were actually enrolled: 47.3% started HD therapy and 52.7% started PD therapy. Of the patients studied, 751 (81.3%) remained in their initial therapy until the end of the follow-up period, death, or censorship. Age, sex, weight, height, body mass index, creatinine, calcium, and Subjective Global Assessment (SGA) variables did not show statistically significant differences between the two treatment groups. Diabetes, socioeconomic level, educational level, phosphorus, Charlson Co-morbidity Index, and cardiovascular history did show a difference, and were less favorable for patients on PD. Residual renal function was greater for PD patients. Also, there were differences in the median survival time between groups: 27.2 months for PD vs 23.1 months for HD (P=0.001) by the intention-to-treat approach; and 24.5 months for PD vs 16.7 months for HD (P<0.001) by the as-treated approach. When performing univariate Cox analyses using the intention-to-treat approach, associations were with age > or =65 years (hazard ratio (HR)=2.21; confidence interval (CI) 95% (1.77-2.755); P<0.001); history of cardiovascular disease (HR=1.96; CI 95% (1.58-2.90); P<0.001); diabetes (HR=2.34; CI 95% (1.88-2.90); P<0.001); and SGA (mild or moderate-severe malnutrition) (HR=1.47; CI 95% (1.17-1.79); P=0.001); but no association was found with gender (HR=1.03, CI 95% 0.83-1.27; P=0.786). Similar results were found with the as-treated approach, with additional associations found with Charlson Index (0-2) (HR=0.29; Cl 95% (0.22-0.38); P<0.001); Charlson Index (3-4) (HR=0.61; Cl 95% (0.48-0.79); P<0.001); and SGA (mild-severe malnutrition) (HR=1.43; Cl 95% (1.15-1.77); P<0.001). Similarly, the multivariate Cox model was run with the variables that had shown association in previous analyses, and it was found that the variables explaining the survival of patients with end-stage renal disease in our study were age, SGA, Charlson Comorbidity Index 5 and above, diabetes, healthcare regimes I and II, and socioeconomic level 2. The results of Cox proportional risk model in both the as-treated and intention-to-treat analyses showed that there were no statistically significant differences in survival of PD and HD patients: intention-to-treat HD/PD (HR 1.127; CI 95%: 0.855-1.484) and as-treated HD/PD (HR 1.231; CI 95%: 0.976-1.553). In this historical cohort of incident patients, there was a trend, although not statistically significant, for a higher (12.7%) adjusted mortality risk associated with HD when compared to PD, even though the PD patients were poorer, were more likely to be diabetic, and had higher co-morbidity scores than the HD patients. The variables that most influenced survival were age, diabetes, comorbidity, healthcare regime, socioeconomic level, nutrition, and education.
哥伦比亚透析结果(DOC)研究的目标是比较哥伦比亚肾脏单位网络中接受血液透析(HD)与腹膜透析(PD)患者的生存率。DOC研究调查了2001年1月1日至2003年12月1日开始透析治疗并随访至2005年12月1日的新发患者的历史队列,测量了人口统计学、社会经济和临床变量。仅纳入18岁以上的患者。采用Kaplan-Meier法和Cox比例风险模型进行实际治疗和意向性治疗的统计分析。总共有1094名符合条件的患者,实际纳入923名:47.3%开始HD治疗,52.7%开始PD治疗。在研究的患者中,751名(81.3%)在随访期结束、死亡或失访前一直维持初始治疗。年龄、性别、体重、身高、体重指数、肌酐、钙和主观全面评定(SGA)变量在两个治疗组之间未显示出统计学显著差异。糖尿病、社会经济水平水平、教育水平、磷、Charlson合并症指数和心血管病史确实存在差异,且对PD患者不利。PD患者的残余肾功能更好。此外,两组之间的中位生存时间也存在差异:意向性治疗方法中,PD为27.2个月,HD为23.1个月(P=0.001);实际治疗方法中,PD为24.5个月,HD为16.7个月(P<0.001)。采用意向性治疗方法进行单变量Cox分析时,与年龄≥65岁(风险比(HR)=2.21;95%置信区间(CI)(1.77-2.755);P<0.001)、心血管疾病史(HR=1.96;CI 95%(1.58-2.90);P<0.001)、糖尿病(HR=2.34;CI 95%(1.88-2.90);P<0.001)和SGA(轻度或中度-重度营养不良)(HR=1.47;CI 95%(1.17-1.79);P=0.001)有关;但未发现与性别有关(HR=1.03,CI 95% 0.83-1.27;P=0.786)。实际治疗方法也得到了类似结果,还发现与Charlson指数(0-2)(HR=0.29;CI 95%(0.22-0.38);P<0.001)、Charlson指数(3-4)(HR=0.61;CI 95%(0.48-0.79);P<0.001)和SGA(轻度-重度营养不良)(HR=1.43;CI 95%(1.15-1.77);P<0.001)有关。同样,对先前分析中显示有关联的变量进行多变量Cox模型分析,发现本研究中解释终末期肾病患者生存的变量为年龄、SGA、Charlson合并症指数5及以上、糖尿病、医疗保健制度I和II以及社会经济水平2。实际治疗和意向性治疗分析中的Cox比例风险模型结果均显示,PD和HD患者的生存率无统计学显著差异:意向性治疗HD/PD(HR 1.127;CI 95%:0.855-1.484)和实际治疗HD/PD(HR 1.231;CI 95%:0.976-1.553)。在这个新发患者的历史队列中,尽管与PD相比,HD的调整后死亡风险有升高趋势(12.7%),但无统计学显著差异,尽管PD患者比HD患者更贫困、更易患糖尿病且合并症评分更高。对生存影响最大的变量是年龄、糖尿病、合并症、医疗保健制度、社会经济水平、营养和教育。