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雷尼替丁引起的不良肿瘤事件:基于FAERS数据库的分析。

Adverse tumor events induced by ranitidine: an analysis based on the FAERS database.

作者信息

Liu ManTing, Luo DongQiang, Jiang JiaZhen, Shao Ying, Dai DanDan, Hou YiNing, Dou XiangYun, Gao XiaoLu, Zheng BoHui, Liu Tian

机构信息

Guangzhou University of Chinese Medicine, Clifford Hospital, Guangzhou, China.

The first Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.

出版信息

Expert Opin Drug Saf. 2025 Jan;24(1):35-47. doi: 10.1080/14740338.2024.2354325. Epub 2024 May 21.

Abstract

BACKGROUND

Ranitidine induced tumor adverse events remains a contradictory clinical question, due to the limited evidence of tumor risk associated with ranitidine in the real world. The purpose of this study was to evaluate the association of ranitidine with all types of tumors through the FAERS database and to provide a reference for clinical use.

RESEARCH DESIGN AND METHODS

Cancer cases associated with ranitidine in the FAERS database from the first quarter of 2004 to the fourth quarter of 2023 were extracted to analyze demographic characteristics, and a disproportion analysis was performed.

RESULT

A total of 662,998 ranitidine-related cancer cases were screened, and the 50-59 and 60-69 groups accounted for the largest proportion. In PT signal detection, ranitidine was associated with 98 PT, including penal cancer stage II, gastric cancer stage II, et al. In terms of outcome events, adverse events were higher in men (20.65%) than in women (18.47%).

CONCLUSIONS

Ranitidine may induce various tumor-related adverse reactions, especially in long-term users and elderly patients. For these patients, tumor screening should be strengthened, and long-term use of ranitidine should be avoided. Since this study cannot prove causality, further evidence is needed for prospective studies with a larger sample size.

摘要

背景

由于在现实世界中与雷尼替丁相关的肿瘤风险证据有限,雷尼替丁诱发肿瘤不良事件仍然是一个存在争议的临床问题。本研究的目的是通过美国食品药品监督管理局不良事件报告系统(FAERS)数据库评估雷尼替丁与所有类型肿瘤的关联,并为临床应用提供参考。

研究设计与方法

提取2004年第一季度至2023年第四季度FAERS数据库中与雷尼替丁相关的癌症病例,分析人口统计学特征,并进行不成比例分析。

结果

共筛选出662998例与雷尼替丁相关的癌症病例,其中50 - 59岁和60 - 69岁组占比最大。在标准比值比(PT)信号检测中,雷尼替丁与98种PT相关,包括阴茎癌II期、胃癌II期等。在结局事件方面,男性不良事件发生率(20.65%)高于女性(18.47%)。

结论

雷尼替丁可能诱发各种与肿瘤相关的不良反应,尤其是在长期使用者和老年患者中。对于这些患者,应加强肿瘤筛查,并避免长期使用雷尼替丁。由于本研究无法证明因果关系,则需要进一步的证据进行更大样本量的前瞻性研究。

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