度洛西汀和普瑞巴林治疗纤维肌痛的疗效和安全性对照研究

Comparison of the efficacy and safety of duloxetine versus pregabalin in patients with fibromyalgia

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.