Singh Iqbal, Bishnoi Ishu, Agarwal Vivek, Bhatt Shuchi
Department of Urology, University College of Medical Sciences (University of Delhi) and GTB Hospital, Delhi, India.
Urol Ann. 2011 May;3(2):75-81. doi: 10.4103/0974-7796.82172.
To compare efficacy and tolerability of phytotherapy (PT) vs. potassium citrate (KC) in patients with minimal nephrolithiasis. To compare and assess changes in value of certain serum (Ca(2)+, PO(4) (3-), uric acid [UA]) and urinary (24-hr Ca(2+), PO(4) (3-), UA, citrate, oxalate, and urine pH) parameters in patients being treated with PT or KC.
After clearance by the local institutional ethics committee, 60 patients of nephrolithiasis who had consented for the study, were enrolled (as per entry criteria) and randomized into citrate therapy (group-I) or PT (group-II). PT was administered as a nutritional supplement, using a lupeol-based extract (Tablet Calcury™, two tablets twice a day). They were monitored for the changes in the serum and urinary biochemical, radiological, and clinical parameters (efficacy and tolerability) as per protocol.
Group-I patients demonstrated favorable changes in certain biochemical parameters (decreased serum calcium, urinary UA/oxalate, increased urinary citrate and pH) along with significant symptomatic improvement (decrease in visual analogue pain score with increased stone clearance/reduction in stone size). Four (13.3%) patients of group-I had mild upper gastrointestinal discomfort which was controlled with antacids. Group-II patients had favorable changes in biochemical parameters (decreased serum UA and increased urinary citrate) along with significant symptomatic improvement (reduction/clearance in the stone size), but without any noticeable side effects.
Medical therapies with both KC and PT (with lupeol extract using Calcury™) were effective in reducing the stone size and symptoms of nephrolithiasis. It appeared that KC was biochemically efficacious in producing some favorable biochemical changes with some side effects, whereas PT was probably clinically efficacious in hastening stone expulsion (<8 mm) without any observed adverse events. Although both the medical therapies were not effective in all aspects, we believe that PT using lupeol-based extract (Calcury™) may be used as an alternative form of medical therapy in select patients with minimal nephrolithiasis. Long-term randomized placebo-controlled trials are needed to better define the precise role of lupeol-based PT vs. citrate therapy in minimal nephrolithiasis.
比较植物疗法（PT）与柠檬酸钾（KC）对轻度肾结石患者的疗效和耐受性。比较并评估接受PT或KC治疗的患者某些血清参数（Ca(2+)、PO(4)(3-)、尿酸[UA]）和尿液参数（24小时Ca(2+)、PO(4)(3-)、UA、柠檬酸盐、草酸盐和尿液pH值）的变化情况。
经当地机构伦理委员会批准后，60例同意参与研究的肾结石患者（符合入选标准）被纳入研究，并随机分为柠檬酸盐治疗组（I组）或PT治疗组（II组）。PT作为营养补充剂给药，使用基于羽扇豆醇的提取物（Calcury™片，每日两次，每次两片）。按照方案对患者的血清和尿液生化、放射学及临床参数（疗效和耐受性）变化进行监测。
I组患者某些生化参数出现有利变化（血清钙降低、尿UA/草酸盐降低、尿柠檬酸盐和pH值升高），同时症状有显著改善（视觉模拟疼痛评分降低，结石清除率提高/结石尺寸减小）。I组有4例（13.3%）患者出现轻度上消化道不适，使用抗酸剂后得到控制。II组患者生化参数出现有利变化（血清UA降低、尿柠檬酸盐升高），同时症状有显著改善（结石尺寸减小/清除），但未出现任何明显副作用。
KC和PT（使用Calcury™的羽扇豆醇提取物）药物治疗均能有效减小肾结石尺寸并缓解症状。似乎KC在产生一些有利生化变化方面具有生化疗效，但有一些副作用，而PT可能在加速排出<8mm结石方面具有临床疗效，且未观察到不良事件。尽管两种药物治疗并非在所有方面都有效，但我们认为，对于某些轻度肾结石患者，使用基于羽扇豆醇的提取物（Calcury™）的PT可作为一种替代药物治疗形式。需要进行长期随机安慰剂对照试验，以更好地明确基于羽扇豆醇的PT与柠檬酸盐治疗在轻度肾结石中的精确作用。
