一项比较积极补液与大剂量直肠用吲哚美辛预防内镜逆行胰胆管造影术后胰腺炎（AHRI-PEP）有效性的开放标签随机对照试验。
An Open-Label Randomized Controlled Trial Comparing Effectiveness of Aggressive Hydration Versus High-dose Rectal Indomethacin in the Prevention of Postendoscopic Retrograde Cholangiopancreatographic Pancreatitis (AHRI-PEP).
作者信息
Guha Pradipta, Patra Partha S, Misra Debashis, Ahammed Sk Mahiuddin, Sarkar Rajib, Dhali Gopal K, Ray Sukanta, Das Kshaunish
机构信息
Divisions of Gastroenterology.
Gastrointestinal Surgery, School of Digestive and Liver Disease, IPGME&R, Kolkata, West Bengal, India.
出版信息
J Clin Gastroenterol. 2023;57(5):524-530. doi: 10.1097/MCG.0000000000001712. Epub 2022 Apr 21.
BACKGROUND
Although rectal administration of nonsteroidal anti-inflammatory drugs is recommended as the standard pharmacologic modality to prevent postendoscopic retrograde cholangiopancreatography (ERCP) post-ERCP pancreatitis (PEP), vigorous periprocedural hydration (vHR) with lactated Ringer's solution (LR) is emerging as an effective prophylaxis modality for PEP. There has been no head-to-head comparison between these 2.
STUDY
This was a single-center, randomized, open-label, noninferiority, parallel-assigned, equal allocation, controlled clinical trial in a tertiary care hospital. Consecutive adults referred for ERCP, satisfying predefined inclusion criteria, underwent simple randomization and blinded allocation into 2 groups. Those allocated to vHR received intravenous LR at 3 mL/kg/h during procedure, 20 ml/kg bolus immediately afterward, and then at 3 mL/kg/h for another 8 hours. Those randomized to rectal Indomethacin received only per-rectal 100 mg suppository immediately post-ERCP. Assuming PEP of 9% in Indomethacin arm and noninferiority margin of 4%, we calculated sample size of 171 patients in each arm for 80% power and α-error 5%. Primary outcome was incidence of PEP, within 1 week, as defined by Cotton's criteria. All analysis were done by intention-to-treat.
RESULTS
Between October, 2017 to February, 2018, 521 patients were assessed. In all, 352 were enrolled, 178 randomized to vHR, and 174 to per-rectal Indomethacin. Baseline details and ERCP outcomes were not different between 2 groups. PEP occurred in 6 (1.7%) overall, with 1 (0.6%) in hydration arm, and 5 (2.9%) in indomethacin arm; an absolute risk reduction of 2.3% (95% confidence interval: 0.9%-3.5%) and odds ratio of 0.19 (95% confidence interval: 0.02-1.65). Three patients developed severe PEP, all receiving indomethacin.
CONCLUSIONS
vHR with LR is noninferior to postprocedure per-rectal Indomethacin for PEP prevention (ClinicalTrials.govID:NCT03629600).
背景
尽管推荐直肠给药非甾体抗炎药作为预防内镜逆行胰胆管造影术（ERCP）后胰腺炎（PEP）的标准药物治疗方式，但采用乳酸林格氏液（LR）进行术中积极补液（vHR）正成为一种有效的PEP预防方式。这两种方法尚未进行过直接比较。
研究
这是一项在三级医院进行的单中心、随机、开放标签、非劣效性、平行分配、等量分配的对照临床试验。连续纳入符合预定义纳入标准的成年ERCP患者，进行简单随机分组并盲法分配至两组。分配至vHR组的患者在手术期间以3 mL/kg/h的速度静脉输注LR，术后立即给予20 ml/kg的静脉推注，然后再以3 mL/kg/h的速度输注8小时。随机分配至直肠给予吲哚美辛组的患者仅在ERCP术后立即直肠给予100 mg栓剂。假设吲哚美辛组的PEP发生率为9%，非劣效界值为4%，我们计算出每组样本量为171例患者，检验效能为80%，α错误为5%。主要结局是根据Cotton标准定义的1周内PEP的发生率。所有分析均采用意向性分析。
结果
在2017年10月至2018年2月期间，共评估了521例患者。总共352例患者入组，178例随机分配至vHR组，174例随机分配至直肠给予吲哚美辛组。两组之间的基线细节和ERCP结果无差异。总体上有6例（1.7%）发生PEP，补液组1例（0.6%），吲哚美辛组5例（2.9%）；绝对风险降低2.3%（95%置信区间：0.9%-3.5%），比值比为0.19（95%置信区间：0.02-1.65）。3例患者发生严重PEP，均接受了吲哚美辛治疗。
结论
对于预防PEP，采用LR进行vHR不劣于术后直肠给予吲哚美辛（ClinicalTrials.gov标识符：NCT03629600）。
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