Abstract:
This systematic review determines the efficacy and safety of duloxetine for chronic low back pain (CLBP). We queried the PubMed, SCOPUS, and Ovid MEDLINE databases. All level I and II randomized controlled studies published in the English language investigating the efficacy of duloxetine for chronic low back pain were included. Five studies (832 duloxetine-treated patients, 667 placebo-treated patients, and 41 duloxetine and placebo crossover analysis patients) were analyzed. One study was level I evidence and four studies were level II evidence. All five studies reported statistically significant improvements in more than one back-pain-specific clinical outcome score with duloxetine versus placebo. Four studies found that duloxetine 60 mg daily leads to one or more statistically significant improvements versus placebo in Brief Pain Inventory Severity (BPI-S) scores. All five studies found no significant difference in serious adverse events (AEs) between the duloxetine and placebo groups. One study found a higher rate of total AEs among the duloxetine 120 mg group versus the placebo group; however, the same study did not find a significant difference in total AEs among duloxetine 20 mg and 60 mg groups versus placebo. Duloxetine is a safe and effective first-line option for the treatment of CLBP. Current studies demonstrate that 60 mg taken once daily has the highest efficacy for reducing pain and disability while minimizing minor adverse effects. Further randomized controlled trials with long-term follow-up are necessary to determine its long-term effects.
摘要:
该系统评价确定了度洛西汀治疗慢性下腰痛(CLBP)的有效性和安全性。我们询问PubMed,Scopus,和OvidMEDLINE数据库。包括以英语发表的所有I级和II级随机对照研究,这些研究调查了度洛西汀对慢性下腰痛的疗效。五项研究(832名度洛西汀治疗的患者,667名安慰剂治疗的患者,和41名度洛西汀和安慰剂交叉分析患者)进行了分析。一项研究是I级证据,四项研究是II级证据。所有五项研究均报告了度洛西汀与安慰剂相比,在一项以上的背痛特异性临床结果评分中具有统计学上的显着改善。四项研究发现,与安慰剂相比,度洛西汀每天60mg在简短疼痛量表严重程度(BPI-S)评分中可带来一种或多种统计学上的显着改善。所有五项研究均发现度洛西汀组和安慰剂组之间的严重不良事件(AE)没有显着差异。一项研究发现,与安慰剂组相比,度洛西汀120mg组的总不良事件发生率更高;然而,同一项研究未发现度洛西汀20mg组和60mg组与安慰剂组的总不良事件有显著差异.度洛西汀是治疗CLBP安全有效的一线选择。目前的研究表明,每天服用60mg对减轻疼痛和残疾,同时尽量减少轻微的不良反应具有最高的疗效。需要进一步的长期随访随机对照试验来确定其长期效果。