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Protective effect of selenium on cisplatin induced nephrotoxicity: A double-blind controlled randomized clinical trial

机译:硒对顺铂诱导的肾毒性的保护作用:双盲对照随机临床试验

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Background: Renal injury is common following cisplatin infusion. Some agents have been used to attenuate cisplatin nephrotoxicity. However, except hydration, none of them has been proved to be effective. Objective: In this study selenium as an antioxidant supplement was tested on cisplatin induced renal injury. Patients and Methods: 122 cancerous patients (85 male and 37 female; age range of 14 to 82 years old) were enrolled to receive chemotherapy regimens consisting cisplatin. They were allocated into two groups using a random number list . Investigators, patients and analyzers all, were blinded in allocation by using sealed opaque envelopes. Intervention group received a single 400 mcg selenium tablet and patients in control group took a placebo tablet which was similar with selenium preparation in color, weight, shape and taste. Primary end points were an increase in plasma creatinine above 1.5 mg/dl in men and 1.4mg/dl in women, or increase of plasma creatinine more than 50% from baseline or urine flow rate less than 0.5 ml/kg/h. Creatinine level was measured initially and on the 5th day after cisplatin therapy. Results: There was no difference in cumulative dose of cisplatin between the groups (p=0.54). There were not evidences of acute renal failure (ARF) in cases. While, among placebo group, 7 patients had criteria of acute kidney injury. Conclusions: selenium could probably prevent cisplatin-induced acute kidney injury, when it is added to hydration therapy in cancerous patients
机译:背景:顺铂输注后常见肾损伤。一些药物已被用于减轻顺铂的肾毒性。但是,除了水合作用外,没有一种是有效的。目的:在这项研究中,对硒作为抗氧化剂的补充品对顺铂引起的肾损伤进行了测试。患者和方法:纳入122例癌症患者(男85例,女37例;年龄在14至82岁之间)以顺铂为化疗方案。使用随机数列表将它们分为两组。使用密封的不透明信封,调查人员,患者和分析人员都无法进行分配。干预组仅服用400 mcg硒片,对照组患者服用安慰剂片,其颜色,重量,形状和口味与硒制剂相似。主要终点是男性血浆肌酐增加超过1.5 mg / dl,女性血浆肌酐增加超过1.4 mg / dl,或者血浆肌酐增加超过基线的50%以上或尿流率低于0.5 ml / kg / h。最初和在顺铂治疗后第5天测量肌酐水平。结果:两组之间的顺铂累积剂量没有差异(p = 0.54)。在病例中没有急性肾衰竭(ARF)的证据。在安慰剂组中,有7例患者有急性肾损伤的标准。结论:将硒添加到水合作用的癌症患者中,硒可能可以预防顺铂引起的急性肾脏损伤

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