University of Liverpool, Clinical Sciences Building, University Hospital Aintree, Liverpool L9 7AL, United Kingdom.
Ann Intern Med. 2010 Feb 2;152(3):152-8. doi: 10.7326/0003-4819-152-3-201002020-00006.
Treatment of long-standing complex regional pain syndrome (CRPS) is empirical and often of limited efficacy. Preliminary data suggest that the immune system is involved in sustaining this condition and that treatment with low-dose intravenous immunoglobulin (IVIG) may substantially reduce pain in some patients.
To evaluate the efficacy of IVIG in patients with longstanding CRPS under randomized, controlled conditions.
A randomized, double-blind, placebo-controlled crossover trial. (National Research Registry number: N0263177713; International Standard Randomised Controlled Trial Number Registry: 63918259)
University College London Hospitals Pain Management Centre.
Persons who had pain intensity greater than 4 on an 11-point (0 to 10) numerical rating scale and had CRPS for 6 to 30 months that was refractory to standard treatment.
IVIG, 0.5 g/kg, and normal saline in separate treatments, divided by a washout period of at least 28 days.
The primary outcome was pain intensity 6 to 19 days after the initial treatment and the crossover treatment.
13 eligible participants were randomly assigned between November 2005 and May 2008; 12 completed the trial. The average pain intensity was 1.55 units lower after IVIG treatment than after saline (95% CI, 1.29 to 1.82; P < 0.001). In 3 patients, pain intensity after IVIG was less than after saline by 50% or more. No serious adverse reactions were reported.
The trial was small, and recruitment bias and chance variation could have influenced results and their interpretation.
IVIG, 0.5 g/kg, can reduce pain in refractory CRPS. Studies are required to determine the best immunoglobulin dose, the duration of effect, and when repeated treatments are needed.
Association of Anaesthetists of Great Britain and Ireland, University College London Hospitals Charity, and CSL-Behring.
长期复杂区域疼痛综合征（CRPS）的治疗是经验性的，通常疗效有限。初步数据表明，免疫系统参与维持这种疾病，低剂量静脉注射免疫球蛋白（IVIG）治疗可能会显著减轻一些患者的疼痛。
在随机对照条件下评估 IVIG 治疗长期 CRPS 患者的疗效。
一项随机、双盲、安慰剂对照交叉试验。（国家研究注册编号：N0263177713；国际标准随机对照试验编号注册处：63918259）
伦敦大学学院医院疼痛管理中心。
疼痛强度大于 11 点数字评分量表（0 至 10）的 4 分以上，且 CRPS 持续 6 至 30 个月，对标准治疗无反应。
IVIG，0.5 g/kg，生理盐水分别治疗，洗脱期至少 28 天。
主要结果是初始治疗和交叉治疗后 6 至 19 天的疼痛强度。
2005 年 11 月至 2008 年 5 月期间随机分配了 13 名符合条件的参与者；12 名完成了试验。IVIG 治疗后疼痛强度平均降低 1.55 个单位，生理盐水组为 1.29 至 1.82；P < 0.001）。在 3 名患者中，IVIG 治疗后的疼痛强度比生理盐水组降低了 50%或更多。未报告严重不良反应。
试验规模较小，招募偏倚和机会变化可能影响结果及其解释。
0.5 g/kg IVIG 可减轻难治性 CRPS 的疼痛。需要研究确定最佳免疫球蛋白剂量、作用持续时间以及何时需要重复治疗。
英国和爱尔兰麻醉师协会、伦敦大学学院医院慈善基金会和 CSL-Behring。
