叶绿素铜钠制剂治疗CKD患者的单组试验

S. Patankar, A. Sajgure, C. Savangikar, V. A. Savangikar, S. Rangnekar, M. Gharpure
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引用次数: 0

摘要

在一项针对34名慢性肾脏疾病(CKD)患者的前瞻性单臂研究中,在一项为期90天的试验中,患者接受标准护理治疗和含有叶绿素铜钠(IP)的液体组合物,作为前60天的附加治疗,患者在最后30天“关闭”IP。在给药后60天内,观察到血清肌酐、血尿素和尿酸水平显著降低,肾小球滤过率(eGFR)估计值和生活质量健康相关标准显著改善。60 d后停用IP,第90天eGFR仍显著高于第0天。这些观察结果表明,部分/有限逆转肾功能丧失作为IP的挥之不去的影响。这两项研究都是首次为改善CKD患者的生活开辟了新的途径。这是第一个口服产品降低血清肌酐并在60天内改善健康相关生活质量的临床试验报告,也是一个令人惊讶的证据,表明在进行性退行性疾病CKD中肾功能的显著恢复。这项临床试验为管理CKD提供了迄今为止从未有过的机会。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Single Arm Trial in Treatment of CKD Patients with Sodium Copper Chlorophyllin Formulation
In a prospective, single arm study of 34 Chronic Kidney Disease (CKD) patients in a trial of 90 days wherein patients got standard-of-care treatment and liquid composition containing Sodium Copper Chlorophyllin, the Investigational Product (IP), as add-on treatment for first 60 days and patients were ‘off’ the IP for last 30 days. Significant reduction in serum creatinine, Blood Urea and Uric acid level and significant improvement in estimated Glomerular Filtration Rate (eGFR), and Health related criteria for quality of life were observed in 60 days’ period of administration. eGFR remained significantly higher on 90th day than 0 day despite withdrawal of IP after 60 days. These observations suggest partial/limited reversal of lost kidney function as a lingering effect of the IP. Both these are first observations opening up new avenues for improving life of CKD patients. This is first clinical trial report of an orally consumed product that decreases serum creatinine and also actually improved health related quality of life within 60 days and a surprising evidence that suggests significant degree of restoration of kidney function in the progressively degenerative disease CKD. This clinical trial opens opportunities for managing CKD that were never available so far.
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