Clinical evaluation of centrally procured generic and original esomeprazole for the treatment of acute non-variceal upper gastrointestinal bleeding

SU Si; HAN Shaowei; ZHUANG Haicai; XU Na; LI Ying; WANG Xiao; LI Kuan

doi:10.6039/j.issn.1001-0408.2025.13.14

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Clinical evaluation of centrally procured generic and original esomeprazole for the treatment of acute non-variceal upper gastrointestinal bleeding

更新时间：2025-09-24

- Clinical evaluation of centrally procured generic and original esomeprazole for the treatment of acute non-variceal upper gastrointestinal bleeding
- ZHONGGUO YAOFANG Vol. 36, Issue 13, Pages: 1635-1640(2025)
- 作者机构：
  
  1.深圳市人民医院（暨南大学第二临床医学院，南方科技大学第一附属医院）药学部，广东深圳;518020
  2.广东医科大学药学院，广东东莞　523808
  3.香港大学深圳医院药学部，广东深圳　518053
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2025.13.14
  CLC： R975+.2;R969.3
- Received：07 February 2025，
  
  Revised：2025-05-21，
  
  Accepted：28 May 2025，
  
  Published：15 July 2025
- 稿件说明：
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苏斯,韩少伟,庄海才,等.艾司奥美拉唑集采仿制药与原研药用于急性非静脉曲张性上消化道出血的临床评价[J].中国药房,2025,36(13):1635-1640.

SU Si,HAN Shaowei,ZHUANG Haicai,et al.Clinical evaluation of centrally procured generic and original esomeprazole for the treatment of acute non-variceal upper gastrointestinal bleeding[J].ZHONGGUO YAOFANG,2025,36(13):1635-1640.
苏斯,韩少伟,庄海才,等.艾司奥美拉唑集采仿制药与原研药用于急性非静脉曲张性上消化道出血的临床评价[J].中国药房,2025,36(13):1635-1640. DOI： 10.6039/j.issn.1001-0408.2025.13.14.

SU Si,HAN Shaowei,ZHUANG Haicai,et al.Clinical evaluation of centrally procured generic and original esomeprazole for the treatment of acute non-variceal upper gastrointestinal bleeding[J].ZHONGGUO YAOFANG,2025,36(13):1635-1640. DOI： 10.6039/j.issn.1001-0408.2025.13.14.

摘要

目的

评估艾司奥美拉唑集采仿制药与原研药用于急性非静脉曲张性上消化道出血（ANVUGIB）的有效性、安全性及经济性。

方法

回顾性收集2018年1月－2024年3月在深圳市人民医院和香港大学深圳医院就诊的ANVUGIB患者的真实世界临床数据。根据用药类型的不同将患者分为进口原研药组（原研组，221例）和集采仿制药组（仿制组，75例），按3∶1的比例进行倾向性评分匹配（PSM），比较两组的临床疗效、安全性及经济性。

结果

PSM后，共纳入患者241例，其中原研组170例、仿制组71例；两组患者的进一步出血率、二次内镜治疗率、输血率、住院时间、因消化道出血死亡率、30 d内因出血再次就诊率及累计生存率比较，差异均无统计学意义（

＞0.05）。两组患者的不良反应发生率比较，差异无统计学意义（

＞0.05）；且两组患者所在医院上报至国家药品不良反应监测系统的艾司奥美拉唑不良反应发生情况相当。PSM后，仿制组患者的中位总药费、大剂量艾司奥美拉唑费用均显著低于原研组，中位护理费、床位费均显著高于原研组（

＜0.05），而两组患者的中位总住院费、总治疗费、检验费、检查费、材料费及诊金比较差异均无统计学意义（

＞0.05）。

结论

集采仿制艾司奥美拉唑用于ANVUGIB的临床疗效和安全性与原研药相当，且经济性更优。

Abstract

OBJECTIVE

To evaluate the efficacy， safety and economics of the centrally procured generic versus original esomeprazole in the treatment of acute non-variceal upper gastrointestinal bleeding （ANVUGIB）.

METHODS

A retrospective collection of real-world clinical data was conducted for ANVUGIB patients who received treatment at Shenzhen People’s Hospital and University of Hong Kong-Shenzhen Hospital from January 2018 to March 2024. Patients were divided into imported original drug group （original drug group， 221 cases） and centrally procured generic drug group （generic drug group， 75 cases） according to the types of drug used. Propensity score matching （PSM） was performed at a ratio of 3∶1 to compare the clinical efficacy， safety and economics between the two groups.

RESULTS

Totally 241 patients were included after PSM， with 170 in the original drug group and 71 in the generic drug group. There were no significant differences between the two groups in terms of rebleeding rate， rate of second endoscopic intervention， blood transfusion rate， length of hospital stay， mortality due to gastrointestinal bleeding， 30-day readmission due to rebleeding， and overall survival rate （

＞0.05）. The incidence of adverse events among all patients in both groups also showed no statistically significant difference （

＞0.05）； furthermore， the adverse events reported by the respective hospitals to the National Center for ADR Monitoring were comparable between the two groups. After PSM， the median total drug cost and high-dose esomeprazole cost in the generic drug group were significantly lower than those in the original drug group， while the median nursing fee and bed fee were significantly higher than those in the original drug group （

＜0.05）. There was no statistically significant difference between the two groups in terms of median total hospitalization expenses， total treatment costs， laboratory fees， examination fees， material costs， or consultation fees （

＞0.05）.

CONCLUSIONS

The clinical efficacy and safety of centrally procured generic esomeprazole in the treatment of ANVUGIB are comparable to those of the original drug， and it is more economical.

关键词

Keywords

references

《中华消化外科杂志》编辑委员会，《中华消化杂志》编辑委员会 . 急性非静脉曲张性上消化道出血多学科防治专家共识： 2019版 [J ] . 中华消化外科杂志， 2019 ， 18 （ 12 ）： 1094 - 1100 .

KATE V ， SURESHKUMAR S ， GURUSHANKARI B ， et al . Acute upper non-variceal and lower gastrointestinal bleeding [J ] . J Gastrointest Surg ， 2022 ， 26 （ 4 ）： 932 - 949 .

《中华内科杂志》编辑委员会，《中华医学杂志》编辑委员会，《中华消化杂志》编辑委员会，等 . 急性非静脉曲张性上消化道出血诊治指南：2018年，杭州 [J ] . 中华内科杂志， 2019 ， 58 （ 3 ）： 173 - 180 .

GRALNEK I M ， STANLEY A J ， MORRIS A J ， et al . Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage （NVUGIH）：European So- ciety of Gastrointestinal Endoscopy （ESGE） guideline：update 2021 [J ] . Endoscopy ， 2021 ， 53 （ 3 ）： 300 - 332 .

LAINE L ， BARKUN A N ， SALTZMAN J R ， et al . ACG clinical guideline：upper gastrointestinal and ulcer bleeding [J ] . Am J Gastroenterol ， 2021 ， 116 （ 5 ）： 899 - 917 .

张兰，董宪喆，王之舟 . 真实世界研究在国产仿制药临床疗效与安全性评价中的应用及展望 [J ] . 药物不良反应杂志， 2023 ， 25 （ 3 ）： 129 - 132 .

XU Y Y ， TIAN X ， WANG W ， et al . Pharmacokinetics of esomeprazole in critically ill patients [J ] . Front Med （Lausanne）， 2022 ， 8 ： 621406 .

查娴，孙鲁宁，陈潮，等 . 艾司奥美拉唑在重症患者体内药代/药效学研究 [J ] . 中国临床药理学与治疗学， 2024 ， 29 （ 10 ）： 1152 - 1160 .

薛雪，金信妍，鲁春丽，等 . 真实世界研究设计在上市后药品安全性评价的应用 [J ] . 中国药物警戒， 2021 ， 18 （ 11 ）： 1025 - 1028 .

GUO C L T ， WONG S H ， LAU L H S ， et al . Timing of endoscopy for acute upper gastrointestinal bleeding：a territory-wide cohort study [J ] . Gut ， 2022 ， 71 （ 8 ）： 1544 - 1550 .

ARDEVOL A ， IBAÑEZ-SANZ G ， PROFITOS J ， et al . Survival of patients with cirrhosis and acute peptic ulcer bleeding compared with variceal bleeding using current first-line therapies [J ] . Hepatology ， 2018 ， 67 （ 4 ）： 1458 - 1471 .

董艳珍 . 基于多中心真实世界数据的集采与非集采注射用头孢曲松钠临床综合评价 [D ] . 大理：大理大学， 2023 .

岳小林，付娜，赵艳玲，等 . 国家集中带量采购中选药品疗效与安全性的真实世界研究 [J ] . 临床药物治疗杂志， 2022 ， 20 （ 6 ）： 43 - 48 .

国家组织药品集中采购中选仿制药疗效与安全性真实世界研究课题组 . 国家集采仿制药疗效与安全性评价真实世界研究报告：以第二、三批集采为例 [J ] . 中国医疗保险， 2023 （ 10 ）： 5 - 11 .

SALVO E M ， FERKO N C ， CASH S B ， et al . Umbrella review of 42 systematic reviews with meta-analyses：the safety of proton pump inhibitors [J ] . Aliment Pharmacol Ther ， 2021 ， 54 （ 2 ）： 129 - 143 .

LEE P A ， FIKE D ， YANG H ， et al . Do the types and routes of proton pump inhibitor treatments affect Clostridium difficile in ICU patients？ A retrospective cohort study [J ] . Expert Rev Clin Pharmacol ， 2021 ， 14 （ 3 ）： 399 - 404 .

CAROLLO M ， CRISAFULLI S ， SELLERI M ， et al . Agreement of different drug-drug interaction checkers for proton pump inhibitors [J ] . JAMA Netw Open ， 2024 ， 7 （ 7 ）： e2419851 .

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