A long-term study of a bicarbonate/lactate-based peritoneal dialysis solution--clinical benefits. The Bicarbonate/Lactate Study Group.
A long-term study of a bicarbonate/lactate-based peritoneal dialysis solution--clinical benefits. The Bicarbonate/Lactate Study Group.
复制标题
基于碳酸氢盐/乳酸的腹膜透析溶液的长期研究——临床益处。
DOI：
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发表时间：
2000
影响因子：
2.8
通讯作者：
A. Tranaeus
中科院分区：
文献类型：
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作者：
A. Tranaeus
客观化
一种碳酸氢盐/乳酸盐腹膜透析液(Bic/Lac)是基于体外和体外数据开发的，显示出更好地保存细胞功能和纠正输液时的疼痛。
设计
这是一项随机、前瞻性、对照的开放研究，在12个月的治疗期内将新型25 mmoL/L碳酸氢盐/15 mmoL/L乳酸盐与标准40 mmoL/L乳酸盐缓冲腹膜透析液(Lac)进行比较。
设置
17个欧洲肾病中心。
病人
106名(70Bic/Lac和36Lac)透析良好的持续非卧床腹膜透析(CAPD)患者。
干预措施
透析充分性和腹膜平衡测试(PET，4周，3，6和12个月)；24小时超滤(4周，1，3和6个月)；血液生化(2周，0天，1，2，3，6，9和12个月)；以及产品可接受性问卷(1和6个月)。
结果
88名患者完成前6个月的治疗，44名患者完成全年治疗。在血浆碳酸氢盐、腹膜尿素和肌酐清除方面，这些溶液被证明在治疗上是等效的。在整个6个月的治疗期间，Bic/Lac组的超滤量较基线显著增加了约150毫升/天(p<；0.05)。Bic/Lac组的生化指标、不良事件和体格检查结果(除了体重在统计学上有显著增加)在两组之间没有显著差异。41%的服用Bic/Lac液体的患者报告说，注射后疼痛/不适减轻或幸福感增加。
结论
Bic/Lac溶液在纠正尿毒症酸中毒方面安全有效，缓解了流入疼痛/不适，并改善了超滤和体重。
OBJECTIVE
A bicarbonate/lactate peritoneal dialysis solution (Bic/Lac) has been developed based on in vitro and ex vivo data showing better preservation of cell function and correction of pain on infusion.
DESIGN
This was a randomized, prospective, controlled, open-label study comparing a new 25 mmol/L bicarbonate/15 mmol/L lactate with a standard 40 mmol/L lactate-buffered peritoneal dialysis solution (Lac) over a 12-month treatment period.
SETTING
17 European nephrology centers.
PATIENTS
106 (70 Bic/Lac and 36 Lac) well-dialyzed continuous ambulatory peritoneal dialysis (CAPD) patients.
INTERVENTIONS
Dialysis adequacy and peritoneal equilibration test (PET, week -4, months 3, 6, and 12); 24-hour ultrafiltration (week -4, months 1, 3, and 6); blood biochemistry (week -2, day 0, months 1, 2, 3,6, 9, and 12); and a product acceptability questionnaire (months 1 and 6).
RESULTS
88 patients completed the first 6 months, and 44 the full year. The solutions were shown to be therapeutically equivalent with respect to plasma bicarbonate and peritoneal urea and creatinine clearances. Ultrafiltration in the Bic/Lac group increased significantly from baseline by about 150 mL/day for the whole of the 6-month treatment period (p < 0.05). The biochemistry profile, adverse events, and physical examination (except body weight where there was a statistically significant increase in the Bic/Lac group) results did not differ significantly between the two groups. Reduced pain/discomfort on infusion or an increased sense of well-being was reported by 41% of patients on the Bic/Lac fluid.
CONCLUSIONS
The Bic/Lac solution is safe and effective in correcting uremic acidosis, provides relief of inflow pain/discomfort, and improves ultrafiltration and body weight.