肝硬化患者抗凝治疗有效性和安全性的meta分析

doi:10.3969/j.issn.1004-583X.2025.04.001

摘要/Abstract

摘要：

目的探讨抗凝治疗和预防性抗凝治疗在肝硬化伴或不伴门静脉血栓(portal vein thrombosis, PVT)患者中的有效性和安全性。方法根据文献检索策略,分别在 Pubmed、Cochrane、Embase、 Web of Science、知网、万方、维普数据库进行检索,并检索相关参考文献进行文献补充。逐一筛选检索到的文献,并对纳入文献进行质量评价及数据提取,采用Revman5.3和Stata14.0软件进行meta分析。结果总共检索到3423篇文献,按照纳入与排除标准进行文献筛选,最终纳入23篇文献。在肝硬化合并PVT患者中:抗凝治疗组PVT再通率明显高于未抗凝组(OR=3.39,95%CI:2.59-4.44,P<0.001),且未增加不良事件。直接口服抗凝药(direct oral anticoagulants, DOAC)的PVT再通率高于传统抗凝药(OR=39.49,95%CI:9.65-161.68,P<0.001),且大出血发生率低于传统抗凝药(OR=0.35,95%CI:0.13-0.97,P=0.04)。在肝硬化不合并PVT患者中:预防性抗凝组PVT形成率低于不抗凝组(OR=0.15,95%CI:0.05-0.43,P<0.001),两组出血发生率差异无统计学意义(OR=1.96,95%CI:0.72-5.30,P=0.19),预防性抗凝组全因死亡率低于不抗凝组(OR=0.51,95%CI:0.43-0.60,P<0.001)。结论抗凝治疗可以治疗或预防肝硬化患者门静脉血栓形成,是一种相对安全的治疗方法。

关键词: 肝硬化, 抗凝, 预防性抗凝, 门静脉血栓, Meta分析

Abstract:

Objective To investigate the efficacy and safety of anticoagulant therapy and prophylactic anticoagulant therapy in cirrhosis patients with or without portal vein thrombosis (PVT). Methods Literature searchs were conducted using PubMed, Cochrane, Embase, Web of Science, CNKI, Wanfang, and VIP databases, and relevant references were also reviewed. The included literatures were assessed for quality and data extraction. A meta-analysis was conducted using Revman5.3 and Stata14.0. Results Twenty-three eligible articles were included in 3423 retrieved articles. In patients with cirrhosis and PVT, the PVT recanalization rate in the anticoagulant therapy group was significantly higher than that of the non-anticoagulant group (OR=3.39, 95%CI: 2.59-4.44, P<0.001), without an increase in adverse events. The PVT recanalization rate of direct oral anticoagulants (DOAC) was significantly higher than that of traditional anticoagulants (OR=39.49, 95%CI: 9.65-161.68, P<0.001), and the rate of major bleeding was significantly lower than that of traditional anticoagulants (OR=0.35, 95%CI: 0.13-0.97, P=0.04). In patients with cirrhosis without PVT, the rate of PVT formation in the prophylactic anticoagulation group was significantly lower than that of non-anticoagulant group (OR=0.15, 95%CI: 0.05-0.43, P<0.001), with no difference of bleeding between groups (OR=1.96, 95%CI: 0.72-5.30, P=0.19), but the all-cause mortality rate in the prophylactic anticoagulation group was significantly lower (OR=0.51, 95%CI: 0.43-0.60, P<0.001). Conclusion Anticoagulant therapy can treat or prevent PVT in patients with cirrhosis and is a relatively safe treatment.

Key words: liver cirrhosis, anticoagulation, prophylactic anticoagulation, portal vein thrombosis, meta-analysis

中图分类号:

R575.2

苏芮, 王存凯, 王鼎鑫, 蔡聪会, 张建, 侯洪涛, 白云. 肝硬化患者抗凝治疗有效性和安全性的meta分析[J]. 临床荟萃, 2025, 40(4): 293-303.

Su Rui, Wang Cunkai, Wang Dingxin, Cai Conghui, Zhang Jian, Hou Hongtao, Bai Yun. Efficacy and safety of anticoagulant therapy in patients with cirrhosis: A meta-analysis[J]. Clinical Focus, 2025, 40(4): 293-303.

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链接本文: https://lchc.magtechjournal.com/CN/10.3969/j.issn.1004-583X.2025.04.001

https://lchc.magtechjournal.com/CN/Y2025/V40/I4/293

图/表 9

参考文献 45

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作者	年份	国家	随访时间	抗凝方案	试验组人数 /对照组人数	性别 (男/女)	年龄(岁) (试验组/对照组)	肝硬化病因 (病毒/酒精/其他)	Child-Pugh 分级(A/B/C)
					抗凝治疗
Chung^[6]	2014	韩国	至少3月	华法林	14/14	21/7	59.4±12.0 58.7±13.2	19/7/2	13/14/1
Naymagon^[7]	2021	美国	27(12-48)月	华法林、依诺肝素、利伐沙班、阿哌沙班、达比加群	86/128	142/72	60(54-66)	80/43/91	52/99/63
Zhang^[8]	2023	中国	26(13-44)月	华法林、利伐沙班、达比加群、低分子肝素	27/50	44/33	59.0±13.0 60.4±12.3	24/18/35	32/37/8
Tarar^[9]	2023	美国	NA	NA	4015/56490	38721/21784	59.8(58.9-60.6) 59.9(59.7-60.1)	NA	NA
Ai^[10]	2020	中国	6月	利伐沙班或达比加群	40/40	50/30	56.1±16.1 52.3±19.4	NA	NA
Zhou^[11]	2020	中国	6月	1个月那屈肝素钙,5个月华法林	32/32	42/22	55±9 53±10	47/8/9	NA
Chen^[12]	2016	中国	33.2±29.2月 25.9±23月	华法林	30/36	47/19	44.97±12.3 47.86±10.6	42/3/21	NA
Lu^[13]	2024	中国	1年	华法林	30/34	22/42	55(24-69)	45/7/12	42/21/1
Pettinari^[14]	2019	意大利	19(3-94)月	低分子肝素、磺达肝癸钠、VKA	81/101	130/52	57.8±11.2	84/47/51	80/78/24
Florescu^[15]	2021	罗马尼亚	32(3-109)月	依诺肝素、VKA	54/53	54/53	53(23-73) 55.65(25-75)	70/23/14	27/77/3
Scheiner^[16]	2018	奥地利	44.1(14.0-79.1)月	低分子肝素、苯丙香豆素	12/36	32/19	52.9±12.5	6/24/21	14/19/18
Ferreira^[17]	2019	葡萄牙	25(1-146)月	华法林、低分子肝素	35/32	53/27	60±9	11/45/24	21/34/25
Sato^[18]	2023	日本	NA	DOAC、华法林钾、肝素	21/21	31/11	68(64-71) 69(63-77)	7/25/10	NA
Girleanu^[19]	2021	罗马尼亚	6月	依诺肝素	27/27	NA	58.91±8.98	35%酒精	0/28/26
					DOAC vs传统抗凝药
Coons^[20]	2022	美国	最长1年	DOAC VS华法林	44/41	54/31	67.2±9 63.6±10.5	32/20/33	27/41/17
Hanafy^[21]	2019	埃及	NA	利伐沙班VS华法林	40/40	67/13	43.2±3.8	HCV	NA
Hum^[22]	2017	美国	NA	DOAC VS VKA或低分子肝素	27/18	32/13	61(26-90) 58(34-80)	16/11/21	18/21/6
Intagliata^[23]	2016	美国	NA	DOAC VS华法林或低分子肝素	20/19	22/17	57(50-64) 60(55-64)	6/5/28	18/21/0
Nagaoki^[24]	2018	日本	6月	依度沙班VS华法林	20/30	30/20	68(23-83)	33病变	29/16/5
					预防性抗凝治疗
Zhang^[25]	2020	中国	23.8±9.9月 25.0±10.4月	华法林	27/56	61/22	51.7±14.2 51.4±10.5	50/15/18	22/53/8
Villa^[26]	2012	意大利	89±57周 58±37周	依诺肝素	34/36	51/19	56±5 57±7	32/24/14	0/64/6
Sanchez^[27]	2023	西班牙	10.1(0.4-24)月	利伐沙班	41/49	74/16	58.1±7.6	86.7%酒精	NA
Serper^[28]	2021	美国	4.6年	华法林	614/1080	1667/27	64.6±7.5 64.2±8.4	1222HCV/酒精, 472其他	1217/461/16
Serper^[28]	2021	美国	4.6年	DOAC	201/503	697/7	64.0±7.7 64.3±8.4	509HCV/酒精, 195其他	639/65/0

作者	年份	国家	随访时间	抗凝方案	试验组人数 /对照组人数	性别 (男/女)	年龄(岁) (试验组/对照组)	肝硬化病因 (病毒/酒精/其他)	Child-Pugh 分级(A/B/C)
					抗凝治疗
Chung^[6]	2014	韩国	至少3月	华法林	14/14	21/7	59.4±12.0 58.7±13.2	19/7/2	13/14/1
Naymagon^[7]	2021	美国	27(12-48)月	华法林、依诺肝素、利伐沙班、阿哌沙班、达比加群	86/128	142/72	60(54-66)	80/43/91	52/99/63
Zhang^[8]	2023	中国	26(13-44)月	华法林、利伐沙班、达比加群、低分子肝素	27/50	44/33	59.0±13.0 60.4±12.3	24/18/35	32/37/8
Tarar^[9]	2023	美国	NA	NA	4015/56490	38721/21784	59.8(58.9-60.6) 59.9(59.7-60.1)	NA	NA
Ai^[10]	2020	中国	6月	利伐沙班或达比加群	40/40	50/30	56.1±16.1 52.3±19.4	NA	NA
Zhou^[11]	2020	中国	6月	1个月那屈肝素钙,5个月华法林	32/32	42/22	55±9 53±10	47/8/9	NA
Chen^[12]	2016	中国	33.2±29.2月 25.9±23月	华法林	30/36	47/19	44.97±12.3 47.86±10.6	42/3/21	NA
Lu^[13]	2024	中国	1年	华法林	30/34	22/42	55(24-69)	45/7/12	42/21/1
Pettinari^[14]	2019	意大利	19(3-94)月	低分子肝素、磺达肝癸钠、VKA	81/101	130/52	57.8±11.2	84/47/51	80/78/24
Florescu^[15]	2021	罗马尼亚	32(3-109)月	依诺肝素、VKA	54/53	54/53	53(23-73) 55.65(25-75)	70/23/14	27/77/3
Scheiner^[16]	2018	奥地利	44.1(14.0-79.1)月	低分子肝素、苯丙香豆素	12/36	32/19	52.9±12.5	6/24/21	14/19/18
Ferreira^[17]	2019	葡萄牙	25(1-146)月	华法林、低分子肝素	35/32	53/27	60±9	11/45/24	21/34/25
Sato^[18]	2023	日本	NA	DOAC、华法林钾、肝素	21/21	31/11	68(64-71) 69(63-77)	7/25/10	NA
Girleanu^[19]	2021	罗马尼亚	6月	依诺肝素	27/27	NA	58.91±8.98	35%酒精	0/28/26
					DOAC vs传统抗凝药
Coons^[20]	2022	美国	最长1年	DOAC VS华法林	44/41	54/31	67.2±9 63.6±10.5	32/20/33	27/41/17
Hanafy^[21]	2019	埃及	NA	利伐沙班VS华法林	40/40	67/13	43.2±3.8	HCV	NA
Hum^[22]	2017	美国	NA	DOAC VS VKA或低分子肝素	27/18	32/13	61(26-90) 58(34-80)	16/11/21	18/21/6
Intagliata^[23]	2016	美国	NA	DOAC VS华法林或低分子肝素	20/19	22/17	57(50-64) 60(55-64)	6/5/28	18/21/0
Nagaoki^[24]	2018	日本	6月	依度沙班VS华法林	20/30	30/20	68(23-83)	33病变	29/16/5
					预防性抗凝治疗
Zhang^[25]	2020	中国	23.8±9.9月 25.0±10.4月	华法林	27/56	61/22	51.7±14.2 51.4±10.5	50/15/18	22/53/8
Villa^[26]	2012	意大利	89±57周 58±37周	依诺肝素	34/36	51/19	56±5 57±7	32/24/14	0/64/6
Sanchez^[27]	2023	西班牙	10.1(0.4-24)月	利伐沙班	41/49	74/16	58.1±7.6	86.7%酒精	NA
Serper^[28]	2021	美国	4.6年	华法林	614/1080	1667/27	64.6±7.5 64.2±8.4	1222HCV/酒精, 472其他	1217/461/16
Serper^[28]	2021	美国	4.6年	DOAC	201/503	697/7	64.0±7.7 64.3±8.4	509HCV/酒精, 195其他	639/65/0

研究	Selection	Comparability	Outcome	Stars
Chung 2014^[6]	4	2	2	8
Naymagon 2021^[7]	4	2	3	9
Zhang 2023^[8]	4	1	3	8
Tarar 2023^[9]	4	2	3	9
Ai 2020^[10]	4	2	3	9
Chen 2016^[12]	4	2	3	9
Pettinari 2019^[14]	4	1	3	8
Florescu 2021^[15]	4	2	3	9
Scheiner 2018^[16]	4	1	2	7
Ferreira 2019^[17]	4	2	2	8
Sato 2023^[18]	4	2	2	8
Girleanu 2021^[19]	2	2	2	6
Coons 2022^[20]	4	2	2	8
Hum 2017^[22]	4	2	2	8
Intagliata 2016^[23]	4	2	3	9
Nagaoki 2018^[24]	4	2	3	9
Zhang 2020^[25]	4	2	3	9
Serper 2021^[28]	4	2	3	9

研究	Selection	Comparability	Outcome	Stars
Chung 2014^[6]	4	2	2	8
Naymagon 2021^[7]	4	2	3	9
Zhang 2023^[8]	4	1	3	8
Tarar 2023^[9]	4	2	3	9
Ai 2020^[10]	4	2	3	9
Chen 2016^[12]	4	2	3	9
Pettinari 2019^[14]	4	1	3	8
Florescu 2021^[15]	4	2	3	9
Scheiner 2018^[16]	4	1	2	7
Ferreira 2019^[17]	4	2	2	8
Sato 2023^[18]	4	2	2	8
Girleanu 2021^[19]	2	2	2	6
Coons 2022^[20]	4	2	2	8
Hum 2017^[22]	4	2	2	8
Intagliata 2016^[23]	4	2	3	9
Nagaoki 2018^[24]	4	2	3	9
Zhang 2020^[25]	4	2	3	9
Serper 2021^[28]	4	2	3	9