曲马多治疗慢性下腰痛的疗效

Efficacy of tramadol in treatment of chronic low back pain.

作者信息

Schnitzer T J, Gray W L, Paster R Z, Kamin M

机构信息

Office of Clinical Research and Training, Northwestern University, Chicago, IL 60611, USA.

出版信息

J Rheumatol. 2000 Mar;27(3):772-8.

PMID:10743823

Abstract

OBJECTIVE

To evaluate the efficacy and safety of tramadol in the treatment of chronic low back pain.

METHODS

A 3 phase trial: (1) a washout/screening phase; (2) a 3 week, open label, run-in phase; and (3) a 4 week, randomized, placebo controlled, double blind treatment phase. Three hundred eighty outpatients between 21 and 79 years with chronic low back pain with no or a distant history of back surgery enrolled in the open label phase and were treated with tramadol up to 400 mg/day. At the end of the open label phase, patients who tolerated tramadol and perceived benefit from it were randomized to continue treatment with tramadol or to convert to placebo in the double blind phase. Reasons for discontinuing from the open label phase included adverse events, 78 patients (20.5%); drug ineffective, 23 patients (6.1%); and other reasons, 25 patients (6.6%). Two hundred fifty-four patients entered the double blind phase, during which the daily dose was maintained within the range 200-400 mg tramadol or equivalent amount of placebo. The primary outcome measure in the double blind phase was the time to discontinuation due to inadequate pain relief.

RESULTS

The distribution of time to therapeutic failure was significantly (p < or = 0.0001) different in the tramadol group compared to placebo. Kaplan-Meier estimate of the cumulative discontinuation rate due to therapeutic failure was 20.7% in the tramadol group and 51.3% in the placebo group. There were significantly lower (p < or = 0.0001) mean pain visual analog scores (10 cm scale) among tramadol patients (3.5 cm) compared to placebo patients (5.1 cm) at the final visit of the double blind phase. Tramadol patients scored significantly better on the McGill Pain Questionnaire (p = 0.0007) and the Roland Disability Questionnaire (p = 0.0001). Five of 127 tramadol treated patients and 6/127 placebo treated patients discontinued treatment during the double blind phase due to an adverse event. Commonly reported adverse events with tramadol included nausea, dizziness, somnolence, and headache.

CONCLUSION

Among patients who tolerated it well, tramadol was effective for the treatment of chronic low back pain.

摘要

目的

评估曲马多治疗慢性下腰痛的疗效和安全性。

方法

一项分为三个阶段的试验：（1）洗脱/筛查阶段；（2）为期3周的开放标签导入阶段；（3）为期4周的随机、安慰剂对照、双盲治疗阶段。380名年龄在21至79岁之间、患有慢性下腰痛且无背部手术史或仅有远期背部手术史的门诊患者进入开放标签阶段，接受曲马多治疗，剂量最高可达400毫克/天。在开放标签阶段结束时，耐受曲马多且感觉从中获益的患者被随机分为两组，一组在双盲阶段继续接受曲马多治疗，另一组改用安慰剂治疗。开放标签阶段停药的原因包括不良事件，78例患者（20.5%）；药物无效，23例患者（6.1%）；以及其他原因，25例患者（6.6%）。254例患者进入双盲阶段，在此期间，每日剂量维持在200 - 400毫克曲马多或等量安慰剂的范围内。双盲阶段的主要结局指标是因疼痛缓解不足而停药的时间。

结果

与安慰剂组相比，曲马多组治疗失败时间的分布有显著差异（p≤0.0001）。曲马多组因治疗失败导致的累积停药率的Kaplan - Meier估计值为20.7%，安慰剂组为51.3%。在双盲阶段的最后一次访视时，曲马多组患者的平均疼痛视觉模拟评分（10厘米量表）（3.5厘米）显著低于安慰剂组患者（5.1厘米）（p≤0.0001）。曲马多组患者在麦吉尔疼痛问卷（p = 0.0007）和罗兰残疾问卷（p = 0.0001）上的得分显著更高。在双盲阶段因不良事件停药的患者中，127例接受曲马多治疗的患者中有5例，127例接受安慰剂治疗的患者中有6例。曲马多常见的不良事件包括恶心、头晕、嗜睡和头痛。