本帖最後由 lsc0019 於 2009-7-21 23:21 編輯 |
作者：Laurie Barclay, MD
July 8, 2009 — 根據發表於7月1日Lancet期刊的一篇隨機控制、單盲試驗結果，K他命對於重症病患插管時，是傳統etomidate安全、有用的替代鎮靜方法。
在法國的12處急診醫療服務或急診室與65處加護病房中，655名需要鎮靜以進行緊急插管的病患被前溯納入試驗，並以電腦亂數方式隨機指派接受0.3 mg/kg的etomidate (328人)或2 mg/kg的K他命(327人)來進行插管。只有將病患納入試驗的急診醫師知道分組狀況。
分析包括etomidate組234名病患以及K他命組235人的資料。兩組有統計上相似的平均最高後續器官衰竭評分(etomidate組10.3 ± 3.7分、K他命組9.6 ± 3.9分；平均差異為0.7；95% 信心區間[CI]為0.0 - 1.4; P = .056)。兩組的平均插管困難度評分為1分(四分位比為0 - 3；P = .70)，表示插管狀況相似。
相較於K他命組，etomidate組有顯著較高比率的腎上腺機能不足病患(勝算比為6.7；95% CI，3.5 - 12.7)。兩種藥物都沒有出現嚴重的不良反應。
在編輯評論中，奧地利Innsbruck醫學大學的Volker Wenzel醫師與Karl H. Lindner醫師指出，重症病患成功的緊急插管有賴藥物知識與操作技巧和臨床經驗。不幸的是，歐盟緊縮的規定限制了多重創傷等無商業利益的試驗。
Ketamine May Be Useful for Intubation in Critically Ill Patients
By Laurie Barclay, MD
Medscape Medical News
July 8, 2009 — Ketamine is a safe, valuable alternative to conventional etomidate for use as a sedative during intubation in critically ill patients, according to the results of a randomized controlled, single-blind trial reported online in the July 1 issue of The Lancet.
"Critically ill patients often require emergency intubation," write Patricia Jabre, MD, and colleagues from the KETASED Collaborative Study Group. "The use of etomidate as the sedative agent in this context has been challenged because it might cause a reversible adrenal insufficiency, potentially associated with increased in-hospital morbidity. We compared early and 28-day morbidity after a single dose of etomidate or ketamine used for emergency endotracheal intubation of critically ill patients."
At 12 emergency medical services or emergency departments and 65 intensive care units in France, 655 patients requiring sedation for emergency intubation were prospectively enrolled and randomly assigned by a computerized random-number generator list to receive 0.3 mg/kg of etomidate (n = 328) or 2 mg/kg of ketamine (n = 327) for intubation. Group assignment was known to only the emergency medicine physician enrolling patients.
The main outcome measure was the maximal score of the sequential organ failure assessment during the first 3 days in the intensive care unit. Analysis was by modified intent-to-treat, with exclusion from analysis of patients who died before reaching the hospital and those discharged from the intensive care unit earlier than 3 days.
Data were analyzed for 234 patients in the etomidate group and 235 in the ketamine group. Both groups had statistically similar mean maximal sequential organ failure assessment scores (10.3 ± 3.7 for etomidate vs 9.6 ± 3.9 for ketamine; mean difference, 0.7; 95% confidence interval [CI], 0.0 - 1.4; P = .056). Both groups had a median intubation difficulty score of 1 (interquartile ratio, 0 - 3; P = .70) suggesting similar intubation conditions.
Compared with the ketamine group, the etomidate group had a significantly higher percentage of patients with adrenal insufficiency (odds ratio, 6.7; 95% CI, 3.5 - 12.7). No serious adverse events occurred with either study drug.
"Our results show that ketamine is a safe and valuable alternative to etomidate for endotracheal intubation in critically ill patients, and should be considered in those with sepsis," the study authors write.
Limitations of this study include possibly insufficient power to show a significant increase in morbidity rates associated with etomidate use in patients with sepsis.
In an accompanying comment, Dr. Volker Wenzel and Dr. Karl H. Lindner, from Innsbruck Medical University in Innsbruck, Austria, note that successful emergency intubation of critically ill patients depends on pharmacologic knowledge as well as manual skills and clinical experience. Unfortunately, tightening regulations of the European Union hinder trials of commercially noninteresting pathology such as multiple trauma.
"We should be lobbying our parliamentary representatives to help with non-commercial research, otherwise industry lobbyists will continue pushing for rules that only global drug companies can comply with," Drs. Wenzel and Lindner write. "Should that occur, our fate would be similar to physicians in developing countries, who have many questions about optimising health care but cannot do clinical trials to find valid answers."
The French Ministry of Health supported this study. The study authors and editorialists have disclosed no relevant financial relationships.
Lancet. Published online July 1, 2009.