Katz Pablo, Takyar Shweta, Palmer Pamela, Liedgens Hiltrud
a Grünenthal GmbH , Aachen , Germany.
b Parexel International , Chandigarh , UT , India.
Curr Med Res Opin. 2017 May;33(5):899-910. doi: 10.1080/03007995.2017.1294559. Epub 2017 Mar 20.
To conduct a systematic literature review (SLR) and quantitative analysis to assess the comparative efficacy and safety of the sufentanil sublingual tablet system (SSTS) against other available patient controlled analgesia (PCA) options for post-operative analgesia.
An SLR was conducted for studies published between 2004 and 2016. Due to study heterogeneity, subgroup analyses were conducted controlling for differences in imputation methods for missing values, baseline pain severity, and type of surgery. Where sufficient data was available, a mixed treatment comparison (MTC) was performed.
The MTC and subgroup analyses used 13 studies. In direct meta-analysis, there was a statistically significant difference in favor of SSTS compared with intravenous (IV) PCA (morphine) at 24 hours for the patient global assessment (PGA) scores of "good" or "excellent". For the Pain Intensity Score, there were numerical but not statistically significant differences in favor of the SSTS versus IV PCA (morphine) and the patient controlled transdermal system (PCTS) (fentanyl) in the MTC at 6 hours (standardized mean difference -0.27 [credible interval -2.78, 2.09] and -0.36 [-3.89, 3.03], respectively). The onset of pain relief was earlier with the SSTS versus IV PCA (morphine) as shown by the Pain Intensity Difference. Likewise, the onset was earlier compared with PCTS (fentanyl) where data was available. There was a significant difference in favor of SSTS compared with IV PCA (morphine) and with PCTS (fentanyl) for any adverse event, and numerical improvements for withdrawals due to adverse events.
This meta-analysis shows that SSTS is an option for non-invasive management of moderate-to-severe post-operative pain which can be more effective, faster in onset and better tolerated than IV PCA (morphine) and PCTS (fentanyl).
进行一项系统文献综述(SLR)和定量分析,以评估舒芬太尼舌下片系统(SSTS)与其他可用的患者自控镇痛(PCA)方法相比用于术后镇痛的相对疗效和安全性。
对2004年至2016年发表的研究进行了SLR。由于研究的异质性,针对缺失值的插补方法、基线疼痛严重程度和手术类型的差异进行了亚组分析。在有足够数据的情况下,进行了混合治疗比较(MTC)。
MTC和亚组分析使用了13项研究。在直接荟萃分析中,在24小时时,患者总体评估(PGA)评分“良好”或“优秀”方面,与静脉注射(IV)PCA(吗啡)相比,SSTS具有统计学显著差异。对于疼痛强度评分,在MTC中6小时时,SSTS与IV PCA(吗啡)以及患者自控透皮系统(PCTS)(芬太尼)相比,虽有数值差异但无统计学显著差异(标准化均值差分别为-0.27[可信区间-2.78, 2.09]和-0.36[-3.89, 3.03])。如疼痛强度差异所示,SSTS的疼痛缓解起效时间比IV PCA(吗啡)更早。同样,在有数据的情况下,与PCTS(芬太尼)相比起效也更早。在任何不良事件方面,与IV PCA(吗啡)和PCTS(芬太尼)相比,SSTS具有显著差异,且因不良事件导致的退出情况有数值上的改善。
这项荟萃分析表明,SSTS是用于中重度术后疼痛无创管理的一种选择,它可能比IV PCA(吗啡)和PCTS(芬太尼)更有效、起效更快且耐受性更好。