25毫克与50毫克剂量直肠用双氯芬酸预防日本患者内镜逆行胰胆管造影术后胰腺炎的回顾性研究
25 mg versus 50 mg dose of rectal diclofenac for prevention of post-ERCP pancreatitis in Japanese patients: a retrospective study.
作者信息
Yoshihara Takeo, Horimoto Masayoshi, Kitamura Tetsuhisa, Osugi Naoto, Ikezoe Tatsuro, Kotani Kaori, Sanada Toru, Higashi Churi, Yamaguchi Daisuke, Ota Makiyo, Mizuno Tatsunori, Gotoh Yasukazu, Okuda Yorihide, Suzuki Kunio
机构信息
Department of Gastroenterology, Osaka Saiseikai Senri Hospital, Suita, Osaka, Japan.
Division of Environmental Medicine and Population Sciences, Department of Social and Environmental Medicine, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.
出版信息
BMJ Open. 2015 Mar 20;5(3):e006950. doi: 10.1136/bmjopen-2014-006950.
OBJECTIVES
The aim of the present study was to assess the appropriate administration dose of non-steroidal anti-inflammation drugs to prevent pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). Importantly, the 100 mg dose of diclofenac recommended in Western countries has not been permitted in Japan.
DESIGN
A retrospective study.
SETTINGS
A single centre in Japan.
PARTICIPANTS
This study enrolled patients who underwent ERCP at the Department of Gastroenterology, Osaka Saiseikai Senri Hospital, from April 2011 through June 2013, and who received either a 25 or a 50 mg dose of rectal diclofenac after ERCP.
PRIMARY OUTCOME MEASURE
The occurrence of post-ERCP pancreatitis (PEP). A multivariate regression model was used to assess the effect of the 50 mg dose (the 50 mg group) of rectal diclofenac and to compare it to the occurrence of PEP referring to the 25 mg group.
RESULTS
A total of 155 eligible patients received either 25 mg (84 patients) or 50 mg (71 patients) doses of rectal diclofenac after ERCP to prevent PEP. The proportion of PEP was significantly lower in the 50 mg group than in the 25 mg group (15.5% (11/71) vs 33.3% (28/84), p=0.018). In a multivariate analysis, the occurrence of PEP was significantly lower in the 50 mg group than in the 25 mg group even after adjusting potential confounding factors (adjusted OR=0.27, 95% CI 0.11 to 0.70).
CONCLUSIONS
From this observation, the occurrence of PEP was significantly lower among ERCP patients with the 50 mg dose of rectal diclofenac than among those with the 25 mg dose.
目的
本研究旨在评估非甾体类抗炎药预防内镜逆行胰胆管造影术（ERCP）后胰腺炎的合适给药剂量。重要的是，西方国家推荐的100毫克双氯芬酸剂量在日本未被批准使用。
设计
一项回顾性研究。
地点
日本的一个单中心。
参与者
本研究纳入了2011年4月至2013年6月在大阪济生会千里医院胃肠病科接受ERCP治疗，且在ERCP后接受25毫克或50毫克直肠双氯芬酸剂量的患者。
主要观察指标
ERCP后胰腺炎（PEP）的发生情况。采用多因素回归模型评估50毫克剂量（50毫克组）直肠双氯芬酸的效果，并与25毫克组的PEP发生率进行比较。
结果
共有155例符合条件的患者在ERCP后接受了25毫克（84例患者）或50毫克（71例患者）剂量的直肠双氯芬酸以预防PEP。50毫克组的PEP发生率显著低于25毫克组（15.5%（11/71）对33.3%（28/84），p = 0.018）。在多因素分析中，即使在调整潜在混杂因素后，50毫克组的PEP发生率仍显著低于25毫克组（调整后的OR = 0.27，95% CI 0.11至0.70）。
结论
根据本观察结果，接受50毫克直肠双氯芬酸剂量的ERCP患者中PEP的发生率显著低于接受25毫克剂量的患者。
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