在肝硬化患者食管静脉曲张内镜注射硬化治疗中，丙泊酚是一种比咪达唑仑更有效、更安全的镇静剂：一项随机对照试验。
Propofol is a more effective and safer sedative agent than midazolam in endoscopic injection sclerotherapy for esophageal varices in patients with liver cirrhosis: a randomized controlled trial.
作者信息
Watanabe Ko, Hikichi Takuto, Takagi Tadayuki, Suzuki Rei, Nakamura Jun, Sugimoto Mitsuru, Kikuchi Hitomi, Konno Naoki, Takasumi Mika, Sato Yuki, Hashimoto Minami, Irie Hiroki, Obara Katsutoshi, Ohira Hiromasa
机构信息
Department of Endoscopy, Fukushima Medical University Hospital.
Department of Gastroenterology, Fukushima Medical University School of Medicine.
出版信息
Fukushima J Med Sci. 2018 Dec 8;64(3):133-141. doi: 10.5387/fms.2018-21. Epub 2018 Oct 21.
OBJECTIVE
The efficacy of sedation during endoscopic injection sclerotherapy (EIS) for esophageal varices (EVs) in patients with liver cirrhosis remains unclear. The aim of this study is to compare the efficacy and safety between propofol- and midazolam-based sedation for EIS.
METHODS
Twenty-three patients with EVs were prospectively and randomly assigned to midazolam-based (Midazolam group) or propofol-based (Propofol group) sedation. All patients underwent a number connection test (NCT) to evaluate minimal hepatic encephalopathy (MHE) on the day before and at 2 and 24 hours following EIS. The primary endpoint was exacerbation of MHE after EIS, which was defined as deterioration of the NCT. The secondary endpoints were postoperative awareness, technical success rate, frequency of body movement, patient and operator satisfaction, cardiorespiratory dynamics during EIS, and adverse events.
RESULTS
Exacerbations of MHE at 2 hours after EIS compared with those before EIS were not significantly different between the two groups. In both groups, the deterioration of NCT scores before and 2 hours after EIS was observed (Propofol group: 60.0 vs. 70.0 s, P = 0.026; Midazolam group: 42.5 vs. 67.0 s, P = 0.002). There were no significant differences in awareness, technical success rate, or patient satisfaction. However, the frequency of body movement in the Propofol group was significantly lower than that in the Midazolam group (1 vs. 4, P = 0.045), and operator satisfaction in the Propofol group was significantly higher than that in the Midazolam group (P = 0.016). No adverse events were observed.
CONCLUSIONS
Propofol-based sedation exacerbated MHE after EIS similarly to midazolam-based sedation in patients with liver cirrhosis. However, propofol-based sedation provided stable sedation with a lower frequency of body movements and high operator satisfaction.
目的
肝硬化患者内镜下注射硬化治疗（EIS）期间镇静的疗效仍不明确。本研究旨在比较丙泊酚镇静与咪达唑仑镇静用于EIS的疗效和安全性。
方法
23例食管静脉曲张患者被前瞻性随机分为咪达唑仑镇静组（咪达唑仑组）和丙泊酚镇静组（丙泊酚组）。所有患者在EIS前一天以及EIS后2小时和24小时接受数字连接试验（NCT）以评估轻微肝性脑病（MHE）。主要终点是EIS后MHE加重，定义为NCT恶化。次要终点包括术后清醒程度、技术成功率、身体移动频率、患者和操作者满意度、EIS期间的心肺动力学以及不良事件。
结果
两组患者EIS后2小时MHE加重情况与EIS前相比无显著差异。两组均观察到EIS前和EIS后2小时NCT评分恶化（丙泊酚组：60.0对70.0秒，P = 0.026；咪达唑仑组：42.5对67.0秒，P = 0.002）。清醒程度、技术成功率或患者满意度无显著差异。然而，丙泊酚组的身体移动频率显著低于咪达唑仑组（1对4，P = 0.045），丙泊酚组的操作者满意度显著高于咪达唑仑组（P = 0.016）。未观察到不良事件。
结论
在肝硬化患者中，丙泊酚镇静用于EIS后MHE加重情况与咪达唑仑镇静相似。然而，丙泊酚镇静提供了稳定的镇静效果，身体移动频率较低，操作者满意度高。
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