本帖最後由 lsc0019 於 2009-7-21 23:21 編輯
作者：Laurie Barclay, MD
出處：WebMD醫學新聞
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。
KETASED整合研究團體的Patricia Jabre醫師寫道，重症病患通常需要緊急插管。使用etomidate作為鎮靜劑近來受到質疑，因為它會引起可逆的腎上腺機能不足，可能與增加住院期間發病率有關。我們在重症病患緊急氣管插管時，比較使用單一劑量的etomidate或K他命，在初期與28天之後的發病率。
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。
主要結果是測量在加護病房中最初3天的後續器官衰竭評分的最高分數。進行調整式治療意向分析，分析時排除到院前死亡病患以及那些不到3天就從加護病房出院者。
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。
研究作者寫道，我們的結果顯示，K他命對於需要氣管插管的重症病患，是替代etomidate的安全且有效方法，那些有敗血症者可以考慮使用。
研究限制包括，可能無法顯示出敗血症患者因使用etomidate時顯著增加之發病率的相關性。
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。
Wenzel醫師與Lindner醫師寫道，我們應遊說議會代表協助非商業的研究，否則產業界會持續遊說推動只適用全球化藥廠的規範。萬一如此，我們的命運將如同開發中國家的醫生們，他們對於適當的健康照護有諸多疑問，但是無法進行臨床試驗找到確定的答案。
法國健康部支持本研究。研究作者與編輯宣告沒有相關財務關係。
Lancet。線上發表於2009年7月1日。
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. |
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