摘要
目的:为数量较少的盐酸度洛西汀和普瑞巴林治疗纤维肌痛(fibromyalgia,FM)的疗效和安全性比较研究增加证据。方法:收集并分析解放军总医院第一医学中心2020年11月1日至2021年5月1日于我科接受度洛西汀(n=25)或普瑞巴林(n=12)治疗并持续至少4周的两组FM病人的临床资料,分别于基线期和治疗4周末评估两组的疗效指标,记录药物不良反应。疗效指标包括疼痛数字评分法(numerical rating scale,NRS)评分、广泛疼痛指数(widespread pain index,WPI)、症状严重程度(symptom severity scale,SSS)评分、纤维肌痛严重程度(fibromyalgia severity,FS)评分、焦虑自评量表(self-rating anxiety scale,SAS)评分和抑郁自评量表(self-rating depression scale,SDS)评分。结果:度洛西汀组所有疗效指标包括疼痛NRS评分、WPI、SSS评分、FS评分、SAS评分和SDS评分均较基线期明显改善(P<0.001,-P=0.01)。普瑞巴林组疗效指标包括疼痛NRS评分、WPI、SSS评分、FS评分和SAS评分均较基线期明显改善(P<0.001,-P=0.038),SDS评分改善差异无统计学意义。两组间各疗效指标改善值差异均无统计学意义(P=0.227-0.955)。度洛西汀组药物不良反应发生率为64.0%,普瑞巴林组为58.3%,差异无统计学意义。两组均无严重不良反应发生。度洛西汀组发生率超过15%的药物不良反应为恶心、便秘、排尿困难、出汗、头痛、头晕、嗜睡、性欲下降和失眠,普瑞巴林组为头晕、嗜睡和便秘。治疗期间多数药物不良反应逐渐减轻。结论:度洛西汀和普瑞巴林对FM的疗效和安全性均较好,两种药物对FM的总体疗效无明显差异,普瑞巴林不能缓解FM的抑郁症状。
Object:To add to the few evidence on the comparative efficacy and safety of duloxetine and pregabalin in the treatment of patients with fibromyalgia(FM).Methods:Thirty-seven patients with fibromyalgia were divided into two groups with respective treatment for 4 weeks:Duloxetine group(n=25)and Pregabalin group(n=12)from November 1,2020 to May 1,2021.Their clinical data were collected and analyzed.The efficacy outcome measures were assessed before and after 4 weeks'treatment and adverse drug reactions were recorded.The efficacy outcome measures included pain numerical rating scale(NRS),widespread pain index(WPI),symptom severity scale(SSS)score,fibromyalgia severity(FS)scale,self-rating anxiety scale(SAS)and self-rating depression scale(SDS).Results:All the efficacy outcome measures in Duloxetine group,including pain NRS,WPI,SSS score,FS scale,SAS score and SDS score were significantly improved compared with baseline(P<0.001,-P=0.01).In Pregabalin group,the efficacy outcome measures including pain NRS,WPI,SSS score,FS scale and SAS score were significantly improved compared with the baseline(P<0.001,-P=0.038),while the improvement of SDS score was not statistically significant.There was no statistically significant difference between the two groups in the improvement value of each efficacy outcome measure(P=0.227-0.955).Neither substantial difference was found in the incidence of adverse drug reactions,which was 64%in Duloxetine group and 58.3%in Pregabalin group respectively.No serious adverse drug reactions occurred in both groups.Adverse drug reactions with an incidence of>15%were nausea,constipation,dysuria,sweat,headache,dizziness,somnolence,decreased sexual desire and insomnia in Duloxetine group and dizziness,somnolence and constipation in Pregabalin group.Most of adverse drug reactions gradually subsided during the treatment.Conclusion:Both duloxetine and pregabalin are effective and safe in patients with FM.Their overall efficacy has no difference.Pregabalin cannot relieve depressive symptoms in patients with FM.
作者
梁东风
杨春花
张洁
朱剑
LIANG Dongfeng;YANG Chunhua;ZHANG Jie;ZHU Jian(Department of Rheumatology and Immunology,the First Medical Center,Chinese PLA General Hospital,Beijing 100853,China)
出处
《中国疼痛医学杂志》
CAS
CSCD
北大核心
2023年第3期194-200,共7页
Chinese Journal of Pain Medicine