Feriani M, Kirchgessner J, La Greca G, Passlick-Deetjen J
Department of Nephrology, St. Bortolo Hospital, Vicenza, Italy and Fresenius AG Medical Science Department, Oberursel, Germany.
Kidney Int. 1998 Nov;54(5):1731-8. doi: 10.1046/j.1523-1755.1998.00167.x.
Over the past 15 years, lactate has been used successfully as a buffer in peritoneal dialysis solutions, although its effectiveness in the correction of uremic acidosis and its biocompatibility on peritoneal resident cells have been questioned. In addition, some investigators have suggested other potential adverse metabolic effects resulting from the unphysiologically high lactate flux into the body during CAPD. These potential problems associated with lactate-containing CAPD solution prompted the search for alternative buffer-containing solutions. Bicarbonate, the physiological buffer, was considered when the problem of calcium and magnesium carbonate solubility was solved by the use of a two-compartment bag system, allowing the mixing of bicarbonate and divalent cations immediately before infusion. The long-term tolerance, safety, efficacy and therapeutic value of a bicarbonate-buffered peritoneal dialysis solution were evaluated in this study.
This open, randomized, controlled, multicenter study comparing a 34 mmol/liter bicarbonate- with a 35 mmol/liter lactate-buffered peritoneal dialysis solution was performed in two consecutive 12-week-treatment phases. Fourteen Centers participated in this trial.
A total of 69 out of initially 123 randomized patients completed the six-month study period (36 patients in the bicarbonate group and 33 in the lactate group). While the arterial acid base status of the total study population did not change during the study period and no significant difference was observed between the two treatment groups, the acid-base status of patients in the bicarbonate group entering the study with a metabolic acidosis significantly improved (mean +/- SD; blood pH: baseline = 7.361 +/- 0.05, week 12 = 7.380 +/- 0.04, P < 0.05; week 24 = 7.388 +/- 0.03 P < 0.05; plasma bicarbonate: baseline = 19.49 +/- 3.01 mmol/liter, week 12 = 21.16 +/- 2.63 mmol/liter, P < 0.01; week 24 = 21.51 +/- 2.42 mmol/liter, P < 0.01). No significant changes were recorded in acidotic patients treated with the conventional lactate-buffered solution. The changes in plasma bicarbonate from baseline during the study was significantly different between the groups (week 12: lactate = +0.11 +/- 2.21 mmol/liter, bicarbonate = +1.69 +/- 2.55 mmol/liter, P < 0.05, 95% confidence interval for the difference 0.21 to 2.94 mmol/liter; week 24: lactate = +0.03 +/- 2.48 mmol/liter, bicarbonate = +1.82 +/- 2. 96 mmol/liter, P < 0.05, 95% confidence interval for the difference 0.16 to 3.42 mmol/liter). The normalized protein catabolic rate (nPCR) slightly but significantly decreased in the lactate group (baseline -0.90 +/- 0.23 g/kg/day, week 24 -0.83 +/- 0.21 g/kg/day, P < 0.01) and increased in the bicarbonate group (baseline +0.89 +/- 0.28 g/kg/day, week 24 +0.92 +/- 0.26 g/kg/day, P < 0.05). Changes from baseline between groups were significant (week 24, lactate = -0. 099 +/- 0.15 g/kg/day, bicarbonate = 0.049 +/- 0.12 g/kg/day, P < 0. 01, 95% confidence interval for the difference 0.068 to 0.229 g/kg/day). Other evaluated parameters (biochemical profile, peritoneal function parameters, dialysate protein loss) did not differ significantly between the two groups. No adverse effects related to the study solution were recorded.
These results support the efficacy and safety of bicarbonate-buffered peritoneal solutions in a controlled randomized comparison for up to six months. Peritoneal dialysis solutions containing the physiological buffer bicarbonate might effectively replace conventional lactate-buffered CAPD solutions.
在过去15年中，乳酸盐已成功用作腹膜透析液中的缓冲剂，尽管其在纠正尿毒症酸中毒方面的有效性及其对腹膜驻留细胞的生物相容性受到质疑。此外，一些研究人员提出，在持续性非卧床腹膜透析（CAPD）期间，非生理性的高乳酸盐通量进入体内会产生其他潜在的不良代谢影响。与含乳酸盐的CAPD溶液相关的这些潜在问题促使人们寻找含替代缓冲剂的溶液。当通过使用双腔袋系统解决了碳酸钙和碳酸镁的溶解度问题，允许在输注前立即将碳酸氢盐和二价阳离子混合时，生理性缓冲剂碳酸氢盐被纳入考虑。本研究评估了碳酸氢盐缓冲腹膜透析液的长期耐受性、安全性、有效性和治疗价值。
本开放性、随机、对照、多中心研究在两个连续的12周治疗阶段中，比较了34 mmol/L碳酸氢盐缓冲腹膜透析液和35 mmol/L乳酸盐缓冲腹膜透析液。14个中心参与了该试验。
最初随机分组的123例患者中，共有69例完成了为期6个月的研究期（碳酸氢盐组36例，乳酸盐组33例）。虽然在研究期间总体研究人群的动脉酸碱状态没有变化，且两个治疗组之间未观察到显著差异，但以代谢性酸中毒进入研究的碳酸氢盐组患者的酸碱状态有显著改善（平均值±标准差；血液pH：基线=7.361±0.05，第12周=7.380±0.04，P<0.05；第24周=7.388±0.03，P<0.05；血浆碳酸氢盐：基线=19.49±3.01 mmol/L，第12周=21.16±2.63 mmol/L，P<0.01；第24周=21.51±2.42 mmol/L，P<0.01）。用传统乳酸盐缓冲溶液治疗的酸中毒患者未记录到显著变化。研究期间两组血浆碳酸氢盐相对于基线的变化有显著差异（第12周：乳酸盐=+0.11±2.2 mmol/L，碳酸氢盐=+1.69±2.55 mmol/L，P<0.05，差异的95%置信区间为0.21至2.94 mmol/L；第24周：乳酸盐=+0.03±2.48 mmol/L，碳酸氢盐=+1.82±2.96 mmol/L,P<0.05，差异的95%置信区间为0.16至3.42 mmol/L）。乳酸盐组的标准化蛋白分解代谢率（nPCR）略有但显著下降（基线-0.90±0.23 g/kg/天，第24周-0.83±0.21 g/kg/天，P<0.01），而碳酸氢盐组则有所增加（基线+0.89±0.28 g/kg/天，第24周+0.92±0.26 g/kg/天，P<0.05）。两组间相对于基线的变化有显著差异（第24周，乳酸盐=-0.099±0.15 g/kg/天，碳酸氢盐=0.049±0.12 g/kg/天，P<0.01，差异的95%置信区间为0.068至0.229 g/kg/天）。其他评估参数（生化指标、腹膜功能参数、透析液蛋白丢失）在两组间无显著差异。未记录到与研究溶液相关的不良反应。
这些结果支持了在长达6个月的对照随机比较中，碳酸氢盐缓冲腹膜透析液的有效性和安全性。含有生理性缓冲剂碳酸氢盐的腹膜透析液可能有效地替代传统的乳酸盐缓冲CAPD溶液。
