Lee Ho Yung, Choi Hoon Young, Park Hyeong Cheon, Seo Bo Jeung, Do Jun Young, Yun Sung Ro, Song Hyun Yong, Kim Yeong Hoon, Kim Yong-Lim, Kim Dae Joong, Kim Yong Soo, Kim Moon Jae, Shin Sug Kyun
Department of Internal Medicine, Yonsei University College of Medicine, CPO Box 8044, Seoul, Korea.
Nephrol Dial Transplant. 2006 Oct;21(10):2893-9. doi: 10.1093/ndt/gfl393. Epub 2006 Sep 6.
Novel, biocompatible peritoneal dialysis (PD) solutions have become available in recent years. In 2001, low glucose degradation products (GDP), neutral pH solutions became commercially available in Korea. To date, there are no reports regarding the large scale adoption of these solutions in clinical practice and regarding what, if any, impact these solutions have on patient outcomes.
Using a database of almost 4000 patients treated by PD in Korea, we conducted a prospective, longitudinal observational study documenting the patterns of use of one novel low GDP solution (balance, Fresenius Medical Care, St Wendel, Germany) in 1909 PD incident patients between 1 January 2002 and midyear 2005. Outcomes including patient and technique survival and peritonitis rates were analysed using univariate and multivariate analysis.
Prescription of low GDP solutions reached between 70 and 80% by the year 2003 and persisted at this level. Patients prescribed low GDP PD solution tended to be younger and were more likely to be treated in centres with larger enrollment in the database. Survival of diabetic patients treated with the new PD solution was identical to that of the non-diabetic patients treated with standard PD fluids (PDF) and treatment with low GDP PDF independently reduced the relative risk (RR) of death (RR = 0.613; CI 0.50-0.74; P < 0.00001) in a proportional hazards model which included age, diabetes and centre experience. In a univariate analysis, low GDP PD solution was associated with a longer technique survival (P = 0.049) but this effect was not significant in multivariate analysis. No significant differences in peritonitis-free interval or peritonitis rate could be attributed to the prescribed PDF.
Prescription of low GDP, pH-neutral PD solutions has rapidly increased in Korea. This change has resulted in a significant improvement in patient and technique survival without any measurable change in peritonitis incidence or rate. Reasons for the improved patient survival cannot be determined from this analysis and require further study.
近年来，新型生物相容性腹膜透析（PD）溶液已面市。2001年，低葡萄糖降解产物（GDP）、中性pH值的溶液在韩国开始商业化销售。迄今为止，尚无关于这些溶液在临床实践中的大规模应用情况以及它们对患者预后有何影响（若有影响的话）的报道。
利用韩国近4000例接受PD治疗患者的数据库，我们进行了一项前瞻性纵向观察性研究，记录了2002年1月1日至2005年年中1909例新发生PD的患者使用一种新型低GDP溶液（平衡液，费森尤斯医疗护理公司，德国圣文德尔）的使用模式。使用单变量和多变量分析方法分析包括患者和技术生存率以及腹膜炎发生率在内的预后情况。
到2003年，低GDP溶液的处方率达到70%至80%，并维持在这一水平。开具低GDP PD溶液处方的患者往往更年轻，且更有可能在数据库中登记人数较多的中心接受治疗。接受新PD溶液治疗的糖尿病患者的生存率与接受标准PD液（PDF）治疗的非糖尿病患者相同，并且在包含年龄、糖尿病和中心经验的比例风险模型中，使用低GDP PDF治疗可独立降低死亡相对风险（RR = 0.613；CI 0.50 - 0.74；P < 0.00001）。在单变量分析中，低GDP PD溶液与更长的技术生存率相关（P = 0.049），但在多变量分析中这种影响并不显著。无腹膜炎间隔时间或腹膜炎发生率方面的显著差异可归因于所开具的PDF。
在韩国，低GDP、pH值中性的PD溶液的处方率迅速上升。这一变化已使患者和技术生存率显著提高，而腹膜炎发生率或比率没有任何可测量的变化。从本分析中无法确定患者生存率提高的原因，需要进一步研究。
