单剂量丙泊酚注射对慢性每日头痛患者疼痛和生活质量的影响：一项随机双盲对照试验

背景有少量的病例研究提倡静脉输注丙泊酚来治疗慢性每日头痛（chronicdailyheadache；CDH），然而，尚无该疗法的随机对照试验。在本随机双盲对照试验中，我们的目的是观察单剂量的静脉丙泊酚输注（2．4mg＆g）能否显著降低CDH患者临床不适及接下来30天的疼痛。方法符合标准的CDH成人患者，分别静脉输注丙泊酚（n=20）或安慰剂咪达唑仑（n=20）对照组。主要的结果评估包括：①治疗30天后头痛失劳动力调查评分（HeadacheDisabilityInventory；HDI）；②头痛指数（HeadacheIndex，HI），治疗期间30天的头痛强度总评估；③采用用药量化评分表（MedicationQuantificationScale，第1II版）评估镇痛药消耗量。结果输注丙泊酚30天后，HDI降低了9．47点（标准差14．1）（P=0．009），但是其降低程度比认为头痛相关失劳动力调查指数（HDI）有临床意义的降低程度更小。与对照组相比，HDI无显著统计差异。在降低平均头痛强度（用头痛指数评估）或用药量化表（MedicationQuantification Scale）（第111版）方便，组内及两组间无统计学差异。结论单剂量的丙泊酚静脉输注（2．4mg/kg）产生了有统计学意义的变化，但是在输注药物后30天CDH失劳动力方面的改变无临床意义。丙泊酚也不能减轻头痛强度和减少镇痛药的应用。本研究不支持静脉输注丙泊酚临床治疗CDH。

BACKGROUND： 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. METHODS： 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 Medica- tion Quantification Scale version m. RESULTS： 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 sig- nificant within-or between-group reductions in mean pain intensity as measured by the Headache Index or medication use as measured by propofol 2.4 the Medication Quantification Scale version m in either group. CONCLUSIONS： A single IV infusion of 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 dinical management of CDH.