预防性使用低剂量吲哚美辛降低高危人群中ERCP术后胰腺炎的安全性和有效性分析  

Safety and efficacy of prophylactic use of low-dose indomethacin in reducing post-ERCP pancreatitis in high-risk population

作　　者：阿依木克地斯·亚力孔 齐志鹏 陈章涵 贺东黎 荆佳晨 周平红 钟芸诗 Ayimukedisi·Yalikong;QI Zhi-peng;CHEN Zhang-han(Endoscopy Center,Zhongshan Hospital of Fudan University,Shanghai200032,China)

机构地区：[1]复旦大学附属中山医院内镜中心,上海200032 [2]复旦大学附属中山医院徐汇区中心医院,上海200030

出　　处：《中国实用外科杂志》2023年第8期900-905,共6页Chinese Journal of Practical Surgery

基　　金：国家自然科学基金项目(No.82002515,No.82273025,No.82203460);中国博士后基金项目(No.2020M681177,No.2022TQ0070,No.2022M710759);上海扬帆项目(No.20YF1407200);上海市科学技术委员会科研计划项目(No.22JC1403003,No.22XD1402200,No.19140901902,No.22S31903800)。

摘　　要：目的 评估低剂量(50 mg)吲哚美辛术前直肠给药相较于常规剂量(100 mg)对预防高危病人内镜逆行胰胆管造影(ERCP)术后胰腺炎(PEP)的安全性和有效性。方法 前瞻性选择2021年7月至2022年10月接受ERCP治疗的病人并随机分为吲哚美辛低剂量组(50 mg)和常规剂量组(100 mg),于术前30 min直肠给予吲哚美辛栓剂,经过风险评估筛选的PEP高危病人465例(复旦大学附属中山医院91例,复旦大学附属中山医院徐汇区中心医院374例)进行分析。其中低剂量组230例(术前吲哚美辛给药剂量为50 mg),常规剂量组235例(术前吲哚美辛给药剂量为100 mg)。以PEP发生率作为主要分析结果指标,其他不良事件发生率作为次要分析结果指标。结果 低剂量组和常规剂量组PEP发生率分别为4.8%(11/230)和6.0%(14/235),两组差异无统计学意义(χ2=0.3154,P=0.574),无重度胰腺炎发生;低剂量组高淀粉酶血症发生率为9.1%(21/230),常规剂量组为9.8%(23/235),两组差异无统计学意义(χ2=0.0585,P=0.809);低剂量组1例(0.4%)病人出现出血合并穿孔;低剂量组肾功能不全发生率为1.3%(3/230),常规剂量组为0.9%(2/235),两组差异无统计学意义(P=0.683)。结论 与术前常规剂量(100 mg)吲哚美辛直肠给药相比,低剂量(50 mg)吲哚美辛预防高危病人PEP的作用与其一致,安全有效,值得进一步扩大样本量深入研究。Objective To evaluate the safety and efficacy of preoperative rectal administration of low-dose(50mg)indomethacin compared to standard dose(100mg)for preventing post-endoscopic retrograde cholangiopancreatography(ERCP)pancreatitis(PEP)in high-risk patients.Methods Patients who received endoscopic retrograde cholangiopancreatography(ERCP)treatment between July,2021,and October,2022 were prospectively collected and randomized into a low-dose group(50 mg),or a regular-dose group(100 mg)after obtaining informed consent.The 50 mg or 100 mg indomethacin was administered rectally 30 minutes before surgery.A total of 465 high-risk patients(91 patients from Zhongshan Hospital affiliated to Fudan University,and 374 patients from Fudan University and Zhongshan-Xuhui Hospital)were selected after undergoing risk assessment.Of these,230 were assigned to the low-dose group(with a preoperative indomethacin dose of 50mg)and 235 were assigned to the regular-dose group(with a preoperative indomethacin dose of 100mg).The incidence of PEP and other adverse events was recorded to evaluate the safety and efficacy of indomethacin.Results The incidence of PEP in the low-dose group and the regular-dose group was 4.8%(11/230)and 6.0%(14/235),respectively,with no statistically significant difference between the two groups(χ^(2)=0.3154,P=0.574),and no severe pancreatitis occurred.The incidence of hyperamylasemia was 9.1%(21/230) in the low-dose group and 9.8%(23/235)in the regular-dose group,with no statistically significant difference between the two groups(χ^(2)=0.0585,P=0.809).One patient in the low-dose group experienced bleeding and perforation(0.4%).The incidence of renal dysfunction was 1.3%(3/230)in the low-dose group and 0.9%(2/235)in the regular-dose group,with no statistically significant difference between the two groups(P=0.683).Conclusion Low-dose(50 mg)indomethacin is as safe and effective as 100 mg indomethacin in preventing PEP in high-risk patients,which is worth further studying.

关 键 词：内镜逆行胰胆管造影 胰腺炎 吲哚美辛 高危病人 低剂量 

分 类 号：R6[医药卫生—外科学]