不同剂量加巴喷丁治疗带状疱疹后遗神经痛的临床研究

Clinical Study of Different Doses of Gabapentin in Treatment of Postherpetic Neuralgia

目的研究不同剂量加巴喷丁治疗带状疱疹后遗神经痛(PHN)的疗效与安全性。方法选取2020年10月至2021年6月在空军军医大学第一附属医院皮肤科多病区诊治的138例PHN患者作为研究对象,采用随机化法分为安慰剂组(22例)、900 mg/d加巴喷丁组(24例)、1200 mg/d加巴喷丁组(27例)、1800 mg/d加巴喷丁组(23例)、2400 mg/d加巴喷丁组(22例)、3600 mg/d加巴喷丁组(20例),其中安慰剂组口服适量安慰剂和甲钴胺片,其他各组口服不同剂量的加巴喷丁和适量甲钴胺片,均连续治疗12周。比较各组的视觉模拟评分法(VAS)、数字疼痛评分法(NRS)、匹兹堡睡眠质量指数量表(PSQI)评分,临床疗效和不良反应发生情况。结果VAS、NRS及PSQI评分组间与时点间的主效应差异有统计学意义(P<0.01),组间与时点间存在交互作用(P<0.01)。治疗后,各组的VAS、NRS、PSQI评分均低于治疗前(P<0.01),且900 mg/d、1200 mg/d、1800 mg/d、2400 mg/d、3600 mg/d加巴喷丁组均低于安慰剂组(P<0.05)。各组的总有效率比较差异有统计学意义(P<0.01),其中900 mg/d、1200 mg/d、1800 mg/d、2400 mg/d、3600 mg/d加巴喷丁组的总有效率均高于安慰剂组[45.8%(11/24)、77.8%(21/27)、78.3%(18/23)、77.3%(17/22)、75.0%(16/20)比13.6%(3/22)](P<0.05),且900 mg/d加巴喷丁组的总有效率明显低于1200 mg/d、1800 mg/d、2400 mg/d、3600 mg/d加巴喷丁组(P<0.05)。各组的总不良反应发生率比较差异有统计学意义(P<0.05),其中900 mg/d、1200 mg/d、1800 mg/d、2400 mg/d、3600 mg/d加巴喷丁组的总不良反应发生率均高于安慰剂组[20.8%(5/24)、22.2%(6/27)、47.8%(11/23)、77.3%(17/22)、95.0%(19/20)比0](P<0.05),且1800 mg/d加巴喷丁组的不良反应发生率显著高于1200 mg/d加巴喷丁组(P<0.01)。结论不同剂量的加巴喷丁在治疗PHN及改善睡眠质量中均有效,其中1200 mg/d剂量在疗效及安全性方面或为最合适的剂量。

Objective To investigate the efficacy and safety of different dosages of gabapentin in the treatment of postherpetic neuralgia(PHN).Methods A total of 138 patients with PHN diagnosed and treated in the First Affiliated Hospital of Air Force Military Medical University from May 2018 to Oct.2020 wereincluded.They were randomly divided into a placebo group(22 cases),a 900 mg/d gabapentin group(24 cases),a 1200 mg/d gabapentin group(27 cases),a 1800 mg/d gabapentin group(23 cases),a 2400 mg/d gabapentin group(22 cases)and a 3600 mg/d gabapentin group(20 cases).The placebo group was given an appropriate amount of placebo and mecobalamin,while the other groups were given different doses of gabapentin and mecobalamin,and all the groups were treated for 12 weeks.Visual analogue scale(VAS),numerical rating scale(NRS)and Pittsburgh sleep quality index(PSQI),the clinical efficacy as well as the adverse reactions in each group were compared.Results There were statistically significant differences in the main effect of VAS,NRS and PSQI between groups and time points(P<0.01),and there were interactions between groups and time points(P<0.01).After treatment,VAS,NRS and PSQI scores in all groups were lower than before(P<0.01),and the 900 mg/d,1200 mg/d,1800 mg/d,2400 mg/d and 3600 mg/d gabapentin groups were lower than the placebo group(P<0.05).There was significant difference in the total effective rate among the groups(P<0.01).The total effective rates in the 900 mg/d,1200 mg/d,1800 mg/d,2400 mg/d,3600 mg/d gabapentin groups were higher than that in the placebo group[45.8%(11/24),77.8%(21/27),78.3%(18/23),77.3%(17/22),75.0%(16/20)vs 13.6%(3/22)](P<0.05),and the total effective rate of the 900 mg/d gabapentin group was significantly lower than the 1200 mg/d,1800 mg/d,2400 mg/d,3600 mg/d gabapentin groups(P<0.05).There was significant difference in the incidence of total adverse reactions among the groups(P<0.05).The incidences of total adverse reactions in the 900 mg/d,1200 mg/d,1800 mg/d,2400 mg/d and 3600 mg/d gabapentin groups were higher than that in the placebo group[20.8%(5/24),22.2%(6/27),47.8%(11/23),77.3%(17/22),95.0%(19/20)vs 0](P<0.05).The incidence of adverse reactions in the 1800 mg/d gabapentin group was significantly higher than that in the 1200 mg/d gabapentin group(P<0.01).Conclusion Different doses of gabapentin are effective in treating PHN and improving sleep quality,and the 1200 mg/d may be the most appropriate dose in terms of efficacy and safety.