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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
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| 篇名： | 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 |
| TITLE： | Clinical evaluation of centrally procured generic and original esomeprazole for the treatment of acute non-variceal upper gastrointestinal bleeding |
| 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、30d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（P＞0.05）。两组患者的不良反应发生率比较，差异无统计学意义（P＞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（P＜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（P＞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 （P＞0.05）. The incidence of adverse events among all patients in both groups also showed no statistically significant difference （P＞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 （P＜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 （P＞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. |
| 期刊： | 2025年第36卷第13期 |
| 作者： | 苏斯；韩少伟；庄海才；徐娜；李颖；王晓；李宽 |
| AUTHORS： | SU Si，HAN Shaowei，ZHUANG Haicai，XU Na，LI Ying，WANG Xiao，LI Kuan |
| 关键字： | 艾司奥美拉唑；集采仿制药；原研药；急性非静脉曲张性上消化道出血；质子泵抑制剂；真实世界研究；临床疗效；安全性； |
| KEYWORDS： | esomeprazole； centrally procured generic drug； original drug； acute non-variceal upper gastrointestinal bleeding； |
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