Perez Roberto S, Pragt Elien, Geurts José, Zuurmond Wouter W, Patijn Jaap, van Kleef Maarten
VU University Medical Center, Department of Anesthesiology, Amsterdam, The Netherlands.
J Pain. 2008 Aug;9(8):678-86. doi: 10.1016/j.jpain.2008.02.005. Epub 2008 Apr 10.
To assess the effects of intravenous administration of the free radical scavenger mannitol 10% on complaints associated with complex regional pain syndrome Type I (CRPS I), a randomized, placebo-controlled, double-blinded trial was performed. Forty-one CRPS I patients according to the Bruehl et al diagnostic criteria, were included in 2 outpatient pain clinics of 2 university medical centers and randomly assigned to receive either 10% mannitol iv in 1 L 0.9% NaCL in 4 hours for 5 consecutive days or equal volumes of 0.9% NaCL (placebo). Patients in both groups received physical therapy according to protocol and rescue pain medication if required. Complaints on impairment and disability level and quality of life were assessed up to 9 weeks after baseline, with primary measurement points at 2, 6, and 9 weeks. Monitoring of pain using the visual analogue scale took place continuously during the course of the trial. Except for a significant improvement on a subscale of the Jebsen-Taylor hand function test, no significant differences were found between mannitol and placebo treatment. Changes in both groups in the course of the trial were small and clinically irrelevant on all measurement indices. We conclude that intravenous administration of 10% mannitol is not more effective than placebo in reducing complaints for CRPS I patients and provides no addition to already-established interventions for CRPS I. Whether 10% mannitol can provide beneficial effects for subgroups of CRPS I patients with a pathophysiological profile more closely fitting the presumed mode of action for this intervention remains to be established.
This article addresses the efficacy of the intravenous administration of the free radical scavenger mannitol for treatment of CRPS type 1. This intervention is not more effective than placebo in reducing complaints for CRPS I patients and provides no addition to already-established interventions for CRPS I.
为评估静脉注射10%自由基清除剂甘露醇对与Ⅰ型复杂性区域疼痛综合征（CRPS I）相关症状的影响，进行了一项随机、安慰剂对照、双盲试验。按照Bruehl等人的诊断标准，41例CRPS I患者被纳入两所大学医学中心的2个门诊疼痛诊所，并随机分配接受连续5天每天4小时静脉注射1升0.9%氯化钠溶液中含有的10%甘露醇，或等量的0.9%氯化钠溶液（安慰剂）。两组患者均按方案接受物理治疗，并在需要时接受急救止痛药物。在基线后长达9周的时间里评估损伤、残疾水平和生活质量方面的症状，主要测量时间点为第2、6和9周。在试验过程中持续使用视觉模拟量表监测疼痛情况。除了Jebsen-Taylor手功能测试的一个子量表有显著改善外，甘露醇治疗组和安慰剂治疗组之间未发现显著差异。在试验过程中，两组在所有测量指标上的变化都很小，且在临床上无意义。我们得出结论，静脉注射10%甘露醇在减轻CRPS I患者症状方面并不比安慰剂更有效，也不能为已有的CRPS I干预措施增添效果。10%甘露醇是否能为病理生理特征更符合该干预假定作用模式的CRPS I患者亚组提供有益效果，仍有待确定。
本文探讨了静脉注射自由基清除剂甘露醇治疗Ⅰ型CRPS的疗效。这种干预在减轻CRPS I患者症状方面并不比安慰剂更有效，也不能为已有的CRPS I干预措施增添效果。
