几十年来,华法林一直是晚期慢性肾脏疾病(CKD)患者的首选抗凝剂,但随着新型口服抗凝剂(NOAC)的出现,他们的处方急剧增加。在所有NOACS中,阿哌沙班是对肾功能最不依赖的药物,是该患者人群中非常受欢迎的选择。然而,被广泛利用,大多数评估阿哌沙班安全性和有效性的具有里程碑意义的试验排除了肌酐清除率(CrCl)<25mL/min/1.73m2或血清肌酐(SCr)≥2.5mg/dL的患者.其对晚期CKD患者的批准仅来自有限的药代动力学数据。我们进行了一项系统评价,比较了阿哌沙班与华法林在4期和5期CKD患者和透析患者中的安全性和有效性。我们查询了主要的研究文献数据库,包括MEDLINE,PubMed,PubMedCentral(PMC),CochraneCentral,和ScienceDirect查找相关文章,没有任何时间或语言限制。经过筛选和质量检查,我们确定了11项与我们的研究问题相关的研究,其中9项是回顾性队列研究,一项是随机对照试验(RCT)的事后分析,一个是RCT.纳入的研究共有27,007名患者,4,335名患者服用阿哌沙班,22,672名患者服用华法林。结果表明,阿哌沙班预防中风的总体疗效与华法林相当,全身栓塞,静脉血栓栓塞复发,但是阿哌沙班表现出了相当的效果,在一些研究中,关于出血的发生,比华法林更好的安全性。因此,对于4或5期CKD并接受透析的患者,阿哌沙班可能被认为是华法林的合理替代品。根据审查的文章,我们得出的结论是,阿哌沙班与华法林具有相似的疗效和一定程度的安全性,需要更多的随机对照试验来增加证据。
Warfarin has been an anticoagulant of choice in patients with advanced Chronic Kidney Diseases (CKD) at stages 4 and 5 for decades, but with the advent of Novel Oral Anticoagulants (NOACs), there has been a sharp rise in their prescriptions. Among all NOACS, apixaban is the least reliant on kidney function and is a very popular choice for this patient population. However, being utilized extensively, most of the landmark trials evaluating the safety and efficacy of apixaban excluded patients with Creatinine Clearance (CrCl) <25mL/min/1.73 m2 or Serum Creatinine (SCr) ≥2.5mg/dL. Its approval for advanced CKD patients came from limited pharmacokinetic data only. We conducted a systematic
review comparing the safety and efficacy of apixaban to warfarin in patients with stage 4 and 5 CKD and on dialysis. We queried major research literature databases, including MEDLINE, PubMed, PubMed Central (PMC), Cochrane Central, and ScienceDirect to find relevant articles without any time or language restrictions. After screening and quality checks, we identified 11 studies relevant to our research question, of which nine were retrospective cohort studies, one was a post-hoc analysis of a randomized controlled trial (RCT), and one was an RCT. The included studies had a total of 27,007 patients, with 4,335 patients taking apixaban and 22,672 on warfarin. The results indicate that the overall efficacy of apixaban was equivalent to warfarin for the prevention of stroke, systemic embolization, and recurrent venous thromboembolism, but apixaban showed an equivalent and, in some studies, better safety profile than warfarin concerning the occurrence of bleeding. Apixaban may hence be considered a reasonable alternative to warfarin in patients with Stage 4 or 5 CKD and receiving dialysis. In light of the reviewed articles, we conclude that apixaban has similar efficacy and somewhat superior safety profile to warfarin, with more randomized controlled trials required to add to the evidence.