目的:观察二甲双胍联合加巴喷丁及曲马多治疗神经病理性疼痛(NP)的临床疗效与安全性。方法选取2014年3月—2015年3月江苏大学附属医院疼痛科诊断为 NP 且符合纳入与排除标准的患者125例为研究对象。剔除治疗过程中依从性差的患者,最终共纳入66例患者。采用随机数字表法将患者分为Ⅰ组( n =33)和Ⅱ组( n=33)。两组均常规给予加巴喷丁和曲马多口服,Ⅱ组加服二甲双胍治疗,疗程为6个月。记录患者治疗前(T0)、治疗后3个月(T1)、治疗后6个月(T2)药物疗效指标〔视觉模拟评分法(VAS)评分、睡眠评分〕及安全性指标〔肝肾功能指标、空腹血糖、维生素 B12水平、不良反应发生率〕。结果治疗方法与治疗时间在 VAS 评分上有交互作用(P <0.05);Ⅱ组 T1、T2时 VAS 评分低于Ⅰ组(P <0.05);Ⅰ组、Ⅱ组 T1、T2时 VAS 评分均低于 T0时(P <0.05),Ⅱ组 T2时 VAS 评分低于 T1时(P <0.05)。治疗方法与治疗时间在睡眠评分上有交互作用(P <0.05);睡眠评分组间比较,差异无统计学意义(P >0.05);Ⅰ组、Ⅱ组 T1、T2时睡眠评分均低于 T0时(P <0.05),Ⅱ组 T2时睡眠评分低于 T1时(P <0.05)。NP 患者 VAS 评分与睡眠评分在 T0时无直线相关关系(P >0.05);NP 患者 VAS 评分与睡眠评分在 T1、T2时呈正相关(P <0.05)。治疗方法与治疗时间在丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、血尿素氮( BUN)、肌酐( Cr)、空腹血糖、维生素 B12水平上无交互作用( P >0.05);ALT、AST、BUN、Cr、空腹血糖、维生素 B12水平组间比较,差异无统计学意义(P >0.05);ALT、AST、BUN、Cr、空腹血糖、维生素 B12水平治疗时间间比较,差异无统计学意义( P >0.05)。两组患者胃肠道不适、嗜睡、头晕、共济失调、皮肤麻木发生率比较,差异?
Objective To investigate the clinical efficacy and safety of metformin combined with gabapentin and tramadol in the treatment of neuropathic pain(NP). Methods From March 2014 to March 2015,we enrolled 125 patients who were diagnosed as NP and accorded with inclusion and exclusion criteria from the Department of Pain of Affiliated Hospital of Jiangsu University. Patients with poor compliance during treatment were excluded,and 66 patients were enrolled finally. According to random number table method,the patients were divided into two groups:group Ⅰ(n = 33)and group Ⅱ(n = 33). The two groups were routinely treated with gabapentin and tramadol,and group Ⅱ was also given metformin. The treatment lasted for 6 months for both groups. The indexes of efficacy(scores of VAS and sleep)and indexes of safety(hepatorenal function indexes, fasting blood - glucose level,vitamin B12 level and incidence of adverse reaction)were recorded before treatment(T0),three months after treatment(T1)and six months after treatment(T2). Results Interaction existed between treatment method and time points for VAS score(P 〈 0. 05). Group Ⅱ was lower than group Ⅰ in VAS score at T1 and T2(P 〈 0. 05);group Ⅰand group Ⅱ had lower VAS score at T1 and T2 than that at T0(P 〈 0. 05),and group Ⅱ had lower VAS score at T2 than that at T1(P 〈 0. 05). Interaction existed between treatment method and time points for sleep score( P 〈 0. 05);no significant difference existed in sleep score between the two groups(P 〉 0. 05);group Ⅰ and group Ⅱ had lower sleep score at T1 and T2 than that at T0( P 〈 0. 05),and group Ⅱ had lower sleep score at T2 than that at T1( P 〈 0. 05). There was no linear correlation between VAS score and sleep score at T0(P 〉 0. 05);there was positive correlation between VAS score and sleep score at T1 and T2(P 〈 0. 05). No interaction existed between treatment method and time points for the levels of ALT,AST, BU