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一项随机双盲安慰剂对照试验,研究己酮可可碱对高危患者经皮冠状动脉介入治疗后对比剂诱导的肾病减少的影响。

A Randomized Double Blind Placebo Controlled Trial Examining the Effects of Pentoxifylline on Contrast Induced Nephropathy Reduction after Percutaneous Coronary Intervention in High Risk Candidates.

作者信息

Barzi Farnaz, Miri Reza, Sadeghi Roxana, Sistanizad Mohammad, Sadeghi Mohsen, Mahjoob Mohammad Parsa, Chehrazi Mohammad

机构信息

Department of Internal Medicine, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Cardiovascular Research Center, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

出版信息

Iran J Pharm Res. 2019 Spring;18(2):1040-1046. doi: 10.22037/ijpr.2019.12557.10977.

Abstract

Contrast-induced nephropathy (CIN) (known as contrast-induced acute kidney injury) occurs as a result of acute worsening of renal function following a procedure with administration of iodine contrasts agent and remains a substantial concern in clinical practices. The purpose of this study is to investigate the preventive effect of Pentoxifylline supplementation on reduction of CIN occurrence after percutaneous coronary intervention among patients who were high risk of CIN according to Mehran score. In randomized, double-blind clinical trial patients who undergo coronary angiography with Mehran Score ≥ 11 consisted of our population. Patients in a ratio 1:1, divided into two groups received saline 0.9% plus N-acetyl cysteine and Pentoxifylline 400 mg three times per day 24 h before angiography until 48 h after angiography. In control group, the patients received placebo instead of PTX in a same manner as the control group. The endpoint was the incidence of CIN defined as creatinine increase of 0.5 mg/dL within 2 days after contrast. There were no significant differences in baseline characteristics. CIN occurred in 3 (5.5%) and 4 (7.3%) patients of the both groups (Pentoxifylline and control), respectively ( 0.69; incidence odds ratio 1.36; 95% CI 0.29-6.38). No significant differences were seen in secondary outcome measures and changes in the level of creatinine ( 0.54). In high-risk patients undergoing coronary angiography pentoxifylline supplementation had protection effect against contrast-induced nephropathy greater than placebo based hydration, but, not supported by our data.

摘要

对比剂肾病(CIN)(又称对比剂诱导的急性肾损伤)是在使用碘对比剂的检查后肾功能急性恶化的结果,仍是临床实践中的一个重大问题。本研究的目的是调查在根据梅兰评分属于CIN高风险的患者中,补充己酮可可碱对经皮冠状动脉介入术后CIN发生率降低的预防作用。在一项随机、双盲临床试验中,纳入了梅兰评分≥11且接受冠状动脉造影的患者。患者按1:1比例分为两组,一组在血管造影术前24小时至术后48小时,每天3次服用0.9%生理盐水加N - 乙酰半胱氨酸和400毫克己酮可可碱;另一组作为对照组,患者以与试验组相同的方式接受安慰剂而非己酮可可碱。终点指标是CIN的发生率,定义为对比剂注射后2天内肌酐升高0.5mg/dL。两组患者的基线特征无显著差异。两组(己酮可可碱组和对照组)分别有3例(5.5%)和4例(7.3%)患者发生CIN(相对危险度0.69;发病率比值比1.36;95%可信区间0.29 - 6.38)。次要结局指标和肌酐水平变化方面未见显著差异(P = 0.54)。在接受冠状动脉造影的高风险患者中,补充己酮可可碱对对比剂肾病的保护作用大于基于安慰剂的水化治疗,但我们的数据并不支持这一点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d20a/6706721/5b2881509971/ijpr-18-1040-g001.jpg

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