さて今週のNEJMであるが、ERCP直後にインドメタシン座薬を入れておくと膵炎予防になるという論文である。肝心の膵炎の定義だが、
- 上腹部痛
- 24時間後の酵素が3倍以上上昇
- 最低2日は入院してしまう
なので、まあ納得できるかな。
症例数は602人であり前向きのダブルブラインド試験なんですって。これってコントロール群ではプラセボの座薬を入れられるということですね。で、結果は
- 27 of 295 patients (9.2%) インドメタシン座薬群
- 52 of 307 patients (16.9%) コントロール群 (P=0.005)
- 13 patients (4.4%) インドメタシン座薬群
- 27 patients (8.8%) コントロール群 (P=0.03)
むしろこっちの結果が大事かな。こちらも半分に減っている。もともとゼロにはできない話である。座薬一個で発症が減るならよろしいかもね。
Original ArticleA Randomized Trial of Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
B. Joseph Elmunzer, M.D., James M. Scheiman, M.D., Glen A. Lehman, M.D., Amitabh Chak, M.D., Patrick Mosler, M.D., Ph.D., Peter D.R. Higgins, M.D., Ph.D., Rodney A. Hayward, M.D., Joseph Romagnuolo, M.D., Grace H. Elta, M.D., Stuart Sherman, M.D., Akbar K. Waljee, M.D., Aparna Repaka, M.D., Matthew R. Atkinson, M.D., Gregory A. Cote, M.D., Richard S. Kwon, M.D., Lee McHenry, M.D., Cyrus R. Piraka, M.D., Erik J. Wamsteker, M.D., James L. Watkins, M.D., Sheryl J. Korsnes, M.A., Suzette E. Schmidt, B.S.N., C.C.R.P., Sarah M. Turner, B.S., Sylvia Nicholson, C.C.R.C., and Evan L. Fogel, M.D. for the U.S. Cooperative for Outcomes Research in Endoscopy (USCORE)
N Engl J Med 2012; 366:1414-1422April 12, 2012
Background
Preliminary research suggests that rectally administered nonsteroidal antiinflammatory drugs may reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP).
Methods
In this multicenter, randomized, placebo-controlled, double-blind clinical trial, we assigned patients at elevated risk for post-ERCP pancreatitis to receive a single dose of rectal indomethacin or placebo immediately after ERCP. Patients were determined to be at high risk on the basis of validated patient- and procedure-related risk factors. The primary outcome was post-ERCP pancreatitis, which was defined as new upper abdominal pain, an elevation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least 2 nights.
Results
A total of 602 patients were enrolled and completed follow-up. The majority of patients (82%) had a clinical suspicion of sphincter of Oddi dysfunction. Post-ERCP pancreatitis developed in 27 of 295 patients (9.2%) in the indomethacin group and in 52 of 307 patients (16.9%) in the placebo group (P=0.005). Moderate-to-severe pancreatitis developed in 13 patients (4.4%) in the indomethacin group and in 27 patients (8.8%) in the placebo group (P=0.03).
Conclusions
Among patients at high risk for post-ERCP pancreatitis, rectal indomethacin significantly reduced the incidence of the condition. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00820612.)
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