静脉注射免疫球蛋白治疗复杂性区域疼痛综合征：一项随机试验。

Intravenous immunoglobulin treatment of the complex regional pain syndrome: a randomized trial.

机构信息

University of Liverpool, Clinical Sciences Building, University Hospital Aintree, Liverpool L9 7AL, United Kingdom.

出版信息

Ann Intern Med. 2010 Feb 2;152(3):152-8. doi: 10.7326/0003-4819-152-3-201002020-00006.

DOI:10.7326/0003-4819-152-3-201002020-00006

PMID:20124231

Abstract

BACKGROUND

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.

OBJECTIVE

To evaluate the efficacy of IVIG in patients with longstanding CRPS under randomized, controlled conditions.

DESIGN

A randomized, double-blind, placebo-controlled crossover trial. (National Research Registry number: N0263177713; International Standard Randomised Controlled Trial Number Registry: 63918259)

SETTING

University College London Hospitals Pain Management Centre.

PATIENTS

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.

INTERVENTION

IVIG, 0.5 g/kg, and normal saline in separate treatments, divided by a washout period of at least 28 days.

MEASUREMENTS

The primary outcome was pain intensity 6 to 19 days after the initial treatment and the crossover treatment.

RESULTS

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.

LIMITATION

The trial was small, and recruitment bias and chance variation could have influenced results and their interpretation.

CONCLUSION

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.

PRIMARY FUNDING SOURCE

Association of Anaesthetists of Great Britain and Ireland, University College London Hospitals Charity, and CSL-Behring.

摘要

背景

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。

目的

在随机对照条件下评估 IVIG 治疗长期 CRPS 患者的疗效。

设计

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）

地点

伦敦大学学院医院疼痛管理中心。

患者

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。

干预措施

IVIG，0.5 g/kg，生理盐水分别治疗，洗脱期至少 28 天。

测量

主要结果是初始治疗和交叉治疗后 6 至 19 天的疼痛强度。

结果

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。