Khatami Mohammad Reza, Nikravan Nasrin, Salarifar Mojtaba, Poorhosseini Hamid Reza, Sadeghian Saeid, Haj-Zeinali Ali Mohammad, Aghajani Hassan
Nephrology Research Center, Imam Khomeini Hospital, Keshavarz Blvd, Tehran, Iran.
Tehran Herat Center, North Karegar Ave, Tehran, Iran.
Indian J Nephrol. 2020 Nov-Dec;30(6):403-408. doi: 10.4103/ijn.IJN_260_19. Epub 2020 Nov 11.
Despite high rates of morbidity and mortality in patients with contrast-induced nephropathy (CIN), there is no consensus regarding prevention of this well-known complication of contrast media use. One agent that has been widely used in this regard is N-acetyl cysteine (NAC). Nevertheless, its efficacy is still controversial. The aim of this study was to assess the efficacy of NAC, both in the oral and intravenous forms, for the prevention of CIN.
This study is a double-blind randomized placebo controlled clinical trial. We randomized 434 adult patients with chronic kidney disease (constant serum creatinine ≥1.5 mg/dL) who were candidates for coronary angiography/plasty. The patients were categorized into three groups. One group received 1,200 mg NAC intravenously half an hour before the procedure and oral placebo starting 3 days before angiography. The second group received oral NAC 600 mg twice daily for 3 days, starting the day before the intervention and intravenous placebo half an hour before intervention. The third group received both oral and intravenous placebo. CIN was defined as a 25% relative increase in serum creatinine from baseline value, 48 h after use of contrast medium.
Of the 434 patients, 149 received intravenous NAC, 145 received oral NAC, and the remaining 140 received placebo. The incidence of CIN in the three groups was 6.1%, 7.6%, and 10.8%, respectively ( = 0.34).
In patients with chronic kidney disease, neither intravenous nor oral NAC is superior to placebo for preventing CIN.
尽管对比剂肾病(CIN)患者的发病率和死亡率很高,但对于这种使用造影剂时广为人知的并发症的预防尚无共识。在这方面广泛使用的一种药物是N-乙酰半胱氨酸(NAC)。然而,其疗效仍存在争议。本研究的目的是评估口服和静脉注射形式的NAC预防CIN的疗效。
本研究是一项双盲随机安慰剂对照临床试验。我们将434例慢性肾病成年患者(血清肌酐持续≥1.5mg/dL)随机分组,这些患者均为冠状动脉造影/血管成形术的候选者。患者被分为三组。一组在手术前半小时静脉注射1200mg NAC,并在血管造影前3天开始口服安慰剂。第二组在干预前一天开始,每天两次口服600mg NAC,共3天,并在干预前半小时静脉注射安慰剂。第三组接受口服和静脉注射安慰剂。CIN定义为使用造影剂48小时后血清肌酐较基线值相对升高25%。
434例患者中,149例接受静脉注射NAC,145例接受口服NAC,其余140例接受安慰剂。三组中CIN的发生率分别为6.1%、7.6%和10.8%(P = 0.34)。
在慢性肾病患者中,静脉注射或口服NAC在预防CIN方面并不优于安慰剂。