加巴喷丁胶囊治疗疱疹后神经痛的多中心临床观察

A multicenter, randomized, double-blind, placebo-controlled, parallel design study on the efficacy and safety of gabapentin, an anticonvulsant drug in the treatment of postherpetic neuralgia

目的观察加巴喷丁治疗疱疹后神经痛的临床疗效和安全性。方法多中心、随机双盲、安慰剂对照、平行设计临床试验。疱疹后神经痛患者随机分为治疗组和对照组，两组患者分别口服加巴喷丁胶囊1800mg／d或安慰剂胶囊，总共接受6周的药物治疗。于治疗前及治疗后第1、3、6周各随访1次，进行疗效和安全性评价。以视觉模拟评分法进行疱疹后神经痛的疼痛评分作为主要观察指标，以5点严重程度评分方法进行睡眠质量评分作为次要观察指标。结果4个中心共入选141例疱疹后神经痛患者，125例完成试验，其中试验组66例，对照组59例。与用药前相比，用药后1周、3周和6周时，两组在疼痛严重程度、睡眠质量方面均有不同程度改善；试验组在用药后1周、3周改善更为明显。用药后第1周和第3周试验组的有效率分别为29．58％和57．75％，对照组分别为13．04％和40．58％，试验组高于对照组，两组比较，差异均有统计学意义（χ^2CMH分别为5．94，4．12，P〈0．05）。加巴喷丁有较好的耐受性，不良反应主要表现为头晕、头昏、嗜睡和转氨酶升高等。结论加巴喷丁胶囊治疗疱疹后神经痛，能改善患者疼痛严重程度和睡眠质量，不良反应发生率低。

Objective To observe the clinical efficacy and safety of gabapentin in the treatment of postherpetic neuralgia. Methods A multicenter, randomized, double-blind, placebo-controlled, parallel design, 6-week study was performed. Patients with postherpetic neuralgia were recruited into this study and randomly divided into two groups to receive gabapentin or placebo 1800 mg daily in three divided doses with a forced titration schedule, respectively. The primary efficacy measure was change in the pain score based on a visual analogue scale from baseline to the final week of therapy, and secondary measure was the improvement in sleep quality scored on a 5-point severity scale. Efficacy and safety evaluation was performed at baseline, and 1, 3, and 6 weeks after the treatment. Results One hundred and forty-one patients were recruited in four clinical centers, and 125 patients completed the trial, of whom 66 were in the treatment group and 59 in the control group. An improvement was observed in both pain scores and sleep scores on week 1, 3 and 6 in both two groups, and the improvement was greater in gabapentin-treated group than that in the control group. The response rate was 29.58% and 57.75%, respectively in gabapentin-treated group on week 1 and 3, compared to 13.04% and 40.58%, respectively, in the control group （t = 5.94, 4.12, respectively, both P 〈 0.05）. Gabapentin was well tolerated, and the most common adverse events were dizziness, vertigo, somnolence and transient abnormality of hepatic function. Conclusion Gabapentin could markedly reduce pain intensity and improve sleep quality with a low incidence of adverse events in patients with postherpetic neuralgia.