新型口服抗凝药物治疗房颤合并慢性肾病患者的有效性和安全性的系统评价及间接Meta分析

发布时间：2018-03-20 02:12

本文选题：房颤　切入点：慢性肾病　出处：《浙江大学》2015年博士论文　论文类型：学位论文

【摘要】：目的：慢性肾病会增加非瓣膜性房颤患者的血栓风险。新型口服抗凝药物(达比加群、阿哌沙班、利伐沙班)已被批准用于非瓣膜性房颤合并慢性肾病病人的卒中预防。然而,肾功能不全有可能改变新型口服抗凝药物的抗凝效果并增加出血风险。本文用系统综述和间接Meta分析的方法,研究新型口服抗凝药物与华法林在治疗非瓣膜性房颤合并慢性肾病病人的有效性和安全性的比较。方法：利用计算机检索Pubmed, ISI Web of Science, Cochrane图书馆临床对照试验数据库,同时通过手工检索相关系统评价的参考文献作为补充。检索日期为自建库至2015年4月23日。检索已公开发表的随机对照研究。研究的干预与对照分别为三种新型口服抗凝药物(达比加群、阿哌沙班、利伐沙班)和华法林中的一种。观测的结局指标包括：全因死亡率、颅内出血、大出血和体循环栓塞及卒中。应用R软件中的meta和netmeta程序包进行间接Meta分析。结果：共纳入4个研究,包括9776例患者。其中利伐沙班与华法林比较的文献2篇,阿哌沙班与华法林比较的文献1篇,达比加群与华法林比较的文献1篇。对于非瓣膜性房颤合并慢性肾病的病人,传统Meta分析结果显示新型口服抗凝药物在降低房颤合并慢性肾病患者的体循环栓塞和卒中的发生率方面不劣于华法林,且不增加其全因死亡率、大出血及颅内出血发生率。间接Meta分析结果显示利伐沙班、达比加群和阿哌沙班在预防卒中和体循环栓塞方面并无显著差异,阿哌沙班相比于达比加群和利伐沙班大出血风险较低。结论：在非瓣膜性房颤合并慢性肾病患者,新型口服抗凝药在降低卒中及体循环栓塞方面不劣于华法林,且不增加出血风险。阿哌沙班相比于达比加群和利伐沙班大出血较低。目前仍需大样本、多中心的高质量研究,为达比加群、阿哌沙班、利伐沙班这三类药物对非瓣膜性房颤合并肾功能不全患者全因死亡率、大出血和体循环栓塞及卒中等终点提供进一步证据。
[Abstract]:Objective: chronic kidney disease increases in patients with non valvular atrial fibrillation risk of thrombosis. The new oral anticoagulant (dabigatran, this drug Shaaban, Shaaban Lee Laval) has been approved for stroke in nonvalvular atrial fibrillation in patients with chronic kidney disease prevention. However, renal insufficiency may change the new oral anticoagulants the effect of anticoagulant therapy and increase the risk of bleeding. Analysis method of systematic review and indirect Meta this paper, to compare the efficacy and safety of new oral anticoagulants with Hua Falin in the treatment of non valvular atrial fibrillation in patients with chronic kidney disease.
Methods: the Pubmed database using the computer, ISI Web of Science, clinical controlled trials database of Cochrane library, at the same time through the manual retrieval system evaluation related references as a supplement. Retrieval date from setting up to April 23, 2015. Randomized controlled study has been published in retrieval. Intervention and control study were three new oral anticoagulants (Darby with this drug group, Shaaban, Lee and Shaaban) of a warfarin. Including the outcome observation: all-cause mortality, intracranial hemorrhage, bleeding and systemic embolism and stroke. Application of R software in the meta and netmeta package for indirect Meta analysis.
Results: a total of 4 studies were included, involving 9776 patients. Among them Shaaban Lee Laval with warfarin compared with 2 references, a comparison of Shaaban and warfarin 1 literatures, dabigatran and warfarin compared with 1 literatures. For non valvular atrial fibrillation in patients with chronic kidney disease patients, the traditional Meta analysis results showed that new oral anticoagulants in the incidence of noninferior to warfarin for atrial fibrillation and reduce systemic embolism in patients with chronic kidney disease and stroke, and no increase in all-cause mortality, hemorrhage and incidence of intracranial hemorrhage. The results of indirect Meta analysis showed that dabigatran and rivaroxaban, this drug in the prevention of stroke and no Shaaban systemic embolism significantly different, with a Shaaban compared to dabigatran and cutting Shaaban hemorrhage risk is low.
Conclusion: Patients with chronic kidney disease in non valvular atrial fibrillation, the new oral anticoagulants in reducing stroke and systemic embolism is not inferior to warfarin, without increasing the risk of bleeding. This drug compared to Shaaban and Shaaban Lee of dabigatran bleeding is low. There is still need a large sample of high quality the center for dabigatran, O, of Shaaban, Lee Shaaban of these three types of drugs on renal function in non valvular atrial fibrillation in patients with and without all-cause mortality, hemorrhage and systemic embolism and stroke end point to provide further evidence.

【学位授予单位】：浙江大学
【学位级别】：博士
【学位授予年份】：2015
【分类号】：R541.75;R692

【共引文献】