预防性使用低剂量吲哚美辛对减少老年人内镜逆行胰胆管造影术后胰腺炎的有效性分析

Effectiveness of low‑dose of prophylactic indomethacin in reducing post‑endoscopic retrograde cholangiopancreatography pancreatitis in the elderly

摘要:

目的 评价预防性使用低剂量吲哚美辛对降低老年人内镜逆行胰胆管造影术（endoscopic retrograde cholangiopancreatography，ERCP）后胰腺炎（post⁃ERCP pancreatitis， PEP）发生率的有效性。方法 前瞻性纳入自2021年7月至2022年10月在复旦大学附属中山医院和上海市徐汇区中心医院需进行ERCP的患者，并通过DAS电子化中央随机系统将患者随机分为预防性使用吲哚美辛低剂量（50 mg）组及常规剂量（100 mg）组，收集其中年龄≥60岁的老年患者资料，比较两组患者PEP发生率及其他不良反应发生率等指标。结果 共418例老年患者最终纳入研究，复旦大学附属中山医院122例，徐汇区中心医院296例。418例患者中低剂量组201例，常规剂量组217例。低剂量组和常规剂量组PEP发生率差异无统计学意义［5.97%（12/201）比7.37%（16/217），χ²=0.33，P=0.566］，两组间药物相关不良反应发生率差异无统计学意义［4.98%（10/201）比4.15%（9/217），χ²=0.16，P=0.685］。进一步亚组分析发现，年龄60~<70岁的老年患者中共出现13例PEP，低剂量组和常规剂量组PEP发生率差异无统计学意义［6.19%（6/97）比6.60%（7/106），χ²=0.01，P=0.903］，两组间药物相关不良反应发生率差异无统计学意义［6.19%（6/97）比2.83%（3/106），P=0.315］。年龄≥70岁的老年患者中共有15例PEP，低剂量组和常规剂量组PEP发生率差异无统计学意义［5.77%（6/104）比8.11%（9/111），χ²=0.45，P=0.501］，两组间药物相关不良反应发生率差异无统计学意义［3.85%（4/104）比5.41%（6/111），P=0.749］。结论 预防性使用50 mg吲哚美辛降低老年人PEP发生率的效果与100 mg吲哚美辛相当。老年人可预防性使用50 mg吲哚美辛以减少PEP的发生率。

Abstract:

Objective To evaluate the effectiveness of low-dose of prophylactic indomethacin in reducing the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in elderly patients. Methods From July 2021 to October 2022, patients undergoing ERCP in Zhongshan Hospital, Fudan University and Shanghai Xuhui District Central Hospital were enrolled prospectively and assigned to either the low-dose (50 mg) indomethacin group or the conventional-dose (100 mg) group using the DAS electronic central randomization system. Data from elderly patients aged≥60 were collected and compared for the incidence of PEP and other adverse reactions. Results A total of 418 elderly patients (Zhongshan Hospital, Fudan University, n=122; Shanghai Xuhui Distric Central Hospital, n=296) were ultimately included in the study, with 201 in the low-dose group and 217 in the conventional-dose group. There was no significant difference in the incidence of PEP between the low-dose group and the conventional-dose group [5.97% (12/201) VS 7.37% (16/217), χ²=0.33, P=0.566]. There was also no significant difference in drug-related adverse events between the two groups [4.98% (10/201) VS 4.15% (9/217), χ²=0.16, P=0.685]. Further subgroup analysis revealed that among elderly patients aged 60-<70, there were 13 patients diagnosed as having PEP. The incidence of PEP between the low-dose group and the conventional-dose group was not statistically significant [6.19% (6/97) VS 6.60% (7/106), χ²=0.01, P=0.903], and the occurrence of drug-related adverse events between the two groups was not statistically significant [6.19% (6/97) VS 2.83% (3/106), P=0.315]. Among elderly patients aged≥70, there were 15 patients diagnosed as having PEP. The incidence of PEP between the low-dose group and the conventional-dose group was not statistically significant [5.77% (6/104) VS 8.11% (9/111), χ²=0.45, P=0.501], and the occurrence of drug-related adverse events between the two groups was not statistically significant [3.85% (4/104) VS 5.41% (6/111), P=0.749]. Conclusion The prophylactic use of 50 mg indomethacin showed similar efficacy in reducing the incidence of PEP in elderly patients compared with 100 mg indomethacin. Therefore, elderly patients can use 50 mg indomethacin prophylactically to reduce the incidence of PEP.