Hügler Peter, Siebrecht Peter, Hoffmann Klaus, Stücker Markus, Windeler Jürgen, Altmeyer Peter, Laubenthal Heinz
Department of Anesthesiology, Miners' Association Hospital Bottrop, Osterfelderstrasse 156, D-46242 Bottrop, Germany.
Eur J Pain. 2002;6(6):435-45. doi: 10.1016/s1090-3801(02)00046-0.
Recovery after an acute attack of herpes zoster is followed by postherpetic neuralgia (PHN) in 9-14% of all patients. Depending on the patient's age, the severity of the acute attack of herpes zoster and the dermatome involved, the incidence of PHN may be as high as 65%. The purpose of our study was to ascertain the incidence of PHN after a prophylactic intravenous injection of varicella-zoster hyperimmune globulin (VZV-IG) (Varitect Biotest Pharma). For this double-blind placebo-controlled randomised investigation we defined PHN as pain confined to the dermatome previously affected by herpes zoster, and we required a pain intensity of at least 15% points on a visual analogue scale (VAS) for this dermatome. The inclusion criteria were the dermatological diagnosis of herpes zoster together with age over 50 years. On Day 1, 20 patients received a single intravenous infusion of VZV-IG in a dose of 2mL/kg body weight, 20 patients (control group) received a single infusion of human albumin 5% in a dose of 2mL/kg body weight. All patients received acyclovir intravenously in a dose of 15mg/kg body weight per 24h for 5 days. The patients were followed up for a total of 42 days. The incidence of PHN at Day 42 was selected as the main outcome criterion for assessing the efficacy of prophylaxis. On reaching a significant difference between the groups (t test; alpha<0.05) in favour of the active treatment group, prophylaxis of PHN by VZV-IG was assessed as effective. Pain was assessed on a VAS and a NAS. As auxiliary outcome criteria, we used the McGill Pain-Rating Questionnaire in its German version, the revised multidimensional pain scale (RMSS) and the Freiburg symptom list (FBL). All results were assessed by the t test (alpha<0.05). The frequency of PHN in the placebo group was 70% (14/20), in the active treatment group it was 35% (7/20) at Day 42. The results of the McGill test showed the variability of the perception of pain in the placebo group significantly greater. No significant group differences were found in the FBL. Being tested with the RMSS, the patients of the placebo group assessed their pains as significantly "more obstinate" (p=0.047). The results can be summed up by saying that VZV-IG not only reduces the incidence of PHN, but also that in certain respects the patients' assessments of their pain experience were different. In our study we found a 50% reduction in PHN incidence However, the outcome time point of our trial was so close to the acute phase of the zoster illness that spontaneous remissions of PHN still have to be taken into account. Despite the widely varied approaches to the problem, reliably effective therapy, let alone 100% prevention of PHN, is still not feasible.
带状疱疹急性发作后，9%至14%的患者会出现带状疱疹后神经痛（PHN）。根据患者年龄、带状疱疹急性发作的严重程度以及受累的皮节不同，PHN的发病率可能高达65%。我们研究的目的是确定预防性静脉注射水痘-带状疱疹超免疫球蛋白（VZV-IG）（Varitect Biotest Pharma）后PHN的发病率。在这项双盲、安慰剂对照的随机研究中，我们将PHN定义为局限于先前受带状疱疹影响的皮节的疼痛，并且该皮节在视觉模拟量表（VAS）上的疼痛强度至少为15分。纳入标准为带状疱疹的皮肤科诊断以及年龄超过50岁。在第1天，20名患者接受了一次静脉输注VZV-IG，剂量为2mL/kg体重，20名患者（对照组）接受了一次静脉输注5%人白蛋白，剂量为2mL/kg体重。所有患者均接受静脉注射阿昔洛韦，剂量为每24小时15mg/kg体重，共5天。患者总共随访42天。选择第42天的PHN发病率作为评估预防效果的主要结局标准。当两组之间达到有利于活性治疗组的显著差异（t检验；α<0.05）时，VZV-IG预防PHN被评估为有效。通过VAS和NAS评估疼痛。作为辅助结局标准，我们使用了德文版的麦吉尔疼痛评分问卷、修订的多维疼痛量表（RMSS）和弗莱堡症状清单（FBL）。所有结果均通过t检验（α<0.05）进行评估。安慰剂组在第42天的PHN发生率为70%（14/20），活性治疗组为35%（7/20）。麦吉尔测试结果显示，安慰剂组疼痛感知的变异性明显更大。在FBL中未发现显著的组间差异。通过RMSS测试，安慰剂组的患者将他们的疼痛评估为明显“更顽固”（p=0.047）。可以总结为，VZV-IG不仅降低了PHN的发病率，而且在某些方面患者对其疼痛体验的评估也有所不同。在我们的研究中，我们发现PHN发病率降低了50%。然而，我们试验的结局时间点与带状疱疹疾病的急性期非常接近，因此仍需考虑PHN的自发缓解情况。尽管针对该问题的方法多种多样，但可靠有效的治疗方法，更不用说100%预防PHN，仍然不可行。
