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NOACs与华法林用于心脏瓣膜置换术后患者抗凝有效性和安全性的Meta分析
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| 篇名： | NOACs与华法林用于心脏瓣膜置换术后患者抗凝有效性和安全性的Meta分析 |
| TITLE： | Anticoagulant effectiveness and safety of new oral anticoagulants versus warfarin after heart valve replacement ： a meta-analysis |
| 摘要： | 目的 比较新型口服抗凝药（NOACs）与华法林用于心脏瓣膜置换术后患者抗凝的有效性和安全性，旨在为临床用药提供循证参考。方法计算机检索PubMed、Cochrane图书馆、Embase、WebofScience、中国知网、万方数据、维普网，收集NOACs（试验组）对比华法林（对照组）用于心脏瓣膜置换术后患者抗凝的临床研究，检索时限均为建库起至2021年7月。筛选文献、提取资料后，采用Cochrane系统评价员手册5.2.0推荐的偏倚风险评估工具对纳入的随机对照研究（RCT）进行质量评价，采用纽卡斯尔-渥太华量表（NOS）对纳入的队列研究进行质量评价，采用RevMan5.3软件进行Meta分析和敏感性分析。结果共纳入9项研究，包括7项RCT和2项队列研究，共计4962例患者。Meta分析结果显示，生物瓣膜置换/修复术后，试验组患者的卒中/系统性栓塞（SSE）发生率[OR＝0.71，95％CI（0.52，0.97），P＝0.03]、大出血发生率[OR＝0.40，95％CI（0.30，0.54），P＜0.00001]、颅内出血发生率[OR＝0.20，95％CI（0.04，0.95），P＝0.04]均显著低于华法林组，两组患者的全因死亡率比较差异无统计学意义[OR＝1.25，95％CI（0.88，1.79），P＝0.22]。机械瓣膜置换/修复术后，两组患者的SSE发生率[OR＝1.52，95％CI（0.04，60.29），P＝0.82]、全因死亡率[OR＝0.26，95％CI（0.04，1.84），P＝0.18]比较差异均无统计学意义。按随访时间进行的亚组分析结果显示，生物瓣膜置换/修复术后，当随访时间≤3个月时，试验组患者的SSE发生率显著低于对照组[OR＝0.20，95％CI（0.06，0.74），P＝0.03]，而两组患者大出血发生率比较差异无统计学意义[OR＝0.67，95％CI（0.19，2.38），P＝0.53]；当随访时间＞3个月时，两组患者的SSE发生率比较差异无统计学意义[OR＝0.74，95％CI（0.54，1.02），P＝0.07]，而试验组患者的大出血发生率显著低于对照组[OR＝0.39，95％CI（0.29，0.52），P＜0.001]。按研究类型进行的亚组分析结果显示，生物瓣膜置换/修复术后，RCT研究中试验组患者的SSE发生率显著低于对照组[OR＝0.51，95％CI（0.29，0.92），P＝0.03]，而两组患者大出血发生率比较差异无统计学意义[OR＝0.58，95％CI（0.33，1.03），P＝0.06]。队列研究中两组患者的SSE发生率比较差异无统计学意义[OR＝1.03，95％CI（0.40，2.66），P＝0.95]，而试验组患者的大出血发生率显著低于对照组[OR＝0.20，95％CI（0.06，0.74），P＜0.001]。敏感性分析结果显示，所得结果较稳健。结论对于生物瓣膜置换/修复术后患者，NOACs的有效性和安全性均优于或与华法林相当；对于机械瓣膜置换/修复术后患者，NOACs与华法林的有效性和安全性均无显著差异。 |
| ABSTRACT： | OBJECTIVE To compare the anticoagulant effectiveness and safety of new oral anticoagulants （NOACs）and warfarin after heart valve replacement ，and to provide evidence-based reference for clinical drug use. METHODS Retrieved from PubMed，Cochrane Library ，Embase，Web of Science ，CNKI，Wanfang database and VIP ，clinical studies about the use of NOACs versus warfarin after heart valve replacement were collected during the inception to July 2021. After literature screening and data extrac tion，the quality of included randomized controlled trials （RCTs）were evaluat ed by bias risk assessment tool recommended by Cochrane system evaluator manual 5.2.0. After the quality of the included cohort studies was evaluated by Newcastle-Ottawa scale （NOS），RevMan 5.3 software was used for meta-analysis and sensitivity analysis. RESULTS A E-mail：carolmeng_0813@163.com total of 9 studies involving 4 962 patients were included ，of which 7 were RCTs and 2 were cohort studie s. Results of meta-analysis showed that after biological valve replacement/repair ，the incidence of stroke and systemic embolism （SSE）[OR＝0.71，95％CI（0.52，0.97），P＝0.03]，major bleeding [OR ＝0.40，95％CI （0.30，0.54），P＜0.000 01] and intracranial hemorrhage [OR ＝0.20，95％CI（0.04，0.95），P＝0.04] in trial group were significantly lower than warfarin group ；there was no significant difference in all-cause mortality between 2 groups [OR ＝1.25，95％CI（0.88， 1.79），P＝0.22]. After mechanical valve replacement/repair ，there were no significant difference in the incidence of SSE [OR ＝1.52， 95％CI（0.04，60.29），P＝0.82] or all-cause mortality [OR ＝0.26，95％CI（0.04，1.84），P＝0.18] between 2 groups. The results of subgroup analysis according to the follow-up time showed that after biological valve replacement/repair ，the incidence of SSE in trial group was significantly lower than that in control group when the follow-up time was ≤3 months [OR ＝0.20，95％CI（0.06， 0.74），P＝0.03]；but there was no significant difference in the incidence of major bleeding between 2 groups [OR ＝0.67，95％CI （0.19，2.38），P＝0.53]；when the follow-up time was longer than 3 months，there was no statistical significance in the incidence of SSE between 2 groups [OR ＝0.74，95％CI（0.54，1.02），P＝0.07]，while the incidence of major bleeding in trial group was significantly lower than control group [OR ＝0.39，95％CI（0.29，0.52），P＜0.001]. Subgroup analysis by study type showed that after biological valve replacement/repair ，the incidence of SSE in the RCT in trial group was significantly lower than that in control group [OR ＝0.51，95％CI（0.29，0.92），P＝0.03]，but there was no significant difference in the incidence of major bleeding between 2 groups[OR＝0.58，95％CI（0.33，1.03），P＝0.06]. In cohort study ，there was no significant difference in the incidence of SSE between 2 groups [OR ＝1.03，95％CI（0.40，2.66），P＝0.95]，while the incidence of major bleeding in trial group was significantly lower than control group [OR ＝0.20，95％CI（0.06，0.74），P＜0.001]. Sensitivity analysis results showed that the results of the above-mentioned meta-analysis were relatively robust. CONCLUSIONS For the patients underwent biological valve replacement/repair，the effectiveness and safety of NOACs are better than or similar to those of warfarin ；for the patients underwent mechanical valve replacement/repair ，there is no significant difference in the effectiveness and safety between NOACs and warfarin. |
| 期刊： | 2022年第33卷第02期 |
| 作者： | 周强，吴思凡，王熙尧，杨元素，陶瑛瑛，黄晓晖，魏萌 |
| AUTHORS： | ZHOU Qiang，WU Sifan，WANG Xiyao，YANG Yuansu ，TAO Yingying ，HUANG Xiaohui ，WEI Meng |
| 关键字： | 新型口服抗凝药；华法林；心脏瓣膜置换术；术后抗凝；疗效；安全性；Meta分析 |
| KEYWORDS： | new oral anticoagulant ；warfarin；heart valve replacement ；postoperative anticoagulation ；efficacy；safety； |
| 阅读数： | 233 次 |
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