Department of Endocrinology and Metabolism, The Affiliated Hospital of Qingdao University, Shandong Provincial Key Laboratory of Metabolic Diseases and Qingdao Key Laboratory of Gout, Qingdao, China.
Institute of Metabolic Diseases, Qingdao University, Qingdao, China.
Rheumatology (Oxford). 2021 Jun 18;60(6):2661-2671. doi: 10.1093/rheumatology/keaa668.
To compare the efficacy and safety of citrate mixture and sodium bicarbonate on urine alkalization in gout patients under benzbromarone treatment.
A prospective, randomized, parallel controlled trial was conducted among 200 gout patients in the dedicated gout clinic of the Affiliated Hospital of Qingdao University. The participants were randomly divided into two groups (1:1), sodium bicarbonate group (3 g/day) and citrate mixture group (7 g/day). All patients were prescribed with 25 mg/day benzbromarone at initiation and maintained at a dose of 50 mg/day. Clinical and biochemical data were collected at each follow-up time point (baseline, weeks 2, 4, 8 and 12).
A total of 182 patients completed the 12-week urine alkalization study. The urine pH value of both groups increased significantly from the baseline to the final follow-up time point (sodium bicarbonate group, 5.50-6.00, P < 0.05; citrate mixture group, 5.53-5.93, P < 0.05). While the comparisons regarding urine pH between treatment groups showed no significant differences for each time point. The estimated glomerular filtration rate (eGFR) dropped significantly after 12 weeks' trial in the sodium bicarbonate group (P < 0.01), while it was comparable between baseline and the last follow-up (P > 0.05) in the citrate mixture group. Results of urine analysis showed that the incident rate of occult blood in the sodium bicarbonate group was higher than that in the citrate mixture group (38 vs 24%, P < 0.05), accompanied by a similar occurrence of kidney stones. After 12-week follow-up, the frequency of twice gout flare in the citrate mixture group was significantly lower than that in sodium bicarbonate group (4 vs 12%, P = 0.037). No treatment-emergent adverse events occurred.
The efficacy of citrate mixture on urine alkalization is comparable to sodium bicarbonate under benzbromarone treatment without significant adverse events. Citrate mixture is superior to sodium bicarbonate in lowering the incidence of urine occult blood and the frequency of gout attacks.
Registered with ChiCTR (http://www.chictr.org.cn), No. ChiCTR1800018518.
比较枸橼酸盐混合物与碳酸氢钠在苯溴马隆治疗痛风患者尿液碱化中的疗效和安全性。
在青岛大学附属医院痛风专科门诊进行了一项前瞻性、随机、平行对照试验，纳入了 200 例痛风患者。参与者被随机分为两组（1:1），碳酸氢钠组（3g/天）和枸橼酸盐混合物组（7g/天）。所有患者在起始时均给予 25mg/天的苯溴马隆，并维持 50mg/天的剂量。在每次随访时间点（基线、第 2、4、8 和 12 周）收集临床和生化数据。
共有 182 例患者完成了为期 12 周的尿液碱化研究。两组患者的尿 pH 值均从基线显著升高至最后一次随访时间点（碳酸氢钠组，5.50-6.00，P<0.05；枸橼酸盐混合物组，5.53-5.93，P<0.05）。然而，治疗组之间的尿 pH 值比较在每个时间点均无显著差异。碳酸氢钠组在 12 周试验后估算肾小球滤过率（eGFR）显著下降（P<0.01），而枸橼酸盐混合物组在基线和最后一次随访时相似（P>0.05）。尿液分析结果显示，碳酸氢钠组隐血的发生率高于枸橼酸盐混合物组（38%比 24%，P<0.05），同时伴有类似的肾结石发生。经过 12 周的随访，枸橼酸盐混合物组两次痛风发作的频率明显低于碳酸氢钠组（4%比 12%，P=0.037）。未发生治疗相关不良事件。
在苯溴马隆治疗下，枸橼酸盐混合物在尿液碱化方面的疗效与碳酸氢钠相当，且无明显不良事件。枸橼酸盐混合物在降低尿隐血发生率和痛风发作频率方面优于碳酸氢钠。
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