利多卡因凝胶贴膏联合普瑞巴林治疗痛性糖尿病神经病变患者的有效性和安全性  

Efficacy and safety of lidocaine plaster combined with pregabalin for patients with painful diabetic neuropathy

作　　者：李静[1] 黄莹[1] 马超[1] 陶高见[1] 林泓怡[2] Li Jing;Huang Ying;Ma Chao;Tao Gaojian;Lin Hongyi(Department of Painology,Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School,Nanjing City,Jiangsu Province 210008,China;Infection Management Office,Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School,Nanjing City,Jiangsu Province 210008,China)

机构地区：[1]南京大学医学院附属鼓楼医院疼痛医学科,南京市210008 [2]南京大学医学院附属鼓楼医院感染管理办公室,南京市210008

出　　处：《中华疼痛学杂志》2024年第1期37-42,共6页Chinese Journal Of Painology

摘　　要：目的探讨利多卡因凝胶贴膏联合普瑞巴林治疗痛性糖尿病神经病变(PDN)的有效性和安全性。方法选择南京大学医学院附属鼓楼医院疼痛医学科2022年1月3日至2023年1月15日确诊为PDN患者67例,年龄、性别及病程不限,所有患者均常规控制血糖。按随机数字表法将其随机分为2组:普瑞巴林组(33例)单用普瑞巴林口服,150 mg/d起,根据患者疼痛情况逐渐增加药量至疼痛缓解或出现不良反应;联合组(34例)在普瑞巴林组基础上,联合使用利多卡因贴膏,根据疼痛皮肤区域使用,最多同时使用3贴,24 h内贴敷时间不超过12 h。主要观察指标为治疗前和治疗后1、4及12周视觉模拟评分(VAS),次要观察指标包括简式McGill疼痛问卷(SF-MPQ)评分、匹兹堡睡眠质量指数(PSQI)评分和简明健康状况调查表(SF-36)评分,并记录治疗期间不良反应发生情况。结果普瑞巴林组30例,联合组32例完成研究及随访。治疗前,两组患者一般资料比较差异均无统计学意义(P均>0.05)。治疗后1、4、12周,联合组VAS评分分别为(2.9±1.0)、(1.3±0.4)、(1.2±0.4)分,均低于普瑞巴林组(3.6±1.1)、(3.2±0.9)、(3.0±1.0)分(P均<0.05);联合组SF-MPQ评分分别为(13.2±4.1)、(7.2±2.4)、(5.1±1.3)分,均低于普瑞巴林组(16.7±4.3)、(11.5±3.7)、(8.3±1.8)分(P均<0.05)。治疗后4、12周,联合组PSQI评分均低于普瑞巴林组(P均<0.05),联合组SF-36评分均高于普瑞巴林组(P均<0.05)。治疗后12周,联合组普瑞巴林的日用量低于普瑞巴林组[225(150,300)mg比450(300,600)mg,Z=-4.89,P<0.001)]。联合组患者全身不良反应发生率明显低于普瑞巴林组(12.5%比23.3%,χ^(2)=6.13,P=0.014)。结论利多卡因凝胶贴膏联合普瑞巴林治疗PDN镇痛效果更好,且可改善患者的睡眠和生活质量,全身不良反应更少。Objective To evaluate the efficacy and safety of lidocaine plaster combined with pregabalin in the treatment of patients with painful diabetic neuropathy(PDN).Methods Sixty-seven PDN patients,regardless of age,gender or disease course,were selected from January 3,2022 to January 15,2023 in Department of Painology,Nanjing Drum Tower Hospital.All patients were routinely under blood glucose control,and were randomly divided into two groups according to the random number table:the pregabalin group(33 cases)was orally administered pregabalin alone,starting at 150 mg/d,gradually increasing the dosage until pain relief or adverse reactions intolerable;the combination group(34 cases)added lidocaine patches on the painful skin area besides the pregabalin.A maximum of 3 patches were used simultaneously,and the application time within 24 hours did not exceed 12 hours.Visual analogue scale(VAS)was recorded before the treatment and at 1,4,and 12 weeks after the treatment.The second indicators include short form McGill pain questionnaire(SF-MPQ),Pittsburgh sleep quality index(PSQI),36-item short-form health survey(SF-36),and the occurrence of adverse reactions.Results Thirty patients in the pregabalin group,and 32 patients in the combination group finished the study and follow-up.Before the treatment,there was no significant difference in general data between the two groups(all P>0.05).At 1,4 and 12 weeks after the treatment,VAS was lower in the combination group than that in the pregabalin group respectively[(2.9±1.0)vs.(3.6±1.1),(1.3±0.4)vs.(3.2±0.9),and(1.2±0.4)vs.(3.0±1.0),all P<0.05)];SF-MPQ was lower in the combination group than that in the pregabalin group respectively[(13.2±4.1)vs.(16.7±4.3),(7.2±2.4)vs.(11.5±3.7),and(5.1±1.3)vs.(8.3±1.8),all P<0.05].At 4 and 12 weeks after the treatment,PSQI was lower and SF-36 was higher in the combination group than those in the pregabalin group(all P<0.05).The dosage of pregabalin in the combination group was lower than that in the pregabalin group at 12 weeks after th

关 键 词：糖尿病神经病变 神经痛 普瑞巴林 利多卡因凝胶贴膏 

分 类 号：R587.2[医药卫生—内分泌] R741[医药卫生—内科学]