阿伐曲泊帕在慢性肝病相关血小板减少症患者高危侵入性操作治疗中的应用：一项单中心、前瞻性、非随机对照试验

doi:10.3877/cma.j.issn.2095-3232.2026.01.011

中华肝脏外科手术学电子杂志 ›› 2025, Vol. 15 ›› Issue (01) : 66 -72. doi: 10.3877/cma.j.issn.2095-3232.2026.01.011

临床研究

阿伐曲泊帕在慢性肝病相关血小板减少症患者高危侵入性操作治疗中的应用：一项单中心、前瞻性、非随机对照试验

史斌¹, 孟令展², 李虎², 俞鹏², 曹李², 王子政², 邵艳玲², 严锦², 朱震宇²^,^†(

)

¹　100039　北京，解放军总医院第三医学中心器官移植科
²　100039　北京，解放军总医院第五医学中心肝病医学部肝病外科

收稿日期:2025-07-12 出版日期:2025-02-10
通信作者: 朱震宇
基金资助:
国家自然科学基金(92159305); 首都卫生发展科研专项基金(2024-25062)

Application of avatrombopag in patients with chronic liver disease-associated thrombocytopenia undergoing high-risk invasive procedures: a single-center, prospective, non-randomized controlled trial

Bin Shi¹, Lingzhan Meng², Hu Li², Peng Yu², Li Cao², Zizheng Wang², Yanling Shao², Jin Yan², Zhenyu Zhu²^,^†()

¹ Department of Organ Transplantation, the Third Medical Center of Chinese PLA General Hospital, Beijing 100039, China
² Department of Liver Surgery, the Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China

Received:2025-07-12 Published:2025-02-10
Corresponding author: Zhenyu Zhu

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引用本文：

史斌, 孟令展, 李虎, 俞鹏, 曹李, 王子政, 邵艳玲, 严锦, 朱震宇. 阿伐曲泊帕在慢性肝病相关血小板减少症患者高危侵入性操作治疗中的应用：一项单中心、前瞻性、非随机对照试验[J/OL]. 中华肝脏外科手术学电子杂志, 2025, 15(01): 66-72.

Bin Shi, Lingzhan Meng, Hu Li, Peng Yu, Li Cao, Zizheng Wang, Yanling Shao, Jin Yan, Zhenyu Zhu. Application of avatrombopag in patients with chronic liver disease-associated thrombocytopenia undergoing high-risk invasive procedures: a single-center, prospective, non-randomized controlled trial[J/OL]. Chinese Journal of Hepatic Surgery(Electronic Edition), 2025, 15(01): 66-72.

目的

探讨阿伐曲泊帕在慢性肝病相关血小板减少症(CHRT)成人患者接受择期高危侵入性操作中应用的临床效果和安全性。

方法

本前瞻性研究对象为解放军总医院计划择期行侵入性操作的CHRT患者68例。患者均签署知情同意书，符合医学伦理学规定。其中男49例，女19例；平均年龄50岁。根据治疗方案不同分为实验组（17例）和常规组（51例）。实验组患者在术前的10至13 d开始口服阿伐曲泊帕，每天一次，连续5 d，药物剂量根据Plt进行选择：当Plt<40×10⁹/L时，剂量为60 mg/d；当Plt在40~50×10⁹/L时，剂量为40 mg/d。而常规组主要采用观察或其他提升血小板的治疗方法，包括血小板输注以及使用重组人血小板生成素、重组人IL-11、艾曲泊帕和罗米司亭等药物。观察两组患者Plt变化、肝功能指标和不良反应的发生情况。

结果

在筛选期和基线期，实验组Plt分别为（34±8）×10⁹/L、（34±7）×10⁹/L，明显低于常规组的（42±7）×10⁹/L、（41±8）×10⁹/L（t=-4.134，-3.206；P<0.05）。术后10 d，实验组Plt为（80±31）×10⁹/L，明显高于常规组的（49±18）×10⁹/L（t=3.738，P<0.05）。ALT、AST和TB水平在基线期、术前1 d和术后10 d的比较中差异无统计学意义（P>0.05）。实验组和常规组药物不良反应发生率比较差异无统计学意义（P>0.05）。

结论

阿伐曲泊帕作为一种血小板增加剂，能够提高Plt并减少手术相关出血风险，同时具有较好的安全性，在择期行高危侵入性操作的CHRT患者中显示出潜在的临床益处。

关键词: 阿伐曲泊帕, 血小板减少症, 慢性疾病, 重组人血小板生成素, 侵入性操作

Objective

To evaluate clinical efficacy and safety of avatrombopag in adult patients with chronic liver disease-associated thrombocytopenia (CHRT) undergoing elective high-risk invasive procedures.

Methods

In this prospective clinical trial, 68 patients with CHRT undergoing elective invasive procedures in the PLA General Hospital were enrolled. The informed consents of all patients were obtained and the local ethical committee approval was received. Among them, 49 patients were male and 19 female, aged 50 years on average. According to different treatment regimens, they were divided into the study group (n=17) and routine group (n=51). Patients in the study group were given with avatrombopag orally at preoperative 10 to 13 d, once a day for 5 consecutive d. The dosage was selected according to platelet (Plt) count: the dosage was 60 mg/d when Plt was <40×10⁹/L, and 40 mg/d when Plt was ranged from 40 to 50×10⁹/L. In the routine group, observation or other Plt-elevating treatment methods were mainly used, including Plt transfusion and use of recombinant human thrombopoietin, recombinant human IL-11, eltrombopag and romiplostim, etc. The changes of Plt count, liver function indexes and the incidence of adverse reactions were observed between two groups.

Results

In the screening and baseline phases, the Plt count in the study group was (34±8)×10⁹/L and (34±7)×10⁹/L, significantly lower than (42±7)×10⁹/L and (41±8)×10⁹/L in the routine group (t=-4.134, -3.206, both P<0.05). At postoperative 10 d, the Plt count in the study group was (80±31)×10⁹/L, significantly higher than (49±18)×10⁹/L in the routine group (t=3.738, P<0.05). No significant differences were found in the levels of ALT, AST and TB at baseline, postoperative 1 and 10 d (all P>0.05). There was no statistical significance difference in the incidence of adverse drug reactions between two groups (P>0.05).

Conclusions

As a Plt-elevating agent, avatrombopag can elevate Plt and reduce the risk of surgery-related bleeding. In addition, it possesses high safety, showing potential clinical benefits in patients with CHRT undergoing elective high-risk invasive procedures.

Key words: Avatrombopag, Thrombocytopenia, Chronic disease, Recombinant human thrombopoietin, Invasive procedures

表1 两组CHRT患者一般资料比较

组别	例数	年龄(岁, $x ¯$ ±s)	性别(男/女)	病因(例)					肝病进展(例)		肝性脑病(例)	创伤性操作(例)
组别	例数	年龄(岁, $x ¯$ ±s)	性别(男/女)	HBV	HCV	AH	DILI	AIH	肝硬化	HCC	肝性脑病(例)	MWA	EVL	TACE	脾切除	腹腔穿刺	肝癌氩核刀	肝金标置入
实验组	17	59±6	11/6	15	1	0	1	0	13	4	0	6	0	5	2	0	2	2
常规组	51	59±10	38/13	41	2	5	1	2	26	25	1	29	5	7	2	3	4	1
统计值		t=0.038	χ²=0.470	-					χ²=3.684		-	-
P值		0.097	0.493	0.519					0.055		0.553	0.157

表1 两组CHRT患者一般资料比较

组别	例数	年龄(岁, $x ¯$ ±s)	性别(男/女)	病因(例)					肝病进展(例)		肝性脑病(例)	创伤性操作(例)
组别	例数	年龄(岁, $x ¯$ ±s)	性别(男/女)	HBV	HCV	AH	DILI	AIH	肝硬化	HCC	肝性脑病(例)	MWA	EVL	TACE	脾切除	腹腔穿刺	肝癌氩核刀	肝金标置入
实验组	17	59±6	11/6	15	1	0	1	0	13	4	0	6	0	5	2	0	2	2
常规组	51	59±10	38/13	41	2	5	1	2	26	25	1	29	5	7	2	3	4	1
统计值		t=0.038	χ²=0.470	-					χ²=3.684		-	-
P值		0.097	0.493	0.519					0.055		0.553	0.157

表2 两组CHRT患者Plt比较（×10⁹/L，

x ¯

±s）

组别	例数	筛选期	基线期	术前1 d	术后10 d
实验组	17	34±8	34±7	68±32	80±31
常规组	51	42±7	41±8	52±28	49±18
t值		-4.134	-3.206	1.905	3.738
P值		<0.001	0.02	0.061	0.02

表2 两组CHRT患者Plt比较（×10⁹/L，

x ¯

±s）

组别	例数	筛选期	基线期	术前1 d	术后10 d
实验组	17	34±8	34±7	68±32	80±31
常规组	51	42±7	41±8	52±28	49±18
t值		-4.134	-3.206	1.905	3.738
P值		<0.001	0.02	0.061	0.02

表3 两组CHRT患者围手术期肝功能指标比较[M（Q_R）]

组别	例数	ALT（U/L）			AST（U/L）			TB（μmol/L）
组别	例数	基线期	术前1 d	术后10 d	基线期	术前1 d	术后10 d	基线期	术前1 d	术后10 d
实验组	17	20(9)	19(8)	65(194)	28(8)	28(9)	127(316)	20(27)	24(23)	38(41)
常规组	51	21(9)	20(12)	74(73)	33(15)	31(18)	116(152)	24(22)	23(24)	34(20)
Z值		-1.067	-1.223	-0.756	-1.799	-0.580	-1.077	-0.198	-0.287	-0.764
P值		0.286	0.221	0.449	0.072	0.562	0.282	0.843	0.774	0.445

表3 两组CHRT患者围手术期肝功能指标比较[M（Q_R）]

组别	例数	ALT（U/L）			AST（U/L）			TB（μmol/L）
组别	例数	基线期	术前1 d	术后10 d	基线期	术前1 d	术后10 d	基线期	术前1 d	术后10 d
实验组	17	20(9)	19(8)	65(194)	28(8)	28(9)	127(316)	20(27)	24(23)	38(41)
常规组	51	21(9)	20(12)	74(73)	33(15)	31(18)	116(152)	24(22)	23(24)	34(20)
Z值		-1.067	-1.223	-0.756	-1.799	-0.580	-1.077	-0.198	-0.287	-0.764
P值		0.286	0.221	0.449	0.072	0.562	0.282	0.843	0.774	0.445

表4 两组CHRT患者药物不良反应的比较

组别	例数	发热	恶心	腹痛	贫血	低钠血症	头晕	血栓形成	外周性水肿
实验组	17	2	1	1	0	2	1	1	1
常规组	51	6	0	2	1	0	1	0	0
χ²值		0.002	-	0.095	-	-	0.636	-	-
P值		0.961	0.087	0.758	0.553	0.425	0.425	0.087	0.087

表4 两组CHRT患者药物不良反应的比较

组别	例数	发热	恶心	腹痛	贫血	低钠血症	头晕	血栓形成	外周性水肿
实验组	17	2	1	1	0	2	1	1	1
常规组	51	6	0	2	1	0	1	0	0
χ²值		0.002	-	0.095	-	-	0.636	-	-
P值		0.961	0.087	0.758	0.553	0.425	0.425	0.087	0.087

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Application of avatrombopag in patients with chronic liver disease-associated thrombocytopenia undergoing high-risk invasive procedures: a single-center, prospective, non-randomized controlled trial

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Application of avatrombopag in patients with chronic liver disease-associated thrombocytopenia undergoing high-risk invasive procedures: a single-center, prospective, non-randomized controlled trial