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[硬膜外注射类固醇和局部麻醉药治疗带状疱疹患者:1个月后疼痛减轻,但对带状疱疹后神经痛的长期疗效无效——一项随机试验]

[Treatment of patients with herpes zoster by epidural injection of steroids and local anaesthetics: less pain after 1 month, but no effect on long-term postherpetic neuralgia--a randomised trial].

作者信息

Opstelten W, van Wijck A J M, Moons K G M, van Essen G A, Stolker R J, Kalkman C J, Verheij Th J M

机构信息

Julius Centrum voor Gezondheidswetenschappen en Eerstelijns Geneeskunde, Universitair Medisch Centrum Utrecht, Postbus 85.060, 3508 AB Utrecht.

出版信息

Ned Tijdschr Geneeskd. 2006 Dec 2;150(48):2649-55.

Abstract

OBJECTIVE

To assess the effectiveness of a single epidural injection of steroids and local anaesthetics, as a supplement to the standard treatment, for the prevention ofpostherpetic neuralgia in older patients with herpes zoster.

DESIGN

Open randomised trial.

METHOD

In the period September 2001-February 2004, 598 patients, aged > 50 years, with acute herpes zoster (rash for < 7 days) below dermatome C6, were randomly assigned to receive either standard therapy (oral antiviral agents and analgesics) alone or standard therapy plus an additional single epidural injection of 80 mg methylprednisolone and 10 mg bupivacaine. The primary endpoint was the proportion of patients with zoster-associated pain one month after inclusion. The presence and severity of zoster-associated pain at other time points were secondary endpoints.

RESULTS

At one month, pain was reported by 137 (48%) patients in the injection group versus 164 (58%) in the control group (relative risk; RR: 0.83; 95% CI: 0.71-0.97; p = 0.02). After three months, these values were 58 (21%) and 63 (24%), respectively (RR: 0.89; 95% CI: 0.65-1-21; p = 0.47), and at 6 months: 39 (15%) and 44 (17%) (RR: 0.85; 95% CI: 0.57-1-13; p = 0.43). No subgroups were detectable in which the relative risk for pain at one month after inclusion substantially differed from the overall estimate. At one month, the median severity of pain in the injection group was 2 (on a 100-points scale) versus 6 in the control group (p = 0.02). At later follow-up, there was no longer any statistically significant difference in the severity of pain between the two groups. No patient had major adverse events related to the epidural injection.

CONCLUSION

A single epidural injection of steroids and local anaesthetics in the acute phase of herpes zoster resulted in a modest decrease in zoster-associated pain in the first month. This treatment did not, however, prevent long-term postherpetic neuralgia.

摘要

目的

评估单次硬膜外注射类固醇和局部麻醉剂作为标准治疗的补充,对预防老年带状疱疹患者发生带状疱疹后神经痛的有效性。

设计

开放性随机试验。

方法

在2001年9月至2004年2月期间,598例年龄大于50岁、急性带状疱疹(皮疹出现时间小于7天)且病变位于胸6皮节以下的患者,被随机分配接受单独的标准治疗(口服抗病毒药物和镇痛药)或标准治疗加单次硬膜外注射80毫克甲泼尼龙和10毫克布比卡因。主要终点是纳入研究后1个月时伴有带状疱疹疼痛的患者比例。其他时间点带状疱疹相关疼痛的存在情况和严重程度为次要终点。

结果

1个月时,注射组有137例(48%)患者报告疼痛,而对照组为164例(58%)(相对危险度;RR:0.83;95%可信区间:0.71 - 0.97;p = 0.02)。3个月后,这些数值分别为58例(21%)和63例(24%)(RR:0.89;95%可信区间:0.65 - 1.21;p = 0.47),6个月时:39例(15%)和44例(17%)(RR:0.85;95%可信区间:0.57 - 1.13;p = 0.43)。未发现亚组在纳入研究后1个月时疼痛的相对危险度与总体估计值有实质性差异。1个月时,注射组疼痛的中位严重程度为2(采用100分制),而对照组为6(p = 0.02)。在后续随访中,两组之间疼痛严重程度不再有任何统计学上的显著差异。没有患者出现与硬膜外注射相关的重大不良事件。

结论

带状疱疹急性期单次硬膜外注射类固醇和局部麻醉剂在第一个月使带状疱疹相关疼痛略有减轻。然而,这种治疗并不能预防长期的带状疱疹后神经痛。

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