BMC Med. 2020 Apr 9;18(1):91. doi: 10.1186/s12916-020-01542-9.
Chronic kidney disease with metabolic acidosis is common in older people, but the effectiveness of oral sodium bicarbonate therapy in this group is unclear. We tested whether oral sodium bicarbonate provides net health benefit for older people with advanced chronic kidney disease and serum bicarbonate concentrations < 22 mmol/L.
Pragmatic multicentre, parallel group, double-blind, placebo-controlled randomised trial. We recruited adults aged ≥ 60 years with estimated glomerular filtration rate of < 30 mL/min/1.73 m, not receiving dialysis, with serum bicarbonate concentration < 22 mmol/L, from 27 nephrology and geriatric medicine departments in the UK. Participants received oral sodium bicarbonate (up to 3 g/day) or matching placebo given for up to 2 years, randomised in a 1:1 ratio. The primary outcome was between-group difference in the Short Physical Performance Battery (SPPB) at 12 months, adjusted for baseline values, analysed by intention to treat. Secondary outcomes included generic and disease-specific quality of life (EQ-5D and KDQoL tools), anthropometry, renal function, walk distance, blood pressure, bone and vascular health markers, and incremental cost per quality-adjusted life year gained.
We randomised 300 participants between May 2013 and February 2017, mean age 74 years, 86 (29%) female. At 12 months, 116/152 (76%) participants allocated to bicarbonate and 104/148 (70%) allocated to placebo were assessed; primary outcome data were available for 187 participants. We found no significant treatment effect for the SPPB: bicarbonate arm 8.3 (SD 2.5) points, placebo arm 8.8 (SD 2.2) and adjusted treatment effect - 0.4 (95% CI - 0.9 to 0.1, p = 0.15). We found no significant treatment effect for glomerular filtration rate (0.6 mL/min/1.73 m, 95% CI - 0.8 to 2.0, p = 0.39). The bicarbonate arm showed higher costs and lower quality of life as measured by the EQ-5D-3L tool over 1 year (£564 [95% CI £88 to £1154]); placebo dominated bicarbonate under all sensitivity analyses. Adverse events were more frequent in those randomised to bicarbonate (457 versus 400).
Oral sodium bicarbonate did not improve physical function or renal function, increased adverse events and is unlikely to be cost-effective for use by the UK NHS for this patient group.
European Clinical Trials Database (2011-005271-16) and ISRCTN09486651; registered 17 February 2012.
慢性肾脏病伴代谢性酸中毒在老年人中很常见，但在该人群中口服碳酸氢钠治疗的有效性尚不清楚。我们测试了口服碳酸氢钠是否能为晚期慢性肾脏病且血清碳酸氢盐浓度<22mmol/L 的老年人带来净健康益处。
实用、多中心、平行组、双盲、安慰剂对照随机试验。我们招募了年龄≥60 岁、估计肾小球滤过率<30mL/min/1.73m²、未接受透析、血清碳酸氢盐浓度<22mmol/L 的成年人，来自英国 27 个肾病和老年医学科。参与者接受口服碳酸氢钠（高达 3g/天）或匹配的安慰剂治疗，持续 2 年，以 1:1 的比例随机分组。主要结局为 12 个月时短体适能测试（SPPB）的组间差异，根据基线值进行调整，意向治疗分析。次要结局包括一般和疾病特异性生活质量（EQ-5D 和 KDQoL 工具）、人体测量、肾功能、步行距离、血压、骨骼和血管健康标志物以及每获得 1 个质量调整生命年的增量成本。
我们于 2013 年 5 月至 2017 年 2 月期间随机分配了 300 名参与者，平均年龄 74 岁，86 名（29%）为女性。在 12 个月时，152 名接受碳酸氢盐治疗的参与者中有 116 名（76%）和 148 名接受安慰剂治疗的参与者中有 104 名（70%）接受了评估；187 名参与者提供了主要结局数据。我们没有发现治疗对 SPPB 有显著影响：碳酸氢盐组 8.3（SD 2.5）分，安慰剂组 8.8（SD 2.2）分，调整后的治疗效果为-0.4（95%CI-0.9 至 0.1，p=0.15）。我们没有发现肾小球滤过率（0.6mL/min/1.73m²，95%CI-0.8 至 2.0，p=0.39）有显著的治疗效果。碳酸氢盐组在 1 年内的 EQ-5D-3L 工具测量的生活质量（88 英镑[95%CI 88 至 1154 英镑]）更高，成本更高；所有敏感性分析中，安慰剂组都优于碳酸氢盐组。与接受碳酸氢盐治疗的参与者相比，接受碳酸氢盐治疗的参与者发生更多的不良事件（457 例比 400 例）。
口服碳酸氢钠不能改善身体功能或肾功能，增加不良事件，并且不太可能对英国国民保健制度（NHS）在该患者群体中使用具有成本效益。
欧洲临床试验数据库（2011-005271-16）和 ISRCTN09486651；2012 年 2 月 17 日注册。
