Simmonds Mark K, Rashiq Saifudin, Sobolev Igor A, Dick Bruce D, Gray Daniel P, Stewart Bradley J, Jamieson-Lega Kathryn I
Department of Anesthesiology and Pain Medicine, 8-120 Clinical Sciences Building, University of Alberta, Edmonton, Alberta, Canada T6G 2G3.
Anesth Analg. 2009 Dec;109(6):1972-80. doi: 10.1213/ANE.0b013e3181be3f86.
On the basis of a small number of case studies, IV propofol has been advocated for the treatment of chronic daily headache (CDH). There has been no randomized controlled trial of this therapy. Our objective in this randomized, double-blind, placebo-controlled trial was to determine whether a single IV dose of propofol 2.4 mg/kg results in clinically significant reduction in disability or pain in CDH for the next 30 days.
Eligible adults with CDH received either active treatment with IV propofol infusion (n = 20) or active placebo of IV midazolam (n = 20). The main outcome measures were (a) Headache Disability Inventory (HDI) at 30 days posttreatment, (b) Headache Index, a summary measure of headache intensity over the 30-day period, and (c) analgesic consumption measured as the Medication Quantification Scale version III.
Propofol reduced the HDI by 9.47 points (sd 14.1) at 30 days after injection (P = 0.009), but this is a smaller reduction in headache-related disability than that which the developers of the HDI regard as clinically significant. There was no statistically significant change in HDI for the control group. There were no significant within- or between-group reductions in mean pain intensity as measured by the Headache Index or medication use as measured by the Medication Quantification Scale version III in either group.
A single IV infusion of propofol 2.4 mg/kg produces a statistically significant, but not clinically meaningful, reduction in disability from CDH 30 days after infusion and does not reduce pain intensity or analgesic use. This study does not support this regimen of IV propofol for clinical management of CDH.
基于少数病例研究，有人主张静脉注射丙泊酚治疗慢性每日头痛（CDH）。但尚无该疗法的随机对照试验。我们进行这项随机、双盲、安慰剂对照试验的目的是确定静脉注射2.4mg/kg丙泊酚单次剂量是否能在接下来30天内使CDH患者的残疾或疼痛得到临床上显著减轻。
符合条件的CDH成年患者接受静脉注射丙泊酚输注的积极治疗（n = 20）或静脉注射咪达唑仑的积极安慰剂治疗（n = 20）。主要结局指标为：（a）治疗后30天的头痛残疾评定量表（HDI）；（b）头痛指数，即30天内头痛强度的综合指标；（c）以药物量化量表第三版衡量的镇痛药消耗量。
注射后30天，丙泊酚使HDI降低了9.47分（标准差14.1）（P = 0.009），但与HDI开发者认为具有临床意义的头痛相关残疾减轻程度相比，这一降低幅度较小。对照组的HDI无统计学显著变化。两组中，无论是以头痛指数衡量的平均疼痛强度，还是以药物量化量表第三版衡量的药物使用量，组内或组间均无显著降低。
静脉注射2.4mg/kg丙泊酚单次输注在输注后30天可使CDH导致的残疾有统计学显著降低，但无临床意义，且不能减轻疼痛强度或减少镇痛药使用。本研究不支持将该丙泊酚方案用于CDH的临床管理。
