中国实用外科杂志

中国实用外科杂志 ›› 2023, Vol. 43 ›› Issue (08): 900-905.DOI: 10.19538/j.cjps.issn1005-2208.2023.08.14

• 论著 • 上一篇    下一篇

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

阿依木克地斯·亚力孔1，齐志鹏1，陈章涵1，贺东黎2，荆佳晨2，周平红1，钟芸诗1   

  1. 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
  • 出版日期:2023-08-01 发布日期:2023-08-24

  • Online:2023-08-01 Published:2023-08-24

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。

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

Abstract: Safety and efficacy of prophylactic use of low-dose indomethacin in reducing post-ERCP pancreatitis in high-risk population        Ayimukedisi·Yalikong, QI Zhi-peng, CHEN Zhang-han,et al. *Endoscopy Center, Zhongshan Hospital of Fudan University, Shanghai200032, China
Corresponding author: ZHONG Yun-shi, E-mail: zhong.yunshi@zs-hospital.sh.cn
Abstract    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 (χ2= 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 (χ2= 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.

Key words: endoscopic retrograde cholangiopancreatography, pancreatitis, indomethacin, high-risk patients, low-dose