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1.新疆医科大学第一附属医院新疆药物临床研究重点实验室,乌鲁木齐 830054
2.中国药科大学基础医学与临床药学学院,南京 211198
主管药师,硕士。研究方向:临床药学。E-mail:zhuqingmei111@126.com
主管药师,硕士。研究方向:临床药学。E-mail:979401278@qq.com
收稿:2025-08-20,
修回:2025-12-25,
录用:2025-12-29,
纸质出版:2026-02-15
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朱青梅,时敏,杨东亮,等.伏诺拉生治疗消化性溃疡和ESD术后溃疡安全性和有效性的伞形评价 [J].中国药房,2026,37(03):389-394.
ZHU Qingmei,SHI Min,YANG Dongliang,et al.Umbrella review analysis of the safety and efficacy of vonoprazan in the treatment of peptic ulcers and post-ESD ulcers[J].ZHONGGUO YAOFANG,2026,37(03):389-394.
朱青梅,时敏,杨东亮,等.伏诺拉生治疗消化性溃疡和ESD术后溃疡安全性和有效性的伞形评价 [J].中国药房,2026,37(03):389-394. DOI: 10.6039/j.issn.1001-0408.2026.03.20.
ZHU Qingmei,SHI Min,YANG Dongliang,et al.Umbrella review analysis of the safety and efficacy of vonoprazan in the treatment of peptic ulcers and post-ESD ulcers[J].ZHONGGUO YAOFANG,2026,37(03):389-394. DOI: 10.6039/j.issn.1001-0408.2026.03.20.
目的
2
分析伏诺拉生(VPZ)治疗消化性溃疡(PU)和内镜黏膜下剥离术(ESD)术后溃疡的安全性与有效性,为临床实践、医疗决策提供循证药学证据。
方法
2
计算机检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、Embase、Web of Science、the Cochrane Library等数据库,获取VPZ治疗PU和ESD术后溃疡相关的Meta分析/系统评价。由2名研究者独立进行文献筛选、数据提取、文献质量评估、文献重叠程度评估,采用伞形评价分析方法;当纳入的文献高度重叠时,对所有相关原始研究数据重新进行Meta分析。
结果
2
共纳入17项Meta分析,质量从高质量到极低质量不等;所有涉及的结局指标,在纳入的相关Meta分析中均存在非常高的重叠水平(校正覆盖面积为22.22%~100%)。治疗ESD术后溃疡时,与质子泵抑制剂(PPI)比较,VPZ可显著提高ESD术后4周的溃疡愈合率[RR=1.27,95%CI(1.03,1.56),
Z
=2.21,
P
=0.027
]
和溃疡收缩率[MD=0.08,95%CI(0.00,0.16),
Z
=2.09,
P
=0.037
]
,显著降低具有PU病史患者的溃疡复发率[RR=0.49,95%CI(0.32,0.73),
Z
=3.49,
P
=0.001
]
;VPZ组延迟出血率较兰索拉唑亚组显著降低[RR=0.47,95%CI(0.25,0.90),
Z
=2.28,
P
=0.02
]
。治疗PU时,十二指肠溃疡亚组中,VPZ的不良事件发生率明显高于PPI[RR=1.13,95%CI(1.02,1.26),
Z
=2.38,
P
=0.017
]
。
结论
2
对于ESD术后溃疡,VPZ的治疗效果优于PPI,且可以降低具有PU病史患者的溃疡复发率,但在治疗十二指肠溃疡的安全性方面并不具有优势。
OBJECTIVE
2
To analyze the safety and efficacy of vonoprazan (VPZ) in the treatment of peptic ulcer (PU) and post-endoscopic submucosal dissection (ESD) ulcers, providing evidence-based pharmaceutical evidence for clinical practice and medical decision-making.
METHODS
2
Retrieved from CNKI, Wanfang, VIP, CBM, PubMed, Embase, Web of Science, and the Cochrane Library, meta-analyses/systematic reviews related to VPZ in the treatment of PU and post-ESD ulcers were collected. Two researchers independently performed literature screening, data extraction, quality assessment of included studies, and evaluation of literature overlap. By employing the umbrella review analysis, a fresh meta-analysis was conducted on all relevant raw research data when a high degree of overlap was identified among the included studies.
RESULTS
2
A total of 17 meta-analyses were included, with quality ranging from high to very low; all outcome measures involved showed a very high level of overlap in the included meta-analyses (corrected covered area: 22.22%-100%). In the treatment of post-ESD ulcers, compared to proton pump inhibitor (PPI), VPZ significantly improved the ulcer healing rate at 4 weeks post-ESD [RR=1.27, 95%CI (1.03, 1.56),
Z
=2.21,
P
=0.027
]
and the ulcer contraction rate post-ESD [MD=0.08, 95%CI (0.00, 0.16),
Z
=2.09,
P
=0.037
]
, while significantly reducing the ulcer recurrence rate in patients with a history of PU [RR=0.49, 95%CI (0.32, 0.73),
Z
=3.49,
P
=0.001
]
; the delayed bleeding rate in the VPZ group was significantly lower than that in the lansoprazole subgroup [RR=0.47, 95%CI (0.25, 0.90),
Z
=2.28,
P
=0.02
]
. In the
treatment of PU, the incidence of adverse events with VPZ was significantly higher than that with PPI in the duodenal ulcer subgroup [RR=1.13, 95%CI (1.02, 1.26),
Z
=2.38,
P
=0.017
]
.
CONCLUSIONS
2
For post-ESD ulcers, VPZ demonstrates superior therapeutic efficacy compared to PPI and can reduce ulcer recurrence rates in patients with a history of PU. However, it does not offer advantages in terms of safety for duodenal ulcer treatment.
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