普瑞巴林和加巴喷丁辅助性治疗带状疱疹后神经痛的临床研究

Pregabalin and gabapentin in adjuvant treatment of postherpetic neuralgia

目的比较普瑞巴林和加巴喷丁治疗带状孢疹后神经痛（PHN）的临床效果和安全性。方法按自愿原则将168例患者分为A、B、C、D四组，各42例。A组给予安慰剂治疗；B组给予普瑞巴林治疗，维持治疗每日225mg；C组给予普瑞巴林治疗，每日375mg；D组给予加巴喷丁治疗。连续治疗8周后，比较治疗前、后的疼痛程度评分（VAS）变化、睡眠障碍指数（SPI）变化，并评估重点睡眠干扰评分（EMSIS）、疗效和不良反应发生率。结果各组VAS、SPI、EMSIS均明显优于A组，但不良反应发生率要高于A组，差异均有统计学意义（P〈0．05）。C组治疗后的VAS、SPI、EMSIS优于B组，差异有统计学意义（P〈0．05），但是两组在大部分不良反应发生上差异无统计学意义（P〉0．05）；D组VAS评分和大部分不良反应发生率与B组比较，差异有统计学意义（P〈0．05），但是在SPI和EMSIS方面差异无统计学意义（P〉0．05）。D组在VAS评分、SPI、EMSIS和大部分不良反应发生上与C组相比，差异有统计学意义（P〈0．05）。A、B、C、D四组的治疗有效率分别为64．29％、90．48％、92．86和73．81％，治疗优良率分别为21．43％、71．43％、83．33％和54．76％。C组治疗有效率明显好于A、D组，治疗优良率明显好于A、B、D组（P〈0．05）。结论相比于安慰剂和加巴喷丁，普瑞巴林在PHN治疗中具有更好的疗效，可以显著改善患者的疼痛程度评分，减轻疼痛对睡眠的干扰。为了提升治疗有效率，剂量宜选择每日375mg，分3次口服；但是，普瑞巴林的不良反应发生率较高；在临床运用中，必须注意不良反应的观察和控制。

Objective To compare the clinical efficacy and safety of pregabalin and gabapentin pain in the treatment of posttherpetic neuralgia （PHN）. Methods According to the principle of voluntary, 168 patients were divided into A, B, C and D groups, 42 for each group. A group received placebo treatment; B group were treated with a maintenance therapy of pregabalin 225 mg per day; C group were treated with pregabalin 375 mg per day; and D group with Gaba Martin. After 8 weeks＇ continuous treatment, the changes of VAS and SPI before and after treatment were compared and focuses on the sleep disturbance score （EMSIS）, the efficacy, and adverse reaction rate were evaluated. Results The VAS, SPI and EMSIS were better in B, C, and D groups than in A group, and the incidence of adverse reactions was higher in A group than in the other groups, with statistical differences （P 〈 0.05）. The VAS, SPI and EMSIS were better in C group than in B group after the treatment, with statistical differences （P 〈 0.05）, but there were no statistical differences in most adverse reactions between the two groups （P 〉 0.05）. There were statistical differences in VAS and the incidences of most adverse reactions but no statistical differences in SPI and EMSIS between B group and D group. There were statistical dift^rences in VAS, SPI, EMSIS, and the incidences of most adverse reactions between B group and D group （P 〈 0.05）. The effective rates of A, B, C, and D groups were 64.29%, 90.48%, 92.86%, and 73.81%, respectively, and the excellent and good rates were 21.43%, 71.43%, 83.33%, and 54.76%, respectively. The effective rate of C group was significantly better than that of A and D groups, the excellent and good rate was better than that of A, B, and D groups （P 〈 0.05）. Conclusions Comparing with placebo and gabapentin, pregabalin has better curative effect in the treatment of PHN, can significantly improve the patient＇s pain score, and reduce the interference of pain on sleep. In order to improve the treatment efficacy, taking 375 mg orally in 3 times is a good choice. However, pregabalin has high incidence of adverse reactions. In clinical practice, adverse reactions should be attentively observed and controlled.